Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs) (contRAst 2)

November 10, 2023 updated by: GlaxoSmithKline

A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs

This study [contRAst 2 (201791: NCT03970837)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study [contRAst X (209564: NCT04333147)]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.

Study Overview

Status

Terminated

Conditions

Arthritis, Rheumatoid

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1764

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, C1128AAF
    - GSK Investigational Site
  - Cordoba, Argentina, 5000
    - GSK Investigational Site
  - San Juan, Argentina, 5400
    - GSK Investigational Site
- Buenos Aires
  - Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1114ABH
    - GSK Investigational Site
  - Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1430EGF
    - GSK Investigational Site
  - Quilmes, Buenos Aires, Argentina, B1878GEG
    - GSK Investigational Site
- Córdova
  - Cordoba, Córdova, Argentina, X5003DCE
    - GSK Investigational Site
- Tucumán
  - San Miguel de Tucuman, Tucumán, Argentina, T4000AXL
    - GSK Investigational Site
  - San Miguel de Tucumán, Tucumán, Argentina, T4000BRD
    - GSK Investigational Site
Australia
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - GSK Investigational Site
- Queensland
  - Gold Coast, Queensland, Australia, 4222
    - GSK Investigational Site
- South Australia
  - Woodville, South Australia, Australia, 5011
    - GSK Investigational Site
- Tasmania
  - Hobart, Tasmania, Australia, 7000
    - GSK Investigational Site
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - GSK Investigational Site
  - Heidelberg West, Victoria, Australia, 3081
    - GSK Investigational Site
Bulgaria
- - Blagoevgrad, Bulgaria, 2700
    - GSK Investigational Site
  - Pleven, Bulgaria, 5800
    - GSK Investigational Site
  - Plovdiv, Bulgaria, 4000
    - GSK Investigational Site
  - Ruse, Bulgaria, 7002
    - GSK Investigational Site
  - Ruse, Bulgaria, 7000
    - GSK Investigational Site
  - Sevlievo, Bulgaria, 5400
    - GSK Investigational Site
  - Sofia, Bulgaria, 1431
    - GSK Investigational Site
  - Sofia, Bulgaria, 1606
    - GSK Investigational Site
  - Sofia, Bulgaria, 1000
    - GSK Investigational Site
  - Sofia, Bulgaria, 1612
    - GSK Investigational Site
  - Sofia, Bulgaria, 1784
    - GSK Investigational Site
  - Stara Zagora, Bulgaria, 6000
    - GSK Investigational Site
  - Vidin, Bulgaria, 3700
    - GSK Investigational Site
China
- - Beijing, China, 100032
    - GSK Investigational Site
  - Beijing, China, 100144
    - GSK Investigational Site
  - Changchun, China, 130012
    - GSK Investigational Site
  - Changzhou, China, 213003
    - GSK Investigational Site
  - Chengdu, China, 610041
    - GSK Investigational Site
  - Guangzhou, China, 510080
    - GSK Investigational Site
  - Guangzhou, China, 510630
    - GSK Investigational Site
  - Hangzhou, China, 310005
    - GSK Investigational Site
  - Nanjing, China, 210008
    - GSK Investigational Site
  - Shanghai, China, 200040
    - GSK Investigational Site
  - Tianjin, China, 300052
    - GSK Investigational Site
  - Xian, China, 710061
    - GSK Investigational Site
  - Yangzhou, China, 225000
    - GSK Investigational Site
  - Yanji, China, 133000
    - GSK Investigational Site
- Anhui
  - Bengbu, Anhui, China, 233004
    - GSK Investigational Site
- Guangxi
  - Guilin, Guangxi, China, 541001
    - GSK Investigational Site
- Hebei
  - Shijiazhuang, Hebei, China, 050051
    - GSK Investigational Site
- Hubei
  - Wuhan, Hubei, China, 430030
    - GSK Investigational Site
- Hunan
  - Changsha, Hunan, China, 410013
    - GSK Investigational Site
  - ZhuZhou, Hunan, China, 412007
    - GSK Investigational Site
- Inner Mongolia
  - Baotou, Inner Mongolia, China, 014010
    - GSK Investigational Site
  - Tongliao, Inner Mongolia, China, 10050
    - GSK Investigational Site
- Jiangsu
  - Nanjing, Jiangsu, China, 210009
    - GSK Investigational Site
  - Taizhou, Jiangsu, China, 225300
    - GSK Investigational Site
  - Xuzhou, Jiangsu, China, 221009
    - GSK Investigational Site
  - Yancheng, Jiangsu, China, 224001
    - GSK Investigational Site
- Jiangxi
  - Jiujiang, Jiangxi, China, 332000
    - GSK Investigational Site
  - Nanchang,, Jiangxi, China, 330006
    - GSK Investigational Site
- Jilin
  - Changchun, Jilin, China, 130021
    - GSK Investigational Site
- Liaoning
  - Jinzhou, Liaoning, China, 121000
    - GSK Investigational Site
- Zhejiang
  - Huzhou, Zhejiang, China, 313000
    - GSK Investigational Site
Colombia
- - Barranquilla, Colombia, 80020
    - GSK Investigational Site
  - Bogota, Colombia, 110221
    - GSK Investigational Site
  - Bucaramanga, Colombia, 680003
    - GSK Investigational Site
  - Medellin, Colombia, 50015
    - GSK Investigational Site
Estonia
- - Parnu, Estonia, 80010
    - GSK Investigational Site
  - Tallinn, Estonia, 10117
    - GSK Investigational Site
  - Tallinn, Estonia, 13419
    - GSK Investigational Site
  - Tallinn, Estonia, 10128
    - GSK Investigational Site
  - Tartu, Estonia, 50106
    - GSK Investigational Site
  - Tartu, Estonia, 50406
    - GSK Investigational Site
France
- - Cahors, France, 46000
    - GSK Investigational Site
Germany
- - Berlin, Germany, 10117
    - GSK Investigational Site
  - Hamburg, Germany, 20095
    - GSK Investigational Site
  - Magdeburg, Germany, 39120
    - GSK Investigational Site
- Sachsen
  - Dresden, Sachsen, Germany, 01307
    - GSK Investigational Site
- Schleswig-Holstein
  - Rendsburg, Schleswig-Holstein, Germany, 24768
    - GSK Investigational Site
Hungary
- - Budapest, Hungary, 1036
    - GSK Investigational Site
  - Budapest, Hungary, 1023
    - GSK Investigational Site
  - Szekesfehervar, Hungary, 8000
    - GSK Investigational Site
  - Szentes, Hungary, 6600
    - GSK Investigational Site
Japan
- - Aichi, Japan, 455-8530
    - GSK Investigational Site
  - Aichi, Japan, 466-8560
    - GSK Investigational Site
  - Aichi, Japan, 457-8511
    - GSK Investigational Site
  - Chiba, Japan, 260-8712
    - GSK Investigational Site
  - Chiba, Japan, 284-0003
    - GSK Investigational Site
  - Fukuoka, Japan, 814-0180
    - GSK Investigational Site
  - Fukuoka, Japan, 807-8555
    - GSK Investigational Site
  - Fukuoka, Japan, 820-8505
    - GSK Investigational Site
  - Fukuoka, Japan, 804-0025
    - GSK Investigational Site
  - Hiroshima, Japan, 734-8551
    - GSK Investigational Site
  - Hokkaido, Japan, 060-8648
    - GSK Investigational Site
  - Hokkaido, Japan, 053-8567
    - GSK Investigational Site
  - Hokkaido, Japan, 060-0001
    - GSK Investigational Site
  - Hokkaido, Japan, 060-8604
    - GSK Investigational Site
  - Hokkaido, Japan, 063-0811
    - GSK Investigational Site
  - Hokkaido, Japan, 085-0032
    - GSK Investigational Site
  - Hyogo, Japan, 673-1462
    - GSK Investigational Site
  - Hyogo, Japan, 675-1392
    - GSK Investigational Site
  - Ibaraki, Japan, 312-0057
    - GSK Investigational Site
  - Kagawa, Japan, 761-0793
    - GSK Investigational Site
  - Kagoshima, Japan, 891-0133
    - GSK Investigational Site
  - Kanagawa, Japan, 252-0392
    - GSK Investigational Site
  - Kanagawa, Japan, 236-0004
    - GSK Investigational Site
  - Kanagawa, Japan, 232-0024
    - GSK Investigational Site
  - Kanagawa, Japan, 231-8682
    - GSK Investigational Site
  - Kanagawa, Japan, 222-0036
    - GSK Investigational Site
  - Kanagawa, Japan, 245-8575
    - GSK Investigational Site
  - Kochi, Japan, 780-8522
    - GSK Investigational Site
  - Kochi, Japan, 781-0112
    - GSK Investigational Site
  - Kumamoto, Japan, 862-0976
    - GSK Investigational Site
  - Miyagi, Japan, 980-8574
    - GSK Investigational Site
  - Miyagi, Japan, 983-8512
    - GSK Investigational Site
  - Nagano, Japan, 380-8582
    - GSK Investigational Site
  - Nagasaki, Japan, 852-8501
    - GSK Investigational Site
  - Nagasaki, Japan, 850-0832
    - GSK Investigational Site
  - Nagasaki, Japan, 857-1195
    - GSK Investigational Site
  - Niigata, Japan, 940-2085
    - GSK Investigational Site
  - Niigata, Japan, 957-0054
    - GSK Investigational Site
  - Okayama, Japan, 700-0013
    - GSK Investigational Site
  - Okayama, Japan, 700-8557
    - GSK Investigational Site
  - Okayama, Japan, 700-8607
    - GSK Investigational Site
  - Saga, Japan, 843-0393
    - GSK Investigational Site
  - Saitama, Japan, 359-1111
    - GSK Investigational Site
  - Shizuoka, Japan, 430-8558
    - GSK Investigational Site
  - Tokyo, Japan, 142-0054
    - GSK Investigational Site
  - Tokyo, Japan, 142-8666
    - GSK Investigational Site
  - Tokyo, Japan, 153-8515
    - GSK Investigational Site
  - Tokyo, Japan, 104-8560
    - GSK Investigational Site
  - Tokyo, Japan, 113-8431
    - GSK Investigational Site
  - Tokyo, Japan, 113-8519
    - GSK Investigational Site
  - Tokyo, Japan, 198-0042
    - GSK Investigational Site
  - Tokyo, Japan, 204-8585
    - GSK Investigational Site
  - Tottori, Japan, 683-8504
    - GSK Investigational Site
  - Wakayama, Japan, 649-2211
    - GSK Investigational Site
  - Yamaguchi, Japan, 750-8520
    - GSK Investigational Site
Korea, Republic of
- - Anyang-Si, Gyeonggi-do, Korea, Republic of, 14068
    - GSK Investigational Site
  - Cheonan-si, Korea, Republic of, 330-721
    - GSK Investigational Site
  - Daegu, Korea, Republic of, 41944
    - GSK Investigational Site
  - Daegu-si, Korea, Republic of, 42601
    - GSK Investigational Site
  - Gwangju, Korea, Republic of, 61469
    - GSK Investigational Site
  - Incheon, Korea, Republic of, 400-711
    - GSK Investigational Site
  - Seongnam-si, Korea, Republic of, 13620
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 120-752
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 04763
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 06591
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 05505
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 134-727
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 3080
    - GSK Investigational Site
  - Suwon, Korea, Republic of, 16499
    - GSK Investigational Site
Mexico
- - San Luis Potosí, Mexico, 78213
    - GSK Investigational Site
- Durango
  - Mexico City, Durango, Mexico, 06700
    - GSK Investigational Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44650
    - GSK Investigational Site
- Yucatán
  - Merida, Yucatán, Mexico, 97070
    - GSK Investigational Site
Poland
- - Bialystok, Poland, 15-879
    - GSK Investigational Site
  - Bydgoszcz, Poland, 85-065
    - GSK Investigational Site
  - Czestochowa, Poland, 42202
    - GSK Investigational Site
  - Elblag, Poland, 82-300
    - GSK Investigational Site
  - Gdansk, Poland, 80-382
    - GSK Investigational Site
  - Gdynia, Poland, 81-537
    - GSK Investigational Site
  - Grodzisk Mazowiecki, Poland, 05-825
    - GSK Investigational Site
  - Katowice, Poland, 40-040
    - GSK Investigational Site
  - Katowice, Poland, 40-282
    - GSK Investigational Site
  - Krakow, Poland, 30-033
    - GSK Investigational Site
  - Krakow, Poland, 30510
    - GSK Investigational Site
  - Lodz, Poland, 90-127
    - GSK Investigational Site
  - Lodz, Poland, 90-644
    - GSK Investigational Site
  - Lublin, Poland, 20-582
    - GSK Investigational Site
  - Nowy Targ, Poland, 34-400
    - GSK Investigational Site
  - Olsztyn, Poland, 10-117
    - GSK Investigational Site
  - Poznan, Poland, 60-702
    - GSK Investigational Site
  - Poznan, Poland, 61-113
    - GSK Investigational Site
  - Siedlce, Poland, 08-110
    - GSK Investigational Site
  - Sochaczew, Poland, 96-500
    - GSK Investigational Site
  - Warszawa, Poland, 01-192
    - GSK Investigational Site
  - Warszawa, Poland, 02-793
    - GSK Investigational Site
  - Wroclaw, Poland, 50-088
    - GSK Investigational Site
  - Wroclaw, Poland, 52-416
    - GSK Investigational Site
Russian Federation
- - Ekaterinburg, Russian Federation, 620102
    - GSK Investigational Site
  - Kemerovo, Russian Federation, 650066
    - GSK Investigational Site
  - Kemerovo, Russian Federation, 650070
    - GSK Investigational Site
  - Korolev, Russian Federation, 141060
    - GSK Investigational Site
  - Krasnoyarsk, Russian Federation, 660123
    - GSK Investigational Site
  - Moscow, Russian Federation, 129110
    - GSK Investigational Site
  - Moscow, Russian Federation, 115522
    - GSK Investigational Site
  - Moscow, Russian Federation, 111539
    - GSK Investigational Site
  - Moscow, Russian Federation, 115404
    - GSK Investigational Site
  - Novosibirsk, Russian Federation, 630099
    - GSK Investigational Site
  - Novosibirsk, Russian Federation, 630091
    - GSK Investigational Site
  - Omsk, Russian Federation, 644024
    - GSK Investigational Site
  - Saint-Petersburg, Russian Federation, 190068
    - GSK Investigational Site
  - Tomsk, Russian Federation, 634050
    - GSK Investigational Site
  - Ulyanovsk, Russian Federation, 432063
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150062
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150030
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150007
    - GSK Investigational Site
Spain
- - Barcelona, Spain, 08035
    - GSK Investigational Site
  - Barcelona, Spain, 08003
    - GSK Investigational Site
  - Santander, Spain, 39008
    - GSK Investigational Site
  - Sevilla, Spain, 41009
    - GSK Investigational Site
Thailand
- - Bangkok, Thailand, 10400
    - GSK Investigational Site
  - Muang, Thailand, 40002
    - GSK Investigational Site
  - Rajathevee, Thailand, 10400
    - GSK Investigational Site
United Kingdom
- Essex
  - Romford, Essex, United Kingdom, RM1 3PJ
    - GSK Investigational Site
- Middlesex
  - Northwood, Middlesex, United Kingdom, HA6 2RN
    - GSK Investigational Site
- Warwickshire
  - Kenilworth, Warwickshire, United Kingdom, CV8 1JD
    - GSK Investigational Site
United States
- Arizona
  - Flagstaff, Arizona, United States, 86001
    - GSK Investigational Site
  - Glendale, Arizona, United States, 85306
    - GSK Investigational Site
  - Mesa, Arizona, United States, 85210
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85724
    - GSK Investigational Site
- California
  - Poway, California, United States, 92064
    - GSK Investigational Site
  - Riverside, California, United States, 92506
    - GSK Investigational Site
  - Roseville, California, United States, 95661
    - GSK Investigational Site
  - San Diego, California, United States, 92108
    - GSK Investigational Site
  - Tustin, California, United States, 92780
    - GSK Investigational Site
  - Van Nuys, California, United States, 91405
    - GSK Investigational Site
- Colorado
  - Denver, Colorado, United States, 80230
    - GSK Investigational Site
  - Fort Collins, Colorado, United States, 80528
    - GSK Investigational Site
- Florida
  - Aventura, Florida, United States, 33180
    - GSK Investigational Site
  - Boca Raton, Florida, United States, 33486
    - GSK Investigational Site
  - Clearwater, Florida, United States, 33765
    - GSK Investigational Site
  - Daytona Beach, Florida, United States, 32117
    - GSK Investigational Site
  - Gainesville, Florida, United States, 32607
    - GSK Investigational Site
  - Hialeah, Florida, United States, 33016
    - GSK Investigational Site
  - Margate, Florida, United States, 33063
    - GSK Investigational Site
  - Miami, Florida, United States, 33134
    - GSK Investigational Site
  - Miami, Florida, United States, 33155
    - GSK Investigational Site
  - New Port Richey, Florida, United States, 34652
    - GSK Investigational Site
  - Palmetto Bay, Florida, United States, 33157
    - GSK Investigational Site
  - Saint Petersburg, Florida, United States, 33705
    - GSK Investigational Site
  - Tamarac, Florida, United States, 33321
    - GSK Investigational Site
  - Tampa, Florida, United States, 33606
    - GSK Investigational Site
- Georgia
  - Marietta, Georgia, United States, 30060
    - GSK Investigational Site
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - GSK Investigational Site
- Indiana
  - Evansville, Indiana, United States, 47715
    - GSK Investigational Site
- Kansas
  - Wichita, Kansas, United States, 67207
    - GSK Investigational Site
- Kentucky
  - Bowling Green, Kentucky, United States, 42101
    - GSK Investigational Site
- Louisiana
  - Lake Charles, Louisiana, United States, 70601
    - GSK Investigational Site
  - Monroe, Louisiana, United States, 71203
    - GSK Investigational Site
- Maryland
  - Hagerstown, Maryland, United States, 21740
    - GSK Investigational Site
- Massachusetts
  - Worcester, Massachusetts, United States, 01605
    - GSK Investigational Site
- Michigan
  - Grand Blanc, Michigan, United States, 48439
    - GSK Investigational Site
  - Lansing, Michigan, United States, 48910
    - GSK Investigational Site
  - Novi, Michigan, United States, 48375
    - GSK Investigational Site
- New Jersey
  - Freehold, New Jersey, United States, 07728
    - GSK Investigational Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - GSK Investigational Site
- New York
  - Brooklyn, New York, United States, 11201
    - GSK Investigational Site
- North Carolina
  - Greensboro, North Carolina, United States, 27408
    - GSK Investigational Site
- North Dakota
  - Minot, North Dakota, United States, 58701
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73103
    - GSK Investigational Site
  - Yukon, Oklahoma, United States, 73099
    - GSK Investigational Site
- Pennsylvania
  - Duncansville, Pennsylvania, United States, 16635
    - GSK Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15224
    - GSK Investigational Site
  - Wyomissing, Pennsylvania, United States, 19610
    - GSK Investigational Site
- South Carolina
  - Columbia, South Carolina, United States, 29204
    - GSK Investigational Site
  - Myrtle Beach, South Carolina, United States, 29572
    - GSK Investigational Site
  - Summerville, South Carolina, United States, 29486
    - GSK Investigational Site
- Tennessee
  - Knoxville, Tennessee, United States, 37909-1907
    - GSK Investigational Site
- Texas
  - Amarillo, Texas, United States, 79124
    - GSK Investigational Site
  - Austin, Texas, United States, 78745
    - GSK Investigational Site
  - Colleyville, Texas, United States, 76034
    - GSK Investigational Site
  - Corpus Christi, Texas, United States, 78404
    - GSK Investigational Site
  - Dallas, Texas, United States, 75231
    - GSK Investigational Site
  - Houston, Texas, United States, 77084
    - GSK Investigational Site
  - Houston, Texas, United States, 77034
    - GSK Investigational Site
  - Houston, Texas, United States, 77065
    - GSK Investigational Site
  - Lubbock, Texas, United States, 79410
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
  - Tomball, Texas, United States, 77375
    - GSK Investigational Site
- Wisconsin
  - Glendale, Wisconsin, United States, 53217
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Key inclusion criteria

>=18 years of age
Has had RA for >=6 months and was not diagnosed before 16 years of age
Has active disease, as defined by having both*
- >=6/68 tender/painful joint count (TJC), and
- >=6/66 swollen joint count (SJC)
Has at least 1 bone erosion present on hand/wrist or foot radiographs
Has had an inadequate response to one or two of the csDMARDs:
- methotrexate (MTX) 15-25 mg/week** oral or injected
- hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day
- sulfasalazine up to 3000 mg/day
- leflunomide up to 20 mg/day***
- bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement)
- iguratimod up to 50 mg/day
  - If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.
    - A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.
      - Concomitant use of leflunomide and methotrexate is not allowed, for safety reasons.

Key exclusion criteria

History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjögren's syndrome secondary to RA, that may confound the evaluation of the effect of the study intervention.
Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSK3196165 90mg + csDMARD (Global Cohort) Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).	Biological: GSK3196165 (Otilimab) GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.
Experimental: GSK3196165 150mg + csDMARD (Global Cohort) Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.	Biological: GSK3196165 (Otilimab) GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.
Active Comparator: Tofacitinib 5mg + csDMARD (Global Cohort) Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks.	Drug: Tofacitinib Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally.
Placebo Comparator: Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort) Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.	Biological: GSK3196165 (Otilimab) GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC. Drug: Placebo Placebo matching GSK3196165 and Tofacitinib was administered.
Placebo Comparator: Placebo +csDMARD and GSK3196165 150mg +csDMARD (Global Cohort) Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.	Biological: GSK3196165 (Otilimab) GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC. Drug: Placebo Placebo matching GSK3196165 and Tofacitinib was administered.
Placebo Comparator: Placebo +csDMARD and Tofacitinib 5mg +csDMARD (Global Cohort) Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.	Drug: Tofacitinib Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally. Drug: Placebo Placebo matching GSK3196165 and Tofacitinib was administered.
Experimental: GSK3196165 90mg + csDMARD (Asia Cohort) Participants in Asia Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.	Biological: GSK3196165 (Otilimab) GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.
Experimental: GSK3196165 150mg + csDMARD (Asia Cohort) Participants in Asia Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.	Biological: GSK3196165 (Otilimab) GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.
Active Comparator: Tofacitinib 5mg + csDMARD (Asia Cohort) Participants in Asia Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks.	Drug: Tofacitinib Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally.
Placebo Comparator: Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort) Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.	Biological: GSK3196165 (Otilimab) GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC. Drug: Placebo Placebo matching GSK3196165 and Tofacitinib was administered.
Placebo Comparator: Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort) Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.	Biological: GSK3196165 (Otilimab) GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC. Drug: Placebo Placebo matching GSK3196165 and Tofacitinib was administered.
Placebo Comparator: Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort) Participants in Asia Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.	Drug: Tofacitinib Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally. Drug: Placebo Placebo matching GSK3196165 and Tofacitinib was administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo (Global Cohort) Time Frame: Week 12	ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) [visual analogue scale (VAS) with values from 0=best to 100=worst], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant [high sensitivity C-reactive Protein milligram per liter (mg/L) (hsCRP)]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Week 12
Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 (Asia Cohort) Time Frame: Week 12	ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) [visual analogue scale (VAS) with values from 0=best to 100=worst], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant [high sensitivity C-reactive Protein milligram per liter (mg/L) (hsCRP)]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Less Than or Equal to (<=)10 [CDAI Low Disease Activity (LDA)] at Week 12 (Global Cohort) Time Frame: Week 12	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Week 12
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	HAQ-DI is a 20-question instrument that assesses the degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Percentage of Participants Achieving 20% Improvement in ACR20 at Week 24: Non-inferiority Comparison With Tofacitinib (Global Cohort) Time Frame: Week 24	ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) [visual analogue scale (VAS) with values from 0=best to 100=worst], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant [high sensitivity C-reactive Protein milligram per liter (mg/L) (hsCRP)].	Week 24
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Week 24 and Week 52	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10.	Week 24 and Week 52
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Week 24 and Week 52	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10.	Week 24 and Week 52
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12 (Global Cohort) Time Frame: Week 12	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score <=2.8. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms	Week 12
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Week 24 and Week 52	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score <=2.8.	Week 24 and Week 52
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Week 24 and Week 52	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score <=2.8.	Week 24 and Week 52
Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Global Cohort) Time Frame: Week 12	ACR50/70 is calculated as a 50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) [VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Week 12
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Week 24 and Week 52	ACR20/50/70 is calculated as a 20%/50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20%/50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) [VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)].	Week 24 and Week 52
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Week 24 and Week 52	ACR20/50/70 is calculated as a 20%/50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) [VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)].	Week 24 and Week 52
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12 (Global Cohort) Time Frame: Week 12	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Week 12
Percentage of Participants Achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 (Global Cohort) Time Frame: Week 12	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter [mm]/hour[hr]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Week 12
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Week 24 and Week 52	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement.	Week 24 and Week 52
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Week 24 and Week 52	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter [mm]/hour[hr]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement.	Week 24 and Week 52
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Week 24 and Week 52	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement.	Week 24 and Week 52
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Week 24 and Week 52	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter [mm]/hour[hr]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement.	Week 24 and Week 52
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 (Global Cohort) Time Frame: Week 12	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP less than (<)2.6. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Week 12
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12 (Global Cohort) Time Frame: Week 12	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Week 12
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Week 24 and Week 52	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP less than (<)2.6. A negative change from baseline in DAS28-CRP indicates an improvement.	Week 24 and Week 52
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Week 24 and Week 52	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement.	Week 24 and Week 52
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Week 24 and Week 52	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP less than (<)2.6. A negative change from baseline in DAS28-CRP indicates an improvement.	Week 24 and Week 52
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Week 24 and Week 52	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement.	Week 24 and Week 52
Percentage of Participants Achieving a Good/Moderate (European League Against Rheumatism) EULAR Response at Week 12 (Global Cohort) Time Frame: Week 12	DAS28-CRP and DAS28-ESR scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; DAS28<=3.2 and DAS28 decrease from Baseline (>1.2: good response),(>0.6 to <=1.2: moderate response) and (<=0.6: no response); DAS28 >3.2 to <=5.1 and DAS28 decrease from Baseline (>1.2: moderate response),(>0.6 to <=1.2: moderate response) and (<=0.6: no response) and DAS28>5.1 and DAS28 decrease from Baseline (>1.2: moderate response),(>0.6 to <=1.2: no response) and (<=0.6: no response).If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Week 12
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Week 24 and Week 52	DAS28-CRP and DAS28-ESR scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; if current DAS28 <=3.2 and DAS28 decrease from Baseline (>1.2: good response), (>0.6 to <=1.2: moderate response) and (<=0.6: no response); if current DAS28 >3.2 to <=5.1 and DAS28 decrease from Baseline value (>1.2: moderate response), (>0.6 to <=1.2: moderate response) and (<=0.6: no response) and if current DAS28 >5.1 and DAS28 decrease from Baseline value (>1.2: moderate response), (>0.6 to <=1.2: no response) and (<=0.6: no response). If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing.	Week 24 and Week 52
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Week 24 and Week 52	DAS28-CRP and DAS28-ESR scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; if current DAS28 <=3.2 and DAS28 decrease from Baseline (>1.2: good response), (>0.6 to <=1.2: moderate response) and (<=0.6: no response); if current DAS28 >3.2 to <=5.1 and DAS28 decrease from Baseline value (>1.2: moderate response), (>0.6 to <=1.2: moderate response) and (<=0.6: no response) and if current DAS28 >5.1 and DAS28 decrease from Baseline value (>1.2: moderate response), (>0.6 to <=1.2: no response) and (<=0.6: no response). If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing.	Week 24 and Week 52
Number of Participants Achieving ACR/EULAR Remission at Week 12 (Global Cohort) Time Frame: Week 12	Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) <= 1, Swollen Joint Count 66 (SJC66) <= 1, high sensitivity C-reactive Protein (hsCRP) <= 1mg/dl and patient's global assessment of disease activity (PtGA) <= 10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Week 12
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Week 24 and Week 52	Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) <= 1, Swollen Joint Count 66 (SJC66) <= 1, high sensitivity C-reactive Protein (hsCRP) <= 1mg/dl and patient's global assessment of disease activity (PtGA) <= 10.	Week 24 and Week 52
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Week 24 and Week 52	Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) <= 1, Swollen Joint Count 66 (SJC66) <= 1, high sensitivity C-reactive Protein (hsCRP) <= 1mg/dl and patient's global assessment of disease activity (PtGA) <= 10.	Week 24 and Week 52
Percentage of Participants Achieving no Radiographic Progression Van Der Heijde Modified Total Sharp Scores (mTSS) <= 0.5) at Week 12 (Global Cohort) Time Frame: Week 12	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. No radiographic progression is defined as a change from Baseline in van der Heijde mTSS score of <=0.5. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms	Week 12
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Week 24 and Week 52	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. No radiographic progression is defined as a change from Baseline in van der Heijde mTSS score of <=0.5.	Week 24 and Week 52
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Week 24 and Week 52	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. No radiographic progression is defined as a change from Baseline in van der Heijde mTSS score of <=0.5.	Week 24 and Week 52
Change From Baseline in CDAI Total Score at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and week 12	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (PtGA and PhGA VAS with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and week 12
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV).	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV). For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR) [ESR in milimeter/hour (mm/hr)] and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV).	Baseline (Day 1) and Week 12
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR) [ESR in milimeter/hour (mm/hr)] and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV).	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR) [ESR in milimeter/hour (mm/hr)] and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV). For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Van Der Heijde mTSS at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV). For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1) and Week 24	HAQ-DI is a 20-question instrument that assesses the degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 24
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Day 1) and Week 52	HAQ-DI is a 20-question instrument that assesses the degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV). For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1) and Week 52
Change From Baseline in Arthritis Pain VAS at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1) and Week 24 and Week 52	For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 24 and Week 52
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Day 1) and Week 24 and Week 52	For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV). For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1) and Week 24 and Week 52
Change From Baseline in Short Form (SF)-36 Physical Component Scores at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health.Positive change from baseline, reported using T-score change, indicates improvement in overall physical health.Quality Metric software was used for scoring.Baseline=latest pre-dose assessment with NMV, including those from unscheduled visits.CB=subtracting PD visit value from BV.For purpose of all analyses up to week12, placebo arms were pooled into single arm to primarily serve as reference for comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in SF-36 Mental Component Scores at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health.Positive change from baseline, reported using T-score change, indicates improvement in overall mental health.Quality Metric software was used for scoring.Baseline=latest pre-dose assessment with NMV, including those from unscheduled visits.CB=subtracting PD visit value from BV.For purpose of all analyses up to week12, placebo arms were pooled into single arm to primarily serve as reference for comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in SF-36 Domain Scores at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. Quality Metric software was used for scoring for SF-36. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1) and Week 12
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health.Positive change from baseline, reported using T-score change, indicates improvement in overall physical health.Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health.Positive change from baseline, reported using T-score change, indicates improvement in overall mental health.Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. Quality Metric software was used for scoring for SF-36. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality. Each of 8 domains is scored using average, 0-100; higher score represents better health. PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. PCS is primarily derived from 4 domains (PF,role-physical,BP,GH) representing overall physical health. Positive change from baseline, reported using T-score change, indicates improvement in overall physical health. Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality. Each of 8 domains is scored using average, 0-100; higher score represents better health. MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Positive change from baseline, reported using T-score change, indicates improvement in overall mental health. Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning(PF), bodily pain(BP), role limitations due to physical and emotional problems, general health(GH), mental health(MH), social functioning(SF), vitality. The MCS consists of 4 domains (SF, vitality, MH, role-emotional) and PCS consists of 4 domains (PF, role-physical, BP, GH). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. Quality Metric software was used for scoring for SF-36. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Global Cohort) Time Frame: Up to Week 59	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis.	Up to Week 59
Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples were collected for the assessment of change from baseline in hematology parameters including WBC count, platelet count, neutrophils, lymphocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Blood samples were collected for the assessment of change from baseline in hematology parameters including WBC count, platelet count, neutrophils, lymphocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 (Global Cohort) Time Frame: Baseline (Week 12), Week 24 and Week 52	Blood samples were collected for the assessment of change from baseline in hematology parameters including WBC count, platelet count, neutrophils, lymphocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12), Week 24 and Week 52
Change From Baseline in Hematology Parameter of Hemoglobin at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples were collected for the assessment of change from baseline in hematology parameters hemoglobin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Blood samples were collected for the assessment of change from baseline in hematology parameters hemoglobin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Week 12), Week 24 and Week 52	Blood samples were collected for the assessment of change from baseline in hematology parameters hemoglobin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12), Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples were collected for the assessment of clinical chemistry parameters including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP) and gamma-glutamyl transferase (GGT) levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP and GGT levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Week 12), Week 24 and Week 52	Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP and GGT levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12), Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples were collected for the assessment of clinical chemistry parameter total bilirubin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Blood samples were collected for the assessment of clinical chemistry parameter total bilirubin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Week 12), Week 24 and Week 52	Blood samples were collected for the assessment of clinical chemistry parameter total bilirubin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12), Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples were collected for the assessment of clinical chemistry parameter albumin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Blood samples were collected for the assessment of clinical chemistry parameter albumin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Week 12), Week 24 and Week 52	Blood samples were collected for the assessment of clinical chemistry parameter albumin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12), Week 24 and Week 52
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1) and Week 24	Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 24
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Week 12) and Week 24	Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12) and Week 24
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1) and Week 52	Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 52
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Week 4) and Week 52	Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For lipid profile assessments, baseline is interpreted as Week 4.	Baseline (Week 4) and Week 52
Change From Baseline in Lipid Profile Parameter of Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1) and Week 24	Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 24
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Week 12) and Week 24	Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12) and Week 24
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1) and Week 52	Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 52
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Week 4) and Week 52	Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For lipid profile assessments, baseline is interpreted as Week 4.	Baseline (Week 4) and Week 52
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 12 (Global Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1) and Week 24	Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 24
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Week 12) and Week 24	Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12) and Week 24
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort) Time Frame: Baseline (Day 1) and Week 52	Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 52
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Placebo Switched Arms (Global Cohort) Time Frame: Baseline (Week 4) and Week 52	TBlood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For lipid profile assessments, baseline is interpreted as Week 4.	Baseline (Week 4) and Week 52
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort) Time Frame: Up to Week 59	Number of participants with NCI-CTCAE >=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case >=Grade 3 shifts from Baseline. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis.	Up to Week 59
Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody (Global Cohort) Time Frame: At baseline	Blood samples were collected for markers which may influence rheumatoid arthritis. Concentrations of GM-CSF autoantibodies was determined.	At baseline
Number of Participants With Anti-GSK3196165 Antibodies (Global Cohort) Time Frame: Up to Week 52	Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.	Up to Week 52
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Less Than or Equal to (<=)10 [CDAI Low Disease Activity (LDA)] at Week 12 (Asia Cohort) Time Frame: Week 12	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.	Week 12
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	HAQ-DI is a 20-question instrument that assesses the degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Week 24 and Week 52	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Week 24 and Week 52	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12 (Asia Cohort) Time Frame: Week 12	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score <=2.8. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.	Week 12
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Week 24 and Week 52	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score <=2.8. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Week 24 and Week 52	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score <=2.8. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Asia Cohort) Time Frame: Week 12	ACR50/70 is calculated as a 50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) [VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.	Week 12
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Week 24 and Week 52	ACR20/50/70 is calculated as a 20%/50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20%/50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) [VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)]. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Week 24 and Week 52	ACR20/50/70 is calculated as a 20%/50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) [VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)]. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12 (Asia Cohort) Time Frame: Week 12	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.	Week 12
Percentage of Participants Achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 (Asia Cohort) Time Frame: Week 12	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter [mm]/hour[hr]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.	Week 12
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Week 24 and Week 52	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Week 24 and Week 52	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter [mm]/hour[hr]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Week 24 and Week 52	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Week 24 and Week 52	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter [mm]/hour[hr]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 (Asia Cohort) Time Frame: Week 12	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP less than (<)2.6. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.	Week 12
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12 (Asia Cohort) Time Frame: Week 12	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.	Week 12
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Week 24 and Week 52	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP less than (<)2.6. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Week 24 and Week 52	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Week 24 and Week 52	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP less than (<)2.6. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Week 24 and Week 52	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving a Good/Moderate European League Against Rheumatism (EULAR) Response at Week 12(Asia Cohort) Time Frame: Week 12	DAS28-CRP and DAS28-ESR scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; DAS28<=3.2 and DAS28 decrease from Baseline (>1.2: good response),(>0.6 to <=1.2: moderate response) and (<=0.6: no response); DAS28 >3.2 to <=5.1 and DAS28 decrease from Baseline (>1.2: moderate response),(>0.6 to <=1.2: moderate response) and (<=0.6: no response) and DAS28>5.1 and DAS28 decrease from Baseline (>1.2: moderate response),(>0.6 to <=1.2: no response) and (<=0.6: no response).If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing. Percentage values are rounded off.	Week 12
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Week 24 and Week 52	DAS28-CRP and DAS28-ESR scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; if current DAS28 <=3.2 and DAS28 decrease from Baseline (>1.2: good response), (>0.6 to <=1.2: moderate response) and (<=0.6: no response); if current DAS28 >3.2 to <=5.1 and DAS28 decrease from Baseline value (>1.2: moderate response), (>0.6 to <=1.2: moderate response) and (<=0.6: no response) and if current DAS28 >5.1 and DAS28 decrease from Baseline value (>1.2: moderate response), (>0.6 to <=1.2: no response) and (<=0.6: no response). If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Week 24 and Week 52	DAS28-CRP and DAS28-ESR scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; if current DAS28 <=3.2 and DAS28 decrease from Baseline (>1.2: good response), (>0.6 to <=1.2: moderate response) and (<=0.6: no response); if current DAS28 >3.2 to <=5.1 and DAS28 decrease from Baseline value (>1.2: moderate response), (>0.6 to <=1.2: moderate response) and (<=0.6: no response) and if current DAS28 >5.1 and DAS28 decrease from Baseline value (>1.2: moderate response), (>0.6 to <=1.2: no response) and (<=0.6: no response). If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing. Percentage values are rounded off.	Week 24 and Week 52
Number of Participants Achieving ACR/EULAR Remission at Week 12 (Asia Cohort) Time Frame: Week 12	Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) <= 1, Swollen Joint Count 66 (SJC66) <= 1, high sensitivity C-reactive Protein (hsCRP) <= 1mg/dl and patient's global assessment of disease activity (PtGA) <= 10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Week 12
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Week 24 and Week 52	Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) <= 1, Swollen Joint Count 66 (SJC66) <= 1, high sensitivity C-reactive Protein (hsCRP) <= 1mg/dl and patient's global assessment of disease activity (PtGA) <= 10.	Week 24 and Week 52
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Week 24 and Week 52	Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) <= 1, Swollen Joint Count 66 (SJC66) <= 1, high sensitivity C-reactive Protein (hsCRP) <= 1mg/dl and patient's global assessment of disease activity (PtGA) <= 10.	Week 24 and Week 52
Percentage of Participants Achieving no Radiographic Progression Van Der Heijde Modified Total Sharp Scores (mTSS) <= 0.5) at Week 12 (Asia Cohort) Time Frame: Week 12	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. No radiographic progression is defined as a change from Baseline in van der Heijde mTSS score of <=0.5. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.	Week 12
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Week 24 and Week 52	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. No radiographic progression is defined as a change from Baseline in van der Heijde mTSS score of <=0.5. Percentage values are rounded off.	Week 24 and Week 52
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Week 24 and Week 52	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. No radiographic progression is defined as a change from Baseline in van der Heijde mTSS score of <=0.5. Percentage values are rounded off.	Week 24 and Week 52
Change From Baseline in CDAI Total Score at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and week 12	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (PtGA and PhGA VAS with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and week 12
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV). For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR) [ESR in milimeter/hour (mm/hr)] and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR) [ESR in milimeter/hour (mm/hr)] and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR) [ESR in milimeter/hour (mm/hr)] and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Van Der Heijde mTSS at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 24	HAQ-DI is a 20-question instrument that assesses the degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1) and Week 24
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Day 1) and Week 52	HAQ-DI is a 20-question instrument that assesses the degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1) and Week 52
Change From Baseline in Arthritis Pain VAS at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 24 and Week 52	For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 24 and Week 52
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Day 1) and Week 24 and Week 52	For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1) and Week 24 and Week 52
Change From Baseline in Short Form (SF)-36 Physical Component Scores at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health.Positive change from baseline, reported using T-score change, indicates improvement in overall physical health.Quality Metric software was used for scoring.Baseline=latest pre-dose assessment with NMV, including those from unscheduled visits.CB=subtracting PD visit value from BV.For purpose of all analyses up to week12, placebo arms were pooled into single arm to primarily serve as reference for comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in SF-36 Mental Component Scores at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health.Positive change from baseline, reported using T-score change, indicates improvement in overall mental health.Quality Metric software was used for scoring.Baseline=latest pre-dose assessment with NMV, including those from unscheduled visits.CB=subtracting PD visit value from BV.For purpose of all analyses up to week12, placebo arms were pooled into single arm to primarily serve as reference for comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in SF-36 Domain Scores at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. Quality Metric software was used for scoring for SF-36. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1) and Week 12
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health.Positive change from baseline, reported using T-score change, indicates improvement in overall physical health.Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health.Positive change from baseline, reported using T-score change, indicates improvement in overall mental health.Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. Quality Metric software was used for scoring for SF-36. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality. Each of 8 domains is scored using average, 0-100; higher score represents better health. PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. PCS is primarily derived from 4 domains (PF,role-physical,BP,GH) representing overall physical health. Positive change from baseline, reported using T-score change, indicates improvement in overall physical health. Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality. Each of 8 domains is scored using average, 0-100; higher score represents better health. MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Positive change from baseline, reported using T-score change, indicates improvement in overall mental health. Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning(PF), bodily pain(BP), role limitations due to physical and emotional problems, general health(GH), mental health(MH), social functioning(SF), vitality. The MCS consists of 4 domains (SF, vitality, MH, role-emotional) and PCS consists of 4 domains (PF, role-physical, BP, GH). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. Quality Metric software was used for scoring for SF-36. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.	Baseline (Day 1), Week 24 and Week 52
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Asia Cohort) Time Frame: Up to Week 59	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death.	Up to Week 59
Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples were collected for the assessment of change from baseline in hematology parameters including WBC count, platelet count, neutrophils, lymphocytes. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Blood samples were collected for the assessment of change from baseline in hematology parameters including WBC count, platelet count, neutrophils, lymphocytes. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Week 12), Week 24 and Week 52	Blood samples were collected for the assessment of change from baseline in hematology parameters including WBC count, platelet count, neutrophils, lymphocytes. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12), Week 24 and Week 52
Change From Baseline in Hematology Parameter of Hemoglobin at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples was collected for the assessment of hematology parameters. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Blood samples was collected for the assessment of hematology parameters. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Week 12), Week 24 and Week 52	Blood samples was collected for the assessment of hematology parameters. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12), Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples were collected for the assessment of clinical chemistry parameters including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP) and gamma-glutamyl transferase (GGT) levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP and GGT levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Week 12), Week 24 and Week 52	Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP and GGT levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12), Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples were collected for the assessment of clinical chemistry parameter total bilirubin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Blood samples were collected for the assessment of clinical chemistry parameter total bilirubin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Week 12), Week 24 and Week 52	Blood samples were collected for the assessment of clinical chemistry parameter total bilirubin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12), Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples was collected for the assessment of clinical chemistry parameter albumin. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1), Week 24 and Week 52	Blood samples was collected for the assessment of clinical chemistry parameter albumin. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.	Baseline (Day 1), Week 24 and Week 52
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Week 12), Week 24 and Week 52	Blood samples was collected for the assessment of clinical chemistry parameter albumin. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12), Week 24 and Week 52
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 24	Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 24
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Week 12) and Week 24	Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12) and Week 24
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 52	Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 52
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Week 4) and Week 52	Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For lipid profile assessments, baseline is interpreted as Week 4.	Baseline (Week 4) and Week 52
Change From Baseline in Lipid Profile Parameter of Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 24	Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 24
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Week 12) and Week 24	Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12) and Week 24
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 52	Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 52
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Week 4) and Week 52	Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For lipid profile assessments, baseline is interpreted as Week 4.	Baseline (Week 4) and Week 52
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 12 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 12	Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.	Baseline (Day 1) and Week 12
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 24	Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 24
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Week 12) and Week 24	Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.	Baseline (Week 12) and Week 24
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort) Time Frame: Baseline (Day 1) and Week 52	Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.	Baseline (Day 1) and Week 52
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Placebo Switched Arms (Asia Cohort) Time Frame: Baseline (Week 4) and Week 52	Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For lipid profile assessments, baseline is interpreted as Week 4.	Baseline (Week 4) and Week 52
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Asia Cohort) Time Frame: Up to Week 59	Number of participants with NCI-CTCAE >=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case >=Grade 3 shifts from Baseline.	Up to Week 59
Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody (Asia Cohort) Time Frame: At baseline	Blood samples were collected for markers which may influence rheumatoid arthritis. Concentrations of GM-CSF autoantibodies was determined.	At baseline
Number of Participants With Anti-GSK3196165 Antibodies (Asia Cohort) Time Frame: Up to Week 59	Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.	Up to Week 59
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Global Cohort) Time Frame: Week 12 to Week 59	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death.	Week 12 to Week 59
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Global Cohort) Time Frame: Week 12 to Week 59	Number of participants with NCI-CTCAE >=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case >=Grade 3 shifts from Baseline.	Week 12 to Week 59
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Asia Cohort) Time Frame: Week 12 to Week 59	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death.	Week 12 to Week 59
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Asia Cohort) Time Frame: Week 12 to Week 59	Number of participants with NCI-CTCAE >=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case >=Grade 3 shifts from Baseline.	Week 12 to Week 59

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

IQVIA Pty Ltd

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

209564 contRAst X NCT04333147

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2019

Primary Completion (Actual)

October 29, 2021

Study Completion (Actual)

January 18, 2023

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

201791

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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United States, Germany, Japan, Korea, Republic of, Poland, Ukraine, Bulgaria, Canada, Czechia, Estonia, Hungary, Mexico, Russian Federation, South Africa, Spain, Malaysia, Thailand, China, Argentina, Belgium, India, United Kingdom, ... and more
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Completed

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Arthritis, Rheumatoid

Clinical Trials on GSK3196165 (Otilimab)

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CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations