Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA) (contRAst X)

January 12, 2024 updated by: GlaxoSmithKline

A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X [209564: NCT04333147]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) [csDMARD(s)] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study

Study Overview

Status

Terminated

Conditions

Arthritis, Rheumatoid

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2916

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
- - Buenos Aires, Argentina, C1430CKE
    - GSK Investigational Site
  - Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, C1426BOR
    - GSK Investigational Site
  - Cordoba, Argentina, 5000
    - GSK Investigational Site
  - Nueva Cordoba, Argentina, X5000AVE
    - GSK Investigational Site
  - Salta, Argentina, A4400ANW
    - 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
  - Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1417
    - GSK Investigational Site
  - Ciudad Autonoma Buenos aires, Buenos Aires, Argentina, C1046AAQ
    - GSK Investigational Site
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1431FWO
    - GSK Investigational Site
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1128AAF
    - GSK Investigational Site
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1426
    - GSK Investigational Site
  - La Palta, Buenos Aires, Argentina, B1900AXI
    - GSK Investigational Site
  - Mar del Plata, Buenos Aires, Argentina, B7600FYK
    - GSK Investigational Site
  - Quilmes, Buenos Aires, Argentina, B1878GEG
    - GSK Investigational Site
  - San Isidro, Buenos Aires, Argentina, 1643
    - GSK Investigational Site
  - San Nicolas, Buenos Aires, Argentina, B2900DMH
    - GSK Investigational Site
- Córdova
  - Cordoba, Córdova, Argentina, X5003DCE
    - GSK Investigational Site
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2000DSV
    - 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
- Queensland
  - Gold Coast, Queensland, Australia, 4222
    - GSK Investigational Site
- South Australia
  - Woodville, South Australia, Australia, 5011
    - GSK Investigational Site
Belgium
- - Mons, Belgium, 7000
    - GSK Investigational Site
Bulgaria
- - Blagoevgrad, Bulgaria, 2700
    - GSK Investigational Site
  - Pleven, Bulgaria, 5800
    - GSK Investigational Site
  - Plovdiv, Bulgaria, 4000
    - 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, 1612
    - GSK Investigational Site
  - Sofia, Bulgaria, 1784
    - GSK Investigational Site
  - Vidin, Bulgaria, 3700
    - GSK Investigational Site
Canada
- Ontario
  - Brampton, Ontario, Canada, L6T 0G1
    - GSK Investigational Site
- Quebec
  - Trois-Rivieres, Quebec, Canada, G8Z 1Y2
    - GSK Investigational Site
China
- - Beijing, China, 100015
    - GSK Investigational Site
  - Beijing, China, 100144
    - GSK Investigational Site
  - Guangzhou, China, 510080
    - 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
  - 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
  - Taizhou, Jiangsu, China, 225300
    - GSK Investigational Site
  - Xuzhou, Jiangsu, China, 221009
    - GSK Investigational Site
- Jiangxi
  - Nanchang,, Jiangxi, China, 330006
    - GSK Investigational Site
  - Pingxiang, Jiangxi, China, 337055
    - GSK Investigational Site
- Jilin
  - Changchun, Jilin, China, 130021
    - GSK Investigational Site
- Liaoning
  - Jinzhou, Liaoning, China, 121000
    - GSK Investigational Site
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - GSK Investigational Site
- Zhejiang
  - Huzhou, Zhejiang, China, 313000
    - GSK Investigational Site
Colombia
- - Barranquilla, Colombia, 80020
    - GSK Investigational Site
  - Barranquilla, Colombia, 110221
    - GSK Investigational Site
  - Bogotá, Colombia, 110221
    - GSK Investigational Site
  - Bucaramanga, Colombia, 680003
    - GSK Investigational Site
Czechia
- - Brno, Czechia, 638 00
    - GSK Investigational Site
  - Brno, Czechia, 65691
    - GSK Investigational Site
  - Ostrava, Czechia, 70200
    - GSK Investigational Site
  - Praha 10, Czechia, 10000
    - GSK Investigational Site
  - Praha 11, Czechia, 148 00
    - GSK Investigational Site
  - Praha 2, Czechia, 12850
    - GSK Investigational Site
  - Praha 4, Czechia, 140 00
    - GSK Investigational Site
  - Praha 4 Nusle, Czechia, 140 00
    - GSK Investigational Site
  - Praha 5, Czechia, 150 06
    - GSK Investigational Site
  - Uherske Hradiste, Czechia, 686 01
    - GSK Investigational Site
  - Zlin, Czechia, 760 01
    - 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, 50708
    - GSK Investigational Site
Germany
- - 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
- - Baja, Hungary, 6500
    - GSK Investigational Site
  - Balatonfured, Hungary, 8230
    - GSK Investigational Site
  - Budapest, Hungary, 1036
    - GSK Investigational Site
  - Budapest, Hungary, 1023
    - GSK Investigational Site
  - Szekesfehervar, Hungary, 8000
    - GSK Investigational Site
  - Szentes, Hungary, 6600
    - GSK Investigational Site
  - Székesfehérvár, Hungary, 8000
    - GSK Investigational Site
  - Veszprem, Hungary, 8200
    - GSK Investigational Site
India
- - Ahmedabad, India, 380005
    - GSK Investigational Site
  - Ahmedabad, India, 380016
    - GSK Investigational Site
  - Belagavi, India, 590010
    - GSK Investigational Site
  - Hubli, India, 580021
    - GSK Investigational Site
  - Hyderabad, India, 500018
    - GSK Investigational Site
  - Jaipur, India, 302001
    - GSK Investigational Site
  - Jaipur, India, 302006
    - GSK Investigational Site
  - Kolkata, India, 700020
    - GSK Investigational Site
  - Nagpur, India, 440009
    - GSK Investigational Site
  - Nagpur, India, 440012
    - GSK Investigational Site
  - New Delhi, India, 110026
    - GSK Investigational Site
  - Pune, India, 411004
    - GSK Investigational Site
  - Surat, India, 395002
    - 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
  - Chiba, Japan, 270-2296
    - 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, 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, 232-0024
    - GSK Investigational Site
  - Kanagawa, Japan, 231-8682
    - 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, 862-0975
    - 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
  - Saitama, Japan, 359-1111
    - 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
  - Wakayama, Japan, 649-2211
    - GSK Investigational Site
  - Yamaguchi, Japan, 750-8520
    - GSK Investigational Site
Korea, Republic of
- - Anyang-Si, Korea, Republic of, 431-070
    - GSK Investigational Site
  - Cheonan-si, Korea, Republic of, 31151
    - GSK Investigational Site
  - Daegu, Korea, Republic of, 41944
    - GSK Investigational Site
  - Gwangju, Korea, Republic of, 61469
    - GSK Investigational Site
  - Incheon, Korea, Republic of, 22332
    - GSK Investigational Site
  - Seongnam-si, Korea, Republic of, 13620
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 06591
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 05505
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 03722
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 3080
    - GSK Investigational Site
  - Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
    - GSK Investigational Site
Latvia
- - Adazi, Latvia, LV2164
    - GSK Investigational Site
  - Liepaja, Latvia, LV-3401
    - GSK Investigational Site
Lithuania
- - Kaunas, Lithuania, LT-45130
    - GSK Investigational Site
  - Kaunas, Lithuania, LT-50128
    - GSK Investigational Site
  - Klaipeda, Lithuania, LT-92288
    - GSK Investigational Site
  - Siauliai, Lithuania, 76231
    - GSK Investigational Site
  - Vilnius, Lithuania, LT-01117
    - GSK Investigational Site
Malaysia
- - Klang, Malaysia, 41200
    - GSK Investigational Site
  - Kuala Lumpur, Malaysia, 59100
    - GSK Investigational Site
  - Seremban, Negeri Sembilan, Malaysia, 70300
    - GSK Investigational Site
  - Sibu, Malaysia, 96000
    - GSK Investigational Site
Mexico
- - Durango, Mexico, 34270
    - GSK Investigational Site
  - Mexico, Mexico, 6700
    - GSK Investigational Site
  - San Luis Potosí, Mexico, 78213
    - GSK Investigational Site
- Baja California Sur
  - Mexicali, Baja California Sur, Mexico, 21100
    - GSK Investigational Site
- Durango
  - Mexico City, Durango, Mexico, 06700
    - GSK Investigational Site
- Guanajuato
  - Leon, Guanajuato, Mexico, 37000
    - GSK Investigational Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44650
    - GSK Investigational Site
  - Guadalajara, Jalisco, Mexico, 44130
    - GSK Investigational Site
- Yucatán
  - Merida, Yucatán, Mexico, 97070
    - GSK Investigational Site
Poland
- - Bialystok, Poland, 15-351
    - GSK Investigational Site
  - Bialystok, Poland, 15-879
    - GSK Investigational Site
  - Bydgoszcz, Poland, 85-168
    - 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
  - Gdynia, Poland, 81-338
    - 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, 30-510
    - GSK Investigational Site
  - Kraków, Poland, 30-363
    - GSK Investigational Site
  - Lodz, Poland, 90-127
    - GSK Investigational Site
  - Lodz, Poland, 90-644
    - GSK Investigational Site
  - Lublin, Poland, 20-582
    - GSK Investigational Site
  - Lublin, Poland, 20-362
    - GSK Investigational Site
  - Nowa Sol, Poland, 67-100
    - GSK Investigational Site
  - Olsztyn, Poland, 10-117
    - GSK Investigational Site
  - Poznan, Poland, 60-702
    - GSK Investigational Site
  - Poznan, Poland, 61-113
    - GSK Investigational Site
  - Poznan, Poland, 60-529
    - GSK Investigational Site
  - Poznan, Poland, 60-773
    - GSK Investigational Site
  - Siedlce, Poland, 08-110
    - GSK Investigational Site
  - Sochaczew, Poland, 96-500
    - GSK Investigational Site
  - Staszow, Poland, 28-200
    - GSK Investigational Site
  - Torun, Poland, 87-100
    - GSK Investigational Site
  - Warsaw, Poland, 02-673
    - GSK Investigational Site
  - Warszawa, Poland, 01-192
    - GSK Investigational Site
  - Warszawa, Poland, 00-874
    - GSK Investigational Site
  - Warszawa, Poland, 02-793
    - GSK Investigational Site
  - Warszawa, Poland, 00-465
    - GSK Investigational Site
  - Warszawa, Poland, 02-118
    - GSK Investigational Site
  - Wroclaw, Poland, 52-416
    - GSK Investigational Site
  - Wrocław, Poland, 50-381
    - GSK Investigational Site
  - Zamosc, Poland, 22-400
    - GSK Investigational Site
Russian Federation
- - Ekaterinburg, Russian Federation, 620102
    - GSK Investigational Site
  - Ekaterinburg, Russian Federation, 620043
    - 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, 660022
    - GSK Investigational Site
  - Moscow, Russian Federation, 129110
    - GSK Investigational Site
  - Moscow, Russian Federation, 115522
    - 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, 197022
    - GSK Investigational Site
  - Saint-Petersburg, Russian Federation, 190068
    - GSK Investigational Site
  - Saratov, Russian Federation, 410012
    - GSK Investigational Site
  - Smolensk, Russian Federation, 214025
    - GSK Investigational Site
  - Tomsk, Russian Federation, 634061
    - GSK Investigational Site
  - Tver, Russian Federation, 170036
    - GSK Investigational Site
  - Ulyanovsk, Russian Federation, 432063
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150003
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150062
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150007
    - GSK Investigational Site
Serbia
- - Belgrade, Serbia, 11000
    - GSK Investigational Site
South Africa
- - Bellville, South Africa, 7530
    - GSK Investigational Site
  - Bloemfontein, South Africa, 9301
    - GSK Investigational Site
  - Cape Town, South Africa, 7500
    - GSK Investigational Site
  - Cape Town, South Africa, 7405
    - GSK Investigational Site
  - Johannesburg, South Africa, 2193
    - GSK Investigational Site
  - Johannesburg, South Africa, 2113
    - GSK Investigational Site
  - Kempton Park, South Africa, 1619
    - GSK Investigational Site
  - Pretoria, South Africa, 0002
    - GSK Investigational Site
  - Somerset West, South Africa, 7130
    - GSK Investigational Site
  - Stellenbosch, South Africa, 7600
    - GSK Investigational Site
- Gauteng
  - Pretoria, Gauteng, South Africa, 184
    - GSK Investigational Site
- KwaZulu- Natal
  - Durban, KwaZulu- Natal, South Africa, 4319
    - GSK Investigational Site
Spain
- - Barcelona, Spain, 08035
    - GSK Investigational Site
  - Barcelona, Spain, 08003
    - GSK Investigational Site
  - Cordoba, Spain, 140044
    - GSK Investigational Site
  - Coruña, Spain, 15006
    - GSK Investigational Site
  - Elche, Spain, ?03203
    - GSK Investigational Site
  - Santander, Spain, 39008
    - GSK Investigational Site
  - Santiago De Compostela. La Coruña., Spain, 15706
    - GSK Investigational Site
  - Sevilla, Spain, 41009
    - GSK Investigational Site
  - Valencia, Spain, 46010
    - GSK Investigational Site
Thailand
- - Bangkok, Thailand, 10400
    - GSK Investigational Site
  - Rajathevee, Thailand, 10400
    - GSK Investigational Site
Ukraine
- - Cherkasy, Ukraine, 18009
    - GSK Investigational Site
  - Ivano-Frankivsk, Ukraine, 76008
    - GSK Investigational Site
  - Kharkiv, Ukraine, 61124
    - GSK Investigational Site
  - Kharkiv, Ukraine, 61039
    - GSK Investigational Site
  - Kharkiv, Ukraine, 61176
    - GSK Investigational Site
  - Kyiv, Ukraine, 03049
    - GSK Investigational Site
  - Kyiv, Ukraine, 03037
    - GSK Investigational Site
  - Kyiv, Ukraine, 04054
    - GSK Investigational Site
  - Kyiv, Ukraine, 1023
    - GSK Investigational Site
  - Kyiv, Ukraine, 2002
    - GSK Investigational Site
  - Kyiv, Ukraine, 02125
    - GSK Investigational Site
  - Lutsk, Ukraine, 43024
    - GSK Investigational Site
  - Lutsk, Ukraine, 43005
    - GSK Investigational Site
  - Odessa, Ukraine, 65025
    - GSK Investigational Site
  - Poltava, Ukraine, 36011
    - GSK Investigational Site
  - Vinnytsia, Ukraine, 21018
    - GSK Investigational Site
  - Vinnytsia, Ukraine, 21029
    - GSK Investigational Site
  - Vinnytsia, Ukraine, 21001
    - GSK Investigational Site
  - Vinnytsia, Ukraine, 21050
    - GSK Investigational Site
  - Vinnytsya, Ukraine, 21029
    - GSK Investigational Site
  - Zaporizhzhia, Ukraine, 69014
    - GSK Investigational Site
  - Zaporizhzia, Ukraine, 69065
    - GSK Investigational Site
  - Zhytomyr, Ukraine, 10002
    - GSK Investigational Site
United Kingdom
- - Coventry, United Kingdom, CV3 4FJ
    - GSK Investigational Site
- Kent
  - Orpington, Kent, United Kingdom, BR5 3QG
    - GSK Investigational Site
- Middlesex
  - Northwood, Middlesex, United Kingdom, HA6 2RN
    - GSK Investigational Site
United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - GSK Investigational Site
- Arizona
  - Flagstaff, Arizona, United States, 86001
    - GSK Investigational Site
  - Gilbert, Arizona, United States, 85297
    - GSK Investigational Site
  - Glendale, Arizona, United States, 85306
    - GSK Investigational Site
  - Mesa, Arizona, United States, 85210
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85032
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85037
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85704
    - GSK Investigational Site
- California
  - Covina, California, United States, 91722
    - GSK Investigational Site
  - Poway, California, United States, 92064
    - GSK Investigational Site
  - San Diego, California, United States, 92128
    - GSK Investigational Site
  - San Diego, California, United States, 92108
    - GSK Investigational Site
  - Upland, California, United States, 91786
    - GSK Investigational Site
  - Van Nuys, California, United States, 91405
    - GSK Investigational Site
  - Whittier, California, United States, 90602
    - 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
  - Brandon, Florida, United States, 33511
    - GSK Investigational Site
  - Clearwater, Florida, United States, 33765
    - GSK Investigational Site
  - Daytona Beach, Florida, United States, 32117
    - GSK Investigational Site
  - Jacksonville, Florida, United States, 32207
    - GSK Investigational Site
  - Miami, Florida, United States, 33173
    - GSK Investigational Site
  - Miami, Florida, United States, 33134
    - GSK Investigational Site
  - Miami, Florida, United States, 33165
    - GSK Investigational Site
  - Miami, Florida, United States, 33155
    - GSK Investigational Site
  - Miami Lakes, Florida, United States, 33014
    - GSK Investigational Site
  - Miami Lakes, Florida, United States, 33016
    - GSK Investigational Site
  - New Port Richey, Florida, United States, 34652
    - GSK Investigational Site
  - Orlando, Florida, United States, 32835
    - GSK Investigational Site
  - Palmetto Bay, Florida, United States, 33157
    - GSK Investigational Site
  - Tamarac, Florida, United States, 33321
    - GSK Investigational Site
  - Tampa, Florida, United States, 33614
    - GSK Investigational Site
  - Tampa, Florida, United States, 33603
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30318
    - GSK Investigational Site
  - Marietta, Georgia, United States, 30060
    - GSK Investigational Site
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - GSK Investigational Site
- Illinois
  - Skokie, Illinois, United States, 60076
    - 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
  - Wheaton, Maryland, United States, 20902
    - 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
- Missouri
  - Saint Louis, Missouri, United States, 63141
    - GSK Investigational Site
- Nebraska
  - Lincoln, Nebraska, United States, 68516
    - GSK Investigational Site
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - GSK Investigational Site
- New Jersey
  - Freehold, New Jersey, United States, 07728
    - GSK Investigational Site
- New York
  - Brooklyn, New York, United States, 11201
    - GSK Investigational Site
- North Carolina
  - Fayetteville, North Carolina, United States, 30214
    - GSK Investigational Site
  - Greensboro, North Carolina, United States, 27408
    - GSK Investigational Site
- North Dakota
  - Minot, North Dakota, United States, 58701
    - GSK Investigational Site
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - GSK Investigational Site
  - Vandalia, Ohio, United States, 45377
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73103
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73104
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73112
    - GSK Investigational Site
  - Yukon, Oklahoma, United States, 73099
    - GSK Investigational Site
- South Carolina
  - Greenville, South Carolina, United States, 29601
    - GSK Investigational Site
  - Summerville, South Carolina, United States, 29486
    - GSK Investigational Site
- Texas
  - Amarillo, Texas, United States, 79124
    - GSK Investigational Site
  - Austin, Texas, United States, 78731
    - GSK Investigational Site
  - Austin, Texas, United States, 78745
    - GSK Investigational Site
  - Baytown, Texas, United States, 77521
    - GSK Investigational Site
  - Colleyville, Texas, United States, 76034
    - GSK Investigational Site
  - Dallas, Texas, United States, 75231
    - GSK Investigational Site
  - Houston, Texas, United States, 77084
    - GSK Investigational Site
  - Houston, Texas, United States, 77090
    - GSK Investigational Site
  - Houston, Texas, United States, 77065
    - GSK Investigational Site
  - Houston, Texas, United States, 77089
    - GSK Investigational Site
  - Lubbock, Texas, United States, 79410
    - GSK Investigational Site
  - Plano, Texas, United States, 75024
    - GSK Investigational Site
  - The Woodlands, Texas, United States, 77382
    - GSK Investigational Site
  - Tomball, Texas, United States, 77375
    - GSK Investigational Site
  - Waco, Texas, United States, 76710
    - 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

Inclusion Criteria:

Participants with rheumatoid arthritis who are aged >=18 years at the time of signing informed consent, who have completed one of the qualifying GSK3196165 clinical studies and who, in the opinion of the investigator, may benefit from treatment with GSK3196165.
Body weight >=40 kilograms (kg).
Male or female participants are eligible to participate as long as they meet the contraceptive eligibility criteria and agree to abide by the contraceptive requirements.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
For participants on methotrexate (MTX): must be willing to continue treatment with oral folic acid (at least 5 mg/week) or equivalent while receiving MTX (mandatory co-medication for MTX treatment).

Exclusion Criteria:

Had study intervention permanently discontinued at any time during a qualifying study except any participant with a new diagnosis of latent Mycobacterium tuberculosis (TB) at the end of study assessment in a qualifying study and currently undertaking or willing to complete at least 4 weeks of anti-TB treatment off study treatment, per world health organization (WHO) or national guidelines prior to re-commencing therapy and complete the remainder of anti-TB treatment while on study.
Evidence of latent TB (as documented by a positive QuantiFERON-TB Gold plus test or T-SPOT.TB test, no findings on medical history or clinical examination consistent with active TB, and a normal chest radiograph) except for participants that
- Are currently undertaking or willing to complete at least 4 weeks of anti-TB therapy off study treatment, as per WHO or national guidelines prior to re- commencing study treatment and agree to complete the remainder of anti-TB treatment while in the study or
- Had documented evidence of satisfactory anti-TB treatment as per WHO or national guidelines following review by a physician specializing in TB on entry to a qualifying study.
Current or previous active TB regardless of treatment.
Were temporarily discontinued from study intervention at the time of the final study visit of a qualifying study and, in the opinion of the investigator, participation in the extension study poses an unacceptable risk for the participant's participation.
A new cancer or malignancy except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured by the investigator.
Have developed any lymphoproliferative disorder during a qualifying study, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, or signs and symptoms suggestive of current lymphatic disease.
Have significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the participant's participation.
Participants who are expected to be non-compliant with restrictions on medications and vaccinations prior to the study, during the study or during the 8-week safety follow-up of the study.
Participants who are currently participating in any interventional clinical study other than a qualifying GSK3196165 clinical study.
Abnormal chest radiograph within the last 12 weeks judged by the investigator as clinically-significant.
Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
History of sensitivity to any of the study treatments, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

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: Otilimab 90 mg Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.	Biological: Otilimab (GSK3196165) GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC. Drug: csDMARD(s) Stable dose of csDMARD(s) as standard of care (SoC).
Experimental: Otilimab 150 mg Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.	Biological: Otilimab (GSK3196165) GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC. Drug: csDMARD(s) Stable dose of csDMARD(s) as standard of care (SoC).

Participant Group / Arm

Intervention / Treatment

Experimental: Otilimab 90 mg

Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.

Biological: Otilimab (GSK3196165)

GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

Drug: csDMARD(s)

Stable dose of csDMARD(s) as standard of care (SoC).

Experimental: Otilimab 150 mg

Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.

Biological: Otilimab (GSK3196165)

GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

Drug: csDMARD(s)

Stable dose of csDMARD(s) as standard of care (SoC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) Time Frame: Up to approximately 145 Weeks	An AE is defined as 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. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs were included.	Up to approximately 145 Weeks
Change From Baseline in Hematology Parameter of Platelet Count at Week 24 Time Frame: Baseline (Day 01) and Week 24	Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.	Baseline (Day 01) and Week 24
Change From Baseline in Hematology Parameter of Platelet Count at Week 48 Time Frame: Baseline (Day 01) and Week 48	Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.	Baseline (Day 01) and Week 48
Change From Baseline in Hematology Parameter of Platelet Count at Week 96 Time Frame: Baseline (Day 01) and Week 96	Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.	Baseline (Day 01) and Week 96
Change From Baseline in Hematology Parameter of Platelet Count at Week 144 Time Frame: Baseline (Day 01) and Week 144	Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.	Baseline (Day 01) and Week 144
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 Time Frame: Baseline (Day 01) and Week 24	Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.	Baseline (Day 01) and Week 24
Change From Baseline in Hematology Parameter of Hemoglobin at Week 48 Time Frame: Baseline (Day 01) and Week 48	Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.	Baseline (Day 01) and Week 48
Change From Baseline in Hematology Parameter of Hemoglobin at Week 96 Time Frame: Baseline (Day 01) and Week 96	Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.	Baseline (Day 01) and Week 96
Change From Baseline in Hematology Parameter of Hemoglobin at Week 144 Time Frame: Baseline (Day 01) and Week 144	Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.	Baseline (Day 01) and Week 144
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 Time Frame: Baseline (Day 01) and Week 24	Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.	Baseline (Day 01) and Week 24
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 Time Frame: Baseline (Day 01) and Week 48	Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.	Baseline (Day 01) and Week 48
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 Time Frame: Baseline (Day 01) and Week 96	Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.	Baseline (Day 01) and Week 96
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 Time Frame: Baseline (Day 01) and Week 144	Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.	Baseline (Day 01) and Week 144
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 Time Frame: Baseline (Day 01) and Week 24	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.	Baseline (Day 01) and Week 24
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 Time Frame: Baseline (Day 01) and Week 48	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.	Baseline (Day 01) and Week 48
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 Time Frame: Baseline (Day 01) and Week 96	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.	Baseline (Day 01) and Week 96
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 Time Frame: Baseline (Day 01) and Week 144	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.	Baseline (Day 01) and Week 144
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 Time Frame: Baseline (Day 01) and Week 24	Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides	Baseline (Day 01) and Week 24
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 Time Frame: Baseline (Day 01) and Week 48	Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides	Baseline (Day 01) and Week 48
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 Time Frame: Baseline (Day 01) and Week 96	Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides	Baseline (Day 01) and Week 96
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 Time Frame: Baseline (Day 01) and Week 144	Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides	Baseline (Day 01) and Week 144
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities Time Frame: Up to approximately 145 Weeks	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 approximately 145 Weeks
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24 Time Frame: Baseline (Day 01) and Week 24	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.	Baseline (Day 01) and Week 24
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48 Time Frame: Baseline (Day 01) and Week 48	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.	Baseline (Day 01) and Week 48
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96 Time Frame: Baseline (Day 01) and Week 96	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.	Baseline (Day 01) and Week 96
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144 Time Frame: Baseline (Day 01) and Week 144	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.	Baseline (Day 01) and Week 144

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 Time Frame: Week 24, 48, 96 and 144	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, 48, 96 and 144
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 Time Frame: Week 24, 48, 96 and 144	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, 48, 96 and 144
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 Time Frame: Week 24, 48, 96 and 144	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). PtGA is transformed to a 0-10 scale before computing the total score. 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, 48, 96 and 144
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 Time Frame: Week 24, 48, 96 and 132	The DAS28-ESR is a measure of RA disease activity calculated using TJC28,SJC28, ESR (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate 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, 48, 96 and 132
Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 Time Frame: Week 24, 48, 96 and 144	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. Simple Disease Activity Index based ACR/EULAR remission is achieved if a has SDAI <= 3.3. The SDAI is the sum of the tender/painful joint count and swollen joint count, employing 28 joints; PtGA and PhGA (on a scale of 0-10); and hsCRP (mg/L). Percentage values are rounded off.	Week 24, 48, 96 and 144
Absolute Values for Clinical Disease Activity Index (CDAI) Total Score Time Frame: Week 24, 48, 96 and 144	CDAI total score is a composite score consisting of the sum of TJC28, TJC28, PtGA (visual analogue scale with values from 0=best to 100=worst) and 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.	Week 24, 48, 96 and 144
Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) Time Frame: Week 24, 48, 96 and 144	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- PtGA is transformed to a 0-10 scale before computing the total score. CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity.	Week 24, 48, 96 and 144
Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Time Frame: Week 24, 48, 96 and 132	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). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity.	Week 24, 48, 96 and 132
Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS) Time Frame: Week 24 and 48	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.	Week 24 and 48
Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) Time Frame: Week 24, 48, 96 and 144	The HAQ-DI includes 20 questions which assesses difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming, Hygiene, Arising, Reach, Eating, Grip, Walking, Common Daily Activities. The questions assess domain scores ranging from 0 "without any difficulty" to 3 "unable to do." Scores on each domain were summed and averaged to provide an overall score ranging from 0 to 3, where higher score reflected worse status and a lower score indicates better quality of life.	Week 24, 48, 96 and 144
Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) Time Frame: Week 24, 48, 96 and 144	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.	Week 24, 48, 96 and 144
Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) Time Frame: Week 24, 48, 96 and 144	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. Quality Metric software was used for scoring.	Week 24, 48, 96 and 144
Absolute Values SF-36 Domain Scores Time Frame: Week 24, 48, 96 and 144	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. Quality Metric software was used for scoring for SF-36.	Week 24, 48, 96 and 144
Absolute Values SF-36 Physical Component Scores (PCS) Time Frame: Week 24, 48, 96 and 144	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. Quality Metric software was used for scoring.	Week 24, 48, 96 and 144
Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Time Frame: Week 24, 48, 96 and 144	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.	Week 24, 48, 96 and 144
Number of Participants With Anti-GSK3196165 Antibodies Time Frame: Week 120	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	Week 120

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

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)

May 12, 2020

Primary Completion (Actual)

February 24, 2023

Study Completion (Actual)

February 24, 2023

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

209564

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.

Clinical Trials on Arthritis, Rheumatoid

Janssen Research & Development, LLC

Withdrawn

A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With Methotrexate

Active Rheumatoid Arthritis; Rheumatoid Arthritis
Centocor, Inc.

Completed

A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis

Rheumatoid Arthritis, Juvenile
Yuanyuan Zhang

Recruiting

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis (RA) | Rheumatoid Arthritis-Associated Interstitial Lung Disease | Difficult-to-Treat Rheumatoid Arthritis

China
Amgen

Terminated

Etanercept Plus Methotrexate Versus Methotrexate Alone in Children With Polyarticular Course Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis
Children's Hospital Medical Center, Cincinnati
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Completed

Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis

United States
Amgen
Immunex Corporation

Completed

Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis
Assistance Publique - Hôpitaux de Paris
Societe Francaise de Rhumatologie

Recruiting

French National Registry: ART REGISTRY (Observational Study) (ART)

RheumatoId Arthritis

France
University Hospital, Toulouse

Completed

Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients (STAR)

RheumatoId Arthritis

France
Amsterdam UMC, location VUmc
European Commission

Completed

The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (Gloria)

RheumatoId Arthritis

Netherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
David Grant U.S. Air Force Medical Center

Completed

The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis

RheumatoId Arthritis

United States

Clinical Trials on Otilimab (GSK3196165)

GlaxoSmithKline
IQVIA Pty Ltd

Completed

Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors (contRAst 3)

Arthritis, Rheumatoid

United States, Germany, Canada, Czechia, Poland, South Africa, Korea, Republic of, Spain, Japan, Argentina, Belgium, Hungary, United Kingdom, Italy, Lithuania
GlaxoSmithKline

Withdrawn

A Study in Healthy Japanese Participants to Evaluate the Safety and Pharmacokinetics of Otilimab

Arthritis, Rheumatoid
GlaxoSmithKline
IQVIA Pty Ltd

Terminated

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)

Arthritis, Rheumatoid

United States, Australia, Germany, Japan, Korea, Republic of, Poland, Bulgaria, Estonia, Hungary, Mexico, Russian Federation, Spain, Thailand, Colombia, China, Argentina, United Kingdom, France
GlaxoSmithKline

Completed

A Study to Investigate the Efficacy and Safety of GSK3196165 in Inflammatory Hand Osteoarthritis

Osteoarthritis

Netherlands, United States, Germany, United Kingdom, Poland
GlaxoSmithKline
IQVIA Pty Ltd

Completed

Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (contRAst 1)

Arthritis, Rheumatoid

Hungary, Poland, Malaysia, Spain, China, Russian Federation, India, United Kingdom, Italy, Serbia
GlaxoSmithKline

Completed

Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease (OSCAR)

Severe Acute Respiratory Syndrome

United States, Russian Federation, Peru, Netherlands, Spain, South Africa, United Kingdom, Argentina, Brazil, France, Canada, Mexico, Poland, Belgium, India, Japan, Chile, Colombia, Italy
GlaxoSmithKline

Completed

Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

Japan
GlaxoSmithKline
Parexel

Completed

Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Germany, United States, Poland
Sebastian Videla
Institut d'Investigació Biomèdica de Bellvitge; Institut Català de la Salut

Withdrawn

ANGIOTENSIN AGENTS AND REDUCTION OF THE PRESCRIPTION OF ANTIDEPRESSANT DRUGS: A RETROSPECTIVE COHORT STUDY USING REAL-WORLD DATA

Depression | Hypertension | ACE Inhibitors | ARB

Spain
GlaxoSmithKline

Completed

Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

Ukraine, Bulgaria, Canada, Czechia, Estonia, Germany, Hungary, Italy, Mexico, Poland, Russian Federation, South Africa, Spain, United Kingdom

Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA) (contRAst X)

A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis

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 Otilimab (GSK3196165)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations