Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX (ORAL1069)

Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: CP-690,550; Drug: CP-690,550; Drug: Disease-modifying antirheumatic drug

• Study Type: Interventional
• Enrollment (Actual): 956
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1015ABO
    • OMI - Organización Médica de Investigación
  • Buenos Aires, Argentina, C1034ACO
    • Saint Dennis Medical Group S.A.
  • Buenos Aires, Argentina, C1428DZF
    • Consultorios Reumatológicos Pampa
• Australia
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Rheumatology Research Unit Sunshine Coast
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital, Department of Rheumatology
  • Victoria
    • Malvern East, Victoria, Australia, 3145
      • Emeritus Research
• Belgium
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent - Reumatologie
• Brazil
  • Rio de Janeiro, Brazil, 22271-100
    • CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda
  • GO
    • Goiania, GO, Brazil, 74110-120
      • CIP - Centro Internacional de Pesquisas
    • Goiania, GO, Brazil, 74115-030
      • Clinica de Raios X Nabyh Salum S/S - Clinica Sao Matheus
  • PR
    • Curitiba, PR, Brazil, 80060-240
      • Centro de Estudos em Terapias Inovadoras
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital São Lucas da PUCRS
  • SP
    • Sao Paulo, SP, Brazil, 04266-010
      • CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Revmatologichno Otdelenie, MBAL - Plovdiv
  • Ruse, Bulgaria, 7002
    • MBAL-Ruse, AD, IV Terapevtichno i kardiologichno otdelenie
  • Sofia, Bulgaria, 1612
    • MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia
  • Sofia, Bulgaria, 1606
    • MBAL na Voennomeditsinska Akademia - Sofia, Klinika po Revmatologia i Kardiologia
  • Sofia, Bulgaria, 1709
    • DKTs "Sveta Anna", Sofia; Konsultativen kabinet po Revmatologia
  • Veliko Tarnovo, Bulgaria, 5000
    • MOBAL "D-r Stefan Cherkezov" AD, Revmokardiologichno otdelenie s intenziven sektor
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5M 0H4
      • Rheumatology Research Associates Ltd.
  • British Columbia
    • Victoria, British Columbia, Canada, V8V 3P9
      • PerCuro Clinical Research Ltd.
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
      • Manitoba Clinic
  • Ontario
    • Burlington, Ontario, Canada, L7L 0B7
      • Burlington Rheumatology and Osteoporosis Clinic
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Dr. William G. Bensen Medicine Professional Corporation
    • Hamilton, Ontario, Canada, L8N 2B6
      • MAC Research Inc.
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Office of Dr. Fernando Bianchi
    • Kitchener, Ontario, Canada, N2M 5N6
      • KW Musculoskeletal Research Inc.
    • Ottawa, Ontario, Canada, K1H 1A2
      • Rheumatology Research Associates
    • St. Catharines, Ontario, Canada, L2N 7E4
      • Niagara Peninsula Arthritis Centre
    • Windsor, Ontario, Canada, N8X 5A6
      • Clinical Research and Arthritis Centre
    • Windsor, Ontario, Canada, N8X 1K7
      • Windsor Radiological Associates
• Chile
  • Rancagua, Chile, 2841959
    • Hospital Regional de Rancagua
  • IX Region
    • Temuco, IX Region, Chile, 4790928
      • Consulta Privada Dra. Lucia Ponce
  • RM
    • Santiago, RM, Chile, 7501126
      • Centro de Estudios Reumatologicos
    • Santiago, RM, Chile, 7510186
      • Consulta Privada Dra. Marta Aliste
  • V Region
    • Vina del Mar, V Region, Chile, 2570017
      • Estudios Clinicos V Region
• Colombia
  • Atlantico
    • Barranquilla, Atlantico, Colombia
      • Centro de Reumatologia y Ortopedia
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 0000
      • Centro Integral de Reumatologia e Inmunologia CIREI
  • Santander
    • Bucaramanga, Santander, Colombia
      • Servimed E.U
• Costa Rica
  • Cartago, Costa Rica, 00000
    • Centro de Reumatología y Osteoporosis, Cartago
  • San Jose, Costa Rica, 00000
    • Hospital CIMA San Jose
• Czechia
  • Brno, Czechia, 62500
    • Fakultní Nemocnice Brno
  • Brno - Zidenice, Czechia, 61500
    • Revmacentrum MUDr. Mostera, s.r.o.
  • Hradec Kralove, Czechia, 50005
    • Fakultni nemocnice Hradec Kralove
  • Ostrava-Poruba, Czechia, 70800
    • Revmatologicka ambulance
  • Praha 2, Czechia, 128 50
    • Revmatologicky Ustav
  • Praha 4, Czechia, 140 00
    • Revmatologicka ambulance
• Dominican Republic
  • Santo Domingo, Dominican Republic, 00000
    • Patricia Alvarez Site
• Germany
  • Aachen, Germany, 52064
    • Privat-Praxis, Rheumatologie (P515)
  • Berlin, Germany, 14059
    • Schlosspark-Klinik
  • Erlangen, Germany, 91054
    • Studienambulanz, Medizinische Klinik 3 Universitaetsklinikum Erlangen
  • Halle, Germany, 06108
    • Schwerpunktpraxis Rheumatologie FAE Innere Medizin
  • Hamburg, Germany, 22081
    • Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie
  • Nuernberg, Germany, 90429
    • Arztpraxis, Internist - Rheumatologie
  • Ratingen, Germany, 40882
    • Rheumaforschung - Studienambulanz Dr. Wassenberg
  • Rheine, Germany, 48431
    • Schwerpunktpraxis fuer Rheumatologie
• Hungary
  • Balatonfüred, Hungary, 8230
    • Drug Research Center Kft. Reumatologiai Szakrendeles
  • Budapest, Hungary, 1027
    • Revita Reumatologiai Rendelo
  • Budapest, Hungary, H-1036
    • Synexus Magyarorszag Kft.
  • Mezokovesd, Hungary, 3400
    • Mozgasszervi Rehabilitacios Kozpont, Reumatologiai szakrendeles
  • Szolnok, Hungary, H-5000
    • MAV Korhaz es Rendelointezet
• India
  • Ahmedabad, India, 380015
    • Shalby Hospital
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500 004
      • Mahavir Hospital & Research Center
    • Secunderabad, Andhra Pradesh, India, 500003
      • Department of rheumatology
  • Gujarat
    • Ahmedabad, Gujarat, India, 380009
      • Rheumatic Disease Clinic
  • Karnataka
    • Bangalore, Karnataka, India, 560 054
      • Shirdi Sai Hospital
  • Maharashtra
    • Pune, Maharashtra, India, 411 001
      • Jehangir Clinical Development Centre Pvt. Ltd.
    • Pune, Maharashtra, India, 411 001
      • Arthritis Research and Care Foundation
• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital, Rheumatology, Internal Medicine
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center, Rheumatology, Internal Medicine
• Malaysia
  • Kuching, Malaysia, 93586
    • Sarawak General Hospital
  • Negeri Sembilan
    • Seremban, Negeri Sembilan, Malaysia, 70300
      • Hospital Tuanku Ja'afar
  • Selangor Darul Ehsan
    • Petaling Jaya, Selangor Darul Ehsan, Malaysia, 46150
      • Sunway Medical Centre
• Mexico
  • Coahuila
    • Torreon, Coahuila, Mexico, 27000
      • Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44620
      • Unidad de Investigacion en Enfermedades Cronico Degenerativas
    • Guadalajara, Jalisco, Mexico, 44158
      • Instituto Jaliscience de Investigación Clínica SA de CV
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64020
      • Hospital Universitario Jose Eleuterio Gonzalez
• New Zealand
  • Christchurch, New Zealand, 8022
    • The Canterbury Geriatric Medical Research Trust, c/- The Princess Margaret Hospital
  • Hamilton, New Zealand, 3204
    • Ryburns Building, Waikato Hospital
  • Timaru, New Zealand, 7910
    • Timaru Hospital, Clinical Trials Unit
  • Auckland
    • Otahuhu, Auckland, New Zealand, 1640
      • Centre for Clinical Research and Effective Practice (CCREP Middlemore Hospital
• Peru
  • Callao, Peru, C-02
    • Hospital Nacional IV Alberto Sabogal Sologuren
  • Lima, Peru, L-27
    • Instituto Peruano del Hueso y la Articulacion SAC-Privado-Lima/Centro de Investigacion IPHAR
  • Lima, Peru, L 27
    • Clinica Anglo Americana
  • Lima, Peru, L-27
    • Centro Medico Corpac
• Philippines
  • Cebu City, Philippines, 6000
    • Chong Hua Hospital
  • Davao City, Philippines, 8000
    • Brokenshire Integrated Health Ministries, Inc. Brokenshire Memorial Hospital
  • Manila, Philippines, 1003
    • Rayuma Klinik, OPD Department, Jose R. Reyes Memorial Medical Center
• Poland
  • Gdynia, Poland, 81-367
    • Przychodnia Medyczna Lekarskiej Spoldzielni Pracy
  • Gdynia, Poland, 81-384
    • Centrum Leczenia Chorob Cywilizacyjnych Sp. z.o.o. SKA Oddzial Gdynia
  • Katowice, Poland, 40-748
    • Centrum Leczenia Chorob Cywilizacyjnych Sp. z o.o. SKA Oddzial Katowice
  • Warszawa, Poland, 01-192
    • Synexus SCM Sp. z o.o. Oddzial Warszawa
  • Warszawa, Poland, 02-118
    • Rheuma Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce School of Medicine
  • Ponce, Puerto Rico, 00717-1321
    • Edificio Parra
• Russian Federation
  • Barnaul, Russian Federation, 656024
    • State Healthcare Institution Regional Clinical Hospital
  • Ekaterinburg, Russian Federation, 620102
    • State Healthcare Institution
  • Ekaterinburg, Russian Federation, 620149
    • State Educational Institution of Higher Professional Education
  • Ekaterinburg, Russian Federation, 620109
    • Ltd. Medical Association "Novaya Bolnitsa" (X-Ray Only)
  • Kemerovo, Russian Federation, 650099
    • State Healthcare Institution Regional Clinical Hospital for War Veterans
  • Novosibirsk, Russian Federation, 630055
    • Federal State Institution named after Academician E.N. Meshalkin, Novosibirsk State Research
  • Novosibirsk, Russian Federation, 630117
    • Scientific Research Institute of Clinical and Experimental Lymphology of the Siberian Branch of RAMS
  • Saint Petersburg, Russian Federation, 197341
    • Almazov Federal Heart, Blood and Endocrinology Centre
  • Smolensk, Russian Federation, 214019
    • Smolensk State Medical Academy, Clinical Research Centre of Diagnostic Medicine and Drugs
  • St. Petersburg, Russian Federation, 194291
    • Clinical Hospital #122 named after L.G. Sokolov of the Federal Medical-Biological Agency
  • St. Petersburg, Russian Federation, 198260
    • St. Petersburg State Institution of Healthcare Consultative-diagnostic Center #85
  • St. Petersburg, Russian Federation, 190068
    • State Health Institution City Hospital # 25, City Rheumatology Center of St. Petersburg
  • St. Petersburg, Russian Federation, 197706
    • State Healthcare Institution City Hospital # 40 of Administrative Health Resort District
  • Tomsk, Russian Federation, 634063
    • Regional State Healthcare Institution of Tomsk Regional Clinical Hospital
• Slovakia
  • Bratislava, Slovakia, 81108
    • Reumatolog s.r.o.
  • Dunajska Streda, Slovakia, 92901
    • AAGS, s.r.o. , nestatne zdravotnicke zariadenie
  • Nove Zamky, Slovakia, 94001
    • Reumatologicka ambulancia, Ecclesia, s.r.o.
  • Piestany, Slovakia, 921 12
    • Narodny ustav reumatickych chorob
  • Zilina, Slovakia, 010 01
    • Neštátna Reumatologická Ambulancia
• Spain
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Malaga, Spain, 29009
    • Hospital Civil. Hospital Regional Universitario Carlos Haya
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15705
      • Hospital Nuestra Señora de La Esperanza
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital De Basurto
• Sweden
  • Malmo, Sweden, 205 02
    • Skånes Universitetssjukhus i Malmö
  • Sundsvall, Sweden, 851 86
    • Sundsvalls sjukhus- Medicinkliniken
  • Uppsala, Sweden, 751 85
    • Akademiska sjukhuset, Reumatologmottagningen
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Chung-Ho Memorial Hospital, Kaohsiung Medical University
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital, Mahidol University
  • Bangkok, Thailand, 10400
    • Rheumatology Unit, Department of Internal Medicine, Rajavithi Hospital
  • Bangkok
    • Phayathai, Bangkok, Thailand, 10400
      • Rheumatology Unit, Department of Internal Medicine, Phramongkutklao Hospital
• Ukraine
  • Kyiv, Ukraine, 04053
    • State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"
  • Kyiv, Ukraine, 04114
    • State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"
  • Lviv, Ukraine, 79011
    • Municipal City Clinical Hospital #4, Department of Rheumatology
  • Odesa, Ukraine, 65026
    • Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology
  • Vinnitsa, Ukraine, 21018
    • Vinnitsa Regional Clinical Hospital n.a. M.I. Pirogov
  • Crimea
    • Simferopol, Crimea, Ukraine, 95017
      • CRI "Clinical Territorial Medical Association "University Clinic", Department of Rheumatology
• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Catalina Pointe Clinical Research, Inc.
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Diagnostic Clinic
  • California
    • La Jolla, California, United States, 92037-0943
      • University of California San Diego Perlman Ambulatory Clinic
    • La Jolla, California, United States, 92093 0943
      • University of California San Diego Center for Innovative Therapy
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC
    • Los Angeles, California, United States, 90033
      • USC Keck School of Medicine
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles (UCLA)
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC, Lower Level Pharmacy
  • Florida
    • Gainesville, Florida, United States, 32607
      • Southeastern Arthritis Center
    • Gainesville, Florida, United States, 32607
      • Southeastern Imaging and Diagnostics
    • Gainesville, Florida, United States, 32607
      • Southeastern Integrated Medical, PL dba Florida Medical Research
    • Miami, Florida, United States, 33173
      • Center for Arthritis and Rheumatic Diseases
    • Sarasota, Florida, United States, 34239
      • Sarasota Arthritis Research Center
    • Tamarac, Florida, United States, 33321
      • West Broward Rheumatology Associates, Inc.
    • Tampa, Florida, United States, 33614
      • Burnette & Silverfield, MDS PLC
    • Tampa, Florida, United States, 33613
      • Bernard F. Germain, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46227
      • Diagnostic Rheumatology And Research, PC
  • Iowa
    • Dubuque, Iowa, United States, 52002
      • Medical Associates Clinic, PC
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Louisiana State University Health Sciences
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Clinical Pharmacology Study Group
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Physician Research Collaboration, LLC
  • New York
    • Albany, New York, United States, 12206
      • The Center for Rheumatology
    • Rochester, New York, United States, 14618
      • AAIR Research Center
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • PMG Research of Hickory, LLC
    • Hickory, North Carolina, United States, 28602
      • PMG Research of Hickory, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Wyomissing, Pennsylvania, United States, 19610
      • Clinical Research Center of Reading, LLP
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina Investigational Drug Services
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina - Rheumatology
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Arthritis Clinic
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Rheumatology Research
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • Fort Worth, Texas, United States, 76107
      • University of North Texas Health Science Center at Fort Worth
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98101
      • Investigational Drug Service
  • West Virginia
    • Clarksburg, West Virginia, United States, 26301
      • Mountain State Clinical Research
    • Clarksburg, West Virginia, United States, 26301
      • United Hospital Center (Imaging Only)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
• Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
• Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL

Exclusion Criteria:

• Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
• History of any other rheumatic autoimmune disease other than Sjogren's syndrome
• No malignancy or history of malignancy
• History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
• No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 5 mg BID CP-690,550	Drug: CP-690,550; Oral tablets administered at a dose of 5 mg BID for 24 months; Drug: CP-690,550; Oral tablets administered at a dose of 10 mg BID for 24 months
EXPERIMENTAL: 10 mg BID CP-690,550	Drug: CP-690,550; Oral tablets administered at a dose of 5 mg BID for 24 months; Drug: CP-690,550; Oral tablets administered at a dose of 10 mg BID for 24 months
ACTIVE_COMPARATOR: methotrexate	Drug: Disease-modifying antirheumatic drug; Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months; Other Names: DMARD, MTX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Total Sharp Score (mTSS) at Month 6	mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).	Month 6
Change From Baseline at Month 6 in mTSS	mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.	Month 6
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6	ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire [HAQ]), and 5) C-reactive protein (CRP).	Month 6
Absolute Blood Pressure (BP) Values (mmHg)	BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Change From Baseline in BP Values (mmHg)	BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.	Months 1, 2, 3, 6, 9, 12, 15, 18, and 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mTSS Score at Baseline, Months 12 and 24	mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).	Baseline, Months 12 and 24
Change From Baseline in mTSS Score at Months 12 and 24	mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.	Months 12 and 24
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24	mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (≤)0.5 in mTSS is considered to be no progression in the mTSS.	Months 6, 12, and 24
Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24	Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of ≤0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.	Months 6, 12, and 24
Erosion Scores	Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.	Baseline, Months 6, 12, and 24
JSN Scores	JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.	Baseline, Months 6, 12, and 24
Change From Baseline in Erosion Scores	Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.	Months 6, 12, and 24
Change From Baseline in JSN Scores	JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.	Months 6, 12, and 24
Percentage of Participants Achieving an ACR70 Response	ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 1, 2, 3, 9, 12, 15, 18, 21, and 24
Percentage of Participants Achieving an ACR20 Response	ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants Achieving an ACR50 Response	ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Tender Joints Count (TJC)	Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in TJC	Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Swollen Joints Count (SJC)	Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in SJC	Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Patient Assessment of Arthritis Pain	Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm=no pain and 100 mm=most severe pain.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in Patient Assessment of Arthritis Pain	Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm=no pain and 100 mm=most severe pain.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Physician Global Assessment of Arthritis	Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in Physician Global Assessment of Arthritis	Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Patient Global Assessment of Arthritis	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in Patient Global Assessment of Arthritis	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
C-Reactive Protein	CRP measured in milligrams per liter (mg/L)	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in CRP	Change from Baseline in CRP measured in mg/L.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP	DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (≤)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) less than (<)2.6 = remission.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])	DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour [mm/hour]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in DAS28-3(CRP)	DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in DAS28-4(ESR)	DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With DAS28-3(CRP) ≤3.2	DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With DAS28-4(ESR) ≤3.2	DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With DAS28-3(CRP) <2.6	DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With DAS28-4(ESR) <2.6	DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)	DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)	DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With an ACR70 Response Sustained at Least 6 Months	ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits	ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits	ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits	ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.	Months 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits	DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.	Months 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits	DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.	Months 3, 6, 9, 12, 15, 18, 21, and 24
Health Assessment Questionnaire Disability Index (HAQ-DI)	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in HAQ-DI Score	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Short Form 36 (SF-36) Mental Component Score	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
SF-36 Physical Component Score	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in SF-36 Mental Component Score	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in SF-36 Physical Component Score	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
SF-36 Domain Scores	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in SF-36 Domain Scores	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Work Limitation Questionnaire (WLQ) Score	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).	Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in WLQ Scores	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).	Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
WLQ Work Loss Index Score	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).	Baseline and Months 3, 6, and 12
Change From Baseline in WLQ Work Loss Index Score	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).	Months 3, 6, 12, 15, 18, 21, and 24
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline and Months 3, 6, 12, 18, and 24
Change From Baseline in EQ-5D Health State Profile Utility Score	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Months 3, 6, 12, 18, and 24
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6	Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.	Baseline and Months 3 and 6
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24	RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.	Months 12, 18, and 24
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.	Baseline and Months 3 and 6
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.	Months 12, 18, and 24
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.	Baseline and Months 3 and 6
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.	Months 12, 18, and 24
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6	RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.	Baseline and Months 3 and 6
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24	RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.	Months 12, 18, and 24
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU	Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.	Baseline, Months 3, 6, 12, 18, and 24
Change From Baseline in Work Productivity and HCRU at Months 3 and 6	RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.	Months 3 and 6
Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24	RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.	Months 12, 18, and 24
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.	Months 3 and 6
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24	RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.	Months 12, 18, and 24
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6	RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.	Months 3 and 6
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24	RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.	Months 12, 18, and 24
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6	RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.	Months 3 and 6
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24	RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.	Months 12, 18, and 24
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU	Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.	Months 3, 6, 12, 18, and 24
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3	Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.	Baseline and Months 1, 2, and 3
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported	Months 1, 2, 3, 6, 12, 18, and 24
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24	Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.	Months 6, 12, 18, and 24
Change From Baseline in MOS-SS at Months 1, 2, and 3	Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.	Months 1, 2, and 3
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24	Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.	Months 6, 12, 18, and 24
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale	FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status	Baseline and Months 1, 2, 3, 6, 12, 18, and 24
Change From Baseline in FACIT-Fatigue Scale	FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status	Months 1, 2, 3, 6, 12, 18, and 24
Change From Baseline in Heart Rate		Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in Temperature		Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:
• Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
• Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
• Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
• Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
• Dikranian AH, Gonzalez-Gay MA, Wellborne F, Alvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1):e002103. doi: 10.1136/rmdopen-2021-002103.
• Bykerk VP, Lee EB, van Vollenhoven R, Gruben DC, Fallon L, Woolcott JC, Keystone E. Identification of Distinct Disease Activity Trajectories in Methotrexate-Naive Patients With Rheumatoid Arthritis Receiving Tofacitinib Over Twenty-Four Months. Arthritis Care Res (Hoboken). 2022 Jan;74(1):131-141. doi: 10.1002/acr.24709.
• Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7.
• van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476.
• Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.
• Strand V, Kavanaugh A, Kivitz AJ, van der Heijde D, Kwok K, Akylbekova E, Soonasra A, Snyder M, Connell C, Bananis E, Smolen JS. Long-Term Radiographic and Patient-Reported Outcomes in Patients with Rheumatoid Arthritis Treated with Tofacitinib: ORAL Start and ORAL Scan Post-hoc Analyses. Rheumatol Ther. 2018 Dec;5(2):341-353. doi: 10.1007/s40744-018-0113-7. Epub 2018 May 14.
• van Vollenhoven RF, Lee EB, Fallon L, Zwillich SH, Wilkinson B, Chapman D, DeMasi R, Keystone E. Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity and the Probability of Achieving Low Disease Activity at Month 6. Arthritis Care Res (Hoboken). 2019 Jan;71(1):71-79. doi: 10.1002/acr.23585.
• Fleischmann RM, Huizinga TW, Kavanaugh AF, Wilkinson B, Kwok K, DeMasi R, van Vollenhoven RF. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. RMD Open. 2016 Jul 26;2(2):e000262. doi: 10.1136/rmdopen-2016-000262. eCollection 2016.
• Fleischmann R, Strand V, Wilkinson B, Kwok K, Bananis E. Relationship between clinical and patient-reported outcomes in a phase 3 trial of tofacitinib or MTX in MTX-naive patients with rheumatoid arthritis. RMD Open. 2016 Apr 26;2(1):e000232. doi: 10.1136/rmdopen-2015-000232. eCollection 2016.
• Lee EB, Fleischmann R, Hall S, Wilkinson B, Bradley JD, Gruben D, Koncz T, Krishnaswami S, Wallenstein GV, Zang C, Zwillich SH, van Vollenhoven RF; ORAL Start Investigators. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014 Jun 19;370(25):2377-86. doi: 10.1056/NEJMoa1310476.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2010
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: December 23, 2009
• First Submitted That Met QC Criteria: December 23, 2009
• First Posted (ESTIMATE): December 25, 2009

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: clinical trial; rheumatic diseases; DMARD; joint diseases; autoimmune diseases; MTX; oral JAK inhibitor; anti-Inflammatory agents
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib; Antirheumatic Agents
• Other Study ID Numbers: A3921069; 2009-016987-34 (EUDRACT_NUMBER)