A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: CP-690,550; Drug: CP-690,550; Drug: CP-690,550; Drug: CP-690,550; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Pfizer Investigational Site
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • Pfizer Investigational Site
  • Victoria
    • Malvern East, Victoria, Australia, 3145
      • Pfizer Investigational Site
• Brazil
  • GO
    • Goiania, GO, Brazil, 74110-120
      • Pfizer Investigational Site
  • PR
    • Curitiba, PR, Brazil, 80060-240
      • Pfizer Investigational Site
  • RJ
    • Rio de Janeiro, RJ, Brazil, 22271-100
      • Pfizer Investigational Site
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Pfizer Investigational Site
    • Porto Alegre, RS, Brazil, 90035-903
      • Pfizer Investigational Site
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Pfizer Investigational Site
  • SP
    • Sao Paulo, SP, Brazil, 04266-010
      • Pfizer Investigational Site
    • Sao Paulo, SP, Brazil, 05437-010
      • Pfizer Investigational Site
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • Pfizer Investigational Site
  • Plovdiv, Bulgaria, 4000
    • Pfizer Investigational Site
  • Sofia, Bulgaria, 1606
    • Pfizer Investigational Site
  • Sofia, Bulgaria, 1709
    • Pfizer Investigational Site
• Canada
  • Quebec, Canada, G1V 3M7
    • Pfizer Investigational Site
  • Alberta
    • Edmonton, Alberta, Canada, T5M 0H4
      • Pfizer Investigational Site
  • British Columbia
    • Victoria, British Columbia, Canada, V8V 3P9
      • Pfizer Investigational Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 5E8
      • Pfizer Investigational Site
  • Ontario
    • Hamilton, Ontario, Canada, L8N 2B6
      • Pfizer Investigational Site
    • Newmarket, Ontario, Canada, L3Y 3R7
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M5T 3L9
      • Pfizer Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H2L 1S6
      • Pfizer Investigational Site
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Pfizer Investigational Site
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 0000
      • Pfizer Investigational Site
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Pfizer Investigational Site
  • Santander
    • Bucaramanga, Santander, Colombia
      • Pfizer Investigational Site
• Czech Republic
  • Brno, Czech Republic, 61300
    • Pfizer Investigational Site
  • Brno - Zidenice, Czech Republic, 615 00
    • Pfizer Investigational Site
  • Hostivice, Czech Republic, 253 01
    • Pfizer Investigational Site
  • Pardubice, Czech Republic, 530 02
    • Pfizer Investigational Site
  • Praha 1, Czech Republic, 11000
    • Pfizer Investigational Site
  • Praha 11 - Chodov, Czech Republic, 148 00
    • Pfizer Investigational Site
  • Praha 2, Czech Republic, 128 50
    • Pfizer Investigational Site
  • Zlin, Czech Republic, 760 01
    • Pfizer Investigational Site
• Greece
  • Thessaloniki, Greece, 54 636
    • Pfizer Investigational Site
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500 004
      • Pfizer Investigational Site
    • Secunderabad, Andhra Pradesh, India, 500003
      • Pfizer Investigational Site
  • Andra Pradesh
    • Hyderabad, Andra Pradesh, India, 500 004
      • Pfizer Investigational Site
  • Karnataka
    • Bangalore, Karnataka, India, 560 034
      • Pfizer Investigational Site
    • Bangalore, Karnataka, India, 560 079
      • Pfizer Investigational Site
    • Mangalore, Karnataka, India, 575 001
      • Pfizer Investigational Site
  • Maharashtra
    • Pune, Maharashtra, India, 411 001
      • Pfizer Investigational Site
• Japan
  • Shinjuku-ku, Tokyo, Japan
    • Pfizer Investigational Site
  • Fukuoka
    • Kitakyusyu, Fukuoka, Japan
      • Pfizer Investigational Site
  • Hiroshima
    • Higashihiroshima, Hiroshima, Japan
      • Pfizer Investigational Site
  • Ibaraki
    • Hitachi-shi, Ibaraki, Japan
      • Pfizer Investigational Site
  • Kanagawa
    • Sagamihara, Kanagawa, Japan
      • Pfizer Investigational Site
  • Kumamoto
    • Koushi, Kumamoto, Japan
      • Pfizer Investigational Site
  • Miyagi
    • Sendai, Miyagi, Japan
      • Pfizer Investigational Site
  • Nagasaki
    • Ohmura, Nagasaki, Japan
      • Pfizer Investigational Site
    • Sasebo, Nagasaki, Japan
      • Pfizer Investigational Site
  • Saga
    • Ureshino-shi, Saga, Japan
      • Pfizer Investigational Site
  • Saitama
    • Kawagoe-shi, Saitama, Japan
      • Pfizer Investigational Site
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan
      • Pfizer Investigational Site
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan
      • Pfizer Investigational Site
    • Shinjuku-ku, Tokyo, Japan
      • Pfizer Investigational Site
• Korea, Republic of
  • Daejeon, Korea, Republic of, 302-799
    • Pfizer Investigational Site
  • Incheon, Korea, Republic of, 400-711
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 120-752
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 138-736
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 110-744
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 137-701
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 133-792
    • Pfizer Investigational Site
• Mexico
  • DF
    • Mexico, DF, Mexico, 14000
      • Pfizer Investigational Site
  • Michoacan
    • Morelia, Michoacan, Mexico, 58070
      • Pfizer Investigational Site
• Poland
  • Warszawa, Poland, 02-256
    • Pfizer Investigational Site
  • Wroclaw, Poland, 50-088
    • Pfizer Investigational Site
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Pfizer Investigational Site
  • Kweishan, Taoyuan County, Taiwan, 333
    • Pfizer Investigational Site
  • Taichung, Taiwan, 407
    • Pfizer Investigational Site
  • Tainan, Taiwan, 704
    • Pfizer Investigational Site
  • Taipei, Taiwan, 100
    • Pfizer Investigational Site
  • Taipei, Taiwan, 112
    • Pfizer Investigational Site
• Ukraine
  • Kharkiv, Ukraine, 61178
    • Pfizer Investigational Site
  • Kyiv, Ukraine, 04114
    • Pfizer Investigational Site
  • Lviv, Ukraine, 79011
    • Pfizer Investigational Site
  • Vinnitsa, Ukraine, 21018
    • Pfizer Investigational Site
  • Crimea
    • Simferopol, Crimea, Ukraine, 95017
      • Pfizer Investigational Site
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Pfizer Investigational Site
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Pfizer Investigational Site
  • California
    • San Diego, California, United States, 92108
      • Pfizer Investigational Site
    • Santa Maria, California, United States, 93454
      • Pfizer Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • Pfizer Investigational Site
  • Florida
    • Gainesville, Florida, United States, 32607
      • Pfizer Investigational Site
    • Jacksonville, Florida, United States, 32216
      • Pfizer Investigational Site
    • Sarasota, Florida, United States, 34239
      • Pfizer Investigational Site
    • Tampa, Florida, United States, 33614
      • Pfizer Investigational Site
    • Zephyrhills, Florida, United States, 33542
      • Pfizer Investigational Site
  • Illinois
    • Morton Grove, Illinois, United States, 60053
      • Pfizer Investigational Site
  • Iowa
    • Dubuque, Iowa, United States, 52002
      • Pfizer Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21224-6821
      • Pfizer Investigational Site
    • Wheaton, Maryland, United States, 20902
      • Pfizer Investigational Site
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Pfizer Investigational Site
  • Michigan
    • Bingham Farms, Michigan, United States, 48025
      • Pfizer Investigational Site
    • Kalamazoo, Michigan, United States, 49048
      • Pfizer Investigational Site
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Pfizer Investigational Site
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Pfizer Investigational Site
    • Columbia, Missouri, United States, 65212
      • Pfizer Investigational Site
    • Lee's Summit, Missouri, United States, 64086
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Pfizer Investigational Site
    • Omaha, Nebraska, United States, 68134
      • Pfizer Investigational Site
  • New York
    • Albany, New York, United States, 12206
      • Pfizer Investigational Site
    • Binghamton, New York, United States, 13905
      • Pfizer Investigational Site
    • Syracuse, New York, United States, 13210
      • Pfizer Investigational Site
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Pfizer Investigational Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Pfizer Investigational Site
    • Wyomissing, Pennsylvania, United States, 19610
      • Pfizer Investigational Site
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • Pfizer Investigational Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37909-1900
      • Pfizer Investigational Site
  • Texas
    • Dallas, Texas, United States, 75231
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77074
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78217
      • Pfizer Investigational Site
  • West Virginia
    • Clarksburg, West Virginia, United States, 26301
      • Pfizer Investigational Site
  • Wisconsin
    • Franklin, Wisconsin, United States, 53132
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate

Exclusion Criteria:

• Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1	Drug: CP-690,550; Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Other Names: Double-blind, placebo-controlled period; Drug: CP-690,550; Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.; Other Names: Double-blind, Active Extension Period; Drug: CP-690,550; Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Other Names: Double-blind, placebo-controlled period; Drug: CP-690,550; Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.; Other Names: Double-blind, placebo-controlled period
Experimental: Sequence 2	Drug: CP-690,550; Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Other Names: Double-blind, placebo-controlled period; Drug: CP-690,550; Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.; Other Names: Double-blind, Active Extension Period; Drug: CP-690,550; Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Other Names: Double-blind, placebo-controlled period; Drug: CP-690,550; Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.; Other Names: Double-blind, placebo-controlled period
Placebo Comparator: Sequence 3	Drug: CP-690,550; Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Other Names: Double-blind, placebo-controlled period; Drug: CP-690,550; Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.; Other Names: Double-blind, Active Extension Period; Drug: CP-690,550; Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Other Names: Double-blind, placebo-controlled period; Drug: CP-690,550; Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.; Other Names: Double-blind, placebo-controlled period; Drug: Placebo; Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Other Names: Double-blind, Active Extension Period
Placebo Comparator: Sequence 4	Drug: CP-690,550; Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Other Names: Double-blind, placebo-controlled period; Drug: CP-690,550; Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.; Other Names: Double-blind, Active Extension Period; Drug: CP-690,550; Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Other Names: Double-blind, placebo-controlled period; Drug: CP-690,550; Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.; Other Names: Double-blind, placebo-controlled period; Drug: Placebo; Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Other Names: Double-blind, Active Extension Period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6	ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.	Month 6
Changes From Baseline in 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 ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.	Baseline, Month 6
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.	Baseline, Month 3
Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6	DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6	DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Baseline, Month 1, 3, 6
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6	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, Month 1, 3, 6
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 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, Month 3, 6
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.	Month 1, 3
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.	Month 9, 12, 15, 18, 21, 24
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6	ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.	Month 1, 3, 6
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24	ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.	Month 9, 12, 15, 18, 21, 24
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6	ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.	Month 1, 3, 6
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24	ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.	Month 9, 12, 15, 18, 21, 24
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Baseline, Month 1, 3, 6
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 indicated low disease activity, >3.2 to 5.1 indicated moderate to high disease activity and <2.6 = remission.	Month 9, 12, 15, 18, 21, 24
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24	DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Month 9, 12, 15, 18, 21, 24
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])	DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.	Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])	DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
Modified Total Sharp Scores (mTSS) at Baseline	mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged 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 represented improvement.	Baseline
Modified Total Sharp Scores (mTSS) at Month 12 and 24	mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged 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 represented improvement.	Month 12, 24
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.	Baseline, Month 1, 3, 6
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.	Month 9, 12, 15, 18, 21, 24
Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24	Participants rated the severity of arthritis pain on a 0 to 100 mm visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.	Month 9, 12, 15, 18, 21, 24
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6	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, Month 1, 3, 6
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24	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.	Month 9, 12, 15, 18, 21, 24
Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6	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, Month 1, 3, 6
Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24	Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.	Month 9, 12, 15, 18, 21, 24
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6	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, Month 1, 3, 6
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24	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.	Month 9, 12, 15, 18, 21, 24
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6	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 scores=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, Month 1, 3, 6
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6	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.	Baseline, Month 1, 3, 6
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 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 scores=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.	Month 12, 18, 24
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24	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.	Month 12, 18, 24
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6	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, Month 1, 3, 6
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24	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.	Month 12, 18, 24
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6	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, Month 3, 6
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24	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.	Month 12, 18, 24
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6	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, Month 3, 6
Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24	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]).	Month 12, 18, 24
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 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, over-night 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 or housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.	Baseline, Month 3, 6
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24	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, over-night 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.	Month 12, 18, 24
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 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.	Month 12, 18, 24
Number of Days as Assessed Using RA-HCRU at Baseline, Month 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, Month 1, 3, 6
Number of Days as Assessed Using RA-HCRU at Month 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.	Month 12, 18, 24
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 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 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, Month 1, 3, 6
Number of Hours Per Day as Assessed RA-HCRU at Month 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 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.	Month 12, 18, 24
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6	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, Month 1, 3, 6
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24	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.	Month 12, 18, 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR20 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.	Baseline through Month 12, Month 24
Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response	ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR50 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.	Baseline through Month 12, Month 24
Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response	ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR70 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.	Baseline through Month 12, Month 24
Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. Participants with sustained DAS28-3 (CRP) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.	Baseline through Month 12, Month 24
Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. Participants with sustained DAS28-4 (ESR) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.	Baseline through Month 12, Month 24
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6	DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Month 1, 3, 6
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24	DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Month 9, 12, 15, 18, 21, 24
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 1, 3 and 6	DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Month 1, 3, 6
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24	DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Month 9, 12, 15, 18, 21, 24
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Month 1, 3, 6
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Month 9, 12, 15, 18, 21, 24
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Month 1, 3, 6
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.	Month 9, 12, 15, 18, 21, 24
Association Between Genomic and Metabonomic Variation		Month 24
Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6	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, Month 1, 3, 6
Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24	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, Month 9, 12, 15, 18, 21, 24
Change From Baseline in Heart Rate at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24		Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
Change From Baseline in Body Temperature at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24		Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 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;:
• Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.
• 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.
• 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.
• 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.
• Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14. Erratum In: Ann Rheum Dis. 2017 Mar;76(3):611.
• 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.
• Bartlett SJ, Bingham CO, van Vollenhoven R, Murray C, Gruben D, Gold DA, Cella D. The impact of tofacitinib on fatigue, sleep, and health-related quality of life in patients with rheumatoid arthritis: a post hoc analysis of data from Phase 3 trials. Arthritis Res Ther. 2022 Apr 5;24(1):83. doi: 10.1186/s13075-022-02724-x.
• 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.
• 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.
• Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11.
• 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.
• van der Heijde D, Strand V, Tanaka Y, Keystone E, Kremer J, Zerbini CAF, Cardiel MH, Cohen S, Nash P, Song YW, Tegzova D, Gruben D, Wallenstein G, Connell CA, Fleischmann R; ORAL Scan Investigators. Tofacitinib in Combination With Methotrexate in Patients With Rheumatoid Arthritis: Clinical Efficacy, Radiographic, and Safety Outcomes From a Twenty-Four-Month, Phase III Study. Arthritis Rheumatol. 2019 Jun;71(6):878-891. doi: 10.1002/art.40803. Epub 2019 Apr 24.
• 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 der Heijde D, Tanaka Y, Fleischmann R, Keystone E, Kremer J, Zerbini C, Cardiel MH, Cohen S, Nash P, Song YW, Tegzova D, Wyman BT, Gruben D, Benda B, Wallenstein G, Krishnaswami S, Zwillich SH, Bradley JD, Connell CA; ORAL Scan Investigators. Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study. Arthritis Rheum. 2013 Mar;65(3):559-70. doi: 10.1002/art.37816.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 17, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Estimate): January 18, 2013
• Last Update Submitted That Met QC Criteria: January 14, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: double-blind placebo-controlled investigational drug oral therapy safety and efficacy hand and feet x-rays
• 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
• Other Study ID Numbers: A3921044