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
1 other identifier
interventional
800
15 countries
115
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2009
Typical duration for phase_3
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2009
CompletedFirst Posted
Study publicly available on registry
February 19, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
January 9, 2013
CompletedMay 16, 2024
April 1, 2024
2.1 years
February 17, 2009
December 5, 2012
April 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (44)
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3
Month 1, 3
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24
Month 9, 12, 15, 18, 21, 24
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6
Month 1, 3, 6
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24
Month 9, 12, 15, 18, 21, 24
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6
Month 1, 3, 6
- +39 more secondary outcomes
Other Outcomes (18)
Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response
Baseline through Month 12, Month 24
Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response
Baseline through Month 12, Month 24
Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response
Baseline through Month 12, Month 24
- +15 more other outcomes
Study Arms (4)
Sequence 1
EXPERIMENTALSequence 2
EXPERIMENTALSequence 3
PLACEBO COMPARATORSequence 4
PLACEBO COMPARATORInterventions
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.
Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
Eligibility Criteria
You may qualify if:
- Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate
You may not qualify if:
- Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (115)
Pfizer Investigational Site
Huntsville, Alabama, 35801, United States
Pfizer Investigational Site
Tucson, Arizona, 85704, United States
Pfizer Investigational Site
San Diego, California, 92108, United States
Pfizer Investigational Site
Santa Maria, California, 93454, United States
Pfizer Investigational Site
Colorado Springs, Colorado, 80910, United States
Pfizer Investigational Site
Gainesville, Florida, 32607, United States
Pfizer Investigational Site
Jacksonville, Florida, 32216, United States
Pfizer Investigational Site
Sarasota, Florida, 34239, United States
Pfizer Investigational Site
Tampa, Florida, 33614, United States
Pfizer Investigational Site
Zephyrhills, Florida, 33542, United States
Pfizer Investigational Site
Morton Grove, Illinois, 60053, United States
Pfizer Investigational Site
Dubuque, Iowa, 52002, United States
Pfizer Investigational Site
Lexington, Kentucky, 40536, United States
Pfizer Investigational Site
Baltimore, Maryland, 21224-6821, United States
Pfizer Investigational Site
Wheaton, Maryland, 20902, United States
Pfizer Investigational Site
Worcester, Massachusetts, 01605, United States
Pfizer Investigational Site
Bingham Farms, Michigan, 48025, United States
Pfizer Investigational Site
Kalamazoo, Michigan, 49048, United States
Pfizer Investigational Site
Edina, Minnesota, 55435, United States
Pfizer Investigational Site
Columbia, Missouri, 65203, United States
Pfizer Investigational Site
Columbia, Missouri, 65212, United States
Pfizer Investigational Site
Lee's Summit, Missouri, 64086, United States
Pfizer Investigational Site
Omaha, Nebraska, 68114, United States
Pfizer Investigational Site
Omaha, Nebraska, 68134, United States
Pfizer Investigational Site
Albany, New York, 12206, United States
Pfizer Investigational Site
Binghamton, New York, 13905, United States
Pfizer Investigational Site
Syracuse, New York, 13210, United States
Pfizer Investigational Site
Dayton, Ohio, 45417, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
Pfizer Investigational Site
Wyomissing, Pennsylvania, 19610, United States
Pfizer Investigational Site
Greenville, South Carolina, 29601, United States
Pfizer Investigational Site
Knoxville, Tennessee, 37909-1900, United States
Pfizer Investigational Site
Dallas, Texas, 75231, United States
Pfizer Investigational Site
Houston, Texas, 77074, United States
Pfizer Investigational Site
San Antonio, Texas, 78217, United States
Pfizer Investigational Site
Clarksburg, West Virginia, 26301, United States
Pfizer Investigational Site
Franklin, Wisconsin, 53132, United States
Pfizer Investigational Site
Maroochydore, Queensland, 4558, Australia
Pfizer Investigational Site
Woodville, South Australia, 5011, Australia
Pfizer Investigational Site
Malvern East, Victoria, 3145, Australia
Pfizer Investigational Site
Goiânia, Goiás, 74110-120, Brazil
Pfizer Investigational Site
Curitiba, Paraná, 80060-240, Brazil
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, 04266-010, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, 05437-010, Brazil
Pfizer Investigational Site
Plovdiv, 4000, Bulgaria
Pfizer Investigational Site
Plovdiv, 4002, Bulgaria
Pfizer Investigational Site
Sofia, 1606, Bulgaria
Pfizer Investigational Site
Sofia, 1709, Bulgaria
Pfizer Investigational Site
Edmonton, Alberta, T5M 0H4, Canada
Pfizer Investigational Site
Victoria, British Columbia, V8V 3P9, Canada
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
Pfizer Investigational Site
Hamilton, Ontario, L8N 2B6, Canada
Pfizer Investigational Site
Newmarket, Ontario, L3Y 3R7, Canada
Pfizer Investigational Site
Toronto, Ontario, M5T 3L9, Canada
Pfizer Investigational Site
Montreal, Quebec, H2L 1S6, Canada
Pfizer Investigational Site
Québec, Quebec, G1V 3M7, Canada
Pfizer Investigational Site
Medellín, Antioquia, 0, Colombia
Pfizer Investigational Site
Barranquilla, Atlántico, 0000, Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Pfizer Investigational Site
Bucaramanga, Santander Department, Colombia
Pfizer Investigational Site
Brno, 61300, Czechia
Pfizer Investigational Site
Brno-Židenice, 615 00, Czechia
Pfizer Investigational Site
Hostivice, 253 01, Czechia
Pfizer Investigational Site
Pardubice, 530 02, Czechia
Pfizer Investigational Site
Prague, 11000, Czechia
Pfizer Investigational Site
Prague, 128 50, Czechia
Pfizer Investigational Site
Praha 11 - Chodov, 148 00, Czechia
Pfizer Investigational Site
Zlín, 760 01, Czechia
Pfizer Investigational Site
Thessaloniki, 54 636, Greece
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 004, India
Pfizer Investigational Site
Secunderabad, Andhra Pradesh, 500003, India
Pfizer Investigational Site
Bangalore, Karnataka, 560 034, India
Pfizer Investigational Site
Bangalore, Karnataka, 560 079, India
Pfizer Investigational Site
Mangalore, Karnataka, 575 001, India
Pfizer Investigational Site
Pune, Maharashtra, 411 001, India
Pfizer Investigational Site
Kitakyushu, Fukuoka, Japan
Pfizer Investigational Site
Higashihiroshima, Hiroshima, Japan
Pfizer Investigational Site
Hitachi-shi, Ibaraki, Japan
Pfizer Investigational Site
Sagamihara, Kanagawa, Japan
Pfizer Investigational Site
Koushi, Kumamoto, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Ohmura, Nagasaki, Japan
Pfizer Investigational Site
Sasebo, Nagasaki, Japan
Pfizer Investigational Site
Ureshino-shi, Saga-ken, Japan
Pfizer Investigational Site
Kawagoe-shi, Saitama, Japan
Pfizer Investigational Site
Hamamatsu, Shizuoka, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site
Mexico City, Mexico City, 14000, Mexico
Pfizer Investigational Site
Morelia, Michoacán, 58070, Mexico
Pfizer Investigational Site
Warsaw, 02-256, Poland
Pfizer Investigational Site
Wroclaw, 50-088, Poland
Pfizer Investigational Site
Daejeon, 302-799, South Korea
Pfizer Investigational Site
Incheon, 400-711, South Korea
Pfizer Investigational Site
Seoul, 110-744, South Korea
Pfizer Investigational Site
Seoul, 120-752, South Korea
Pfizer Investigational Site
Seoul, 133-792, South Korea
Pfizer Investigational Site
Seoul, 135-710, South Korea
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Seoul, 137-701, South Korea
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Seoul, 138-736, South Korea
Pfizer Investigational Site
Kaohsiung City, 807, Taiwan
Pfizer Investigational Site
Kweishan, Taoyuan County, 333, Taiwan
Pfizer Investigational Site
Taichung, 407, Taiwan
Pfizer Investigational Site
Tainan, 704, Taiwan
Pfizer Investigational Site
Taipei, 100, Taiwan
Pfizer Investigational Site
Taipei, 112, Taiwan
Pfizer Investigational Site
Simferopol, Autonomous Republic of Crimea, 95017, Ukraine
Pfizer Investigational Site
Kharkiv, 61178, Ukraine
Pfizer Investigational Site
Kyiv, 04114, Ukraine
Pfizer Investigational Site
Lviv, 79011, Ukraine
Pfizer Investigational Site
Vinnitsa, 21018, Ukraine
Related Publications (26)
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PMID: 41448717DERIVEDHetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.
PMID: 39192350DERIVEDWright GC, Mysler E, Kwok K, Cadatal MJ, Germino R, Yndestad A, Kinch CD, Ogdie A. Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials. Rheumatol Ther. 2024 Oct;11(5):1135-1164. doi: 10.1007/s40744-024-00677-y. Epub 2024 Jul 3.
PMID: 38958913DERIVEDCitera G, Jain R, Irazoque F, Madariaga H, Gruben D, Wang L, Stockert L, Santana K, Ebrahim A, Ponce de Leon D. Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety: Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials. Rheumatol Ther. 2024 Feb;11(1):35-50. doi: 10.1007/s40744-023-00612-7. Epub 2023 Nov 5.
PMID: 37925660DERIVEDCharles-Schoeman C, Hyde C, Guan S, Parikh N, Wang J, Shahbazian A, Stockert L, Andrews J. Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib. J Rheumatol. 2023 Jul 15:jrheum.2023-0112. doi: 10.3899/jrheum.2023-0112. Online ahead of print.
PMID: 37453736DERIVEDKristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.
PMID: 36931693DERIVEDDougados M, Taylor PC, Bingham CO 3rd, Fallon L, Brault Y, Roychoudhury S, Wang L, Kessouri M. The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis. RMD Open. 2022 Sep;8(2):e002478. doi: 10.1136/rmdopen-2022-002478.
PMID: 36814062DERIVEDHansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.
PMID: 36601090DERIVEDCurtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.
PMID: 36600185DERIVEDWinthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.
PMID: 36526796DERIVEDDikranian 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.
PMID: 35577477DERIVEDBartlett 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.
PMID: 35382883DERIVEDDikranian 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.
PMID: 34921355DERIVEDWinthrop 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.
PMID: 34870800DERIVEDCohen 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.
PMID: 33127856DERIVEDStrand 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.
PMID: 33059710DERIVEDvan 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.
PMID: 33057725DERIVEDPanaccione 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.
PMID: 32816215DERIVEDvan 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.
PMID: 30666826DERIVEDKivitz 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.
PMID: 30177460DERIVEDHall 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.
PMID: 29949132DERIVEDStrand 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.
PMID: 29761420DERIVEDCohen 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.
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Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Results include data of 1-year analysis.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2009
First Posted
February 19, 2009
Study Start
March 1, 2009
Primary Completion
April 1, 2011
Study Completion
February 1, 2012
Last Updated
May 16, 2024
Results First Posted
January 9, 2013
Record last verified: 2024-04