A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications
Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS
1 other identifier
interventional
795
20 countries
133
Brief Summary
This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2009
133 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2009
CompletedFirst Posted
Study publicly available on registry
March 5, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
January 10, 2013
CompletedJanuary 10, 2013
December 1, 2012
1.7 years
March 3, 2009
December 6, 2012
December 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 (TJC); \>= 20% improvement in swollen joint count (SJC); 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
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;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. 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. 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 Participants Achieving 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) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour\[mm/hour\]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=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, 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 (42)
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12
Month 9, 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12
Month 9, 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6
Week 2, Month 1, 2, 3, 4.5, 6
- +37 more secondary outcomes
Other Outcomes (2)
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
2 weeks
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
2 weeks
Study Arms (4)
Active 5 mg
EXPERIMENTALActive 10 mg
EXPERIMENTALPlacebo Sequence 1
PLACEBO COMPARATORPlacebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.
Placebo Sequence 2
PLACEBO COMPARATORPlacebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.
Interventions
Eligibility Criteria
You may qualify if:
- The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
- The patient has active disease as defined by both \>=4 tender or painful joints on motion and \>= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) \> 28 mm or a C-reactive protein (CRP) concentration \> 7 mg/dL.
- Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
- Patient must remain on at least one background traditional disease modifying antirheumatic drug.
- No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (133)
Pfizer Investigational Site
Huntsville, Alabama, 35801, United States
Pfizer Investigational Site
Jonesboro, Arkansas, 72401, United States
Pfizer Investigational Site
Palo Alto, California, 94304, United States
Pfizer Investigational Site
Stanford, California, 94305, United States
Pfizer Investigational Site
Boulder, Colorado, 80304, United States
Pfizer Investigational Site
Denver, Colorado, 80206, United States
Pfizer Investigational Site
Danbury, Connecticut, 06810, United States
Pfizer Investigational Site
Hamden, Connecticut, 06518, United States
Pfizer Investigational Site
Trumbull, Connecticut, 06611, United States
Pfizer Investigational Site
New Port Richey, Florida, 34652, United States
Pfizer Investigational Site
Ocala, Florida, 34474, United States
Pfizer Investigational Site
Plantation, Florida, 33324, United States
Pfizer Investigational Site
Port Richey, Florida, 34668, United States
Pfizer Investigational Site
Tamarac, Florida, 33321, United States
Pfizer Investigational Site
Tampa, Florida, 33613, United States
Pfizer Investigational Site
Decatur, Georgia, 30033, United States
Pfizer Investigational Site
Marietta, Georgia, 30060, United States
Pfizer Investigational Site
Maywood, Illinois, 60153, United States
Pfizer Investigational Site
Oakbrook Terrace, Illinois, 60181, United States
Pfizer Investigational Site
Rockford, Illinois, 61103-3692, United States
Pfizer Investigational Site
Springfield, Illinois, 62702, United States
Pfizer Investigational Site
Springfield, Illinois, 62703, United States
Pfizer Investigational Site
Vernon Hills, Illinois, 60061, United States
Pfizer Investigational Site
Evansville, Indiana, 47714, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46227, United States
Pfizer Investigational Site
Wichita, Kansas, 67203, United States
Pfizer Investigational Site
Lexington, Kentucky, 40505, United States
Pfizer Investigational Site
Leominster, Massachusetts, 01453, United States
Pfizer Investigational Site
Worcester, Massachusetts, 01605, United States
Pfizer Investigational Site
Edina, Minnesota, 55435, United States
Pfizer Investigational Site
Lincoln, Nebraska, 68516, United States
Pfizer Investigational Site
Albany, New York, 12206, United States
Pfizer Investigational Site
Orchard Park, New York, 14127, United States
Pfizer Investigational Site
Rochester, New York, 14618, United States
Pfizer Investigational Site
Asheville, North Carolina, 28801, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28210, United States
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18015, 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, United States
Pfizer Investigational Site
Austin, Texas, 78705, United States
Pfizer Investigational Site
Dallas, Texas, 75235, United States
Pfizer Investigational Site
Seattle, Washington, 98133, United States
Pfizer Investigational Site
Tacoma, Washington, 98405-2308, United States
Pfizer Investigational Site
Tacoma, Washington, 98405, United States
Pfizer Investigational Site
Clarksburg, West Virginia, 26301, United States
Pfizer Investigational Site
Campsie, New South Wales, 2194, Australia
Pfizer Investigational Site
Cairns, Queensland, 4870, Australia
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
Shenton Park, Western Australia, 6008, Australia
Pfizer Investigational Site
Viña del Mar, Región de Valparaíso, 2570017, Chile
Pfizer Investigational Site
Santiago, RM, 7510186, Chile
Pfizer Investigational Site
Santiago, RM, 8360156, Chile
Pfizer Investigational Site
Providencia, Santiago, RM, 7530206, Chile
Pfizer Investigational Site
Viña del Mar, 2570017, Chile
Pfizer Investigational Site
Hefei, Anhui, 230001, China
Pfizer Investigational Site
Hefei, Anhui, 230022, China
Pfizer Investigational Site
Guangzhou, Guangdong, 510260, China
Pfizer Investigational Site
Guangzhou, Guangdong, 510630, China
Pfizer Investigational Site
Wuhan, Hubei, 430030, China
Pfizer Investigational Site
Changsha, Hunan, 410008, China
Pfizer Investigational Site
Nanjing, Jiangsu, 210029, China
Pfizer Investigational Site
Suzhou, Jiangsu, 215006, China
Pfizer Investigational Site
Jinan, Shandong, 250012, China
Pfizer Investigational Site
Qingdao, Shandong, 266011, China
Pfizer Investigational Site
Xi’an, Shanxi, 710032, China
Pfizer Investigational Site
Chengdu, Sichuan, 610041, China
Pfizer Investigational Site
Hangzhou, Zhejiang, 310009, China
Pfizer Investigational Site
Beijing, 100020, China
Pfizer Investigational Site
Beijing, 100044, China
Pfizer Investigational Site
Beijing, 100853, China
Pfizer Investigational Site
Shanghai, 200001, China
Pfizer Investigational Site
Shanghai, 200003, China
Pfizer Investigational Site
Shanghai, 200433, China
Pfizer Investigational Site
Tianjin, 300052, China
Pfizer Investigational Site
Barranquilla, Atlántico, 0000, Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Pfizer Investigational Site
Bucaramanga, Santander Department, Colombia
Pfizer Investigational Site
Opatija, 51410, Croatia
Pfizer Investigational Site
Zagreb, 10000, Croatia
Pfizer Investigational Site
Frederiksberg, 2000, Denmark
Pfizer Investigational Site
Helsinki, 00120, Finland
Pfizer Investigational Site
Hyvinkää, 05800, Finland
Pfizer Investigational Site
Tampere, 33520, Finland
Pfizer Investigational Site
Berlin, 14059, Germany
Pfizer Investigational Site
Dresden, 01067, Germany
Pfizer Investigational Site
Hamburg, 22081, Germany
Pfizer Investigational Site
Leipzig, 04103, Germany
Pfizer Investigational Site
Nuremberg, 90429, Germany
Pfizer Investigational Site
Rheine, 48431, Germany
Pfizer Investigational Site
Maroussi Athens, 15126, Greece
Pfizer Investigational Site
Putrajaya, Kuala Lumpur, 62250, Malaysia
Pfizer Investigational Site
Seremban, Negeri Sembilan, 70300, Malaysia
Pfizer Investigational Site
Batu Caves, Selangor, 68100, Malaysia
Pfizer Investigational Site
Subang Jaya, Selangor, 47500, Malaysia
Pfizer Investigational Site
Torreón, Coahuila, 27000, Mexico
Pfizer Investigational Site
Morelia, Michoacán, 58249, Mexico
Pfizer Investigational Site
Cuernavaca, Morelos, 62270, Mexico
Pfizer Investigational Site
México, Querétaro, 76178, Mexico
Pfizer Investigational Site
Mérida, Yucatán, 97000, Mexico
Pfizer Investigational Site
Bialystok, 15-337, Poland
Pfizer Investigational Site
Bialystok, 15-461, Poland
Pfizer Investigational Site
Kościan, 64-000, Poland
Pfizer Investigational Site
Poznan, 60-773, Poland
Pfizer Investigational Site
Torun, 87-100, Poland
Pfizer Investigational Site
Moscow, 115093, Russia
Pfizer Investigational Site
Moscow, 115446, Russia
Pfizer Investigational Site
Petrozavodsk, 185019, Russia
Pfizer Investigational Site
Nové Zámky, 94001, Slovakia
Pfizer Investigational Site
Poprad, 058 01, Slovakia
Pfizer Investigational Site
Považská Bystrica, 017 01, Slovakia
Pfizer Investigational Site
Rimavská Sobota, 979 01, Slovakia
Pfizer Investigational Site
Senica, 905 01, Slovakia
Pfizer Investigational Site
Žilina, 010 01, Slovakia
Pfizer Investigational Site
A Coruña, A Coruña, 15006, Spain
Pfizer Investigational Site
Santiago de Compostela, A Coruña, 15705, Spain
Pfizer Investigational Site
Madrid, Madrid, 28046, Spain
Pfizer Investigational Site
Málaga, Malaga, 29009, Spain
Pfizer Investigational Site
Seville, Sevilla, 41013, Spain
Pfizer Investigational Site
Falun, 791 82, Sweden
Pfizer Investigational Site
Gothenburg, 413 46, Sweden
Pfizer Investigational Site
Uppsala, 751 85, Sweden
Pfizer Investigational Site
Rajathevee, Bangkok, 10400, Thailand
Pfizer Investigational Site
Amphoe Muang, Chiang Mai, 50200, Thailand
Pfizer Investigational Site
Muang District, Khonkaen, 40002, Thailand
Pfizer Investigational Site
Metropolitan Borough of Wirral, Merseyside, CH49 5PE, United Kingdom
Pfizer Investigational Site
Cannock, Staffs, WS11 2XY, United Kingdom
Pfizer Investigational Site
Solihull, West Midlands, B91 2JL, United Kingdom
Pfizer Investigational Site
Newcastle upon Tyne, NE1 4LP, United Kingdom
Pfizer Investigational Site
Caracas, DC/ Municipio Libertados, 1040-A, Venezuela
Pfizer Investigational Site
Caracas, Distrito Federal, 1010, Venezuela
Related Publications (27)
Strand V, Schulze-Koops H, Al-Emadi S, Kinch CD, Gruben D, Germino R, Connell CA, Mysler E. Sex differences in the efficacy, safety and persistence of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of phase III and long-term extension trials. BMJ Open. 2025 Dec 24;15(12):e082366. doi: 10.1136/bmjopen-2023-082366.
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: 37925660DERIVEDTesser J, Gul A, Olech E, Oelke K, Lukic T, Kwok K, Ebrahim A. Efficacy and safety of tofacitinib in patients with rheumatoid arthritis by previous treatment: post hoc analysis of phase II/III trials. Arthritis Res Ther. 2023 Nov 2;25(1):214. doi: 10.1186/s13075-023-03154-z.
PMID: 37919780DERIVEDCharles-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: 33059710DERIVEDPanaccione 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: 32816215DERIVEDLi ZG, Liu Y, Xu HJ, Chen ZW, Bao CD, Gu JR, Zhao DB, An Y, Hwang LJ, Wang L, Kremer J, Wu QZ. Efficacy and Safety of Tofacitinib in Chinese Patients with Rheumatoid Arthritis. Chin Med J (Engl). 2018 Nov 20;131(22):2683-2692. doi: 10.4103/0366-6999.245157.
PMID: 30425195DERIVEDKivitz 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: 29949132DERIVEDBird P, Bensen W, El-Zorkany B, Kaine J, Manapat-Reyes BH, Pascual-Ramos V, Witcombe D, Soma K, Zhang R, Thirunavukkarasu K. Tofacitinib 5 mg Twice Daily in Patients with Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs: A Comprehensive Review of Phase 3 Efficacy and Safety. J Clin Rheumatol. 2019 Apr;25(3):115-126. doi: 10.1097/RHU.0000000000000786.
PMID: 29794874DERIVEDCohen 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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PMID: 24026258DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
March 3, 2009
First Posted
March 5, 2009
Study Start
May 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
January 10, 2013
Results First Posted
January 10, 2013
Record last verified: 2012-12