A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
NCT ID: NCT00853385
Last Updated: 2013-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
717 participants
INTERVENTIONAL
2009-05-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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5mg
CP 690,550
tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months
10 mg
CP-690,550
tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months
Placebo Sequence 1
Placebo
placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
Placebo Sequence 2
Placebo
tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
adalimumab
Biologic TNFi
placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months
Interventions
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CP 690,550
tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months
CP-690,550
tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months
Placebo
placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
Placebo
tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
Biologic TNFi
placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) \>28 mm in the local laboratory. 2. CRP \>7 mg/L in the central laboratory.
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.
Exclusion Criteria
* History of any other autoimmune rheumatic 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
* Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
* Patients who have previously received adalimumab therapy for any reason.
* Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
* Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Gilbert, Arizona, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Paradise Valley, Arizona, United States
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Phoenix, Arizona, United States
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Jonesboro, Arkansas, United States
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Fair Oaks, California, United States
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San Diego, California, United States
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Boulder, Colorado, United States
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Largo, Florida, United States
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Naples, Florida, United States
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Palm Harbor, Florida, United States
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Pinellas Park, Florida, United States
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Plantation, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Rockford, Illinois, United States
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Evansville, Indiana, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Haverhill, Massachusetts, United States
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Worcester, Massachusetts, United States
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Grand Rapids, Michigan, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Greenville, South Carolina, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Mesquite, Texas, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Clarksburg, West Virginia, United States
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St Leonards, New South Wales, Australia
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Cairns, Queensland, Australia
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Maroochydore, Queensland, Australia
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Malvern East, Victoria, Australia
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Sarajevo, , Bosnia and Herzegovina
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Sevlievo, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Vancouver, British Columbia, Canada
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Lunenburg, Nova Scotia, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Rancagua, Región del Libertador General Bernardo O’Higgins, Chile
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Santiago, RM, Chile
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Santiago, RM, Chile
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Providencia, Santiago, RM, Chile
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Cartago, Cartago Province, Costa Rica
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San José, Provincia de San José, Costa Rica
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San José, Provincia de San José, Costa Rica
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Osijek, , Croatia
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Split, , Croatia
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Zagreb, , Croatia
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Brno, , Czechia
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Brno, , Czechia
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Brno, , Czechia
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Brno - Zidenice, , Czechia
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Hlučín, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Praha 11 - Chodov, , Czechia
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Zlín, , Czechia
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Frederiksberg, , Denmark
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Randers NOE, , Denmark
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Santo Domingo, Santo Domingo Province, Dominican Republic
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Hyvinkää, , Finland
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Aachen, , Germany
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Berlin, , Germany
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Frankfurt am Main, , Germany
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Halle, , Germany
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Halle, , Germany
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Herne, , Germany
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Ratingen, , Germany
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Würzburg, , Germany
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Morelia, Michoacán, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Lipa City, Batangas, Philippines
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Angeles City, Pampanga, Philippines
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Cebu City, , Philippines
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Bialystok, , Poland
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Cieszyn, , Poland
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Kościan, , Poland
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Krakow, , Poland
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Sopot, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Bratislava, , Slovakia
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Dunajská Streda, , Slovakia
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Košice, , Slovakia
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Nové Zámky, , Slovakia
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Povazska Dystrica, , Slovakia
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Žilina, , Slovakia
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Daegu, , South Korea
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Gwangju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, A Coruña, Spain
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Santiago de Compostela, A Coruña, Spain
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Madrid, Madrid, Spain
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Vigo, Pontevedra, Spain
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Seville, Sevilla, Spain
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Valencia, Valencia, Spain
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Rajathevee, Bangkok, Thailand
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Amphoe Muang, Chiang Mai, Thailand
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Metropolitan Borough of Wirral, Merseyside, United Kingdom
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Cannock, Staffs, United Kingdom
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Dudley, West Midlands, , United Kingdom
Countries
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References
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Hetland 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.
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Curtis 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.
Winthrop 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.
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.
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.
Bergman M, Tundia N, Yang M, Orvis E, Clewell J, Bensimon A. Economic Benefit from Improvements in Quality of Life with Upadacitinib: Comparisons with Tofacitinib and Methotrexate in Patients with Rheumatoid Arthritis. Adv Ther. 2021 Dec;38(12):5649-5661. doi: 10.1007/s12325-021-01930-4. Epub 2021 Oct 12.
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.
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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.
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.
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Related Links
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Other Identifiers
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A3921064
Identifier Type: -
Identifier Source: org_study_id
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