A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
NCT ID: NCT00814307
Last Updated: 2013-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
611 participants
INTERVENTIONAL
2009-02-28
2010-06-30
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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Active 5mg
CP-690,550
5mg CP-690,550 BID PO for 6 months
Active 10 mg
CP-690,550
10 mg CP-690,550 BID PO for 6 months
Placebo Sequence 1
Placebo
Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit
Placebo Sequence 2
Placebo
Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit
Interventions
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CP-690,550
5mg CP-690,550 BID PO for 6 months
CP-690,550
10 mg CP-690,550 BID PO for 6 months
Placebo
Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit
Placebo
Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit
Eligibility Criteria
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Inclusion Criteria
* The patient has active disease at both Screening and Baseline, 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
* Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* Patient has washed out of all DMARDs other that antimalarials
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
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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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Jacksonville, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Venice, Florida, United States
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Zephyrhills, Florida, United States
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Rockford, Illinois, United States
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Frederick, Maryland, United States
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Hyannis, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Teaneck, New Jersey, United States
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Albany, New York, United States
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Olean, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Minot, North Dakota, United States
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Dayton, Ohio, United States
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Bethlehem, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Greenville, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Dallas, 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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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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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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Bucaramanga, Santander Department, Colombia
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Barranquilla, , Colombia
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Brno, , Czechia
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Česká Lípa, , 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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Zlín, , Czechia
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Santo Domingo, Santo Domingo Province, Dominican Republic
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Berlin, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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München, , Germany
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Nuremberg, , Germany
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Hyderabad, Andhra Pradesh, India
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Secunderabad, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Mangalore, Karnataka, India
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Pune, Maharashtra, India
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Putrajaya, Kuala Lumpur, Malaysia
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Kota Kinabalu, Sabah, Malaysia
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Kuching, Sarawak, Malaysia
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Petaling Jaya, Selangor, Malaysia
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Chihuahua City, Chihuahua, Mexico
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Tijuana, Estado de Baja California, Mexico
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Guadalajara, Jalisco, Mexico
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Monterrey, Nuevo León, Mexico
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Dasmariñas, Cavite, Philippines
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Bajada, Davao City, Phlippines, Philippines
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Las Piñas, , Philippines
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Manila, , Philippines
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Warsaw, , Poland
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Wroclaw, , Poland
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San Juan, , Puerto Rico
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Petrozavodsk, , Russia
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Smolensk, , Russia
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Simferopol, Crimea, , Ukraine
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Vinnitsa, , Ukraine
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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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.
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.
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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.
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Related Links
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Other Identifiers
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A3921045
Identifier Type: -
Identifier Source: org_study_id
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