A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis
NCT ID: NCT01484561
Last Updated: 2014-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
148 participants
INTERVENTIONAL
2012-04-30
2013-02-28
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
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Sequence 1
CP-690,550 or Placebo
CP-690,550 10 mg twice a day (BID) orally or placebo BID orally, approximately 72 days
Sequence 2
Placebo
Placebo BID orally, approximately 72 days
Interventions
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CP-690,550 or Placebo
CP-690,550 10 mg twice a day (BID) orally or placebo BID orally, approximately 72 days
Placebo
Placebo BID orally, approximately 72 days
Eligibility Criteria
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Inclusion Criteria
* The patient must have active disease at both Screening and predose on Day 1 of Period 1.
* Patient must have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD), non-biologic or biologic, due to ineffectiveness or intolerance.
Exclusion Criteria
* Serious medical conditions that would make treatment with CP-690,550 potentially unsafe.
* A patient who has a history of asthma, multiple allergies or severe allergy (eg, anaphylaxis) to any substance. In particular, a history of allergy to iodine, povidone-iodine, iohexol or other iodinated contrast media.
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
South Miami, Florida, United States
Pfizer Investigational Site
Albany, New York, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Tacoma, Washington, United States
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Erlangen, , Germany
Pfizer Investigational Site
Würzburg, , Germany
Pfizer Investigational Site
Mérida, Yucatán, Mexico
Pfizer Investigational Site
Bialystok, , Poland
Pfizer Investigational Site
Bydgoszcz, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Wroclaw, , Poland
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Petrozavodsk, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seville, Sevilla, Spain
Pfizer Investigational Site
Barakaldo, Vizcaya, Spain
Pfizer Investigational Site
Bilbao, Vizcaya, Spain
Pfizer Investigational Site
A Coruña, , Spain
Countries
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References
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Kristensen 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.
Hansen 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.
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.
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.
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.
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.
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.
Kremer JM, Kivitz AJ, Simon-Campos JA, Nasonov EL, Tony HP, Lee SK, Vlahos B, Hammond C, Bukowski J, Li H, Schulman SL, Raber S, Zuckerman A, Isaacs JD. Evaluation of the effect of tofacitinib on measured glomerular filtration rate in patients with active rheumatoid arthritis: results from a randomised controlled trial. Arthritis Res Ther. 2015 Apr 6;17(1):95. doi: 10.1186/s13075-015-0612-7.
Related Links
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Other Identifiers
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A3921152
Identifier Type: -
Identifier Source: org_study_id
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