A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
NCT ID: NCT00550446
Last Updated: 2013-01-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
386 participants
INTERVENTIONAL
2007-09-30
2009-01-31
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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1
Adalimumab
40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.
2
CP-690-550
15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
3
CP-690-550
10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
4
CP-690-550
5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
5
CP-690,550
3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
6
CP-690,550
1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
7
Placebo
Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)
Interventions
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Adalimumab
40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.
CP-690-550
15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
CP-690-550
10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
CP-690-550
5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
CP-690,550
3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
CP-690,550
1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
Placebo
Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)
Eligibility Criteria
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Inclusion Criteria
* Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)
* Subjects must not be currently taking any DMARD other than an antimalarial
Exclusion Criteria
* Subjects who previously received adalimumab (Humira®) therapy for any reason.
* Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis
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
Mesa, Arizona, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Northridge, California, United States
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
Stanford, California, United States
Pfizer Investigational Site
Tarzana, California, United States
Pfizer Investigational Site
Upland, California, United States
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Orlando, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Morton Grove, Illinois, United States
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Rockford, Illinois, United States
Pfizer Investigational Site
Cedar Rapids, Iowa, United States
Pfizer Investigational Site
Wichita, Kansas, United States
Pfizer Investigational Site
Wichita, Kansas, United States
Pfizer Investigational Site
New Orleans, Louisiana, United States
Pfizer Investigational Site
Hickory, North Carolina, United States
Pfizer Investigational Site
Hickory, North Carolina, United States
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Dayton, Ohio, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, United States
Pfizer Investigational Site
Knoxville, Tennessee, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Mesquite, Texas, United States
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
Pleven, , Bulgaria
Pfizer Investigational Site
Sofia, , Bulgaria
Pfizer Investigational Site
Sofia, , Bulgaria
Pfizer Investigational Site
Sofia, , Bulgaria
Pfizer Investigational Site
Santiago, RM, Chile
Pfizer Investigational Site
Santiago, RM, Chile
Pfizer Investigational Site
Providencia, Santiago, RM, Chile
Pfizer Investigational Site
Split, , Croatia
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Zagreb, , Croatia
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Brno, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Prague, , Czechia
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Praha 11 - Chodov, , Czechia
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Zlín, , Czechia
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Dresden, , Germany
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Hamburg, , Germany
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Hildesheim, , Germany
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Leipzig, , Germany
Pfizer Investigational Site
Goudi, Athens, Greece
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Thessaloniki, , Greece
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Szolnok, , Hungary
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Florence, , Italy
Pfizer Investigational Site
Genova, , Italy
Pfizer Investigational Site
México, D.f., Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico
Pfizer Investigational Site
Cuernavaca, Morelos, Mexico
Pfizer Investigational Site
Metepec, State of Mexico, Mexico
Pfizer Investigational Site
Constanța, Constanța County, Romania
Pfizer Investigational Site
Iași, Iaşi, Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Piešťany, , Slovakia
Pfizer Investigational Site
Žilina, , Slovakia
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Kharkiv, , Ukraine
Pfizer Investigational Site
Kyiv, , Ukraine
Pfizer Investigational Site
Lviv, , Ukraine
Pfizer Investigational Site
Vinnitsa, , Ukraine
Pfizer Investigational Site
Zaporizhzhia, , 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.
Wright 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.
Charles-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.
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.
Suzuki M, Shoji S, Miyoshi S, Krishnaswami S. Model-Based Comparison of Dose-Response Profiles of Tofacitinib in Japanese Versus Western Rheumatoid Arthritis Patients. J Clin Pharmacol. 2020 Feb;60(2):198-208. doi: 10.1002/jcph.1514. Epub 2019 Sep 12.
Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.
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.
Wallenstein GV, Kanik KS, Wilkinson B, Cohen S, Cutolo M, Fleischmann RM, Genovese MC, Gomez Reino J, Gruben D, Kremer J, Krishnaswami S, Lee EB, Pascual-Ramos V, Strand V, Zwillich SH. Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials. Clin Exp Rheumatol. 2016 May-Jun;34(3):430-42. Epub 2016 Apr 28.
Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14.
Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
Fleischmann R, Cutolo M, Genovese MC, Lee EB, Kanik KS, Sadis S, Connell CA, Gruben D, Krishnaswami S, Wallenstein G, Wilkinson BE, Zwillich SH. Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. Arthritis Rheum. 2012 Mar;64(3):617-29. doi: 10.1002/art.33383.
Related Links
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Other Identifiers
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A3921035
Identifier Type: -
Identifier Source: org_study_id
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