| Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks |
| A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis |
| The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA). |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Rheumatoid Arthritis |
|
|
- Experimental: 5 mg BID
CP 690,550 5 mg BID
Intervention: Drug: CP-690,550
- Experimental: 15 mg BID
CP 690,550 15 mg BID
Intervention: Drug: CP-690,550
- Experimental: 30 mg BID
Oral tablets administered at a dose of 30 mg BID for 6 weeks
Intervention: Drug: CP-690,550
- Placebo Comparator: Placebo
Placebo
Intervention: Other: Placebo
|
- 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.
- Kremer JM, Bloom BJ, Breedveld FC, Coombs JH, Fletcher MP, Gruben D, Krishnaswami S, Burgos-Vargas R, Wilkinson B, Zerbini CA, Zwillich SH. The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo. Arthritis Rheum. 2009 Jul;60(7):1895-905. doi: 10.1002/art.24567. Erratum in: Arthritis Rheum. 2012 May;64(5):1487.
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| |
| Completed |
| 264 |
| June 2006 |
| June 2006 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- The subject has a history of inadequate response to at least 1, but no more than 4, of the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)
Exclusion Criteria:
- Current Therapy With Any DMARD Or Biologic
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 70 Years (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, Brazil, Canada, Germany, Italy, Mexico, Slovakia, Spain, United States |
| Austria |
| |
| NCT00147498 |
| A3921019 |
| No |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| December 2012 |
