| Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan |
| A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD |
| To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for the treatment of signs and symptoms in patients with active RA who failed an adequate trial of therapy with at least 1 DMARD in a 12-week therapy. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Arthritis, Rheumatoid |
- Drug: Placebo
Placebo BID, 3 blinded tablets administered BID for 12 weeks
- Drug: CP-690,550
10mg BID, 3 blinded tablets administered BID for 12 weeks
- Drug: CP-690,550
15mg BID, 3 blinded tablets administered BID for 12 weeks
- Drug: CP-690,550
1mg BID, 3 blinded tablets administered BID for 12 weeks
- Drug: CP-690,550
3mg BID, 3 blinded tablets administered BID for 12 weeks
- Drug: CP-690,550
5mg BID, 3 blinded tablets administered BID for 12 weeks
|
- Placebo Comparator: Placebo
Intervention: Drug: Placebo
- Experimental: CP-690,550, 10mg
Intervention: Drug: CP-690,550
- Experimental: CP-690,550, 15mg
Intervention: Drug: CP-690,550
- Experimental: CP-690,550, 1mg
Intervention: Drug: CP-690,550
- Experimental: CP-690,550, 3mg
Intervention: Drug: CP-690,550
- Experimental: CP-690,550, 5mg
Intervention: Drug: CP-690,550
|
- 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. Erratum in: Ann Rheum Dis. 2017 Mar;76(3):611.
- Tanaka Y, Takeuchi T, Yamanaka H, Nakamura H, Toyoizumi S, Zwillich S. Efficacy and safety of tofacitinib as monotherapy in Japanese patients with active rheumatoid arthritis: a 12-week, randomized, phase 2 study. Mod Rheumatol. 2015 Jul;25(4):514-21. doi: 10.3109/14397595.2014.995875.
- 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.
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| |
| Completed |
| 318 |
| July 2010 |
| July 2010 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Subjects must have failed an adequate trial of therapy with at least 1 DMARD due to lack of efficacy or toxicity.
Exclusion Criteria:
- Current therapy with any DMARD
|
| Sexes Eligible for Study: |
All |
|
| 20 Years to 70 Years (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Japan |
| |
| |
| NCT00687193 |
| A3921040 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| March 2013 |
