| Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, 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 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone |
| The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis. |
| 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
0 mg BID, 3 blinded tablets administered BID for 12 weeks
- Drug: CP-690,550
10 mg BID, 3 blinded tablets administered BID for 12 weeks
- Drug: CP-690,550
1 mg BID, 3 blinded tablets administered BID for 12 weeks
- Drug: CP-690,550
3 mg BID, 3 blinded tablets administered BID for 12 weeks
- Drug: CP-690,550
5 mg BID, 3 blinded tablets administered BID for 12 weeks
|
- Placebo Comparator: CP-690,550, 0mg
Intervention: Drug: Placebo
- Experimental: CP-690,550, 10mg
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.
- 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.
|
| |
| Completed |
| 140 |
| September 2008 |
| September 2008 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Active rheumatoid arthritis
- Inadequate response to stably dosed methotrexate
Exclusion Criteria:
- Current therapy with any DMARD or biologic other than methotrexate
|
| 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 |
| |
| |
| NCT00603512 |
| A3921039 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| December 2012 |
