Trials / Completed
CompletedNCT00814307
A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 611 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CP-690,550 | 5mg CP-690,550 BID PO for 6 months |
| DRUG | CP-690,550 | 10 mg CP-690,550 BID PO for 6 months |
| DRUG | Placebo | Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit |
| DRUG | Placebo | Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2010-06-01
- Completion
- 2010-06-01
- First posted
- 2008-12-24
- Last updated
- 2013-01-18
- Results posted
- 2013-01-11
Locations
95 sites across 16 countries: United States, Brazil, Bulgaria, Chile, Colombia, Czechia, Dominican Republic, Germany, India, Malaysia, Mexico, Philippines, Poland, Puerto Rico, Russia, Ukraine
Source: ClinicalTrials.gov record NCT00814307. Inclusion in this directory is not an endorsement.