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A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy
The primary objective of this study is to compare the efficacy and safety of 3 dose levels of oral ERB-041 administered daily for 12 weeks versus placebo in subjects with active rheumatoid arthritis who have had a suboptimal response to therapy with stable doses of methotrexate (MTX).
Details
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 159 |
| Start date | 2005-08 |
| Completion | 2006-10-19 |
Conditions
- Rheumatoid Arthritis
Interventions
- Methotrexate plus ERB-041 for 12 weeks
- Placebo for 12 weeks
Primary outcomes
- -ACR 20 response at Week 12
Countries
United States, Canada, Hungary, Italy, Mexico, Spain