Rheumatoid Arthritis Clinical Trial
Official title:
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
Verified date | September 2020 |
Source | Wyeth is now a wholly owned subsidiary of Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 159 |
Est. completion date | October 19, 2006 |
Est. primary completion date | October 19, 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of active rheumatoid arthritis for at least 6 months and on a stable dose of methotrexate for at least 12 weeks - Rheumatoid arthritis onset after 16 years of age Exclusion Criteria: - Any significant health problem other than rheumatoid arthritis - History of male or female reproductive system cancer - Clinically significant laboratory abnormalities |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
United States, Canada, Hungary, Italy, Mexico, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | -ACR 20 response at Week 12 | |||
Secondary | Secondary efficacy measures include ACR 50 and ACR 70 response. |
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