Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00141830
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Primary Completion: 2006-10-19
• Study Completion: 2006-10-19
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
-ACR 20 response at Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy measures include ACR 50 and ACR 70 response.