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

Wyeth is now a wholly owned subsidiary of Pfizer0 sites159 target enrollmentAugust 2005

ConditionsRheumatoid Arthritis

DrugsMethotrexate plus ERB-041 for 12 weeks Placebo for 12 weeks

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 159
Primary Endpoint: -ACR 20 response at Week 12
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

August 2005

End Date

October 19, 2006

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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