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NCT00141830 Clinical Trial

Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00141830
Other study ID # 3142A1-202
Secondary ID B23810102005-001
Status Completed
Phase Phase 2
First received
Last updated
Start date August 2005
Est. completion date October 19, 2006

Study information
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

Clinical Trial 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).

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Methotrexate plus ERB-041 for 12 weeks

• Placebo for 12 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  Italy,  Mexico,  Spain, 

Outcome
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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