Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

Wyeth

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo for 12 weeks; Drug: Methotrexate plus ERB-041 for 12 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141830

3142A1-202

2005-001319-23 (EudraCT Number)

B2381010 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 159 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind