Study Evaluating TMI-005 in Active Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00095342
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The primary objective of this clinical research study is to compare the efficacy and the safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active Rheumatoid Arthritis (RA) who have been receiving stable doses of Methotrexate (MTX).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-11-02
• Study First Submitted QC: 2004-11-02
• Study First Posted: 2004-11-03
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-08
• Last Update Posted: 2009-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

• Meet American College of Rheumatology (ACR) criteria for RA
• Have active RA
• Disease duration of at least 6 months
• Disease onset at > 16 years of age.

Exclusion Criteria

• Any prior use of anti-TNF alpha biologics, rituximab, receipt of anti-CD4 or diphtheria interleukin-2 fusion protein or other immunosuppressive biologics (except for anakinra)
• Largely or wholly incapacitated with the subject bedridden or confined to a wheelchair, permitting limited or no self-care
• Pregnant or breastfeeding women or women planning to become pregnant during the study or within 12 weeks after the last dose of test article

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL