COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Cyclooxygenase 2 Inhibitors

Criteria

Inclusion criteria:

• Rheumatoid arthritis (RA) for at least 12 months.

• Required a non-steroidal anti-inflammatory drug (NSAID) or COX-2 inhibitor for RA for at least 5 out of 7 days of each week for the 4 weeks prior to screening.

Exclusion criteria:

• Any history of cardiovascular disease (e.g., heart attack, stroke, congestive heart failure, uncontrolled high blood pressure), documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or who have a history of peripheral arterial embolism.

• Have an active stomach ulcer or history of any stomach tear or bleeding.