COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Drug: GW406381

Study type: Interventional

Funder types: Industry

Identifiers

NCT00113308

CXA30009

Details and patient eligibility

About

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

Enrollment: 2,208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind