A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

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

Details

• Lead Sponsor: Abbott
• Collaborator: Eisai Co., Ltd.
• Treatments: Adalimumab

Criteria

Inclusion Criteria

• Rheumatoid arthritis based on the American College of Rheumatology criteria

• Methotrexate or leflunomide naïve

• Disease duration less than or equal to 2 years from diagnosis

Exclusion Criteria

• History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV

• Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus

• Joint surgery involving joints to be assessed within 8 weeks prior to Screening