A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the efficacy on joint damage and safety in RA patients treated with DMARDs in a double blind, placebo controlled study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Clinically diagnosed as rheumatoid arthritis by the revised ACR criteria

• Those who have been treated with an adequate stable dose of either methotrexate, salazosulfapyridine or bucillamine

• Those who have at least one erosion on X-ray of hands, wrists or feet

Exclusion Criteria:

• Those who have been treated with any biologic drugs or leflunomide

• Those who meet Class 4 with the Steinbrocker functional classification