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

FK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

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.

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