Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of the combination of tacrolimus + methotrexate compared to methotrexate alone in the treatment of the signs and symptoms of rheumatoid arthritis over 6 months in patients with partial response to methotrexate.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Methotrexate; Tacrolimus

Criteria

Inclusion Criteria

• Willing to discontinue DMARDs, other than methotrexate

• Has a diagnosis of Rheumatoid Arthritis using American College of Rheumatology Criteria, of at least 6 months duration

• Have been receiving oral or parenteral methotrexate for at least 3 months

Exclusion Criteria

• Has received tacrolimus for any indication

• Has moderate or severe liver disease

• Has a known history of HIV infection

• Has serum creatinine outside the normal range