A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study

This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.

Inclusion Criteria:

• Patients with more than 6 months history of rheumatoid arthritis according to ACR criteria
• Patients who have been treated unsuccessfully to more than single DMARDs including methotrexate at the discretion of investigator
• ESR ≥ 30 mm/h or CRP ≥ 1.0 mg/dL (ESR: Erythrocyte Sedimentation Rate, CRP: C-Reactive Protein)
• Patients are required to have at least 3 of 66 joints assessed as swollen
• Patients are required to have at least 6 of 68 joints assessed as painful with pressure

Exclusion Criteria:

• Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
• Previous experience of tacrolimus (ointment excluded)
• Renal impairment or serum creatinine > 1.4 mg/dL
• Liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, SGOT/SGPT > 2x upper limit normal
• Patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:Blood glucose level >110mg/dl before the meal and >200mg/dl after the meal HbA1c > 6.4%
• Cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications
• Other investigational drug within last 30 days
• Patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study