Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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%