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

Astellas

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: Tacrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT01224418

PRGRA-08-01-KOR

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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