A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate
- Registration Number
- NCT01224418
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tacrolimus group Tacrolimus -
- Primary Outcome Measures
Name Time Method ACR20 response rate compared to baseline Baseline and up to 6 months (ACR20: 20% improvement in American College of Rheumatology Core Set)
- Secondary Outcome Measures
Name Time Method ACR50 response rate compared to baseline Baseline and up to 6 months ACR70 response rate compared to baseline Baseline and up to 6 months Changes from baseline in 100mm pain VAS (Visual Analogue Scale) Baseline and up to 6 months Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test For 6 months