The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-UMIN000007205
- Lead Sponsor
- Juntendo University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
Not provided
Patients are excluded if they meet any one of the following criteria. 1)Patients whose disease activities are not expected to be fully controlled by combination therapy of tacrolimus and MTX, because their disease activities are very high. 2)Patients having suffered from hypersensitivity against the ingredients of tacrolimus capsules. 3)Patients being administered cyclosporine or bosentan. 4)Patients being administered potassium sparing diuretics. 5)Patients who are pregnant or suspected to be pregnant; or patients who are breast-feeding; or patients who are expected to be pregnant during the study period. 6)Patients who are administered Tacrolimus within three months before informed consent. 7)Patients having an active infectious disease. 8)Patient who have active parenchymatous pneumonia or active interstitial pneumonia (including idiopathic pneumonia) 9)Patients who have abnormal glucose tolerance (a fasting blood sugar level is 110 or more mg/dL, and the blood sugar level after a meal is 200 or more mg/dL) 10Patients who have renal disfunction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of remission according to Simplified Disease Activity Index (SDAI) scoring method at week 24
- Secondary Outcome Measures
Name Time Method