Rheumatoid arthritis
Conditions
Interventions
1) Tacrolimus Oral administration of tacrolimus is started usually at a dose of 1.5 mg/day immediately after informed consent is obtained. The dose can be increased or decreased within the limits of
Sponsors
Juntendo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible if they meet all the following criteria. 1) Patients who are diagnosed as rheumatoid arthritis, not less than 65 years old, and provide written informed consent. 2) Patients whose SDAI, an index of a disease activity, is more than 3.3, although MTX was administered for at least three months at the maximum tolerated dose.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of remission according to Simplified Disease Activity Index (SDAI) scoring method at week 24 | — |
Countries
Japan
Outcome results
None listed