Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients
Not Applicable
Recruiting
- Conditions
- rheumatoid arthritis
- Registration Number
- JPRN-UMIN000015433
- Lead Sponsor
- Department of Medical Pharmaceutics , Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
Patients were excluded from the study if any of the following criteria applied: (1) concurrent pregnancy, (2) the presence of serious complications in the heart, lung, kidney, etc., (3) perform of surgical operation for rheumatoid arthritis within a period of 6 months before administration (4) use of glucocorticoids(10.1 mg/day) within a period of one month before administration , (5)patients have received biological products, tacrolimus, mizoribin or (6) any other reason for which the investigator judged the patient to be unfit for study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method myelosuppression, ALT, AST, LDH, ALP, gamma-GTP,BUN, Scr, eGFR, CK, interstitial pneumonia
- Secondary Outcome Measures
Name Time Method DAS28-CRP,European League Against Rheumatism (EULAR) criteria, clinical disease activity index (CDAI), simplified disease activity index (SDAI), odified Health Assessment Questionnaire