rheumatoid arthritis
Conditions
Interventions
methotrexate
Sponsors
Department of Medical Pharmaceutics , Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who satisfied the following inclusion criteria were selected for enrollment in the study: Patients (1) RA patients , (2) patients have received methotrexate and (3) 20- years of age, and (4)Dose is 4, 6 or 8 mg/dweek,(5) patients have notreceived biological products, (6) leukocyte counts > 3000/microL each patient included in the study gave a written informed consent.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| myelosuppression, ALT, AST, LDH, ALP, gamma-GTP,BUN, Scr, eGFR, CK, interstitial pneumonia | — |
Secondary
| Measure | Time frame |
|---|---|
| DAS28-CRP,European League Against Rheumatism (EULAR) criteria, clinical disease activity index (CDAI), simplified disease activity index (SDAI), odified Health Assessment Questionnaire | — |
Countries
Japan
Contacts
Public ContactHideto To
Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama Department of Medical Pharmaceutics
Outcome results
None listed