Rheumatoid arthritis
Conditions
Interventions
administration of weekly MTX dose at once
administration by dividing three times of weekly MTX dose
Sponsors
Yokohama Minami Kyousai Hospital Santen Pharmaceutical CO.,Ltd.
Santen Pharmaceutical CO.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients, fulfilled the ACR 1987 reviced criteria for the classification of rheumatoid arthritis and patients, fulfilled the ACR/EULAR 2010 criteria for the classification of rheumatoid arthritis. 2) Patients that are determined to need additional doses above 8mg / week despite of treatment with methotrexate 3) Outpatients (there are no schedules of hospitalization during a clinical trial period). 4) Patients who can provide written informed concent by themselves.
Exclusion criteria
Exclusion criteria: (Complication) Patients who had any of the following diagnoses or medical history 1)Autoimmune disease, except for RA and Sjogren's syndrome, and malignancy. 2)Drug allergy 3)Severe heart, lung, liver, kidney and heamatological disorders (Treatment) 4)Patient who recived intramuscular, intoravenous or epidural injection of corticosteroids within 4 weeks prior to the entry or during study 5)Patient who recived intraarticular corticosteroid at dose of over 20mg/month of prednisolone, and patients who recieved intraarticular corticosteroid at any dose within 4weeks prior to study entry or the day for observation of first end point 6)Patient who recived systemic corticosteroid with a dose of>10mg of predonisolone within 4 weeks prior to the study or during the study and Patients whose corticosteroid dose were changed within 4 weeks prior to the day for observation of first end point 7)Patient who received NSAIDs with an overdosage within 4 weeks prior to the study entry or during the study (Surgery) 8)Patient who had surgery judged to have an influence on this study by doctor 9)Patient who had the following treatment or procedure:plasma exchange, leukocyte depleted therapy or arthrocentesis against affected joint. except for the arthrocenesis following intraarticular injection of corticosteroid, within 4 weeks prior to the study entry or during the study (Others) 10)Patient who is in pregnancy, lactating, or with a possibility of the pregnancy and woman who hopes for pregnancy during study or within 1 month after the end of this study, and man who wishes his partner be pregnant during the study or within 3 months after the end of this study 11)Patient who can not go to a hospital for check-up on an appointed day 12)When principal investigator or sub investigators of this study judge the patients disqualified as a subject of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event rates by questionnaire in observation period | — |
Secondary
| Measure | Time frame |
|---|---|
| SDAI of 12 weeks and 19 weeks from the start of observation period DAS28 of 12 weeks and 19weeks from the start of observation period Concentration of MTX polyglutamates in red blood cells Laboratory test values in observation period | — |
Countries
Japan
Contacts
Public ContactMasahiro Okamoto
Santen Pharmaceutical CO.,Ltd. Rheumatology Research & Development Center
Outcome results
None listed