Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate.
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-UMIN000007404
- Lead Sponsor
- KONAMON Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Not provided
APatients who had any of the following diagnoses or medical history: 1) Autoimmune disease except for Sjogren syndorome, and malignancy 2) Drug allergy 3) Severe heart, lung, liver. kidney and hematolodical 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)Patient who participated other clinical trial program within 4 months prior to the study entry (including post-marketing clinical study) 13)When principal investigator or sub investigators of this study judge the patients disqualified as a subject of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method average DAS28 score on 6 months
- Secondary Outcome Measures
Name Time Method Progression of total Sharp Score from base line on 12 months functional remission rate on 6 months and 12months (mHAQ<0.5) remission rate on 12 months mean of MMP-3 on 6 months and 12 months decrease in MMP-3 from base line on 6months and 12 months