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. - Comparison between concomitant therapy of non-biologic anti-rheumatic drugs and therapy with MTX dose escalation aiming for remission on RA patient (CONAMON Study)

KONAMON Study Group0 个研究点目标入组 90 人开始时间: 2012年3月1日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 招募中
发起方
入组人数: 90

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: ot applicable 至 ot applicable（—）
性别: All

入选标准

未提供

排除标准

•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

研究者

发起方

KONAMON Study Group

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