JPRN-UMIN000021157已完成未知
Clinical trial for efficacy and safety related to weekly dosage regimens of methotrexate - Clinical trial for Adverse event related to Weekly dosage regimens of Methotrexate (ADDMe trial)
Yokohama Minami Kyousai Hospital0 个研究点目标入组 120 人开始时间: 2016年2月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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
- •(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 at any dose within 4weeks prior to study entry or first end point 6)Pateint whose body weight is less than or equal to 40kg 7)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 first end point 8)Patient who received NSAIDs with an overdosage within 4 weeks prior to the study entry or during the study. 9) Patient who is currently under treatment or treatmented with biologics, JAK inhibitor or immunosappressants within 8 weeks prior to the study entry. (Surgery) 10)Patient who had surgery judged to have an influence on this study by doctor 11)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) 12)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 13)Patient who can not go to a hospital for check-up on an appointed day 14)When principal investigator or sub investigators of this study judge the patients disqualified as a subject of this study
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