EUCTR2006-006812-31-NL进行中（未招募）1 期
Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study
university medical centre utrecht0 个研究点目标入组 120 人开始时间: 2007年6月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. diagnosis: all subtypes JIA according to ILAR classification (15).
- •2. MTX oral (dosing 10-20mg/m2/week)
- •3. other medication: NSAID, biologicals (etanercept, infliximab, anakinra) allowed
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. MTX parenteral
- •2. Other diagnosis
- •3. Steroid usage (more than 0.2mg/kg/day)
- •4. Other MTX related side effects:
- •4a. Abnormal Liver function tests (definitie (1) waarsch verdubbeling uitgangswaarde
- •4b. Abnormal renal function tests (serum creatinin increasing to twice baseline values)
- •4c. Cytopenias (see above(1))
- •5. History of non-compliance to earlier treatments not related to MTX
- •6. Patients currently included in other studies
研究者
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