NCT02494505已完成3 期
Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- occurrence of a relapse during the tapering off period
研究概览
简要总结
The main objective is to study if the mycophenolate could decrease the proportion of patients who relapse during the IVIG tapering period and after the IVIG withdrawal.
详细描述
The secondary objectives are :
- Study if the mycophenolate could improve the proportion of withdrew patients.
- Study if the mycophenolate could improve the reduction of IVIG dose or could prolong the interval between two courses of IVIG compared to the baseline interval at month 12 and month 24 (= sparing treatment criteria).
- Study if mycophenolate could short the delay to perform the IVIG withdrawal.
- Study if mycophenolate could improve the clinical scores (ONLS, R-ODS MRC, INCAT sensory, 10 meters test) or pain score at month 12 and month 24.
- Study if mycophenolate could improve the quality of life at month12 and month 24.
- Identify clinical, biological and electrophysiological factors associated with withdrawal.
- To assess the pharmacokinetics factors (Area under the curve measuring the exposure to mycophenolate) and the pharmacogenetic factors (cytochrome and carrier, FcgammaR) associated with withdrawal.
- Evaluate the tolerance of Mycophenolate in this new indication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
mycophenolate mofetil
Experimental
干预措施: Mycophenolate Mofetil (Drug)
placebo
Placebo Comparator
placebo pills
干预措施: placebo (Drug)
结局指标
主要结局
occurrence of a relapse during the tapering off period
时间窗: up to 18 months
occurrence of a relapse during the tapering off period (up to 18 months after baseline) or after the withdrawal during the monitoring period. (the withdrawal is defined by the ability to reach the last day of IVIG treatment)
次要结局
- Proportion of withdrew patients(6 months after the withdrawal)
- Time to reach the withdrawal(24 months)
- 10 meters test(24 months)
- Proportion of withdrew patients at the end of the study(24 months)
- Sparing treatment (composite criteria)(24 months)
- ONLS scale(24 months)
- MRC scale(24 months)
- INCAT sensory test(24 months)
- SF-36(24 months)
- Nottingham scale(24 months)
- global cost(24 months)
- EVA pain score(24 months)
- R-ODS scale(24 months)
研究者
研究点 (1)
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