NCT00683969已完成3 期
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia Gravis
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
- 136
- 主要终点
- Proportion of subjects reaching responder status
研究概览
简要总结
The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients 18 to 80 years of age;
- •diagnosis of myasthenia gravis;
- •history of myasthenia weakness involving more than ocular (ie eye) or peri-ocular muscle;
- •duration of myasthenia gravis symptoms (including ocular symptoms) <=10 years;
- •prednisone dose >=20 mg/day (or equivalent alternate-day dose) for >=4 weeks.
排除标准
- •female patients who are pregnant, breastfeeding, or lactating;
- •regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 2 weeks prior to randomization;
- •any prior clinically significant use of CellCept or other immunosuppressive therapy (except corticosteroids), or within 8 weeks prior to randomization.
研究组 & 干预措施
1
Experimental
干预措施: mycophenolate mofetil (CellCept) (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of subjects reaching responder status
时间窗: Week 36
次要结局
- Time to start of response(Event driven)
- Mean and median prednisone dose and cholinesterase inhibitor dose(Week 36)
- Adverse events, lab parameters, vital signs(Throughout study)
研究者
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