NCT00408213已完成3 期
A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of Prednisone
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
- AEs, laboratory parameters, vital signs.
研究概览
简要总结
This 2 arm study will provide optional continuation of double-blind treatment with CellCept or placebo, in patients with myasthenia gravis who have achieved good symptom control in study WX17798. Patients who have completed 36 weeks of treatment in study WX17798, with stable prednisone dosing for the last 4 weeks, can continue on blinded treatment with CellCept (1g bid) or placebo until the database for WX17798 is locked and unblinded. 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
- •subjects who have completed 36 weeks of treatment in study WX17798, and who have demonstrated good symptom control with a stable prednisone dose for the final 4 weeks of that study.
排除标准
- •regularly scheduled plasma exchange or intravenous immunoglobulin treatment;
- •medical condition, adverse event or intolerance of double-blind treatment which would preclude continuation.
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
AEs, laboratory parameters, vital signs.
时间窗: Throughout study
次要结局
未报告次要终点
研究者
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