EUCTR2004-000596-34-HU进行中（未招募）不适用
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 corticosteoids in subjects with myasthenia gravis.
F. Hoffmann-La Roche Ltd as part of the Aspreva Rare Disease Program0 个研究点目标入组 136 人开始时间: 2005年6月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 136
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
- •Diagnosis of myasthenia gravis meeting all of the following criteria:
- •- history of myasthenic weakness involving more than ocular or peri-ocular muscles
- •- history of positive edrophonium chloride test or abnormal neuromuscular transmission demonstrated by electrodiagnostic testing
- •- history of elevated AchR antiodies
- •Disease severity history: MGFA classification II, III or IVa
- •Duration of MG symptoms (including ocular symptoms) = 10 years
- •Prednisone dose of = 20 mg/day (or equivalent alternate day dose) for at least 4 weeks prior to randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnancy, breastfeeding or lactation
- •Receiving plasma exchange or intravenous immunoglobulin treatment regularly or within 2 weeks prior to randomization
- •Receiving MMF or other immunosuppressant therapy (except corticosteroids) within 8 weeks prior to randomization
- •Severe weakness of oropharyngeal and/or respiratory muscles (MGFA Class IVb or V; compromised airway protection; MG crisis or impending crisis)
- •Thymectomy within 6 months prior to randomization
- •Presence or history of immune deficiency, malignancy, lymphoproliferative disease or previous total lymphoid irradiation, frequent and/or serious viral infection, systematic or invasive fungal disease within 2 years prior to randomization, significant kidney or liver dysfunction, pulmonary insufficiency requiring supplemental oxygen, bone marrow insufficiency
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