EUCTR2004-000596-34-CZ进行中（未招募）不适用
A prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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
- •Subject of either sex, 18 to 80 years of age (inclusive)
- •diagnosis of MG 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
- •history of elevated AChR antibodies
- •disease severity history: Myasthenia Gravis Foundation of
- •America (MGFA) classification II, III, or IVa
- •duration of MG symptoms (including ocular symptoms) = 10
- •requirement of immunosuppressive therapy in the judgment of the
- •investigator
- •prednisone dose of =20mg/day (or equivalent alternate day dose)
- •for at least 4 weeks prior to randomization
- •if subject is taking a cholinesterase inhibitor (i.e. pyridostigmine
- •bromide), a stable regimen is required for at least 2 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 regularly scheduled plasma exchange (PE) or
- •intravenous immunoglobulin (IVIG) treatment or receiving PE or
- •IVIG treatment within 2 weeks prior to randomization
- •receiving MMF or other immunosuppressant therapy (except
- •corticosteroids) within 8 weeks prior to randomization
- •any prior clinically significant use of MMF or other
- •immunosuppressant therapy (except corticosteroids)
- •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:
- •severe active gastrointestinal disease; persistent severe diarrhea;
- •gastrointestinal hemorrhage
- •active unhealed peptic ulcer within 3 months prior to
- •randomization
- •immune deficiency
- •lymphoproliferative disease or previous total lymphoid irradiation
- •chronic or frequent drug-resistant bacterial infections or presence
- •of active infection requiring antimicrobial treatment
- •frequent and/or serious viral infection
- •systemic or invasive fungal disease within 2 years prior to
- •randomization
- •significant kidney or liver dysfunction
- •pulmonary insufficiency requiring supplemental oxygen
- •bone marrow insufficiency
研究者
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