A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of participants who complete planned maintenance PLEX regimen
研究概览
简要总结
Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance PLEX) is sometimes used to prevent relapses. This observational registry will record feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX for NMO.
详细描述
Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance PLEX) is sometimes used to prevent relapses. This observational registry will record feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX for participants with NMO, NMO spectrum disorders, and recurrent idiopathic longitudinally extensive transverse myelitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Neuromyelitis optica
- •Neuromyelitis optica spectrum disorder
- •Recurrent idiopathic longitudinally extensive myelitis
- •Age 18 years or greater
排除标准
- •Any condition that in the opinion of the investigator could increase a participant's risk by participating in the observational study or confound the outcome of the study
结局指标
主要结局
Number of participants who complete planned maintenance PLEX regimen
时间窗: One year
Number of participants with adverse events
时间窗: One year
Annualized clinical relapse rate
时间窗: One year
次要结局
- Median Expanded Disability Status Score (EDSS)(One year)
研究者
Dean Wingerchuk
Principal Investigator
Mayo Clinic