Comparison of the Efficacy and Safety of Immunoadsorption and Plasma Exchange for Acute Attack of Refractory Neuromyelitis Optica Spectrum Disorders: a Prospective, Multicenter, Single-blind, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 主要终点
- Changes in EDSS scores
研究概览
简要总结
Neuromyelitis optica spectrum disorder (NMOSD) is one common demyelinating disease of the central nervous system in young adults, with high rate of disability and recurrence, and poor natural course, which can cause a serious burden on families and society. To today, there is still a lack of prospective, multi-center, large sample clinical trial evidence for the treatment and prognosis of acute attack of NMOSD patients. This study will conduct a prospective, multi-center, single-blind, randomized controlled clinical trial of acute attacked NMOSD patients in China. The researchers plan to collect 144 NMOSD patients with acute attack in three research centers of Guangzhou (the Third Affiliated Hospital of Sun Yat-sen University, the Zhongshan Ophthalmic Center of Sun Yat-sen University, and the Guangdong 999 Brain hospital), to study the safety and efficacy of immunoadsorption therapy.
The subjects will be randomized into immunoadsorption group and plasma exchange group, and the following indicators will be evaluated: (1) changes in EDSS scores and visual acuity before and after treatment; (2) changes in AQP4-IgG levels; (3) the safety of immunoadsorption treatment.
This study is aimed to determine the efficacy and safety of immunoadsorption therapy for acute attack of refractory NMOSD patients, and to provide more sufficient clinical evidence for the therapy selection for acute phase of NMOSD patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should meet the 2015 International NMOSD with acute attacks diagnostic criteria (including first episodes and recurrences)
- •When NMOSD Patients with acute attacks undergo a course of hormone shock therapy (5-10g total methylprednisolone), EDSS ≥ 6.0 or visual acuity ≤ 20/200
- •Serum AQP4-IgG positive (CBA test)
排除标准
- •Weight <25Kg
- •Nursing or pregnant women
- •Unable to establish a peripheral or central vascular access
- •The use of rituximab and gamma-ball shocks within 3 months prior to enrollment
- •Using immunoadsorption and/or plasma exchange therapy within 3 months before enrollment
- •ACEI drugs must be taken within 1 week before the first treatment and during treatment and cannot be stopped
研究组 & 干预措施
Immunoadsorption group
patients' blood purification treatment protocal is Protain A Immunoadsorption method.
干预措施: blood purification equipment (Device)
Plasma exchange group
patients' blood purification treatment protocal is Plasma exchange method.
干预措施: blood purification equipment (Device)
结局指标
主要结局
Changes in EDSS scores
时间窗: 4 weeks after the last treatment vs.baseline ( first treatment)
Changes in EDSS scores of 4 weeks after the last treatment of plasma exchange or immunoadsorption compared with the first treatment
次要结局
- Comparison of follow-up results of LogMAR(the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment))
- Comparison of follow-up results of EDSS scores(the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment))
- Comparison of follow-up results of AQP4-IgG level(the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment))
研究者
Wei Qiu
professor
Third Affiliated Hospital, Sun Yat-Sen University