Immunoadsorption or Plasma Exchange - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in the "Expanded Disability Status Scale" (EDSS)
研究概览
简要总结
In this prospective controlled monocentric observational study, we assessed safety and efficacy of therapy with IA or PE in patients with neurological autoimmune diseases. In the subgroup analysis of MS patients also the EDSS was evaluated. In addition, we investigated possible pathomechanisms, such as cytokine alterations under therapy.
详细描述
Plasma exchange (PE) and immunoadsorption (IA) are first- or second line treatment options in patients with neurological autoimmune disease, including multiple sclerosis, neuromyelitis optica, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré-Syndrom) or autoimmune encephalitis. This prospective controlled monocentric observational study of patients treated with either tryptophan IA or PE in cases of autoimmune neurological therapy refractory disease was performed between 2016 and 2019. The main outcome parameter for efficiency was clinical improvement after completion of treatment with PE/IA. Symptoms were assessed before the first and after the last IA/PE. In total, all patients receive 5 treatments. As patients with various neurological autoimmune diseases were included in the study, the overall treatment response was categorized descriptively as improvement or no improvement of symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •autoimmune neurological therapy refractory disease
排除标准
- •Intake of Angiotensin-converting-enzyme inhibitors (ACE inhibitors) because of allergic reactions by using tryptophan adsorber
- •contraindication for any anticoagulation
- •contraindication for treatment with citrate dextrose anticoagulation
结局指标
主要结局
Change in the "Expanded Disability Status Scale" (EDSS)
时间窗: After 7 days. EDSS were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).
In the subgroup of MS patients, disability was evaluated by EDSS. The Expanded Disability Status Scale is a scale system for the systematic recording (assessment) of disability in neurological patients suffering from multiple sclerosis. The scale is used to classify the severity of disability by symptoms, ranging from 0 (no symptoms) to a maximum of grade 10 (death from MS).
Change in descriptive characterization of Symptoms
时间窗: After 7 days. Symptoms were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).]
Patients with various neurological autoimmune diseases were included in the study, the overall treatment response was categorized descriptively as improvement or no improvement of symptoms.
次要结局
- Change in concentration of human cytokines(After 7 days. Cytokines were measured before and after the first intervention (day 1) and immediately before and after the last intervention (day 7).)
- Change in concentration of Immunglobulins(After 7 days. Immunglobulins were measured before and after the first intervention (day 1) and immediately before after the last intervention (day 7).)
研究者
Prof. Dr. Julia Weinmann-Menke
Head of the Department of Nephrology and Dialysis
University Medical Center Mainz