NCT02671682已完成不适用
Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis and Clinically Isolated Syndrome
Albert Christian Ludolph, Prof.2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2016年2月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Multiple Sclerosis Functional Composite (MSFC)
研究概览
简要总结
This observational study investigates the efficacy and safety of immunoadsorption versus plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated syndrome who do not fully recover after a high doses of intravenous corticosteroids.
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
- None
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy)
- •informed consent
- •age ≥ 12 years old
排除标准
- •clinical or laboratory signs of infection
- •intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment
结局指标
主要结局
Multiple Sclerosis Functional Composite (MSFC)
时间窗: 4 weeks
次要结局
- Visually Evoked Potentials (VEP; P100 latency)(4 weeks)
- EuroQol (EQ5D-5L)(2 and 4 weeks)
- Thickness of Retinal Nerve Fiber Layer (RNFL) in Optical Coherence Tomography (OCT)(4 weeks)
- Verbaler Lern- und Merkfähigkeitstest (VLMT) score(4 weeks)
- MSFC(2 weeks)
- Vision(4 weeks)
- Expanded Disability Status Scale (EDSS)(2 and 4 weeks)
- Response Rate(4 weeks)
- Somatosensory Evoked Potentials (SEP; Medianus and Tibialis; N20-, P40-latency)(4 weeks)
- Thickness of Ganglion Cell Layer (GCL) in OCT(4 weeks)
- Symbol Digit Modalities Test (SDMT) score(4 weeks)
研究者
Albert Christian Ludolph, Prof.
Prof. Dr.
University of Ulm
研究点 (2)
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