EUCTR2016-000464-42-DE进行中（未招募）1 期
A Prospective, Open-label, Interventional Phase IIIb Clinical Trial to Investigate the Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab - LemCourse
Genzyme GmbH0 个研究点目标入组 100 人开始时间: 2016年4月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
入选标准
- •-A patient with RRMS who has received two courses of alemtuzumab and has an active disease defined by clinical or imaging features.
- •-Patients with at least 1 relapse within 12 months prior to screening.
- •-Signed written consent form.
- •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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients who have any of the contraindications noted in the Summary of Product Characteristics (SmPC) of alemtuzumab.
- •-Patients who received previously more than 2 courses alemtuzumab.
- •-Patients have received and/or have been receiving any disease modifying MS treatment (excluding corticosteroids) after the second and before the planned additional course of alemtuzumab.
- •-Patients who received alemtuzumab within less than last 12 months.
- •-Patients, who are unwilling or unable to complete the questionnaires being used in the study.
- •-Patients, who are currently participating in an investigational interventional study.
研究者
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