EUCTR2021-004791-34-NL进行中（未招募）1 期
Efficacy, safety and cost-effectiveness of B cell tailored ocrelizumab versus standard ocrelizumab in relapsing remitting multiple sclerosis: a randomized controlled trial
VU medical center0 个研究点目标入组 296 人开始时间: 2022年3月15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
- 296
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
- 性别
- All
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •A current diagnosis of relapsing remitting multiple sclerosis according
- •to the 2017 McDonald criteria34
- •Age of 18 to 60 years
- •EDSS score of 0 to 6.5 inclusive
- •Treatment with ocrelizumab for a minimum of 48 weeks (two 300 mg infusions and one 600 mg infusion)
- •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 296
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Previous treatment with alemtuzumab, cladribine or stem cell transplantation
- •Relapse in the past 3 months prior to inclusion
- •Subsequent treatment with another DMT next to ocrelizumab in the past 6 months prior to inclusion
- •Inability to undergo regular MRI scanning
- •Women who are pregnant or expect to become pregnant during the study period
研究者
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