Efficacy, safety and cost-effectiveness of B cell tailored ocrelizumab versus standard ocrelizumab in relapsing remitting multiple sclerosis (BLOOMS): a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 296
- 试验地点
- 21
- 主要终点
- The two co-primary end points are the difference of percentage of confirmed relapse-free patients between the two treatment groups after 96 weeks follow-up and the difference of percentage of patients without new/enlarging T2 MRI lesions between the two treatment groups after 96 weeks follow-up.
研究概览
简要总结
With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of MS disease activity compared to the standard (fixed 24 week interval) treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •A current diagnosis of relapsing remitting multiple sclerosis according to the 2017 McDonald criteria
- •Age of 18 or older
- •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)
- •Last ocrelizumab interval not extended, maximum of 7,5 months between the infusions
排除标准
- •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
结局指标
主要结局
The two co-primary end points are the difference of percentage of confirmed relapse-free patients between the two treatment groups after 96 weeks follow-up and the difference of percentage of patients without new/enlarging T2 MRI lesions between the two treatment groups after 96 weeks follow-up.
The two co-primary end points are the difference of percentage of confirmed relapse-free patients between the two treatment groups after 96 weeks follow-up and the difference of percentage of patients without new/enlarging T2 MRI lesions between the two treatment groups after 96 weeks follow-up.
次要结局
未报告次要终点
研究者
J.Killestein
Scientific
Amsterdam UMC Stichting