NCT06433752招募中不适用
REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 111
- 主要终点
- Annualized Relapse Rate (ARR)
研究概览
简要总结
The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Multiple Sclerosis (MS) diagnosis.
- •Participants who have not received any BRIUMVI® (ublituximab-xiiy) infusion prior to study start. Participants who have been prescribed BRIUMVI® (ublituximab-xiiy) but have not yet received their first infusion on Day 1 of 150 milligrams (mg) can be included.
排除标准
- •Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration or any non-live vaccines within 2 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration.
- •Any active infection (e.g., active Hepatitis B virus [HBV])
- •Concurrent participation in any interventional MS trials, or planned concurrent treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during the study period.
研究组 & 干预措施
BRIUMVI® (Ublituximab-xiiy)
Participants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS.
干预措施: No Intervention (Other)
结局指标
主要结局
Annualized Relapse Rate (ARR)
时间窗: Up to Week 96
次要结局
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 96)
- Number of Participants with Infusion Related Reaction (IRR) at Each Infusion(Up to Week 96)
研究者
研究点 (111)
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