A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Percentage of Participants Relapse-free at Month 6
研究概览
简要总结
The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns. The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Daclizumab
干预措施: Daclizumab (Drug)
结局指标
主要结局
Percentage of Participants Relapse-free at Month 6
时间窗: Month 6
Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The Kaplan-Meier estimate of the percentage of participants relapse-free at Month 6 is reported.
次要结局
- Percentage of Participants Experiencing Relapse Requiring Hospitalization and/or Steroid Treatment at Month 12(Month 12)
- Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12(Months 6 and 12)
- Number of Participants With Clinically Relevant Shifts in Laboratory Assessments(First dose of study drug to within 30 days of last dose (up to 11 months))
- Annualized Relapse Rate (ARR) at Month 12(Month 12)
- Percentage of Participants Relapse-free at Month 12(Month 12)
- Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12(Months 6 and 12)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(First dose of study drug to within 30 days of last dose (up to 11 months))
- Permanent Discontinuation Rate of Daclizumab at Month 12(Month 12)