Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients (Prevention of Relapses and Delay of Progression of Physical Disability in Secondary Progressive Multiple Sclerosis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions
研究概览
简要总结
This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis.
详细描述
This is a non-interventional study, and as such there is no binding treatment strategy, diagnosis/treatment procedures or visit schedule. The investigator should administer Mayzent as labelled. Routine medical practice will apply to visit frequency and evaluation variables, and only these data will be collected by the sponsor as part of the study procedures. The investigator should record data in the applicable CRFs at every visit if possible.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis
排除标准
- 未提供
研究组 & 干预措施
Mayzent
Patients administered Mayzent by prescription
干预措施: Mayzent (Drug)
结局指标
主要结局
Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions
时间窗: 24 months
A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal. An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Mayzent or whose causality is not recorded
次要结局
- Time to confirmed disability progression continuing for ≥ 6 months from the start of administration as assessed by the EDSS(24 months)
- Physician's Global Assessment (PGA) of disease activity(month 12 and month 24)
- Changes over time in Expanded Disability Status Scale (EDSS) score(Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24)
- Time to confirmed disability progression continuing for ≥ 3 months from the start of administration as assessed by the EDSS(24 months)
- Annual relapse rate(24 months)