NCT01034644已完成不适用
A Multinational, Multicenter, Single Visit, Exploratory Pharmacogenetic Trial and Long-term Follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon Beta-1a Subcutaneously in Multiple Sclerosis) Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers
研究概览
简要总结
This study, PRISMS-15 is a single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial.
The aim of this trial is to provide additional data on the driving factors of IFN beta response and the long-term outcomes of Rebif® treatment.
This is a Phase IV trial involving subjects who previously participated in the PRISMS trial. To address the trial objectives, a single visit will be performed, at least 3 months after the onset of the last relapse.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
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
- •Was randomized in the PRISMS study
- •Is willing and able to comply with the protocol
- •Written informed consent given before any trial-related activities are carried out
排除标准
- •Is unwilling or unable to participate in the study
结局指标
主要结局
The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers
时间窗: 1 day
次要结局
- Current EDSS score(1 day)
- Current course of MS: RRMS or SPMS(1 day)
- Immunogenicity assessment(1 day)
- Change in EDSS since randomization(1 day)
研究者
研究点 (1)
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