NCT02519413已完成不适用
A Retrospective, Multi-Center, Observational Study to Assess the Effect of Tecfidera® Delayed-Release Capsules on Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis (REALIZE)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 483
- 试验地点
- 2
- 主要终点
- Estimated CD8+ count change from baseline following Tecfidera initiation
研究概览
简要总结
The primary objective of the study is to retrospectively investigate changes in lymphocyte counts and lymphocyte subtypes, with a focus on CD4+ and CD8+ T cells, in participants on Tecfidera therapy for at least 6 months. The secondary objective is to investigate changes in lymphocyte subtypes other than CD4+ and CD8+ T cells.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Initiated Tecfidera treatment for the first time on or after 27 March 2013 and received at least 6 months of continuous treatment with Tecfidera
- •Clinical diagnosis of a relapsing form of MS
- •A baseline measurement for ALC and absolute CD4+ or CD8+ count within 6 months prior to Tecfidera initiation
- •At least 1 measurement for ALC and absolute CD4+ or CD8+ count while on Tecfidera therapy for at least 6 months
排除标准
- •Clinical diagnosis of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) prior to Tecfidera initiation
- •Participation in DEFINE 109MS301 (NCT00420212) or CONFIRM 109MS302 (NCT00451451)
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Estimated CD8+ count change from baseline following Tecfidera initiation
时间窗: 6 and 12 months
Estimated CD4+ count change from baseline following Tecfidera initiation
时间窗: 6 and 12 months
Estimated absolute lymphocyte count (ALC) change from baseline following Tecfidera initiation
时间窗: 6 and 12 months
次要结局
- Change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation(6 and 12 months)
- Percentage change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation(6 and 12 months)
- Raw absolute counts for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation(6 and 12 months)
- Raw absolute counts for additional lymphocyte subsets (other than CD4+ and CD8+)(6 and 12 months)
- Percentage change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation(6 and 12 months)
- Time to pre-determined lymphocyte counts following Tecfidera initiation(Up to 12 months)
- Potential predictors of low lymphocyte counts following Tecfidera initiation(6 and 12 months)
- Change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation(6 and 12 months)
研究者
研究点 (2)
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