NCT05974852已完成不适用
Effect of Ocrelizumab on Choroid Plexus Changes in Patients With Primary-progressive Multiple Sclerosis Participating in the ORATORIO: a Post-hoc Analysis of a Double-blind, Randomized, Phase 3, Placebo-controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 732
- 试验地点
- 1
- 主要终点
- T2 lesion volume
研究概览
简要总结
The goal of this non-interventional, observational study is to learn if cortical plexus enhancement in patients with primary progressive multiple sclerosis occurs in response to the autoimmune inflammatory process.
详细描述
To study the effect of ocrelizumab on choroid plexus changes in patients with primary-progressive multiple sclerosis participating in the ORATORIO: a post-hoc analysis of a double-blind, randomized, phase 3, placebo-controlled study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient participating in the ORATORIO study
- •MRI scans available at baseline
- •Presence of T2-weighted image (WI) (FLAIR, T2/PD), and 3D T1-WI at baseline
排除标准
- 未提供
结局指标
主要结局
T2 lesion volume
时间窗: 5 years
T2 lesion volume as measured using MRI.
次要结局
- Changes in choroid plexus(5 years)
研究者
Robert Zivadinov, MD, PhD
Principal Investigator
State University of New York at Buffalo
研究点 (1)
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