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临床试验/NCT05974852
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

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 732 人开始时间: 2023年10月1日最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Zivadinov, MD, PhD

Principal Investigator

State University of New York at Buffalo

研究点 (1)

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