临床试验/NCT05974839

NCT05974839进行中（未招募）不适用

Effect of Ocrelizumab on Cortical Lesion Accumulation 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: 2024年4月16日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: State University of New York at Buffalo
入组人数: 732
试验地点: 1
主要终点: Cortical lesion number accumulation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this non-interventional, observational study is to determine whether cortical pathology can be slowed down by use of ocrelizumab.

详细描述

To study the effect of ocrelizumab on cortical lesion accumulation 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 2D/3D T1-WI at baseline

排除标准

未提供

结局指标

主要结局

Cortical lesion number accumulation

时间窗: 5 years

Cortical lesion accumulation as measured using MRI between subjects on placebo and subjects who took ocrelizumab.

次要结局

Cortical lesion number accumulation and disability.(5 years)

研究者

发起方

State University of New York at Buffalo

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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