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NCT05974839 Clinical Trial

Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With PPMS (ORATORIO-Cortical)

Primary Progressive Multiple Sclerosis Clinical Trial

— ORATORIO-Cort  

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05974839
Other study ID # 00007536
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date September 30, 2025

Study information
Verified date April 2024
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 732
Est. completion date September 30, 2025
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Ocrelizumab
Non-interventional

Locations
Country Name City State
United States Buffalo Neuroimaging Analysis Center Buffalo New York

Sponsors (2)
Lead Sponsor Collaborator
State University of New York at Buffalo Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cortical lesion number accumulation Cortical lesion accumulation as measured using MRI between subjects on placebo and subjects who took ocrelizumab. 5 years
Secondary Cortical lesion number accumulation and disability. Cortical lesion number accumulation as measured by MRI for subjects who developed disability over the course of the placebo-controlled phase of the study. 5 years
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