Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS

Active, not recruiting

• Conditions: Primary Progressive Multiple Sclerosis

• Registration Number: NCT05974852
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-03
• Study Start: 2023-10-01
• Primary Completion: 2024-02-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 732

Inclusion Criteria

• 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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T2 lesion volume	5 years	T2 lesion volume as measured using MRI.

Secondary Outcome Measures

Name	Time	Method
Changes in choroid plexus	5 years	Changes in choroid plexus as measured using MRI.

Trial Locations

Locations (1)

Buffalo Neuroimaging Analysis Center; 🇺🇸 Buffalo, New York, United States