Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS

NCT ID: NCT05974852

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 732 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-12-30

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

Conditions

Primary Progressive Multiple Sclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Ocrelizumab

Non-interventional

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Robert Zivadinov, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Buffalo Neuroimaging Analysis Center

Buffalo, New York, United States

Countries

United States

Other Identifiers

00007537

Identifier Type: -

Identifier Source: org_study_id