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NCT05974852 Clinical Trial

Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS

Primary Progressive Multiple Sclerosis Clinical Trial

— ORATORIO-CP  

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05974852
Other study ID # 00007537
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 learn if cortical plexus enhancement in patients with primary progressive multiple sclerosis occurs in response to the autoimmune inflammatory process.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 732
Est. completion date September 30, 2025
Est. primary completion date November 1, 2024
Accepts healthy volunteers
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 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 T2 lesion volume T2 lesion volume as measured using MRI. 5 years
Secondary Changes in choroid plexus Changes in choroid plexus as measured using MRI. 5 years
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