Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS (ORATORIO-CP)

March 5, 2026 updated by: Robert Zivadinov, MD, PhD, State University of New York at Buffalo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

732

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Buffalo Neuroimaging Analysis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with primary progressive multiple sclerosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T2 lesion volume
Time Frame: 5 years
T2 lesion volume as measured using MRI.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in choroid plexus
Time Frame: 5 years
Changes in choroid plexus as measured using MRI.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00007537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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