Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With PPMS (ORATORIO-Cortical) (ORATORIO-Cort)
September 24, 2024 updated by: Robert Zivadinov, MD, PhD, State University of New York at Buffalo
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
The goal of this non-interventional, observational study is to determine whether cortical pathology can be slowed down by use of ocrelizumab.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
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
-
-
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
No
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 2D/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 |
|---|---|---|
|
Cortical lesion number accumulation
Time Frame: 5 years
|
Cortical lesion accumulation as measured using MRI between subjects on placebo and subjects who took ocrelizumab.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortical lesion number accumulation and disability.
Time Frame: 5 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
February 28, 2024
Study Completion (Actual)
February 28, 2024
Study Registration Dates
First Submitted
July 18, 2023
First Submitted That Met QC Criteria
August 2, 2023
First Posted (Actual)
August 3, 2023
Study Record Updates
Last Update Posted (Actual)
September 26, 2024
Last Update Submitted That Met QC Criteria
September 24, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Disease Attributes
- Chronic Disease
- Multiple Sclerosis
- Multiple Sclerosis, Chronic Progressive
- Sclerosis
- Physiological Effects of Drugs
- Immunologic Factors
- Ocrelizumab
Other Study ID Numbers
- 00007536
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
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.