Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With PPMS (ORATORIO-Cortical)

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05974839
• Collaborator: Genentech, Inc. (Industry)
• Enrollment: 732
• Anticipated Duration (Months): 25

Study Details

Study Description

Brief Summary

The goal of this non-interventional, observational study is to determine whether cortical pathology can be slowed down by use of ocrelizumab.

Condition or Disease	Intervention/Treatment	Phase
Primary Progressive Multiple Sclerosis	Other: Ocrelizumab

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 Design

• Study Type: Observational
• Anticipated Enrollment: 732 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: 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
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Sep 30, 2025

Outcome Measures

Primary Outcome Measures

1. Cortical lesion number accumulation [5 years]

   Cortical lesion accumulation as measured using MRI between subjects on placebo and subjects who took ocrelizumab.

Secondary Outcome Measures

1. Cortical lesion number accumulation and disability. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• State University of New York at Buffalo
• Genentech, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Zivadinov, MD, PhD, Principal Investigator, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT05974839
• Other Study ID Numbers: 00007536
• First Posted: Aug 3, 2023
• Last Update Posted: Aug 3, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Ocrelizumab

Study Results

No Results Posted as of Aug 3, 2023