ORATORIO-CP: Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS
Sponsor
State University of New York at Buffalo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05974852
Collaborator
Genentech, Inc. (Industry)
732
1
25
29.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational
Anticipated Enrollment
:
732 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
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
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
- T2 lesion volume [5 years]
T2 lesion volume as measured using MRI.
Secondary Outcome Measures
- Changes in choroid plexus [5 years]
Changes in choroid plexus as measured using MRI.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Buffalo Neuroimaging Analysis Center | Buffalo | New York | United States | 14203 |
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:
NCT05974852
Other Study ID Numbers:
- 00007537
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
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: