Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With PPMS (ORATORIO-Cortical)
Active, not recruiting
- Conditions
- Primary Progressive Multiple Sclerosis
- Registration Number
- NCT05974839
- Lead Sponsor
- State University of New York at Buffalo
- Brief Summary
The goal of this non-interventional, observational study is to determine whether cortical pathology can be slowed down by use of 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 732
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Buffalo Neuroimaging Analysis Center
🇺🇸Buffalo, New York, United States