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

State University of New York at Buffalo732 enrolled

Overview

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

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

732

Conditions

Primary Progressive Multiple Sclerosis

Interventions

OcrelizumabOTHER

Non-interventional

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Buffalo Neuroimaging Analysis Center

Buffalo, New York, United States

Outcomes

Primary Outcomes

Cortical lesion number accumulation

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

Time frame: 5 years

Secondary Outcomes

Cortical lesion number accumulation and disability.

Cortical lesion number accumulation as measured by MRI for subjects who developed disability over the course of the placebo-controlled phase of the study.

Time frame: 5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.