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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05974839
Acronym
ORATORIO-Cort
Enrollment
732
Registered
2023-08-03
Start date
2023-10-01
Completion date
2024-02-28
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Progressive Multiple Sclerosis

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.

Interventions

OTHEROcrelizumab

Non-interventional

Sponsors

Genentech, Inc.
CollaboratorINDUSTRY
State University of New York at Buffalo
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Cortical lesion number accumulation5 yearsCortical lesion accumulation as measured using MRI between subjects on placebo and subjects who took ocrelizumab.

Secondary

MeasureTime frameDescription
Cortical lesion number accumulation and disability.5 yearsCortical lesion number accumulation as measured by MRI for subjects who developed disability over the course of the placebo-controlled phase of the study.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026