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Completed

NCT Number: NCT05974839

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

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

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Key information

Conditions

Primary Progressive Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Buffalo Neuroimaging Analysis Center

Buffalo, New York, 14203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocrelizumab

Other

Non-interventional

Primary outcomes

  1. Cortical lesion number accumulation

    Time frame: 5 years

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

Secondary outcomes

  1. Cortical lesion number accumulation and disability.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study 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

Acronym: ORATORIO-Cort

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 3, 2023
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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