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OpenTrials
Completed

NCT Number: NCT05974852

Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS

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.

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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 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

Who can participate

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 3D T1-WI at baseline

Exclusion criteria

  • None

Treatment and study plan

Ocrelizumab

Other

Non-interventional

Primary outcomes

  1. T2 lesion volume

    Time frame: 5 years

    T2 lesion volume as measured using MRI.

Secondary outcomes

  1. Changes in choroid plexus

    Time frame: 5 years

    Changes in choroid plexus as measured using MRI.

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 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

Acronym: ORATORIO-CP

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2023
Registry last updated
Mar 9, 2026

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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