Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis

CompletedProgressive MSNCT03396822

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Gadoteridol

    Diagnostic agent

Results by group

Change in the Number of Enhancing Leptomeningeal Foci on 1 Year Follow up Compared to Baseline in MS Patients Treated With Ocrelizumab.

1 year

GroupValueIntervalNumber analysed
Participants With Baseline Meningeal Enhancement0.07 number of enhancing foci2.9 (Standard Deviation)14

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Participants With Baseline Meningeal Enhancement140 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change in the Number of Enhancing Leptomeningeal Foci on 1 Year Follow up Compared to Baseline in MS Patients Treated With Ocrelizumab.

    1 year

    MRI lesions

Other measures (1)

  • Reduction in the Proportion of Participants With Meningeal Enhancement After Treatment With Ocrelizumab Compared to Pre-treatment Baseline.

    1 year

Who could take part

Progressive MS · 18 to 65

Show the full criteria

Inclusion criteria

* A diagnosis of relapsing or primary progressive multiple sclerosis according to revised 2010 McDonald Criteria * Ages 18 to 65, inclusive * Have been prescribed ocrelizumab by their treating physician for treatment of multiple sclerosis, with the 1st infusion to occur within 30 days of enrollment

Exclusion criteria

* Inability to provide informed consent * Inability to undergo MRI due to implantable devices or metallic foreign bodies considered unsafe in the MRI magnet * Known severe allergic reaction (anaphylaxis) in the past to gadolinium contrast * A current diagnosis of severe kidney failure and/or use of hemodialysis * Currently pregnant or lactating * History of a seizure disorder

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Multiple Sclerosis (MS) is an autoimmune disorder of the central nervous system. In MS, inflammation is known to attack areas of the brain, spinal cord, and optic nerves; resulting in disability. Current MRI technology provides an adequate view of the impact of MS on the "white matter" of the brain, which contains many of the connections between neurons. Quantification of lesions in the white matter due to MS are a standard part of clinical trials and clinical care in MS. However, it has long been known that MS not only can affect the white matter, but also the "gray matter," which contains the majority of the nerve cells in the brain and can cause inflammation in the meninges (the protective tissue that surrounds the brain and spinal cord). Autopsy studies have shown that the inflammation seen in the meninges is driven by a B-cells, a subset of white blood cells and that meningeal inflammation may be responsible for damage to the gray matter of the brain. Ocrelizumab is a new treatment for multiple sclerosis. This medication works by targeting and destroying circulating B-cells. It is thought that this may reduce the level of meningeal inflammation in patients with multiple sclerosis. By reducing meningeal inflammation, this medication may result in less damage to the gray matter and subsequently less disability in MS patients. In this study, the investigators will evaluate the use of a method on 7 tesla (7T) MRI to identify inflammation in the meninges as a potential predictor of response to ocrelizumab treatment for multiple sclerosis. Further, the investigators will evaluate if this MRI technique can be used to monitor the long-term effect of the medication on meningeal inflammation and the development of damage to the gray matter of the brain.

Papers

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    History

      1. Started

        Sept 2018

      2. Main results due

        May 2023

      3. Finished

        May 2023

      4. Results posted

        Feb 2024

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