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

NCT03396822 | Completed Results FDA Drug

• 1 other identifier: HP-00074320
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; 7T MRI; Meningeal inflammation

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

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

  1 year

Other Outcomes (1)

• Change in the Volume of Contrast Enhancement on Follow up Compared to Baseline.

  1 year

Interventions

Gadoteridol DRUG

gadolinium MRI contrast

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with multiple sclerosis who have been prescribed ocrelizumab

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

gadoteridol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Daniel Harrison
• Organization: University of Maryland School of Medicine

dharrison@som.umaryland.edu

410-328-5605

Study Officials

• Daniel M Harrison, M.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 11, 2018
• Study Start: September 24, 2018
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: February 28, 2024
• Results First Posted: February 5, 2024

Record last verified: 2024-02

Locations

US (1)