People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
Northwestern University
100 participants
Nov 15, 2025
OBSERVATIONAL
Conditions
Summary
The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not. For Aim 1, the cohort, patient-derived disability status (PDDS) score, and ambulation score (self-reported) will be the primary endpoints of interest. For Aim 2, the clinical trial, PIRA will be measured pre-GLP-1 start and at study end (week 72). A composite score of disability, similar to the ORATORIO13 trial will be constructed including EDSS score, 25-foot timed walk, 9-hole peg test, and SDMT score.
Eligibility
Inclusion Criteria13
- Diagnosis of MS (2019 revised McDonald criteria) of any type (PPMS, RRMS, SPMS) by a neurologist,
- Adult age 18-70 years,
- BMI \>=24.0 kg/m2,
- Taken at least one dose of Ocrelizumab prior to study entry,
- EDSS \<7.0,
- Able to provide individual informed consent,
- MRI available to confirm the diagnosis of MS.
- Exposed to GLP-1 agonist treatment in the last 3 years or less, or starting on a GLP-1 agonist in the coming \<3 months,
- Willing to report monthly patient-reported outcomes remotely or in-person.
- Able to present for baseline and follow up in person,
- Unexposed to a GLP-1 agonist in the past year,
- Starting on a GLP-1 agonist in the next \<6 months,
- Plan to be exposed to GLP-1 agonist for a minimum of 72 weeks following enrollment.
Exclusion Criteria12
- Prior exposure to Mavenclad, Lemtrada, Cyclophosphamide, stem cell transplant or related bone marrow suppressive treatment,
- Current clinical trial participant,
- Unable to speak a language for which translation can be found in the hospital system,
- Unclear documentation of MS diagnosis or prior or current MS treatment,
- Relapse within the past 3 months,
- Recent major surgical procedure in the past 6 months,
- Exposure to steroids (systemic) within the past 3 months,
- Not on Ocrelizumab in the past \>9 months,
- Moribund status,
- Underweight or experiencing protein malnutrition,
- Unable to provide consent voluntarily due to reasons of capacity or other reasons (e.g. incarcerated, dementia, etc.),
- Unable to complete the study activities for any reason as deemed by the study investigator.
Interventions
Glucagon-like peptide-1 agonist agent is the study agent of interest. This study will not supply the GLP-1 drug but depends on the patient's clinical prescription of this drug.
All participants will be treated with Ocrelizumab for the indication of MS; however, the study will not provide Ocrelizumab as it will be part of the participant's routine clinical care.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07207148