NCT07207148 People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
| NCT ID | NCT07207148 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-15 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-11-15 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. Additional Inclusion Criteria Aim 1: * 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. Additional Inclusion Criteria Aim 2: * 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.
Contact & Investigator
Farrah J Mateen
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT07207148 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07207148 currently recruiting?
Yes, NCT07207148 is actively recruiting participants. Contact the research team at dylan.rice@northwestern.edu for enrollment information.
Where is the NCT07207148 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07207148 clinical trial?
NCT07207148 is sponsored by Northwestern University. The principal investigator is Farrah J Mateen at Northwestern University. The trial plans to enroll 100 participants.
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