Actively Recruiting
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
Led by Northwestern University · Updated on 2026-03-17
100
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of MS (2019 revised McDonald criteria) of any type (PPMS, RRMS, SPMS) by a neurologist
- Adults aged 18 to 70 years
- Body mass index (BMI) of 24.0 kg/m2 or higher
- Have taken at least one dose of Ocrelizumab prior to study entry
- Expanded Disability Status Scale (EDSS) score less than 7.0
- Able to provide individual informed consent
- MRI available to confirm the diagnosis of MS
- For Aim 1: Exposed to GLP-1 agonist treatment within the last 3 years or starting a GLP-1 agonist within 3 months
- For Aim 1: Willing to report monthly patient-reported outcomes remotely or in person
- For Aim 2: Able to attend baseline and follow-up visits in person
- For Aim 2: No GLP-1 agonist exposure in the past year
- For Aim 2: Planning to start a GLP-1 agonist within 6 months
- For Aim 2: Plan to take GLP-1 agonist for at least 72 weeks after enrollment
You will not qualify if you...
- Prior exposure to Mavenclad, Lemtrada, Cyclophosphamide, stem cell transplant, or related bone marrow suppressive treatment
- Currently enrolled in another clinical trial
- Unable to speak a language supported by the hospital system for translation
- Unclear documentation of MS diagnosis or prior/current MS treatment
- Relapse within the past 3 months
- Major surgery within the past 6 months
- Systemic steroid use within the past 3 months
- Not treated with Ocrelizumab in the past 9 months
- Moribund status
- Underweight or experiencing protein malnutrition
- Unable to provide voluntary consent due to capacity or other reasons (e.g., incarceration, dementia)
- Unable to complete study activities for any reason as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
D
Dylan Rice, BA
CONTACT
C
Caroline Gebczak, BS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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