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Clinical Trial NCT07207148 for Multiple Sclerosis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Northwestern UniversityPeople With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists 100
Clinical Trial NCT07207148 is an observational study for Multiple Sclerosis that is recruiting. It started on November 15, 2025 with plans to enroll 100 participants. Led by Northwestern University, it is expected to complete by August 31, 2028. The latest data from ClinicalTrials.gov was last updated on March 17, 2026.
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 sco...
Show MoreDetailed Description
STUDY PROCEDURES:
Aim 1 will allow fully remote participation, drawing from geographically diverse settings throughout the USA. Participants in Aim 1 do not need to visit the study site in person or be independently mobile but must be continuously available during the study timeframe remotely for PROMS and study surveys and calls.
Participants will be enrolled for an estimated 72 weeks: Measurements will be request...
Show MoreOfficial Title
People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
Conditions
Multiple SclerosisPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- STU00224018
NCT ID Number
Start Date (Actual)
2025-11-15
Last Update Posted
2026-03-17
Completion Date (Estimated)
2028-08-31
Enrollment (Estimated)
100
Study Type
Observational
Status
Recruiting
Keywords
Ocrelizumab
GLP-1
Obesity
Weight loss
Progressive MS
Multiple sclerosis
Biomarkers
Weight
Overweight
Neuroprotection
Semaglutide
glucagon-like peptide-1
GLP-1
Obesity
Weight loss
Progressive MS
Multiple sclerosis
Biomarkers
Weight
Overweight
Neuroprotection
Semaglutide
glucagon-like peptide-1
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Aim 1 The cohort will implement patient-reported outcome measures (PROMs) in 60 people with MS already treated with both Ocrelizumab and a GLP-1 agonist to assess progression and ambulation, while recording drug tolerability and potential adverse events, weight loss, disease-based outcomes focused on progression, and MS-focused quality of life. | GLP-1 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. Ocrelizumab (US) 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. |
Aim 2 The cohort will include a single-arm, open-label trial of 40 Ocrelizumab-treated MS patients who are soon starting GLP-1 agonists, monitored prospectively for 2 years to measure MS progression (clinical disability worsening, stability or improvement) every 3 months, including (a) clinical assessments (e.g. EDSS, 25-foot timed walk, SDMT) as used in the ORATORIO trial of Ocrelizumab, (b) PROMs on progression in MS inc...Show More | GLP-1 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. Ocrelizumab (US) 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
PIRA | The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not. | From enrollment to the end of study at 72 weeks. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Neurofilament light chain | There will be blood draws in Aim 2's clinical trial population. Aim 1's observational, interactive cohort will have an optional blood draw component. In both cases, the blood tests will involve send out testing for neurofilament light chain and in Aim 2, glial fibrillary acidic protein. | From the start of Aim 2 to the end of treatment at 72 weeks. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Northwestern University399 active studies to exploreGenentech, Inc.Study Responsible Party
Farrah Mateen, Principal Investigator, Professor of Neurology, Northwestern University Feinberg School of Medicine
Study Central Contact
Contact: Dylan Rice, BA, 240-362-4800, [email protected]
Contact: Caroline Gebczak, BS, 630-313-0470, [email protected]
1 Study Locations in 1 Countries
Illinois
Northwestern Memorial Hospital, Chicago, Illinois, 60611, United States
Dylan Rice, BA, Contact, 240-362-4800, [email protected]
Caroline Gebczak, BS, Contact, 630-313-0470, [email protected]
Farrah J Mateen, MD, PhD, Principal Investigator
Recruiting