People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists
Recruiting · NCT07207148 · Observational (researchers observe without assigning treatment) · Lead sponsor: Northwestern University
View the official record on ClinicalTrials.gov →Interventions studied
GLP-1Ocrelizumab (US)
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed across 1 US state.
- Northwestern Memorial Hospital - Chicago, Illinois, United States