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People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists

NCT07207148

RecruitingN/A

Sponsor: Northwestern University

Conditions: Multiple Sclerosis

Interventions: GLP-1, Ocrelizumab (US)

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (1)

Chicago, Illinois, United States