Northwestern University
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.
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 requested every four weeks (i.e. q28 days) on a specifically designed survey instrument for MS participants. Participants will be asked to report medication dosing, adherence to medicine,…
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 hosp…
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.
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.
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