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

Sponsored by Northwestern University

About this study

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, tolerability, weight, height, and exercise activities. Self-reported scales will be administered to the participants as well (measuring disability, fatigue, mood, and quality of life). Participants …

Where this study is enrolling

Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.