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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at worsening disability that happens without an MS flare-up in people treated with ocrelizumab and GLP-1 medicines. It is for adults ages 18–70 with multiple sclerosis (MS). The trial part measures disability before starting a GLP-1 medicine and again at week 72.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have any type of MS diagnosed by a neurologist using the required guidelines, with an MRI scan available to confirm it.
  • Be 18–70 years old and have a BMI of at least 24. BMI is a measure of weight compared with height.
  • Have taken at least one dose of ocrelizumab before joining.
  • Have an EDSS score below 7. This scale measures disability from MS.
  • Be able to understand the study and freely agree to join.
  • For Aim 1: Have used a GLP-1 medicine within the last 3 years, or plan to start one in less than 3 months. Be willing to report symptoms and abilities each month remotely or in person.
  • For Aim 2: Be able to attend the first and follow-up visits in person, and have had no GLP-1 medicine in the past year.
  • For Aim 2: Plan to start a GLP-1 medicine in less than 6 months and use it for at least 72 weeks after joining.

Who can't join

  • Have ever received Mavenclad, Lemtrada, cyclophosphamide, a stem cell transplant, or a related treatment that lowers the bone marrow’s ability to make blood cells.
  • Are currently in another clinical trial, or have unclear records of your MS diagnosis or past or current MS treatment.
  • Speak a language for which the hospital cannot find translation help.
  • Have had an MS flare-up or used steroids that affect the whole body within the past 3 months.
  • Have had major surgery within the past 6 months, or have gone more than 9 months without ocrelizumab.
  • Are near death, underweight, or not getting enough protein.
  • Cannot freely agree to join because of limits on decision-making or other reasons, such as dementia or being in prison.
  • Cannot complete the study tasks, as judged by the study doctor.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

IL