Predicting disease activity and rebound risk in MS patients treated with S1PR modulators
Predicting Disease Activity and Rebound Risk in MS Patients Treated With Sphingosine-1-phosphate Receptor Modulators (S1PRM)
This study looks at how stopping treatment with certain MS medications affects disease activity in people with relapsing-remitting multiple sclerosis to help manage their condition better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT05828901 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with relapsing-remitting multiple sclerosis (RRMS) who are either currently treated with or have recently stopped treatment with sphingosine-1-phosphate receptor modulators (S1PRMs) like ozanimod. The study aims to analyze immune cell responses to understand the risk of rebound disease activity after discontinuation of treatment. By evaluating the effects of S1PRMs on disease progression and relapse rates, the research seeks to provide insights into the management of MS. Participants will provide written informed consent and will be monitored for changes in disease activity.
Who should consider this trial
Good fit: Ideal candidates include adult patients with relapsing-remitting multiple sclerosis who are either on ozanimod treatment or have recently discontinued it.
Not a fit: Patients who are not diagnosed with relapsing-remitting multiple sclerosis or those with hypersensitivity to ozanimod will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for severe relapses after stopping S1PRMs, leading to better management strategies for MS.
How similar studies have performed: While there have been retrospective analyses on the risks associated with fingolimod, the specific risks of rebound disease activity with newer S1PRMs like ozanimod are not well established, making this study a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria "On treatment": * Adult patients with RRMS (McDonald criteria 2017) fulfilling the Swiss medic label for ozanimod * Written informed consent Inclusion Criteria "Off treatment": * Adult patients with RRMS (McDonald criteria 2017) who stop ozanimod as indicated in clinical routine. * Written informed consent Exclusion Criteria "On treatment" and "Off treatment": * All vulnerable persons defined by Swiss law including, but not limited to pregnant women, prisoners etc. * Hypersensitivity and allergy against ozanimod or tablet ingredients. * People not understanding the ICF due to mental disabilities. * People with insufficient German or French language skills.
Where this trial is running
Bern
- Neurology department — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Robert Hoepner, PD Dr. med. — Insel Gruppe AG, University Hospital Bern
- Study coordinator: Robert Hoepner, PD Dr. med.
- Email: robert.hoepner@insel.ch
- Phone: +41316329465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.