Examining how well patients stick with ozanimod treatment for relapsing-remitting multiple sclerosis
Observational, Multicenter Study to Describe the Persistence in Relapsing Remitting Multiple Sclerosis Naive Patients With Low-moderate Activity Treated With Ozanimod (Zeposia®) in Clinical Practice in Spain
This study looks at how well people with relapsing-remitting multiple sclerosis stick to their new ozanimod treatment and how it affects their health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05811416 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather clinical data on the persistence of ozanimod treatment in patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). It focuses on treatment-naïve participants who have recently started ozanimod, assessing its effects on various outcome parameters relevant to the participants. The study will track participants over time to understand how well they adhere to the treatment regimen and the impact on their condition.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with RRMS who have recently begun treatment with ozanimod and have low-to-moderate disease activity.
Not a fit: Patients who have previously been treated with ozanimod or other disease-modifying therapies for RRMS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term effectiveness and adherence to ozanimod treatment for RRMS patients.
How similar studies have performed: While this study focuses on ozanimod, similar observational studies have shown success in understanding treatment persistence and outcomes in other therapies for RRMS.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Relapsing-remitting multiple sclerosis (RRMS) diagnosis by 2017 revised McDonald criteria at the treatment start * Participant who started treatment with ozanimod for the first time 3 months (+/- 2 weeks) before inclusion, according to European Union (EU) Summary of Product Characteristics (SmPC) and/or Spanish therapeutic positioning report (TPR) recommendation and following routine clinical practice of the participating hospital * Low-to-moderate activity, defined as less than 2 relapses in the previous year before starting the treatment with ozanimod Exclusion Criteria: * Prior exposure to ozanimod or any other disease modifier treatment (DMT) for RRMS before starting treatment with ozanimod subject of this study * Participant who has started ozanimod within a clinical trial Note: Other protocol-defined inclusion/exclusion criteria apply
Where this trial is running
Barcelona
- Local Institution - 0001 — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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.