A Study to Describe the Persistence With Ozanimod Treatment in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
Recruiting
- Conditions
- Relapsing-remitting Multiple Sclerosis (RRMS)
- Registration Number
- NCT05811416
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of the study is to collect clinical data on the persistence with ozanimod treatment, as well as to describe its effects on participant-relevant outcome parameters in treatment-naïve participants with RRMS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants on treatment with ozanimod at 24 months At month 24 Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation Up to 24 months
- Secondary Outcome Measures
Name Time Method Percentage of participants with ozanimod treatment discontinuation Up to 24 months Proportion of participants with a decrease SDMT score of ≥4 points At month 3, 12 and 24 Proportion of participants with a stable SDMT score At month 3, 12 and 24 Proportion of participants with change of ≥1.0 point from baseline in expanded disability status scale (EDSS) score at Month 3, 12 and 24 Baseline, Month 3, 12 and 24 Change from baseline in number of new or enlarging gadolinium enhancing brain lesions at month 12 and 24 Baseline, Month 12 and 24 Percentage of participants with ozanimod treatment at 3 and 12 months At month 3 and month 12 Change from baseline in SDMT score at month 3, 12 and 24 Baseline, Month 3, 12 and 24 Number of Participants with at least one Adverse Event (AE) Up to 24 months Description of sociodemographic characteristics of participants Baseline, up to 24 months Change from baseline in Neurofilament light (NfL) levels at month 6, 12 and 24 Baseline, Month 6, 12 and 24 Percentage of participants switching to treatment alternative Up to 24 months Annualized relapse rate at month 12 month and month 24 At month 12 and month 24 Proportion of participants with an increase in Symbol Digit Modalities Test (SDMT) score of ≥4 points At month 3, 12 and 24 Change from baseline in EDSS score at Month 3, 12 and 24 Baseline, Month 3, 12 and 24 Number of Participants with AE that imply discontinuation of ozanimod Up to 24 months Change from baseline in number of new or enlarging hypointense T1 lesions at month 12 and 24 Baseline, Month 12 and 24 Change from baseline in number of new or enlarging hypointense T2 lesions at month 12 and 24 Baseline, Month 12 and 24 Description of clinical characteristics of participants Baseline, up to 24 months
Trial Locations
- Locations (1)
Local Institution - 0001
🇪🇸Barcelona, Spain