Relapsing-remitting Multiple Sclerosis (RRMS)
Conditions
Keywords
Ozanimod, Zeposia, Relapsing-remitting multiple sclerosis
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation | Up to 24 months |
| Percentage of participants on treatment with ozanimod at 24 months | At month 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with ozanimod treatment at 3 and 12 months | At month 3 and month 12 |
| Percentage of participants with ozanimod treatment discontinuation | Up to 24 months |
| 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 |
| 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 |
| Change from baseline in SDMT score at month 3, 12 and 24 | Baseline, Month 3, 12 and 24 |
| Change from baseline in Neurofilament light (NfL) levels at month 6, 12 and 24 | Baseline, Month 6, 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 EDSS score at Month 3, 12 and 24 | Baseline, Month 3, 12 and 24 |
| 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 |
| Change from baseline in number of new or enlarging gadolinium enhancing brain lesions at month 12 and 24 | Baseline, Month 12 and 24 |
| Number of Participants with at least one Adverse Event (AE) | Up to 24 months |
| Number of Participants with AE that imply discontinuation of ozanimod | Up to 24 months |
| Description of sociodemographic characteristics of participants | Baseline, up to 24 months |
| Description of clinical characteristics of participants | Baseline, up to 24 months |
Countries
Spain
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed