A Study to Describe the Persistence With Ozanimod Treatment in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Relapsing-remitting Multiple Sclerosis (RRMS)

Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants that have initiated ozanimod. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ozanimod, Zeposia, Relapsing-remitting multiple sclerosis