A Study Investigating the Utilization, Effectiveness and Quality of Life in Clinical Practice in Germany for Participants With Relapsing-remitting Multiple Sclerosis Treated With Ozanimod (Zeposia®)

Study Overview
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Brief Summary
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The purpose of this study is to collect real-world data and to gain insights about long-term usage of ozanimod (Zeposia ®), its effect on well-defined outcome parameters comprising participant-relevant outcomes, as well as quality of life, effectiveness, and incidence of adverse events.

Official Title
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Ozanimod (Zeposia®) In Patients With RRMS: A 5-Year, Multicenter, Prospective, Non-Interventional Study to Document Utilization, Effectiveness and Quality of Life in Clinical Practice in Germany (OZEAN)

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS) The decision upon treatment with ozanimod must have been made before enrollment and independently of this non-interventional observational study All data on ozanimod treatment are collected prospectively. The retrospective documentation of ozanimod therapy and enrollment of participants that are already on ozanimod therapy is not allowed Exclusion Criteria: Special warnings, precautions and contraindications specified in the current version of the Summary of Product Characteristics (SmPC) Hypersensitivity to the active substance(s) or to any of the excipients of ozanimod as specified in the prescribing information must not be enrolled Participation in any other clinical studies Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with relapsing-remitting multiple sclerosis (RRMS) treated with Ozanimod<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants persistence with therapy |  | Up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of participant demographics characteristics: Age |  | At baseline | 
| Distribution of participant demographics characteristics: Sex |  | At baseline | 
| Distribution of participant demographics characteristics: Height |  | At baseline | 
| Distribution of participant demographics characteristics: Body weight |  | At baseline | 
| Distribution of clinical characteristics: Smoking status |  | At baseline | 
| Distribution of clinical characteristics: Multiple Sclerosis (MS) diagnosis |  | At baseline | 
| Distribution of clinical characteristics: MS anamnesis/history |  | At baseline | 
| Distribution of clinical characteristics: Prior diseases |  | At baseline | 
| Distribution of clinical characteristics: Concomitant diseases |  | At baseline | 
| Distribution of clinical characteristics: Concomitant medication |  | At baseline | 
| Distribution of clinical characteristics: Prior MS medication |  | At baseline | 
| Distribution of clinical characteristics: Physical examination |  | At baseline | 
| Distribution of clinical characteristics: Reasons for switch to ozanimod |  | At baseline | 
| Distribution of clinical characteristics: Treatment start with ozanimod |  | At baseline | 
| Distribution of clinical characteristics: Treatment with ozanimod dose interruptions |  | Up to 60 months | 
| Distribution of clinical characteristics: Discontinuation, defined as physician's documentation of a discontinuation of ozanimod treatment |  | Up to 60 months | 
| Distribution of clinical characteristics: Reason for discontinuation |  | Up to 60 years | 
| Distribution of clinical characteristics: Subsequent MS treatment |  | Up to 68 years | 
| Distribution of clinical characteristics: Persistence with therapy |  | Up to 60 years | 
| Distribution of clinical characteristics: Adherence to therapy |  | Up to 60 years | 
| Treatment Satisfaction Questionnaire for Medication (TSQM v1.4) |  | Up to 68 months | 
| Symbol Digit Modalities Test (SDMT) |  | Up to 68 months | 
| Fatigue scale for motor and cognitive functions (FSMC) |  | Up to 68 months | 
| Multiple Sclerosis Quality of Life-54 (MSQOL-54) |  | Up to 68 months | 
| United Kingdom Neurological Disability Rating Scale (UNDS) |  | Up to 68 months | 
| Clinical Relapse defined as the annualized relapse rate (ARR) |  | Up to 68 months | 
| Expanded disability status scale (EDSS) |  | Up to 68 months | 
| Work Productivity and Activity Index-Multiple Sclerosis (WPAI-MS German v2.1) |  | Up to 68 months | 
| Multiple Sclerosis Health Resource Survey (MS-HRS 3.0) |  | Up to 68 months | 
| Incidence rate for Adverse Events (AEs) |  | Up to 60 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Relapsing-Remitting, Ozanimod, Zeposia®