A Post-Authorization, Long-term Study of Ozanimod Real-world Safety

Study Overview
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Brief Summary
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The purpose of this study is to determine the rates of adverse events of interest (AEIs) in a real-world population of participants with relapsing remitting multiple sclerosis (RRMS) receiving Ozanimod, sphingosine-1 phosphate (S1P) receptor modulator, compared to the rates of these events in two population of participants: Participants not exposed to ozanimod with RRMS who have received treatment with other S1P-receptor modulators disease modifying treatments (DMTs) Participants not exposed to ozanimod with RRMS who have received treatment with other non-S1P-receptor modulators disease modifying treatments (DMTs)

Official Title
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ORION (Ozanimod Real-World Safety - A Post- Authorisation Multi-National Long-term Non-Interventional Study)

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of multiple sclerosis (MS) recorded on or before the index prescription Have at least 6 months of continuous enrollment in the data source (thereby providing medical and dispensing/prescription history data, along with an operational definition of new use) before the index date Exclusion Criteria: • Participants with dispensing/prescription of more than one cohort defining drug on the index date 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 initiating treatment with ozanimod<br> | |
| Participants initiating an sphingosine-1 phosphate (S1P) modulator<br> | |
| Participants initiating other non-S1P-receptor modulators disease modifying treatments (DMTs)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse cardiovascular events (MACE) |  | Up to 10 years | 
| Incidence of serious opportunistic infection (SOI) |  | Up to 10 years | 
| Incidence of serious acute liver injury (SALI) |  | Up to 10 years | 
| Incidence of macular edema |  | Up to 10 years | 
| Identified rate of malignancies identified based upon the presence of at least 1 international classification of diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code |  | Up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic bradycardia |  | Up to approximately 5 years | 
| Incidence of progressive multifocal leukoencephalopathy (PML) |  | Up to approximately 5 years | 
| Incidence of posterior reversible encephalopathy syndrome (PRES) |  | Up to approximately 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsing-Remitting Multiple Sclerosis, Ozanimod, Serious opportunistic infections, Serious acute liver injury, Malignancy, Macular edema