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

Running, not enrolling

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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)

Key facts

Study ID

NCT05605782

Run by

Bristol-Myers Squibb

People needed

9000

Starts

2021-09-02

Expected to finish

2033-07-26

Last updated by the study team

2025-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Participants with dispensing/prescription of more than one cohort defining drug on the index date
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Evidera — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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