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

NCT05605782 · tracked via the Priya Life Science USA tracker

Sponsor

Bristol-Myers Squibb

Phase

Observational

Started

2021-09-02

Last updated

2025-06-26

Condition(s) studied

Multiple Sclerosis, Relapsing-Remitting

Study summary

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)

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Evidera	Bethesda	Maryland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05605782 on ClinicalTrials.gov ↗ ← All trials in the USA