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

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Multiple Sclerosis, Relapsing-Remitting

Study type: Observational

Funder types: Industry

Identifiers

NCT05605782

EUPAS44615 (Registry Identifier)

IM047-009

Details and patient eligibility

About

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)

Enrollment: 9,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

9,000 participants in 3 patient groups

Participants initiating treatment with ozanimod

Participants initiating an sphingosine-1 phosphate (S1P) modulator

Participants initiating other non-S1P-receptor modulators disease modifying treatments (DMTs)