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

Active, not recruiting

• Conditions: Multiple Sclerosis, Relapsing-Remitting

• Registration Number: NCT05605782
• Lead Sponsor: Bristol-Myers Squibb

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-10-31
• Last Update Submitted: 2022-10-31
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04
• Primary Completion: 2032-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence of progressive multifocal leukoencephalopathy (PML)	Up to approximately 5 years
Incidence of posterior reversible encephalopathy syndrome (PRES)	Up to approximately 5 years
Incidence of symptomatic bradycardia	Up to approximately 5 years

Trial Locations

Locations (1)

Evidera; 🇺🇸 Bethesda, Maryland, United States