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

N/AActive Not RecruitingNCT05605782

Bristol-Myers Squibb9,000 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

9,000

Conditions

Multiple Sclerosis, Relapsing-Remitting

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Evidera

Outcomes

Primary Outcomes

Incidence of major adverse cardiovascular events (MACE)

Time frame: Up to 10 years

Incidence of serious opportunistic infection (SOI)

Time frame: Up to 10 years

Incidence of serious acute liver injury (SALI)

Time frame: Up to 10 years

Incidence of macular edema

Time frame: 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

Time frame: Up to approximately 2 years

Secondary Outcomes

Incidence of symptomatic bradycardia

Time frame: Up to approximately 5 years

Incidence of progressive multifocal leukoencephalopathy (PML)

Time frame: Up to approximately 5 years

Incidence of posterior reversible encephalopathy syndrome (PRES)

Time frame: Up to approximately 5 years