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Active Not Recruiting
NCT05605782
A Post-Authorization, Long-term Study of Ozanimod Real-world Safety
Conditions: Multiple Sclerosis, Relapsing-Remitting
Sex: All
Ages: 18 Years – N/A
Enrollment: 9000
Sponsor: Bristol-Myers Squibb
Location: United States
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 Criteria
Inclusion Criteria:Have a diagnosis of multiple sclerosis (MS) recorded on or before the index prescriptionHave 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 dateExclusion Criteria:• Participants with dispensing/prescription of more than one cohort defining drug on the index dateOther protocol-defined inclusion/exclusion criteria apply
Source: ClinicalTrials.gov (NCT05605782). StuddyBuddy aggregates publicly available trial information.