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

NCT05605782

Active Not RecruitingN/A

Sponsor: Bristol-Myers Squibb

Conditions: Multiple Sclerosis, Relapsing-Remitting

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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)
  • Bethesda, Maryland, United States