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

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

NCT ID: NCT05605782

Condition: Multiple Sclerosis, Relapsing-Remitting

Conditions: Official terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis

Conditions: Keywords:
Relapsing-Remitting Multiple Sclerosis
Ozanimod
Serious opportunistic infections
Serious acute liver injury
Malignancy
Macular edema

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Retrospective

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)

Criteria for eligibility:

Study pop:
The study population will include men and women at least 18 years old who have a diagnosis of multiple sclerosis and are new users of ("initiate") treatment with one of three cohort-defining treatments. Participants will be grouped into the following cohorts: - Exposed: Starting ozanimod - Non-exposed: Starting another sphingosine 1-phosphate (S1P) receptor modulator - Non-exposed: Starting a disease modifying treatment other than an S1P receptor modulator

Sampling method: Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Evidera

Address:
City: Bethesda
Zip: 20814
Country: United States

Start date: June 30, 2022

Completion date: December 31, 2032

Lead sponsor:
Agency: Bristol-Myers Squibb
Agency class: Industry

Source: Bristol-Myers Squibb

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05605782
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
https://www.bmsstudyconnect.com/s/US/English/USenHome