Clinical trial NCT05605782: A Post-Authorization, Long-term Study of Ozanimod Real-world Safety
Official title: ORION (Ozanimod Real-World Safety - A Post- Authorisation Multi-National Long-term Non-Interventional Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Relapsing-Remitting Multiple Sclerosis
Ozanimod
Serious opportunistic infections
Serious acute liver injury
Malignancy
Macular edema
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-11-04
Enrollment: 9000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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)


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

Primary outcomes:
measure: Incidence of major adverse cardiovascular events (MACE)
timeFrame: Up to 10 years
measure: Incidence of serious opportunistic infection (SOI)
timeFrame: Up to 10 years
measure: Incidence of serious acute liver injury (SALI)
timeFrame: Up to 10 years
measure: Incidence of macular edema
timeFrame: Up to 10 years
measure: 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
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Incidence of symptomatic bradycardia
timeFrame: Up to approximately 5 years
measure: Incidence of progressive multifocal leukoencephalopathy (PML)
timeFrame: Up to approximately 5 years
measure: Incidence of posterior reversible encephalopathy syndrome (PRES)
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Evidera
state: Maryland
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: