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

ORION (Ozanimod Real-World Safety - A Post- Authorisation Multi-National Long-term Non-Interventional Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05605782

Acronym

ORION

Enrollment

9000

Registered

2022-11-04

Start date

2021-09-02

Completion date

2033-07-26

Last updated

2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Relapsing-Remitting Multiple Sclerosis, Ozanimod, Serious opportunistic infections, Serious acute liver injury, Malignancy, Macular edema

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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	Up to approximately 2 years
Incidence of serious opportunistic infection (SOI)	Up to 10 years
Incidence of serious acute liver injury (SALI)	Up to 10 years
Incidence of macular edema	Up to 10 years
Incidence of major adverse cardiovascular events (MACE)	Up to 10 years

Secondary

Measure	Time frame
Incidence of posterior reversible encephalopathy syndrome (PRES)	Up to approximately 5 years
Incidence of symptomatic bradycardia	Up to approximately 5 years
Incidence of progressive multifocal leukoencephalopathy (PML)	Up to approximately 5 years

Countries

United States

Outcome results