Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Sclerosis, Relapsing-Remitting | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Participants initiating treatment with ozanimod
- label
- Participants initiating an sphingosine-1 phosphate (S1P) modulator
- label
- Participants initiating other non-S1P-receptor modulators disease modifying treatments (DMTs)
Primary outcomes (5)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available