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Active, Not Recruiting

NCT Number: NCT05605782

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

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Macular Degeneration Macular Edema Multiple Sclerosis Neoplasms Nervous System Diseases Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evidera

Bethesda, Maryland, 20814, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of major adverse cardiovascular events (MACE)

    Time frame: Up to 10 years

  2. Incidence of serious opportunistic infection (SOI)

    Time frame: Up to 10 years

  3. Incidence of serious acute liver injury (SALI)

    Time frame: Up to 10 years

  4. Incidence of macular edema

    Time frame: Up to 10 years

  5. 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

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Incidence of symptomatic bradycardia

    Time frame: Up to approximately 5 years

  2. Incidence of progressive multifocal leukoencephalopathy (PML)

    Time frame: Up to approximately 5 years

  3. Incidence of posterior reversible encephalopathy syndrome (PRES)

    Time frame: Up to approximately 5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: ORION

Important dates

Study start
2021
Primary completion
2033
Study completion
2033
First posted
Nov 4, 2022
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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