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

June 23, 2025 updated by: Bristol-Myers Squibb

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

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)

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Evidera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Participants initiating treatment with ozanimod
Participants initiating an sphingosine-1 phosphate (S1P) modulator
Participants initiating other non-S1P-receptor modulators disease modifying treatments (DMTs)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2021

Primary Completion (Estimated)

July 26, 2033

Study Completion (Estimated)

July 26, 2033

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM047-009
  • EUPAS44615 (Registry Identifier: EU PAS Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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