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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05605782
Recruitment Status : Active, not recruiting
First Posted : November 4, 2022
Last Update Posted : November 4, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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)

Condition or disease
Multiple Sclerosis, Relapsing-Remitting

Study Design
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Study Type : Observational
Actual Enrollment : 9000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: ORION (Ozanimod Real-World Safety - A Post- Authorisation Multi-National Long-term Non-Interventional Study)
Actual Study Start Date : June 30, 2022
Estimated Primary Completion Date : December 31, 2032
Estimated Study Completion Date : December 31, 2032

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05605782


Locations
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United States, Maryland
Evidera
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05605782    
Other Study ID Numbers: IM047-009
EUPAS44615 ( Registry Identifier: EU PAS Registry )
First Posted: November 4, 2022    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: October 2022
Keywords provided by Bristol-Myers Squibb:
Relapsing-Remitting Multiple Sclerosis
Ozanimod
Serious opportunistic infections
 Serious acute liver injury
Malignancy
Macular edema
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases