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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— ORION  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05605782
• Other study ID #: IM047-009
• Secondary ID: EUPAS44615
• Status: Active, not recruiting
• Start date: June 30, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: October 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9000
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
United States	Evidera	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major adverse cardiovascular events (MACE)		Up to 10 years
Primary	Incidence of serious opportunistic infection (SOI)		Up to 10 years
Primary	Incidence of serious acute liver injury (SALI)		Up to 10 years
Primary	Incidence of macular edema		Up to 10 years
Primary	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
Secondary	Incidence of symptomatic bradycardia		Up to approximately 5 years
Secondary	Incidence of progressive multifocal leukoencephalopathy (PML)		Up to approximately 5 years
Secondary	Incidence of posterior reversible encephalopathy syndrome (PRES)		Up to approximately 5 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls