An observational study in Multiple Sclerosis, Relapsing-Remitting, sponsored by Bristol-Myers Squibb. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Bristol-Myers Squibb · Observational
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:
602 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 80 are open to participants now.
This study's enrollment of 9,000 is above the median of 116 across 151 observational studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Incidence of major adverse cardiovascular events (MACE)
Time frame: Up to 10 years
Incidence of serious opportunistic infection (SOI)
Time frame: Up to 10 years
Incidence of serious acute liver injury (SALI)
Time frame: Up to 10 years
Incidence of macular edema
Time frame: 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
Incidence of symptomatic bradycardia
Time frame: Up to approximately 5 years
Incidence of progressive multifocal leukoencephalopathy (PML)
Time frame: Up to approximately 5 years
Incidence of posterior reversible encephalopathy syndrome (PRES)
Time frame: Up to approximately 5 years
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Multiple Sclerosis, Relapsing-Remitting→
Bristol-Myers Squibb