An observational study in Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy, sponsored by Bristol-Myers Squibb. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Bristol-Myers Squibb · Observational
This study will evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by John Cunningham virus (JCV), among people with multiple sclerosis who have been treated with ozanimod. The study will collect and review reported cases of PML to describe patient characteristics and estimate how often PML occurs among people treated with ozanimod. Researchers will assess factors that may be associated with the occurrence of PML, such as age, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia, and JCV antibody status .
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This study's planned enrollment of 15 is below the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
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Adults diagnosed with multiple sclerosis who have been treated with ozanimod and have reported potential progressive multifocal leukoencephalopathy events identified through the Bristol Myers Squibb safety database, spontaneous post-marketing reports, post-marketing observational studies with primary data collection, or patient support programs.
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Exclusion Criteria:
Patients with multiple sclerosis exposed to at least one dose of ozanimod who develop progressive multifocal leukoencephalopathy
Drug: Ozanimod
As per product label
Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosis
Participant characteristics and potential risk factors evaluated include: age at PML symptom onset, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia during ozanimod exposure, lymphopenia at PML diagnosis, duration of lymphopenia, anti-John Cunningham virus (JCV) antibody status within 6 months after ozanimod initiation, anti-JCV antibody status at PML symptom onset, and change in JCV index before PML symptom onset.
Time frame: Up to 15 years
Incidence rate of progressive multifocal leukoencephalopathy (PML) among ozanimod-exposed participants overall and by risk factor category
Incidence rates will be calculated as the number of PML cases divided by estimated person-years of ozanimod exposure and reported as cases per 100,000 person-years with 95% confidence intervals. Incidence rates will be reported overall and by risk factor category, including age, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia during ozanimod exposure, and anti-John Cunningham virus antibody status within 6 months after ozanimod initiation.
Time frame: Up to 15 years
Plan to share: No
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