Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
Part of paid clinical trials in Lawrenceville, New Jersey.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT07732907
- Status
- Recruiting
Conditions
- Multiple Sclerosis
- Progressive Multifocal Leukoencephalopathy
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ozanimod — DRUGAs per product label
Study Details
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 .
Key Dates
- First listed
- Jul 29, 2026
- Start date
- Jun 4, 2026
- Status verified
- Jul 2026
- Primary completion
- Jul 31, 2041
- Completion
- Jul 31, 2041
Study Design
- Enrollment
- 15 participants (estimated)
Arms
- Arm: Ozanimod CohortPatients with multiple sclerosis exposed to at least one dose of ozanimod who develop progressive multifocal leukoencephalopathy
Primary Outcome Measure
Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosis [ Time Frame: Up to 15 years ]
Central Contacts
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
- First line of the email MUST contain NCT # and Site #.
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Bristol Myers Squibb | Lawrenceville | New Jersey | 08648 | - |
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