Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosis
研究概览
简要总结
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 .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adverse event (AE) report with MedDRA Preferred Term of " John Cunningham virus (JCV) cerebrospinal fluid test positive", " JCV granule cell neuronopathy", or "Progressive multifocal leukoencephalopathy (PML)" reported to the Sponsor between 4-Jun-2026 and 31-Jul-
- •AE report(s) originating from spontaneous post-marketing reports, post-marketing observational studies with primary data collection, or patient support programs.
- •Diagnosis of multiple sclerosis before the initial AE report.
- •Exposure to at least one dose of ozanimod before onset of PML symptoms.
- •PML event assessed as "definite" or "probable" by the adjudication committee.
- •PML assessed as "related" to ozanimod by the adjudication committee.
排除标准
- •There are no additional exclusion criteria.
研究组 & 干预措施
Ozanimod Cohort
Patients with multiple sclerosis exposed to at least one dose of ozanimod who develop progressive multifocal leukoencephalopathy
干预措施: Ozanimod (Drug)
结局指标
主要结局
Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosis
时间窗: Up to 15 years
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.
次要结局
- Incidence rate of progressive multifocal leukoencephalopathy (PML) among ozanimod-exposed participants overall and by risk factor category(Up to 15 years)