Long-term Surveillance of Patients With Multiple Sclerosis to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections Among Patients Treated With Natalizumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 675
- 试验地点
- 15
- 主要终点
- Number of Participants with Serious Adverse Events (SAEs) of Other Opportunistic Infections (OIs) who are Taking Natalizumab
研究概览
简要总结
The primary objective of the study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) and serious adverse events (SAEs) of other opportunistic infections (OIs) among all participants taking natalizumab. The secondary objectives of the study are to estimate the incidence of SAEs, to estimate the incidence of SAEs among participant subgroups defined by demographic and clinical factors (age, gender, duration of treatment, pregnancy, breastfeeding), to characterize and estimate incidences of malignancies, hypersensitivity reactions and John Cunningham Virus (JCV) positivity among all participants taking natalizumab, and to count and describe pregnancies and breastfeeding among participants previously exposed to natalizumab.
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
- •Participants starting with natalizumab after 1st January 2019 and participating in the ReMuS will be included in this study
排除标准
- •Not Applicable (NA)
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Natalizumab Cohort
The cohort will include participants with MS who are newly treated with natalizumab (administered as a standard of care/routine clinical practice) from 1st January 2019 including those participants who terminate or discontinue the treatment during the observational period.
干预措施: Natalizumab (Drug)
结局指标
主要结局
Number of Participants with Serious Adverse Events (SAEs) of Other Opportunistic Infections (OIs) who are Taking Natalizumab
时间窗: Up to 6 years
SAE means such adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product. Serious OI means such OI which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a birth defect in offspring.
Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab
时间窗: Up to 6 years
次要结局
- Number of Participants With SAEs(Up to 6 years)
- Number of Participants With SAEs Among Participant Subgroups Defined by Demographic and Clinical Factors(Up to 6 years)
- Number of Participants With Malignancies who are Taking Natalizumab(Up to 6 years)
- Number of Participants With Hypersensitivity Reactions who are Taking Natalizumab(Up to 6 years)
- Number of Participants who are John Cunningham Virus (JCV) Positive and Taking Natalizumab(Up to 6 years)
- Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab(Up to 6 years)