Long-term surveillance of patients with multiple sclerosis to report progressive multifocal leukoencephalopathy and other serious opportunistic infections among patients treated with natalizumab

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  NATALIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AG03) natalizumab

  natalizumab
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  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 subjects taking natalizumab.
• Outcomes:
  Number of Subjects With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab, Number of Subjects With Serious Adverse Events (SAEs) of Other Opportunistic Infections (OIs) who are Taking Natalizumab. ; Number of Subjects: With SAEs, With SAEs Among Subject Subgroups Defined by Demographic and Clinical Factors, With Malignancies who are Taking Natalizumab, With Hypersensitivity Reactions who are Taking Natalizumab, Who are John Cunningham Virus (JCV) Positive and Taking Natalizumab, Who are Pregnant and Breastfeeding and Who Were Previously Exposed to Natalizumab.
• Data analysis plan:
  Categorical variables will be summarised numerically and as rate by each category. Continuous variables will be summarised as mean ± standard deviation (SD), median, minimum and maximum.