An observational study utilising data from the US Tysabri TOUCH programme and select EU MS Registries to estimate the risk of progressive multifocal leukoencephalopathy (PML) and other serious opportunistic infections among patients who were exposed to an MS disease modifying treatment prior to treatment with Tysabri

Study type

• Study topic:
  Disease /health condition

  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:
  Other
• Non-interventional study design, other:
  Patient Registry Study

Study drug and medical condition

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

  natalizumab
• Medical condition to be studied:
  Progressive multifocal leukoencephalopathy

  Multiple sclerosis

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  80327

Study design details

• Main study objective:
  To estimate the incidence of progressive multifocal leucoencephalopathy(PML) among patients who switched to Tysabri from disease modifying therapies(DMTs), including newer DMTs(including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs(interferon beta and glatiramer acetate)
• Outcomes:
  To estimate the incidence of progressive multifocal leucoencephalopathy (PML) among patients who switched to Tysabri from disease modifying therapies (DMTs) and to estimate the incidence of other serious opportunistic infections among patients who switch to Tysabri from newer DMTs and the established DMTs.
• Data analysis plan:
  Risk Estimation

Documents

Study report

101MS411 CSR Synopsis V1 PASS Final 16Sep2024_Redacted.pdf