TOP: Tysabri® Observational Program

Study type

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

  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

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:
  Relapsing-remitting 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:
  6620

Study design details

• Main study objective:
  The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of natalizumab in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.
• Outcomes:
  • Number of participants with serious adverse events (SAE); • Annualized Relapse Rate (ARR); • Time to first relapse ; • Percentage of subjects with relapse ; • Percentage of subjects with disability progression ; • Percentage of subjects that reach Expanded Disability Status Score (EDSS) milestones ; • Percentage of subjects whose EDSS worsened, stabilized or improved ; • Evaluation of baseline disease characteristics ; • Evaluation of short-term disease outcomes
• Data analysis plan:
  All data will be summarized by presenting the frequency distributions for discrete endpoints and summary statistics (i.e. mean, standard deviation, median, and range) for continuous endpoints.