German Tysabri-Data-Register (Tysabri-Register)

Study type

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

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational multicenter register (NIS)

Study drug and medical condition

• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Age groups:
  • 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:
  1830

Study design details

• Main study objective:
  The primary objective of the German Tysabri-Data-Register is to examine the long-term safety profile of Tysabri in heterogeneous groups of MS patients. Secondary objective is to identify risk factors (baseline disease characteristics) for adverse events which might act as potential prognostic indicators.
• Outcomes:
  The primary outcome the incidence, type and characteristics of adverse events in MS patients treated with Tysabri in routine clinical care. For the secondary objective the following factors will be evaluated: a) EDSS progressionb) Annual relapse rate.
• Data analysis plan:
  All adverse events (AEs) will be assessed prospectively. Safety will be monitored by estimating the cumulative incidence overall and stratified by type of disease severity. Type, severity of AEs, and proportion of patients experiencing multiple AEs (more than one AE) will be examined using descriptive statistics. Potential risk factors of AE occurrence will be identified by subgroup analyses (e.g. stratified by age, gender, medical history of MS therapies, disease duration, comorbidities, EDSS). Multiple adjustments will be done by logistic regression. All SAEs will be reported to the manufacturer immediately after becoming aware. The manufacturer will subsequently report to the regulating authority.Data on adverse events (non-serious AE) and effectiveness of Tysabri therapy will be analyzed every six month (6-month Interim analyses) and reported.