Prospective Cohort Study of Long-Term Safety of Teriflunomide in Multiple Sclerosis Patients in Europe (OBS12573)

Study type

• Study topic:
  Human medicinal product

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

  Drug utilisation
• 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

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA31) teriflunomide

  teriflunomide
• Medical condition to be studied:
  Relapsing-remitting multiple sclerosis

Population studied

• Short description of the study population:
  MS patients treated and not treated with teriflunomide identified in a pooled analysis of national Multiple Sclerosis registries.; Inclusion criteria.; • All Patients with a diagnosis of MS ;; • Aged 18 years or more at the date of entry in the cohort;; • registered in a MS registry database (as noted in section I9);; • treated with a Disease Modifying Therapy during the study period;; • patients who provide written consent (if appropriate and in accordance with local law)
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Relapsing-remitting multiple sclerosis patients
• Estimated number of subjects:
  15000

Study design details

• Main study objective:
  To characterize the long term safety profile of teriflunomide and determine the incidence of adverse events of special interest (AESI) in a real life setting. These include acute liver injuries, infections (included opportunistic), interstitial lung disease and pancreatic effects, cancers, cardiovascular events.
• Data analysis plan:
  The analysis consists in three major parts:The primary analysis will describe the population of subjects treated with teriflunomide and subjects treated with other DMT. This part will be essentially descriptive.The secondary analyses will consist in computing incidence rates and 95% confidence intervals of adverse events of special interest listed in the protocol, and to evaluate whether teriflunomide treated is associated with an increased risk of any of the AESI compared with other DMT. This requires computation of person-years.The exploratory analyses will be more detailed analyses to evaluate identified risks of adverse events in teriflunomide patients compared to groups of patients with similar characteristics. These analyses will be carried out only if the following conditions are fulfilled for a given AESI:- Statistically significant associations are found in the pooled results - Absence of heterogeneity in the pooled results