OBSERVATIONAL SAFETY AND EFFECTIVENESS STUDY OF PATIENTS WITH POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS TREATED WITH TOCILIZUMAB

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Observational safety and effectiveness study as post-marketing commitment to FDA and EMA
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ROACTEMRA
• Study drug International non-proprietary name (INN) or common name:
  TOCILIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC07) tocilizumab

  tocilizumab
• Medical condition to be studied:
  Juvenile idiopathic arthritis
• Additional medical condition(s):
  Polyarticular juvenile idiopathic arthritis

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  To assess the long-term safety and effectiveness of TCZ in relation to comparator biologics in the treatment of pJIA in a real-world setting for 5 years.
• Outcomes:
  - Rate of serious adverse events ; - Rates of serious adverse events in the following categories of special interest: * Infections * Cardiovascular events * Malignancies * Gastrointestinal perforations ; - Rate and treatment outcome of uveitis - Growth patterns - Development patterns; - Juvenile Arthritis Disease Activity Score in 10 joints (JADAS-10)
• Data analysis plan:
  Descriptive summary analyses will be used to characterize baseline demographics, medical history, medications, growth and development. ; Incidence rates, with 95% confidence intervals, will be provided for serious adverse events. Height standard deviation scores will be summarized descriptively over time by treatment group. The data for development patterns will be summarized by gender for each treatment group. ; The rate of uveitis and description of treatment outcome will be summarized. JADAS-10 will be summarized over time.