Pharmacovigilance In Juvenile Idiopathic Arthritis Patients Treated With Biologic Agents And/Or Methotrexate. A Pediatric Rheumatology International Trials Organisation (PRINTO)/Pediatric Rheumatology European Society (PRES) Registry (Pharmachild JIA registry)

Study type

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

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

  Other
• Non-interventional study design, other:
  Prescription event monitoring

Study drug and medical condition

• Name of medicine:
  ILARIS

  Simponi
• Anatomical Therapeutic Chemical (ATC) code:
  100000096862

  abatacept

  100000096865

  etanercept

  100000096866

  infliximab

  100000096868

  adalimumab

  100000096869

  certolizumab pegol

  100000096873

  anakinra

  100000096874

  rilonacept

  100000096877

  tocilizumab
• Medical condition to be studied:
  Juvenile idiopathic arthritis

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  •To assess the long-term safety and efficacy of biologic agents and MTX for the treatment of children and adolescents with JIA. •To compare incidence rates of emergent moderate, severe adverse events (AEs) and serious A (SAE) observed in paediatric subjects with JIA
• Outcomes:
  Proportion of JIA paediatric subjects with biologic agents and MTX -emergent moderate/severe and SAEs, referred as:•All moderate/severe AEs and SAEs,•All additional moderate/severe AEs and SAEs which may modify the safety profile of biologic agents and MTX. •Three to 10-year and longer probability of not experiencing AEs•Incidence rate of biologic agents and MTX-emergent moderate/severe AEs and SAEs in a JIA population in comparison with incidence rates observed in JIA subjects treated with MTX in association with other DMARDs•Frequency of subjects meeting the ACR Pediatric criteria for improvement and clinical remission on and off medication
• Data analysis plan:
  Analysis will be mainly descriptive in nature. For continuous numeric data (e.g. baseline demographic data such as age), the descriptive statistics including number of subjects (n), mean, standard deviation (SD), median, and inter-quartile ranges will be summarized by dose group. For categorical data, the frequency count will be presented by dose group. Safety and tolerability will be summarized by treatment group. The number and percentage of subjects experiencing treatment emergent adverse event will be summarized by system organ class, preferred term, and treatment group. The number and percentage of subjects with clinically important laboratory abnormalities and vital signs measurements during the treatment period will be summarized by dose.Concomitant medications will be tabulated by generic drug name. Moderate/severe AEs and SAEs will be coded according to the current version of MedDRA.