An Observational Registry of Abatacept in Patients with Juvenile Idiopathic Arthritis

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ABATACEPT
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA24) abatacept

  abatacept
• Medical condition to be studied:
  Juvenile idiopathic arthritis

Population studied

• Short description of the study population:
  The study population will include patients with JIA who are or were treated with abatacept according to physicians’/families’ decisions. The population may also include patients who received abatacept in an ongoing or completed clinical trial. Patients will be recruited from clinical pediatric rheumatology centers in countries where abatacept is approved for JIA or available in the market.
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  720

Study design details

• Main study objective:
  The primary objective of this study is to describe the long-term safety of abatacept treatment for JIA by quantifying the incidence rates of serious infections, autoimmune disorders, and malignancies.
• Data analysis plan:
  Descriptive statistics of the variables collected will be presented. Incidence rates of serious infections, autoimmune disorders, and malignancies will be estimated by dividing the number of cases by the person-time at risk. Ninety-five percent confidence intervals, assuming Poisson distribution of the rates, will be calculated for each incidence rate estimate. Incidence rates will be stratified by variables such as JIA subtype, prior JIA therapy, duration of abatacept use prior to study entry, age at initiation, co-morbid conditions, and baseline JIA activity. A subset evaluation describing the characteristics of patients 2 to 5 years at enrollment will be performed.