A Long-term, Multi-center, Longitudinal Post-marketing, Observational Study to Assess Long Term Safety and Effectiveness of HUMIRA® (Adalimumab) in Children With Moderately to Severely Active Polyarticular or Polyarticular-course Juvenile Idiopathic Arthritis (JIA) (STRIVE)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  HUMIRA
• Study drug International non-proprietary name (INN) or common name:
  ADALIMUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB04) adalimumab

  adalimumab
• Medical condition to be studied:
  Juvenile idiopathic arthritis

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  849

Study design details

• Main study objective:
  The primary objective of this study is to evaluate the long term safety of Humira in patients with moderately to severely active polyarticular or polyarticular-course JIA who are prescribed and treated in accordance with the approved local Humira product label under the conditions of a routine clinical setting.
• Outcomes:
  -Incidence of Serious Adverse Events (SAEs)-Incidence of Adverse Events (AEs) of Interest, -Pediatric American College of Rheumatology (PedACR) 50-PedACR 70-PedACR 30-Child Health Questionnaire (CHQ-PF50)-PedACR 90-Juvenile arthritis disease activity score (JADAS)-Physical function of Disability Index of Childhood Health Assessment Questionnaire
• Data analysis plan:
  The number and percent of patients experiencing SAEs and AEs of special interest during the registry, regardless of whether the AEs are reported during or after Humira or MTX treatment, will be tabulated by body system and Medical Dictionary for Drug Regulatory Activities (MedDRA) preferred term. Rates (event per 100 patient year of observation) of SAEs and AEs of Special Interest and 95% confidence interval will be provided.

Documents

Study results

P10-262-pmos-results-rpt-Abstract_Redacted.pdf