A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA (adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn’s Disease (CD) - CAPE

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  HUMIRA
• Medical condition to be studied:
  Crohn's disease

Population studied

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

  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  1434

Study design details

• Main study objective:
  This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the product label.
• Outcomes:
  -Number (No.) and percentage of subjects with SAEs-No. and percentage of subjects with AESI of infections, malignancies, and pregnancies-No. and percentage of subjects with other AESI-No. of treatment-emergent SAEs per 100 patient years (PYs)-No. of treatment-emergent AESI per 100 PYs of infections, malignancies-No. of treatment-emergent other AESI per 100 PYs, -Short Pediatric Crohn's Disease Activity Index (sh-PCDAI)-Physician's Global Assessment of Disease Activity (PGA)-IMPACT III-Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ)-Work Productivity and Activity Impairment (WPAI) Questionnaire
• Data analysis plan:
  For effectiveness data, continuous variables will be summarized using descriptive statistics by the number of non-missing observations, mean, 95% CI for mean, standard deviation, 1st quartile, median, 3rd quartile, minimum, and maximum. Categorical variables will be summarized using frequencies and percentages.For safety data, treatment-emergent adverse events (AEs) will be coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA). The number and percent of patients experiencing serious AEs and AEs of interest will be tabulated by system organ class (SOC) and MedDRA preferred term (PT). Events per 100 patient-years, i.e. the number of treatment-emergent serious adverse events (SAEs) and adverse events of special interest (AESI) per 100 patient-years, will be tabulated. Complete, specific details of the statistical analysis will be described and fully documented in the Statistical Analysis Plan (SAP).