A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)

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

• Study drug International non-proprietary name (INN) or common name:
  ADALIMUMAB
• Medical condition to be studied:
  Colitis ulcerative

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  5450

Study design details

• Main study objective:
  The primary objective of this study is to evaluate the long-term safety of HUMIRA® in moderately to severely active UC adult patients (18 years of age or older) who are treated per routine clinical practice.
• Outcomes:
  Number and percent of patients experiencing serious adverse events (SAEs) and adverse events of interest (AEIs), - Safety reporting forms will be used to estimate health care resource utilization - Partial Mayo Score - CRP, hemoglobin and fecal calprotectin values - Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) - Work Productivity and Activity Impairment (WPAI) - Treatment Satisfaction Questionnaire for Medication (TSQM) - EQ-5D-5L
• Data analysis plan:
  For demographics/baseline, medical history, previous/concomitant medication and effectiveness data, categorical variables will be summarized using frequencies and percentages. Continuous variables will be summarized using descriptive statistics by the number of non-missing observations, mean, standard deviation, 1st quartile, median, 3rd quartile, minimum and maximum. In addition for effectiveness data, 95% CI for the mean will be provided. For safety data, treatment-emergent (TE) and observational 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 TE and observational AEs will be summarized as well as tabulated by system organ class (SOC) and MedDRA preferred term (PT). The number of AEs per 100 patient-years will be summarized. In addition, by-patient listings will be provided for TE and observational AEs.