Vedolizumab-5001: Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ENTYVIO
• Study drug International non-proprietary name (INN) or common name:
  VEDOLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA33) vedolizumab

  vedolizumab
• Medical condition to be studied:
  Colitis ulcerative

  Crohn's disease

Population studied

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

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The primary objective of the study is to assess the prevalence of major structural birth defects in infants of women with UC or CD exposed to vedolizumab during pregnancy, compared to women with UC or CD exposed to other biologic agents.
• Outcomes:
  Primary outcome included the major structural defects (either cosmetic or functional significance to the child) identified after infant's birth up to 1 year of age. Secondary outcome included the minor structural defects (neither cosmetic or functional significance to the child) identified through dysmorphology examination after infant's birth up to 1 year of age.
• Data analysis plan:
  Primary analysis between the vedolizumab-exposed group and the other biologic agents-exposed group will use Fisher exact test for univariate comparisons and logistic regression for multivariate analysis with adjustment for confounders.