Mirikizumab Pregnancy Registry (I6T-MC-B006)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  MIRIKIZUMAB

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  To estimate the relative birth prevalence of major congenital malformations (up to 12 months) among infants born to women exposed
• Outcomes:
  Major congenital malformations
• Data analysis plan:
  Descriptive analyses will be generated for all enrolled women and infants.