Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

AIMOVIG

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

ERENUMAB

Anatomical Therapeutic Chemical (ATC) code

(N02CD01) erenumab
erenumab

Medical condition to be studied

Migraine
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)
      • Adults (46 to < 65 years)

Special population of interest

Pregnant women

Estimated number of subjects

1421
Study design details

Main study objective

This study will address a requirement by the Food and Drug Administration (FDA) to conduct a prospective observational study of pregnant women exposed to erenumab-aooe to evaluate maternal, fetal, and infant outcomes.

Outcomes

The primary objective is to estimate the proportion of major congenital malformations in infants of women with migraine exposed to erenumab-aooe during pregnancy compared to infants of women with migraine unexposed to erenumab-aooe (internal comparator). In women exposed to erenumab-aooe during pregnancy, estimate and compare the proportion of pregnancy complications, spontaneous abortions, stillbirths, elective terminations, and preterm birth. In infants, estimate and compare the proportion of small-for-gestational age, minor congenital malformations, and postnatal growth and development deficiency through the first year of life.

Data analysis plan

To describe baseline patient characteristics, continuous variables will be reported as mean (standard deviation), median, minimum, maximum and range, and categorical variables will be summarized as number and proportion of the total study population. The overall frequency (proportion, 95% confidence interval CI) of select maternal, fetal, and infant outcomes will be calculated. Primary and secondary outcome frequencies in the erenumab-aooe exposed cohort will be compared with the internal comparator cohort using the risk ratio (95% CIs).