Study type

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

AJOVY

Medical condition to be studied

Migraine
Population studied

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Adults (18 to < 46 years)

Estimated number of subjects

1000
Study design details

Main study objective

to assess major adverse maternal, fetal, and infant outcomes during pregnancy and up to 1 year after birth, comparing women exposed to AJOVY (fremanezumab) before or during pregnancy to comparison groups unexposed to AJOVY

Outcomes

major congenital anomalies, minor congenital malformations, pregnancy complications, including preeclampsia and eclampsia, pregnancy outcomes, including spontaneous abortions, elective terminations, stillbirths, preterm births, small-for-gestational-age birth (intrauterine growth retardation), and low birth weight (<2500 g), and other adverse outcomes, including postnatal growth and development abnormalities.

Data analysis plan

Descriptive statistics will be provided for the primary endpoint, major congenital malformation rates as well as secondary endpoints of interest, including number, percentage, and 95% confidence intervals (CIs).
Rates of adjudicated major congenital malformations on prospectively enrolled patients will be provided.
The main analyses will be inferential to compare the rates of major congenital malformations between the AJOVY group and each of the 2 internal comparison groups, using a generalized linear model and adjusted for exposure time category (first trimester, second trimester, and third trimester, as appropriate), maternal age group (18 to 39 years, and ≥40 years), and migraine type (episodic and chronic migraine).