GENESIS: AIMOVIG® Pregnancy Exposure Registry (20180125)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39266
• EU PAS number:
  EUPAS37799
• Study ID:
  39266
• Official title and acronym:
  GENESIS: AIMOVIG® Pregnancy Exposure Registry (20180125)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  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 (Aimovig ®) to evaluate maternal, fetal, and infant outcomes. This study is being conducted to understand the safety of administering erenumab-aooe during pregnancy in women. Data from pregnant women who are eighteen years or older, experience migraines, and were exposed to erenumab-aooe, and their infants will be included in this study. The erenumab-aooe exposed cohort will be compared with two unexposed comparator cohorts: 1) women with migraine who have not been exposed to erenumab-aooe before or during pregnancy (internal comparator), and 2) pregnant women without migraine (external comparator). The planned study period is approximately 7 years. The total duration per patient will be up to 21 months. The registry will identify and record pregnancy complications, major and minor congenital malformations, spontaneous abortions, still births, elective terminations, preterm births, small-for-gestational age births, postnatal growth and development deficiency, and any other adverse outcomes.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 20/08/2018

Actual: 20/08/2018

Study start date

Planned: 25/01/2021

Actual: 27/01/2021

Data analysis start date

Planned: 30/11/2027

Date of interim report, if expected

Planned: 30/11/2024

Date of final study report

Planned: 30/11/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original erenumab 20180125 .pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Protocol 20180125