Status: Planned First registered on: 28/10/2020
Last updated on: 13/11/2020
1. Study identification
EU PAS Register NumberEUPAS37799
Official titleGENESIS: AIMOVIG® Pregnancy Exposure Registry (20180125)
Study title acronymGENESIS
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?Yes: United States
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableProtocol 20180125
2. Research centres and Investigator details
Coordinating study entity
Centre nameAmgen
Centre locationUSA
Details of (Primary) lead investigator
Title Dr
Last name Amgen Inc.
First name Global Development Leader
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?1

IQVIA
Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/08/201820/08/2018
Start date of data collection14/01/2021
Start date of data analysis30/11/2027
Date of interim report, if expected30/11/2024
Date of final study report30/11/2028
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAmgen100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Amgen Inc.
First name Global Development Leader
Address line 1One Amgen Center Drive
Address line 2 
Address line 3 
CityThousand Oaks, CA 
Postcode91320-1799 
CountryUnited States
Phone number (incl. country code)18054473505 
Alternative phone number 
Fax number (incl. country code) 
Email address medinfo@amgen.com
Public Enquiries
Title Ms 
Last name Amgen Inc. 
First name Global Development Leader 
Address line 1One Amgen Center Drive 
Address line 2 
Address line 3 
CityThousand Oaks, CA 
Postcode91320-1799 
CountryUnited States 
Phone number (incl. country code)18054473505 
Alternative phone number 
Fax number (incl. country code) 
Email address medinfo@amgen.com 
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