Aimovig Pregnancy Exposure Registry

Study Overview
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Brief Summary
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The primary objective of this study 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 erenumeb-aooe.

Official Title
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GENESIS: AIMOVIG® Pregnancy Exposure Registry

Conditions
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Migraine

Intervention / Treatment
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* Drug: erenumab-aooe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older (at time of signing the informed consent) Currently pregnant The outcome of the pregnancy must not be known Confirmed clinical diagnosis of migraine Exclusion Criteria: Women currently participating in another investigational device or investigational drug study, currently taking an investigational medicinal product, or having taken an investigational product within 3 months prior to last menstrual period (LMP) or during pregnancy. Other investigational procedures while participating in this study are excluded. Women exposed to any medications that target the calcitonin gene-related peptide (CGRP) pathway (ie, CGRP monoclonal antibody [mAb] or gepants) in the period from 5 half-lives prior to LMP through the end of pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Erenumab-aooe-exposed<br>Pregnant women with confirmed migraine who received erenumab-aooe before or during pregnancy will qualify to be included in the cohort. Dosing and treatment duration of erenumab-aooe as part of this observational study is at the discretion of the healthcare provider (HCP) in accordance with local clinical practice and local labeling. | Drug: erenumab-aooe<br>* Dose and treatment duration will be advised by the HCP<br>* Other names: Aimovig®;|
| Erenumab-aooe-unexposed (Internal Comparator)<br>Pregnant women with clinically confirmed migraine who were not exposed to erenumab-aooe before or during pregnancy will be included in the internal comparator cohort. | |
| Women Without Migraine (External Comparator)<br>Pregnant woman without migraine will be included in this cohort as external comparator. The Metropolitan Atlanta Congenital Defects Program (MACDP) birth defects classification system will be used to characterize major and minor congenital malformations for this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Infants Experiencing Major Congenital Malformations |  | Up to 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Women with Pregnancy Complications Following Erenumab-aooe Administration |  | Week 52 | 
| Number of Women Experiencing Spontaneous Abortion, Still Birth, Elective Termination, and Preterm Birth |  | Up to Approximately 38 Weeks | 
| Percentage of Infants of Women Exposed to Erenumab-aooe who are Small-for-gestational age |  | Up to Approximately 38 Weeks | 
| Percentage of Infants of Women Exposed to Erenumab-aooe Experiencing Minor Congenital Malformations |  | Up to Week 52 | 
| Percentage of Infants of Women Exposed to Erenumab-aooe with Postnatal Growth and Development Deficiency Through the First Year of life |  | Up to Week 52 | 
| Percentage of Participants with Maternal Outcomes | Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth. | Up to Approximately 38 Weeks | 
| Percentage of Participants with Fetal Outcomes | Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth. | Up to Approximately 38 Weeks | 
| Percentage of Participants with Infant Outcomes | Infant outcomes: minor congenital malformations, size for gestational age, low birth weight, postnatal growth and development. | Up to Week 52 | 
| Frequency of Major Congenital Malformations of Women with Migraine Exposed to Erenumab-aooe During Pregnancy with Women Representing the Prevalence of Birth Defects in the General Population (External Comparator) |  | Up to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erenumab-Aooe, AIMOVIG®