NCT03936335Recruiting

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)

Regeneron Pharmaceuticals

Start Date

9/30/2019

Completion Date

1/21/2027

Summary

The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations \[MCMs\], small for gestational age \[SGA\]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.

Eligibility Criteria

Age Range: 18 years to 49 years

Key Inclusion Criteria: * Continuous medical and pharmacy benefit coverage for at minimum 6 months prior to and including the estimated LMP * Diagnosis code indicative of AD in the period from up to 1 year prior to the estimated LMP through the end of the pregnancy Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Interventions

DRUG

dupilumab

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Conditions

Adverse Pregnancy OutcomesAtopic Dermatitis

Locations

Regeneron Research Site

Boston, Massachusetts 02215

United States