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Recruiting NCT03936335
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Trial Parameters
Condition Adverse Pregnancy Outcomes
Sponsor Regeneron Pharmaceuticals
Study Type OBSERVATIONAL
Phase N/A
Enrollment 3,930
Sex FEMALE
Min Age 18 Years
Max Age 49 Years
Start Date 2019-09-30
Completion 2027-01-21
All Conditions
Interventions
dupilumab
Brief 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
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