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Completed
NCT03936335
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Conditions: Adverse Pregnancy Outcomes, Atopic Dermatitis
Sex: Female
Ages: 18 Years – 49 Years
Healthy volunteers: No
Enrollment: 12343
Sponsor: Regeneron Pharmaceuticals
Location: Regeneron Research Site Boston Massachusetts
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
Source: ClinicalTrials.gov (NCT03936335). StuddyBuddy aggregates publicly available trial information.