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

NCT03936335

RecruitingN/A

Sponsor: Regeneron Pharmaceuticals

Conditions: Adverse Pregnancy Outcomes, Atopic Dermatitis

Interventions: dupilumab

Countries: United States

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 overview

Sex: FEMALE

Age: 18 Years to 49 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (1)
  • Boston, Massachusetts, United States