May 3, 2019
October 29, 2020
The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of 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.
|: Dupilumab cohort
Exposed to dupilumab during the relevant exposure window: First trimester Pregnancy
No study drug will be administered. This study is based on an analysis of automated medical and prescription claims, supplemented by information abstracted from the medical record.
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
Contact: Clinical Trials Administrator 844-734-6643 email@example.com
United States, Massachusetts
Regeneron Research Site
Study Director: Clinical Trial Management Regeneron Pharmaceuticals