Atopic Dermatitis Clinical Trial
Official title:
Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)
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.
Status | Recruiting |
Enrollment | 3930 |
Est. completion date | July 21, 2027 |
Est. primary completion date | July 21, 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Regeneron Research Site | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Regeneron Pharmaceuticals | Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of major congenital malformations | Initially identified through the presence of corresponding codes on the insurance claims, confirmed through medical record review for infant outcomes: 01 April 2017 through 31 July 2023 | Up to 21 months | |
Secondary | Incidence of spontaneous abortion or miscarriage | Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024 | Up to 9 months | |
Secondary | Incidence of stillbirth | Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024 | Up to 9 months | |
Secondary | Incidence of small for gestational age | Identified through the presence of corresponding codes on the insurance claims for infant outcomes: 01 April 2017 through 31 July 2023 | Up to 21 months |
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