NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
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)
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