An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-49
SponsorRegeneron Pharmaceuticals
About this trial
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
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- dupilumab
Treatment groups
3,930 Participants
are divided into 3 treatment groupsSponsors and collaborators
Regeneron Pharmaceuticals
Lead sponsor
Sanofi
Collaborator
Source ClinicalTrials.gov