An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Recruiting · NCT03936335 · Observational (researchers observe without assigning treatment) · Lead sponsor: Regeneron Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 49 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- Regeneron Research Site - Boston, Massachusetts, United States