RECRUITING

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)

Description

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.

Study Overview

Study Details

Study overview

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 and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)

Condition
Adverse Pregnancy Outcomes
Intervention / Treatment

-

Contacts and Locations

Boston

Regeneron Research Site, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 49 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Regeneron Pharmaceuticals,

Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

2027-07-21