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

RECRUITING

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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.

Conditions:

Adverse Pregnancy Outcomes Atopic Dermatitis

Study Start (Actual) 2019-09-30

Primary Completion (Estimated) 2027-07-21

Study Completion (Estimated) 2027-07-21

Enrollment (Estimated) 3930

Study Type OBSERVATIONAL

Phase N/A

Locations:

📍 Boston, Massachusetts, United States

Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to 49 Years (ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2019-04-30
First Submitted that Met QC Criteria2019-04-30
First Posted2019-05-03

Study Record Updates

Last Update Submitted that Met QC Criteria2023-05-11
Last Update Posted2023-05-12
Last Verified2023-05