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NCT03936335 Clinical Trial

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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03936335
Other study ID # R668-AD-1760
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 30, 2019
Est. completion date July 21, 2027

Study information
Verified date May 2023
Source Regeneron Pharmaceuticals
Contact Clinical Trials Administrator
Phone 844-734-6643
Email clinicaltrials@regeneron.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 3930
Est. completion date July 21, 2027
Est. primary completion date July 21, 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• dupilumab
No study drug will be administered. This study is based on an analysis of automated medical and prescription claims, supplemented by information abstracted from the medical record.

Locations
Country Name City State
United States Regeneron Research Site Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Regeneron Pharmaceuticals Sanofi

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of major congenital malformations Initially identified through the presence of corresponding codes on the insurance claims, confirmed through medical record review for infant outcomes: 01 April 2017 through 31 July 2023 Up to 21 months
Secondary Incidence of spontaneous abortion or miscarriage Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024 Up to 9 months
Secondary Incidence of stillbirth Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024 Up to 9 months
Secondary Incidence of small for gestational age Identified through the presence of corresponding codes on the insurance claims for infant outcomes: 01 April 2017 through 31 July 2023 Up to 21 months
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