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
This trial does not accept healthy volunteersQualifiers
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 population
Adult women with AD who are pregnant between 01 April 2017 and 31 March 2024 (with the start of pregnancy to be defined by the estimated last menstrual period (LMP))
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
dupilumab
DrugNo 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.
Treatment groups
3,930 Participants
are divided into 3 treatment groupsGroup A: Dupilumab cohort1 intervention
Group B: Other systemic therapy or phototherapy cohort0 interventions
Group C: Unexposed cohort0 interventions
Trial outcomes
Primary outcomes
1
Prevalence of MCMs
Initially identified through the presence of corresponding codes on the insurance claims, confirmed through medical record review for infant outcomes: 01 April 2017 through December 2024
Time frame
Up to 21 monthsSecondary outcomes
1
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
Time frame
Up to 9 months2
Incidence of stillbirth
Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024
Time frame
Up to 9 months3
Incidence of SGA
Identified through the presence of corresponding codes on the insurance claims for infant outcomes: 01 April 2017 through December 2024
Time frame
Up to 21 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Regeneron Pharmaceuticals
Lead sponsor
Sanofi
Collaborator
Source ClinicalTrials.gov