An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dupilumab.
- Who it may be relevant to
- Registry conditions: Adverse Pregnancy Outcomes, Atopic Dermatitis. Basic parameters: 18 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Prevalence of MCMs [Time frame: Up to 21 months]
Secondary outcome measures (3)
- Incidence of spontaneous abortion or miscarriage [Time frame: Up to 9 months]
- Incidence of stillbirth [Time frame: Up to 9 months]
- Incidence of SGA [Time frame: Up to 21 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Regeneron Research Site — Boston
Identifiers
NCT: NCT03936335 · R668-AD-1760 · 43838