Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:
• 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
Locations
United States
Massachusetts
Regeneron Research Site
RECRUITING
Boston
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2019-09-30
Estimated Completion Date: 2027-01-21
Participants
Target number of participants: 3930
Treatments
Dupilumab cohort
Exposed to dupilumab during the relevant exposure window:~* First trimester~* Pregnancy
Other systemic therapy or phototherapy cohort
Exposed to systemic medications other than dupilumab or to phototherapy during the relevant exposure window:~* First trimester~* Pregnancy
Unexposed cohort
* Not exposed to systemic medications (including dupilumab) or phototherapy; and~* Received topical prescription therapy, or a second diagnosis for AD on a date that differs from the base population qualifying AD diagnosis date during the relevant exposure window:~* First trimester~* Pregnancy
Related Therapeutic Areas
Sponsors
Collaborators: Sanofi
Leads: Regeneron Pharmaceuticals