NCT03936335 An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
| NCT ID | NCT03936335 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regeneron Pharmaceuticals |
| Condition | Adverse Pregnancy Outcomes |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,930 participants |
| Start Date | 2019-09-30 |
| Primary Completion | 2027-01-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,930 participants in total. It began in 2019-09-30 with a primary completion date of 2027-01-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Clinical Trial Management
STUDY DIRECTOR
Regeneron Pharmaceuticals
Frequently Asked Questions
Who can join the NCT03936335 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 49 Years, studying Adverse Pregnancy Outcomes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03936335 currently recruiting?
Yes, NCT03936335 is actively recruiting participants. Contact the research team at clinicaltrials@regeneron.com for enrollment information.
Where is the NCT03936335 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03936335 clinical trial?
NCT03936335 is sponsored by Regeneron Pharmaceuticals. The principal investigator is Clinical Trial Management at Regeneron Pharmaceuticals. The trial plans to enroll 3,930 participants.