Observational study on pregnancy outcomes in women with atopic dermatitis
Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)
This study looks at how pregnancy outcomes differ for women with atopic dermatitis who are treated with dupilumab compared to those who aren't, to see if the treatment affects things like miscarriage and infant health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3930 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | dupilumab |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03936335 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate and compare the incidence of adverse pregnancy outcomes, such as spontaneous abortion and stillbirth, as well as the prevalence of infant outcomes like major congenital malformations and being small for gestational age, in women with atopic dermatitis who are treated with dupilumab during pregnancy versus those who are not. It is an observational retrospective cohort study, meaning it will analyze existing data from medical records rather than conducting new interventions. The study will focus on women diagnosed with atopic dermatitis and will assess their pregnancy outcomes based on their treatment status.
Who should consider this trial
Good fit: Ideal candidates for this study are women with a diagnosis of atopic dermatitis who are pregnant or planning to become pregnant and have been treated with dupilumab.
Not a fit: Patients who do not have atopic dermatitis or those who are not pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of dupilumab treatment during pregnancy for women with atopic dermatitis.
How similar studies have performed: While there may be studies on pregnancy outcomes in women with atopic dermatitis, this specific comparison involving dupilumab is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Regeneron Research Site — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.