An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
NCT ID: NCT03936335
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3930 participants
OBSERVATIONAL
2019-09-30
2027-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Dupilumab cohort
Exposed to dupilumab during the relevant exposure window:
* First trimester
* Pregnancy
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.
Other systemic therapy or phototherapy cohort
Exposed to systemic medications other than dupilumab or to phototherapy during the relevant exposure window:
* First trimester
* Pregnancy
No interventions assigned to this group
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
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis code indicative of AD in the period from up to 1 year prior to the estimated LMP through the end of the pregnancy
18 Years
49 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Research Site
Boston, Massachusetts, United States
Countries
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Central Contacts
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Other Identifiers
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43838
Identifier Type: REGISTRY
Identifier Source: secondary_id
R668-AD-1760
Identifier Type: -
Identifier Source: org_study_id
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