Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-01 @ 2:47 PM
Study NCT ID:
NCT03936335
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2019-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3930}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-01-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2019-04-30', 'studyFirstSubmitQcDate': '2019-04-30', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of MCMs', 'timeFrame': 'Up to 21 months', 'description': 'Initially identified through the presence of corresponding codes on the insurance claims, confirmed through medical record review for infant outcomes: 01 April 2017 through December 2024'}], 'secondaryOutcomes': [{'measure': 'Incidence of spontaneous abortion or miscarriage', 'timeFrame': 'Up to 9 months', 'description': 'Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024'}, {'measure': 'Incidence of stillbirth', 'timeFrame': 'Up to 9 months', 'description': 'Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024'}, {'measure': 'Incidence of SGA', 'timeFrame': 'Up to 21 months', 'description': 'Identified through the presence of corresponding codes on the insurance claims for infant outcomes: 01 April 2017 through December 2024'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adverse Pregnancy Outcomes', 'Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult women with AD who are pregnant between 01 April 2017 and 31 March 2024 (with the start of pregnancy to be defined by the estimated last menstrual period (LMP))', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Continuous medical and pharmacy benefit coverage for at minimum 6 months prior to and including the estimated LMP\n* Diagnosis code indicative of AD in the period from up to 1 year prior to the estimated LMP through the end of the pregnancy\n\nNote: Other Protocol Defined Inclusion / Exclusion Criteria Apply'}, 'identificationModule': {'nctId': 'NCT03936335', 'briefTitle': 'An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)', 'orgStudyIdInfo': {'id': 'R668-AD-1760'}, 'secondaryIdInfos': [{'id': '43838', 'type': 'REGISTRY', 'domain': 'EU HMA-EMA Catalogue'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dupilumab cohort', 'description': 'Exposed to dupilumab during the relevant exposure window:\n\n* First trimester\n* Pregnancy', 'interventionNames': ['Drug: dupilumab']}, {'label': 'Other systemic therapy or phototherapy cohort', 'description': 'Exposed to systemic medications other than dupilumab or to phototherapy during the relevant exposure window:\n\n* First trimester\n* Pregnancy'}, {'label': 'Unexposed cohort', 'description': '* Not exposed to systemic medications (including dupilumab) or phototherapy; and\n* 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:\n* First trimester\n* Pregnancy'}], 'interventions': [{'name': 'dupilumab', 'type': 'DRUG', 'otherNames': ['REGN668', 'Dupixent®', 'SAR23189'], 'description': '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.', 'armGroupLabels': ['Dupilumab cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Regeneron Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Clinical Trials Administrator', 'role': 'CONTACT', 'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643'}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}