Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-28 @ 7:47 AM
Study NCT ID:
NCT06627335
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2024-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D004485', 'term': 'Eczema'}], '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'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5621}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of major congenital malformation (MCM)s', 'timeFrame': 'Up to 12 months after birth', 'description': "Defined as any major structural or chromosomal defect in live-born infants, stillbirths or spontaneous losses equal to or greater than 20 weeks' gestation, or electively terminated pregnancies of any gestational age."}], 'secondaryOutcomes': [{'measure': 'Number of small-for-gestational age (SGA) births', 'timeFrame': 'At time of delivery', 'description': 'Defined as a birthweight at or below the 10th percentile for a given gestational age.'}, {'measure': 'Number of Pregnancy outcomes', 'timeFrame': 'Up to birth', 'description': 'Number of live births, still births, recognized spontaneous abortions and number of elective terminations as defined in the protocol.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ruxolitinib', 'Atopic Dermatitis', 'pruritus', 'eczema', 'topical therapy', 'JAK inhibitor'], 'conditions': ['Pregnancy Related', 'Atopic Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://incyteclinicaltrials.com/studies/incb18424-ma-iai-403', 'label': 'An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis'}]}, 'descriptionModule': {'briefSummary': 'This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Exposure cohort study of women within the US with atopic dermatitis (AD) who were exposed to ruxolitinib cream at any time during their pregnancy period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 14 years or older at pregnancy outcome.\n* Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021.\n* At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort).\n* A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception.\n* Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy.\n* For infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). Infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). A 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias.\n\nExclusion Criteria:\n\n• One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.'}, 'identificationModule': {'nctId': 'NCT06627335', 'briefTitle': 'An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis', 'orgStudyIdInfo': {'id': 'INCB18424-MA-IAI-403'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants of women with AD exposed to ruxolitinib cream during pregnancy', 'interventionNames': ['Drug: Ruxolitinib Cream']}, {'label': 'Infants of women with AD exposed to a TCS prior to or during pregnancy', 'interventionNames': ['Drug: TCS']}], 'interventions': [{'name': 'Ruxolitinib Cream', 'type': 'DRUG', 'otherNames': ['Opzelura'], 'description': 'Ruxolitinib Cream', 'armGroupLabels': ['Infants of women with AD exposed to ruxolitinib cream during pregnancy']}, {'name': 'TCS', 'type': 'DRUG', 'description': 'Topical corticosteroid', 'armGroupLabels': ['Infants of women with AD exposed to a TCS prior to or during pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27560', 'city': 'Morrisville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Syneos Health (remote site)', 'geoPoint': {'lat': 35.82348, 'lon': -78.82556}}], 'centralContacts': [{'name': 'Incyte Corporation Call Center (US)', 'role': 'CONTACT', 'email': 'medinfo@incyte.com', 'phone': '1.855.463.3463'}], 'overallOfficials': [{'name': 'Incyte Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}