Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT06126835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-01
First Post:
2023-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607776', 'term': 'ozanimod'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2828}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2032-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2023-10-06', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of major congenital malformations among infants', 'timeFrame': 'Up to 10 years', 'description': 'To estimate and compare the prevalence of major congenital malformations among infants born to pregnant women with UC who were exposed to ozanimod during first trimester relative to the prevalence among (i) infants born to women with UC exposed to conventional UC treatments and (ii) infants born to women with UC exposed to advanced UC treatment during first trimester of pregnancy.'}], 'secondaryOutcomes': [{'measure': 'Number of spontaneous abortions', 'timeFrame': 'Up to 10 years'}, {'measure': 'Number of stillbirths', 'timeFrame': 'Up to 10 years'}, {'measure': 'Number of participants with pre-eclampsia', 'timeFrame': 'Up to 10 years'}, {'measure': 'Number of participants with eclampsia', 'timeFrame': 'Up to 10 years'}, {'measure': 'Number of preterm births', 'timeFrame': 'Up to 10 years'}, {'measure': 'Number of infants small for gestational age', 'timeFrame': 'Up to 10 years'}, {'measure': 'Number of serious or opportunistic infections in liveborn infants up to 1 year of age', 'timeFrame': 'Up to 10 years'}, {'measure': 'Number of infant postnatal growth deficiencies', 'timeFrame': 'Up to 10 years'}, {'measure': 'Number of infant developmental deficiencies', 'timeFrame': 'Up to 10 years'}, {'measure': 'Number of neonatal hospitalizations', 'timeFrame': 'Up to 10 years'}, {'measure': 'Number of infant deaths', 'timeFrame': 'Up to 10 years'}, {'measure': 'Number of neonatal deaths', 'timeFrame': 'Up to 10 years'}, {'measure': 'Number of perinatal deaths', 'timeFrame': 'Up to 10 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult women with UC who became pregnant between June 1, 2021 and September 1, 2030', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 49 years on date of conception\n* Date of conception between June 1, 2021 and September 1, 2030\n* Continuous medical and pharmacy coverage for a minimum of 6 months prior to date of last menstrual period through the end of the pregnancy episode\n* Diagnosis of UC during the 12 months prior to conception through the end of the first trimester\n\nExclusion Criteria:\n\n* • Pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes)'}, 'identificationModule': {'nctId': 'NCT06126835', 'briefTitle': 'A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring', 'orgStudyIdInfo': {'id': 'IM047-025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ozanimod exposed', 'interventionNames': ['Drug: Ozanimod']}, {'label': 'Conventional therapy exposed', 'interventionNames': ['Drug: Conventional therapy']}, {'label': 'Advanced therapy exposed', 'interventionNames': ['Drug: Advanced therapy']}], 'interventions': [{'name': 'Ozanimod', 'type': 'DRUG', 'description': 'Women with UC exposed to ozanimod during pregnancy', 'armGroupLabels': ['Ozanimod exposed']}, {'name': 'Conventional therapy', 'type': 'DRUG', 'description': 'Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy', 'armGroupLabels': ['Conventional therapy exposed']}, {'name': 'Advanced therapy', 'type': 'DRUG', 'description': 'Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy', 'armGroupLabels': ['Advanced therapy exposed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55344', 'city': 'Eden Prairie', 'state': 'Minnesota', 'country': 'United States', 'facility': 'OptumInsight Life Sciences Inc', 'geoPoint': {'lat': 44.85469, 'lon': -93.47079}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}