Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-01-27 @ 4:38 AM
Study NCT ID:
NCT02103361
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2014-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069549', 'term': 'Ustekinumab'}, {'id': 'C000588857', 'term': 'guselkumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2031-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-26', 'studyFirstSubmitDate': '2014-02-13', 'studyFirstSubmitQcDate': '2014-03-31', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Spontaneous abortions', 'timeFrame': 'From 3 months prior to the first day of the last menstrual period until the day of delivery', 'description': 'Rate of spontaneous abortions'}, {'measure': 'Infant follow-up, growth', 'timeFrame': 'Birth to one year of age', 'description': 'Pre- and post-natal fetal and infant growth, small for gestational age, and preterm delivery'}, {'measure': 'Stillbirths', 'timeFrame': 'From 3 months prior to the first day of the last menstrual period until the day of delivery', 'description': 'Rate of stillbirth'}, {'measure': 'Infant follow-up, Immune system development', 'timeFrame': 'Birth to 1 year of age', 'description': 'Health and development including effects to the immune system development.'}, {'measure': 'Preterm delivery', 'timeFrame': 'Birth', 'description': 'Rate of preterm delivery'}], 'primaryOutcomes': [{'measure': 'Major structural malformations', 'timeFrame': 'From 3 months prior to the first day of the last menstrual period and up to one year of age', 'description': 'The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to major structural birth defects.'}], 'secondaryOutcomes': [{'measure': 'Minor Congenital Structural Malformations', 'timeFrame': 'At dysmorphological exam which will occur at one time point between birth and one year of age', 'description': 'One secondary objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to potential minor malformations.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autoimmune disease', 'pregnancy', 'psoriasis', 'Stelara', 'ustekinumab', 'birth outcome', 'malformation', 'birth defect', 'psoriatic arthritis', "Crohn's Disease", 'Tremfya', 'guselkumab'], 'conditions': ['Psoriasis', 'Pregnancy', 'Psoriatic Arthritis', 'Crohn Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://mothertobaby.org/pregnancy-studies/', 'label': 'Official research website of the Organization of Teratology Information Specialists, Studies coordinated at the University of California, San Diego'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.', 'detailedDescription': 'The purpose of the Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project is to follow pregnant women or women who have delivered a baby, who have been treated with Stelara or Tremfya within 3 months of their last menstrual period (LMP) or during pregnancy to evaluate the possible effect of this medication on the pregnancy outcome including child development and growth up to one year of age.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women who have had exposure to Stelara (ustekinumab) or Tremfya (guselkumab) within 3 months of the last menstrual period, or anytime during pregnancy, and who reside in the U.S. or Canada.\n\nThe Stelara (ustekinumab) exposed group completed enrollment as of September 2019. The Tremfya (guselkumab) remains open to recruitment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documentation of an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months prior to the first day of the last menstrual period (LMP) for any number of days, at any time, at any dose, and at any time until completion of pregnancy.\n* Documentation of gestational timing of the exposure to Stelara (ustekinumab) or Tremfya (guselkumab)\n\nExclusion Criteria:\n\n* Women who have not have an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months of the first day of the last menstrual period.'}, 'identificationModule': {'nctId': 'NCT02103361', 'briefTitle': 'Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Stelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project', 'orgStudyIdInfo': {'id': 'CNTO1275PSO4037'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stelara (ustekinumab) exposed', 'description': 'Stelara (ustekinumab)-exposed pregnant women (this group is now closed to recruitment)', 'interventionNames': ['Drug: Ustekinumab']}, {'label': 'Tremfya (guselkumab) exposed', 'description': 'Tremfya (guselkumab-exposed pregnant women', 'interventionNames': ['Drug: Guselkumab']}], 'interventions': [{'name': 'Ustekinumab', 'type': 'DRUG', 'otherNames': ['Stelara'], 'armGroupLabels': ['Stelara (ustekinumab) exposed']}, {'name': 'Guselkumab', 'type': 'DRUG', 'otherNames': ['Tremfya'], 'armGroupLabels': ['Tremfya (guselkumab) exposed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Johnson', 'role': 'CONTACT'}, {'name': 'Christina Chambers, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Diana Johnson, MS', 'role': 'CONTACT', 'email': 'd4johnson@ucsd.edu', 'phone': '877-311-8972'}, {'name': 'Christina Chambers, PhD, MPH', 'role': 'CONTACT', 'email': 'chchambers@ucsd.edu', 'phone': '877-311-8972'}], 'overallOfficials': [{'name': 'Christina Chambers, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Organization of Teratology Information Specialists', 'class': 'OTHER'}, {'name': 'Janssen Biotech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Co-Director Center for Promotion of Maternal Health and Infant Development', 'investigatorFullName': 'Christina Chambers', 'investigatorAffiliation': 'University of California, San Diego'}}}}