Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-29 @ 12:13 AM
Study NCT ID:
NCT01086059
Status:
COMPLETED
Last Update Posted:
2025-01-28
First Post:
2010-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OTIS Humira Pregnancy Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'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': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 944}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-26', 'studyFirstSubmitDate': '2010-03-11', 'studyFirstSubmitQcDate': '2010-03-11', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major malformations', 'timeFrame': 'Throughout pregnancy and up to 1 year of life', '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 of newborns.'}], 'secondaryOutcomes': [{'measure': 'Minor malformations', 'timeFrame': 'At dysmorphological exam', '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.'}, {'measure': 'Pregnancy outcome', 'timeFrame': 'Throughout pregnancy', 'description': 'Another objective of the study is to evaluate the effects of certain medications when used during pregnancy with respect to spontaneous abortion, stillbirth, and preterm delivery.'}, {'measure': 'Infant follow-up', 'timeFrame': 'Throughout pregnancy and up to 1 year of life', 'description': 'Pre- and post-natal fetal and infant growth, health and development'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Autoimmune diseases', 'adalimumab', 'pregnancy', 'birth defects', 'TNF', 'Tumor necrosis factor'], 'conditions': ["Crohn's Disease", 'Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '31626646', 'type': 'BACKGROUND', 'citation': 'Chambers CD, Johnson DL, Xu R, Luo Y, Lopez-Jimenez J, Adam MP, Braddock SR, Robinson LK, Vaux K, Lyons Jones K; OTIS Collaborative Research Group. Birth outcomes in women who have taken adalimumab in pregnancy: A prospective cohort study. PLoS One. 2019 Oct 18;14(10):e0223603. doi: 10.1371/journal.pone.0223603. eCollection 2019.'}], '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 disease 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 that 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women who reside in the United States, Canada or Puerto Rico.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently pregnant'}, 'identificationModule': {'nctId': 'NCT01086059', 'briefTitle': 'OTIS Humira Pregnancy Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project', 'orgStudyIdInfo': {'id': 'M03-604'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1 - Exposure cohort', 'description': "Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have used adalimumab in the first trimester of pregnancy for any length of time from the date of conception."}, {'label': 'Cohort 2 - Matched Diseased Comparison Cohort', 'description': "Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have not used adalimumab or any TNF antagonist in pregnancy."}, {'label': 'Cohort 3-Non-Diseased Comparison Cohort', 'description': 'Pregnant women without a current diagnosis of an autoimmune disease and who have not used adalimumab or any TNF antagonist at any time in pregnancy nor have they been exposed to any known human teratogen during pregnancy.'}, {'label': 'Cohort 4 - Registry Group', 'description': 'Pregnant women who have used adalimumab for any length of time following the first day of the last menstrual period until the end of pregnancy who do not meet Cohort 1 inclusionary criteria.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093-0828', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Kenneth L Jones, MD', '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': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Professor Department of Pediatrics', 'investigatorFullName': 'Christina Chambers', 'investigatorAffiliation': 'University of California, San Diego'}}}}