Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-17 @ 11:00 PM
Study NCT ID:
NCT02775656
Status:
TERMINATED
Last Update Posted:
2021-04-22
First Post:
2016-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UCB Cimzia Pregnancy Follow-up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'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': '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': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2016-05-16', 'lastUpdatePostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of newborns with major congenital malformations', 'timeFrame': 'At 20 weeks gestation or greater', 'description': 'The prevalence of major congenital malformations (MCMs) reported will be calculated by dividing the number of offspring with MCMs by the total number of live births and fetal losses with an MCM for all enrolled pregnancies and then stratified by treatment during pregnancy. The prevalence of MCMs will be calculated as soon as there are at least 50 prospectively-enrolled patients with an available outcome. Stillbirths and induced abortions (at 20 weeks gestation or greater) with reported MCMs are included in the estimate of the MCM prevalence.'}, {'measure': 'Percentage of pregnancy outcomes with major congenital malformations', 'timeFrame': 'Estimated date of delivery (EDD) up to 6 weeks post-EDD', 'description': 'The pregnancy outcomes with and without MCMs will be summarized using frequency counts by all trimesters of exposure and earliest trimester of exposure.'}], 'secondaryOutcomes': [{'measure': 'Numbers of maternal pregnancy-related events', 'timeFrame': 'During pregnancy up to Week 40', 'description': 'Descriptive statistics will be presented for the numbers of maternal pregnancy-related adverse events (AEs), adverse birth. Frequencies and proportions of adverse pregnancy will be presented using descriptive statistics. Analyses may include (but are not limited to) stratification by trimester of exposure, gestational age at time of consent, maternal age, and geographic region.'}, {'measure': 'Percentage of Vaginal and C-section deliveries', 'timeFrame': 'At birth (Day 0)'}, {'measure': 'Gestational age at birth', 'timeFrame': 'Estimated date of delivery (EDD) up to 6 weeks post-EDD'}, {'measure': 'Birth weight', 'timeFrame': 'Estimated date of delivery (EDD) up to 6 weeks post-EDD'}, {'measure': 'Small for gestation age', 'timeFrame': 'Estimated date of delivery (EDD) up to 6 weeks post-EDD'}, {'measure': 'Percentage of adverse events in infants', 'timeFrame': 'Within the first 18 months of life', 'description': 'Percentage of adverse events (AEs) being collected in infants at study follow-up period (first 18 months)'}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)', 'timeFrame': 'At birth (Day 0)'}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)', 'timeFrame': 'At birth (Day 0)'}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to head circumference (based on the relevant population norm for the infant)', 'timeFrame': 'At birth (Day 0)'}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)', 'timeFrame': '4 months'}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)', 'timeFrame': '4 months'}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to head circumference (based on the relevant population norm for the infant)', 'timeFrame': '4 months'}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)', 'timeFrame': '12 months'}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)', 'timeFrame': '12 months'}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)', 'timeFrame': '18 months'}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)', 'timeFrame': '18 months'}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills', 'timeFrame': 'At birth (Day 0)', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills', 'timeFrame': '4 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills', 'timeFrame': '12 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills', 'timeFrame': '18 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills', 'timeFrame': 'At birth (Day 0)', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills', 'timeFrame': '4 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills', 'timeFrame': '12 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills', 'timeFrame': '18 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language', 'timeFrame': 'At birth (Day 0)', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language', 'timeFrame': '4 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language', 'timeFrame': '12 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language', 'timeFrame': '18 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills', 'timeFrame': 'At birth (Day 0)', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills', 'timeFrame': '4 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills', 'timeFrame': '12 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills', 'timeFrame': '18 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills', 'timeFrame': 'At birth (Day 0)', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills', 'timeFrame': '4 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills', 'timeFrame': '12 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}, {'measure': 'Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills', 'timeFrame': '18 months', 'description': "Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cimzia®', 'CZP', 'Pregnancy Follow up study', 'Autoimmune diseases', 'Pregnancy outcomes', 'major congenital malformations', 'birth outcomes', 'malformation', 'birth defect'], 'conditions': ['Rheumatoid Arthritis (RA)', "Crohn's Disease (CD)", 'Psoriatic Arthritis (PsA)', 'Axial Spondyloarthritis and Ankylosing Spondylitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this observational follow-up study is to collect data systematically on pregnancies and offspring of women who become pregnant while participating in a Certolizumab Pegol (CZP) study or whose pregnancies have otherwise been reported to UCB due to potential CZP exposure during pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of women who become pregnant while enrolled in a Certolizumab Pegol (CZP) study, or whose pregnancies otherwise are reported to UCB due to potential CZP exposure during pregnancy, and any resulting offspring. All pregnancies reported while the patient is enrolled in the CZP study are eligible regardless of treatment arm in the CZP study (eg, commercial or investigational CZP, placebo, or comparator treatment), pregnancy outcome (eg, live birth,spontaneous abortion, induced abortion, stillbirth) or any treatment decisions following discontinuation from the clinical study or report of the pregnancy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy is identified while the patient is participating in an interventional or noninterventional Certolizumab Pegol (CZP) study conducted by UCB, or a development partner, regardless of phase or treatment arm (ie, commercial or investigational, placebo or comparator treatment), or whose pregnancies were spontaneously reported to UCB due to potential CZP exposure during pregnancy\n* Sufficient information to classify the pregnancy as prospective or retrospective is available\n* Full initial reporter (ie, woman or healthcare provider (HCP)) contact information reported to allow for follow-up (name, address, telephone number/email address) and contact information for at least 1 applicable HCP if initial contact is the woman\n* Consent to participate is provided\n\nExclusion Criteria:\n\n* Pregnancies in which the resulting infant is over 1 year of age at the time of informed consent will not be eligible to participate in the study'}, 'identificationModule': {'nctId': 'NCT02775656', 'briefTitle': 'UCB Cimzia Pregnancy Follow-up Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'An Observational Follow-up Study of Women Who Become Pregnant While Participating in a Certolizumab Pegol (CZP) Clinical Study or Whose Pregnancies Have Otherwise Been Reported to UCB Due to Potential CZP Exposure During Pregnancy', 'orgStudyIdInfo': {'id': 'UP0019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective cohort', 'description': 'For a pregnancy to be enrolled in the prospective cohort, the pregnancy outcome cannot be known (ie, no prenatal diagnosis of a fetus with a congenital defect and the pregnancy is still ongoing at the time of consent).'}, {'label': 'Retrospective cohort', 'description': 'For a pregnancy to be enrolled in the retrospective cohort, the pregnancy outcome must already be known (ie, a congenital defect has already been identified at the time of consent into the pregnancy follow-up study, or the pregnancy has been completed at the time of consent).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Up0019 001', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}], 'overallOfficials': [{'name': 'UCB Cares', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UCB Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB BIOSCIENCES, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}, {'name': 'Parexel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}