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NCT02775656 Clinical Trial

UCB Cimzia Pregnancy Follow-up Study

Rheumatoid Arthritis (RA) Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02775656
Other study ID # UP0019
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 2016
Est. completion date December 2017

Study information
Verified date April 2021
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - 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 - Sufficient information to classify the pregnancy as prospective or retrospective is available - 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 - Consent to participate is provided Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Up0019 001 Wilmington North Carolina

Sponsors (3)
Lead Sponsor Collaborator
UCB BIOSCIENCES, Inc. Parexel, Syneos Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of newborns with major congenital malformations 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. At 20 weeks gestation or greater
Primary Percentage of pregnancy outcomes with major congenital malformations The pregnancy outcomes with and without MCMs will be summarized using frequency counts by all trimesters of exposure and earliest trimester of exposure. Estimated date of delivery (EDD) up to 6 weeks post-EDD
Secondary Numbers of maternal pregnancy-related events 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. During pregnancy up to Week 40
Secondary Percentage of Vaginal and C-section deliveries At birth (Day 0)
Secondary Gestational age at birth Estimated date of delivery (EDD) up to 6 weeks post-EDD
Secondary Birth weight Estimated date of delivery (EDD) up to 6 weeks post-EDD
Secondary Small for gestation age Estimated date of delivery (EDD) up to 6 weeks post-EDD
Secondary Percentage of adverse events in infants Percentage of adverse events (AEs) being collected in infants at study follow-up period (first 18 months) Within the first 18 months of life
Secondary 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) At birth (Day 0)
Secondary 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) At birth (Day 0)
Secondary 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) At birth (Day 0)
Secondary 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) 4 months
Secondary 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) 4 months
Secondary 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) 4 months
Secondary 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) 12 months
Secondary 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) 12 months
Secondary 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) 18 months
Secondary 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) 18 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills 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'. At birth (Day 0)
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills 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'. 4 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills 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'. 12 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills 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'. 18 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills 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'. At birth (Day 0)
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills 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'. 4 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills 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'. 12 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills 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'. 18 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language 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'. At birth (Day 0)
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language 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'. 4 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language 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'. 12 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language 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'. 18 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills 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'. At birth (Day 0)
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills 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'. 4 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills 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'. 12 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills 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'. 18 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills 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'. At birth (Day 0)
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills 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'. 4 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills 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'. 12 months
Secondary Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills 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'. 18 months
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