UCB Cimzia Pregnancy Follow-up Study
- Conditions
- Axial Spondyloarthritis and Ankylosing SpondylitisRheumatoid Arthritis (RA)Crohn's Disease (CD)Psoriatic Arthritis (PsA)
- Registration Number
- NCT02775656
- Lead Sponsor
- UCB BIOSCIENCES, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 1
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of newborns with major congenital malformations At 20 weeks gestation or greater 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.
Percentage of pregnancy outcomes with major congenital malformations Estimated date of delivery (EDD) up to 6 weeks post-EDD The pregnancy outcomes with and without MCMs will be summarized using frequency counts by all trimesters of exposure and earliest trimester of exposure.
- Secondary Outcome Measures
Name Time Method Percentage of Vaginal and C-section deliveries At birth (Day 0) Small for gestation age Estimated date of delivery (EDD) up to 6 weeks post-EDD 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 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 Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills 18 months 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'.
Numbers of maternal pregnancy-related events During pregnancy up to Week 40 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.
Birth weight Estimated date of delivery (EDD) up to 6 weeks post-EDD 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 Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills 18 months 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'.
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills 18 months 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'.
Percentage of adverse events in infants Within the first 18 months of life Percentage of adverse events (AEs) being collected in infants at study follow-up period (first 18 months)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language 18 months 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'.
Gestational age at birth Estimated date of delivery (EDD) up to 6 weeks post-EDD Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills 18 months 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'.
Trial Locations
- Locations (1)
Up0019 001
🇺🇸Wilmington, North Carolina, United States