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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- UCB BIOSCIENCES, Inc.
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Percentage of newborns with major congenital malformations
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Percentage of newborns with major congenital malformations
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- Numbers of maternal pregnancy-related events(During pregnancy up to Week 40)
- 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)
- Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills(18 months)
- Percentage of adverse events in infants(Within the first 18 months of life)
- Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language(18 months)
- 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)