UCB Cimzia Pregnancy Follow-up Study

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2017

Arms, Groups and Cohorts

  • Prospective cohort
    • 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).
  • Retrospective cohort
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Numbers of maternal pregnancy-related events
    • Time Frame: 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.
  • Percentage of Vaginal and C-section deliveries
    • Time Frame: At birth (Day 0)
  • Gestational age at birth
    • Time Frame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
  • Birth weight
    • Time Frame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
  • Small for gestation age
    • Time Frame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
  • Percentage of adverse events in infants
    • Time Frame: 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 weight (based on the relevant population norm for the infant)
    • Time Frame: At birth (Day 0)
  • 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)
    • Time Frame: At birth (Day 0)
  • 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)
    • Time Frame: At birth (Day 0)
  • 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)
    • Time Frame: 4 months
  • 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)
    • Time Frame: 4 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)
    • Time Frame: 4 months
  • 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)
    • Time Frame: 12 months
  • 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)
    • Time Frame: 12 months
  • 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)
    • Time Frame: 18 months
  • 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)
    • Time Frame: 18 months
  • Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
    • Time Frame: At birth (Day 0)
    • 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 gross motor skills
    • Time Frame: 4 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 gross motor skills
    • Time Frame: 12 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 gross motor skills
    • Time Frame: 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
    • Time Frame: At birth (Day 0)
    • 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
    • Time Frame: 4 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
    • Time Frame: 12 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
    • Time Frame: 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 language
    • Time Frame: At birth (Day 0)
    • 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 language
    • Time Frame: 4 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 language
    • Time Frame: 12 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 language
    • Time Frame: 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 cognitive skills
    • Time Frame: At birth (Day 0)
    • 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 cognitive skills
    • Time Frame: 4 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 cognitive skills
    • Time Frame: 12 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 cognitive skills
    • Time Frame: 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 social skills
    • Time Frame: At birth (Day 0)
    • 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 social skills
    • Time Frame: 4 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 social skills
    • Time Frame: 12 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 social skills
    • Time Frame: 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’.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UCB BIOSCIENCES, Inc.
  • Collaborator
    • Syneos Health
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • UCB Cares, Study Director, UCB Pharma

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