UCB Cimzia Pregnancy Follow-up Study

April 19, 2021 updated by: UCB BIOSCIENCES, Inc.

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

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 Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States
        • Up0019 001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 20 weeks gestation or greater
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.
Estimated date of delivery (EDD) up to 6 weeks post-EDD

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During pregnancy up to Week 40
Percentage of Vaginal and C-section deliveries
Time Frame: At birth (Day 0)
At birth (Day 0)
Gestational age at birth
Time Frame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
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
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
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)
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 weight (based on the relevant population norm for the infant)
Time Frame: At birth (Day 0)
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)
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)
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
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
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
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
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
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
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
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'.
At birth (Day 0)
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'.
4 months
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'.
12 months
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'.
18 months
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'.
At birth (Day 0)
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'.
4 months
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'.
12 months
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'.
18 months
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'.
At birth (Day 0)
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'.
4 months
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'.
12 months
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'.
18 months
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'.
At birth (Day 0)
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'.
4 months
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'.
12 months
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'.
18 months
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'.
At birth (Day 0)
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'.
4 months
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'.
12 months
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'.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB BIOSCIENCES, Inc.

Collaborators

Syneos Health
Parexel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

May 16, 2016

First Posted (ESTIMATE)

May 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP0019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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