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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB BIOSCIENCES, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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