UCB Cimzia Pregnancy Follow-up Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis (RA), Crohn's Disease (CD), Psoriatic Arthritis (PsA), Axial Spondyloarthritis and Ankylosing Spondylitis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective cohort<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of newborns with major congenital malformations | 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 | 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 | 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 |  | At birth (Day 0) | 
| Gestational age at birth |  | Estimated date of delivery (EDD) up to 6 weeks post-EDD | 
| Birth weight |  | Estimated date of delivery (EDD) up to 6 weeks post-EDD | 
| Small for gestation age |  | Estimated date of delivery (EDD) up to 6 weeks post-EDD | 
| Percentage of adverse events in infants | 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) |  | 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) |  | 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) |  | 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) |  | 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) |  | 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) |  | 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) |  | 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) |  | 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) |  | 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) |  | 18 months | 
| Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cimzia®, CZP, Pregnancy Follow up study, Autoimmune diseases, Pregnancy outcomes, major congenital malformations, birth outcomes, malformation, birth defect