UCB Cimzia Pregnancy Follow-up Study

NCT02775656 | Terminated DMC

• 1 other identifier: UP0019
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cimzia®; CZP; Pregnancy Follow up study; Autoimmune diseases; Pregnancy outcomes; major congenital malformations; birth outcomes; malformation; birth defect

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (36)

• Numbers of maternal pregnancy-related events

  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

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB BIOSCIENCES, Inc.: lead
• Syneos Health: collaborator
• Parexel: collaborator

Study Sites (1)

Up0019 001

Wilmington, North Carolina, United States

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Rheumatoid; Crohn Disease; Arthritis, Psoriatic; Axial Spondyloarthritis; Spondylitis, Ankylosing; Autoimmune Diseases; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Ankylosis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• UCB Cares

  UCB Pharma

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: May 17, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 22, 2021

Record last verified: 2021-04

Locations

US (1)