UCB Cimzia Pregnancy Follow-up Study

Stopped early

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

In brief

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.

Key facts

Study ID

NCT02775656

Run by

UCB BIOSCIENCES, Inc.

People needed

1

Starts

2016-11-01

Expected to finish

2017-12-01

Last updated by the study team

2021-04-22

Who can join

Age: 18 and older, up to 64. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Up0019 001 — Wilmington, North Carolina, United States

Full record on ClinicalTrials.gov

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