UCB Cimzia Pregnancy Follow-up Study



Status:Terminated
Conditions:Arthritis, Rheumatoid Arthritis, Neurology, Neurology, Orthopedic, Crohns Disease
Therapuetic Areas:Gastroenterology, Neurology, Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 64
Updated:6/13/2018
Start Date:November 2016

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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

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.


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
We found this trial at
1
site
Wilmington, North Carolina
?
mi
from
Wilmington, NC
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