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UCB Cimzia Pregnancy Follow-up Study

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UCB

Status

Terminated

Conditions

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

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

Female

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

1 participants in 2 patient groups

Prospective cohort
Description:
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
Description:
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).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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