OTIS Cimzia Pregnancy Registry

University of California San Diego

Status: Active, not recruiting

Conditions: Psoriasis; Psoriatic Arthritis; Crohn's Disease; Ankylosing Spondylitis; Rheumatoid Arthritis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01797224

RA0023

Details and patient eligibility

About

The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for five years after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

Full description

The purpose of the OTIS Autoimmune Diseases in Pregnancy Project, Cimzia Pregnancy Exposure Registry is to follow pregnant women with or without a Cimzia approved indication who have or have not been treated with Cimzia during pregnancy to evaluate the possible effect of these diseases, and or this medication on the pregnancy outcome including child development and growth up to five years of age.

Enrollment: 925 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Currently pregnant

Trial design

925 participants in 4 patient groups

Cohort 1 - Exposed Cohort

Description:

Pregnant women with a current diagnosis of an approved indication who have used Cimzia (certolizumab pegol) in the first trimester of pregnancy for any length of time from the date of conception.

Cohort 2 - Diseased Comparison Cohort

Description:

Pregnant women with a current diagnosis of a Cimzia approved indication who have not used Cimzia (certolizumab pegol) during the current pregnancy.

Cohort 3 - Non-Diseased Comparison Cohort

Description:

Pregnant women without a current diagnosis of an autoimmune disease and who have not used Cimzia (certolizumab pegol) at any time in pregnancy, nor have they been exposed to any known human teratogen during pregnancy.

Group 4 -Cimzia Registry, Not Qualified for the Cohort Study

Description:

Women who have used Cimzia (certolizumab pegol) for any length of time following the first day of the last menstrual period until the end of pregnancy who do not qualify for the prospective cohort study.