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OTIS Autoimmune Diseases in Pregnancy Project

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ClinicalTrials.gov Identifier: NCT01797224
Recruitment Status : Recruiting
First Posted : February 22, 2013
Last Update Posted : March 24, 2017
Sponsor:
Collaborators:
The Organization of Teratology Information Specialists
UCB Pharma
Information provided by (Responsible Party):
Christina Chambers, University of California, San Diego

June 16, 2012
February 22, 2013
March 24, 2017
March 2012
December 2019   (Final data collection date for primary outcome measure)
Major malformations [ Time Frame: Duration of pregnancy and up to 1 year of life ]
The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to major structural birth defects.
Same as current
Complete list of historical versions of study NCT01797224 on ClinicalTrials.gov Archive Site
  • Minor malformations [ Time Frame: At dysmorphological exam which will occur at one time point between birth and 5 years of age ]
    One secondary objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to potential minor malformations.
  • Pregnancy Outcome [ Time Frame: Duration of pregnancy and up to 1 year of life ]
    Another objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to potential minor malformations
  • Infant follow-up [ Time Frame: Duration of pregnancy and up to 5 years of life ]
    Pre- and post-natal fetal and infant growth, health and development
Same as current
Not Provided
Not Provided
 
OTIS Autoimmune Diseases in Pregnancy Project
Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Pregnant women who reside in the United States or Canada.
  • Crohn's Disease
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
Not Provided
  • Cohort 1 - Exposed Cohort
    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
    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
    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
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Same as current
December 2022
December 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently pregnant
Sexes Eligible for Study: Female
Child, Adult, Older Adult
Yes
Contact: Diana Johnson, MS 877-311-8972 d4johnson@ucsd.edu
Contact: Christina Chambers, MPH, PhD 858-246-1740 chchambers@ucsd.edu
United States
 
 
NCT01797224
RA0023
Yes
Not Provided
Not Provided
Christina Chambers, University of California, San Diego
University of California, San Diego
  • The Organization of Teratology Information Specialists
  • UCB Pharma
Principal Investigator: Christina Chambers, PhD University of California, San Diego
University of California, San Diego
March 2017