OTIS Autoimmune Diseases in Pregnancy Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of California, San Diego
Sponsor:
Collaborators:
The Organization of Teratology Information Specialists
UCB, Inc.
Information provided by (Responsible Party):
Christina Chambers, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01797224
First received: June 16, 2012
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition
Crohn's Disease
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Major malformations [ Time Frame: Duration of pregnancy and up to 1 year of life ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Minor malformations [ Time Frame: At dysmorphological exam which will occur at one time point between birth and 5 years of age ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Pre- and post-natal fetal and infant growth, health and development


Estimated Enrollment: 300
Study Start Date: March 2012
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort 1 - Exposed Cohort
Pregnant women with a current diagnosis of RA or Crohn's Disease 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 RA or Crohn's Disease who have or have not used Cimzia (certolizumab pegol) or any tumor necrosis factor (TNF)-antagonist 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) or any TNF-antagonist 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.

Detailed Description:

The purpose of the OTIS Autoimmune Diseases in Pregnancy Project, Cimzia Pregnancy Exposure Registry is to follow pregnant women with or without rheumatoid arthritis (RA) or Crohn's Disease (CD) 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women who reside in the United States or Canada.

Criteria

Inclusion Criteria:

  • Currently pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797224

Contacts
Contact: Diana Johnson, MS 877-311-8972 d4johnson@ucsd.edu
Contact: Christina Chambers, MPH, PhD 858-246-1740 chchambers@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92093
Contact: Diana Johnson, MS    877-311-8972    d4johnson@ucsd.edu   
Principal Investigator: Christina Chambers, MPH, PhD         
Sponsors and Collaborators
University of California, San Diego
The Organization of Teratology Information Specialists
UCB, Inc.
Investigators
Principal Investigator: Christina Chambers, PhD University of California, San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Christina Chambers, Professor, Co-Director Center for Promotion of Maternal Health and Infant Development, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01797224     History of Changes
Other Study ID Numbers: RA0023
Study First Received: June 16, 2012
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Autoimmune disease
certolizumab pegol
Cimzia
pregnancy
birth defect
birth outcome
TNF
Tumor necrosis factor

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Crohn Disease
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Certolizumab pegol
Immunoglobulin Fab Fragments
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014