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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 : October 9, 2019
Sponsor:
Collaborators:
The Organization of Teratology Information Specialists
UCB Pharma
Information provided by (Responsible Party):
Christina Chambers, University of California, San Diego

Study Description
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Brief Summary:
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 or disease
Crohn's Disease Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Psoriasis

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
Study Start Date : March 2012
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797224


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

Locations
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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 Pharma
Investigators
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Principal Investigator: Christina Chambers, PhD University of California, San Diego
More Information
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Additional Information:
Official Research website of the MotherToBaby/OTIS Studies Coordinated at the University of California, San Diego  This link exits the ClinicalTrials.gov site

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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    
Other Study ID Numbers: RA0023
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Keywords provided by Christina Chambers, University of California, San Diego:
Autoimmune disease
certolizumab pegol
Cimzia
pregnancy
 birth defect
birth outcome
TNF
Tumor necrosis factor
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Crohn Disease
Psoriasis
Autoimmune Diseases
Joint Diseases
Musculoskeletal Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents