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OTIS Autoimmune Diseases in Pregnancy Project

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ClinicalTrials.gov Identifier: NCT01086059
Recruitment Status : Active, not recruiting
First Posted : March 12, 2010
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
The Organization of Teratology Information Specialists
Abbott
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 disease 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 one year 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 that 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

Study Design
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Study Type : Observational
Estimated Enrollment : 554 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project
Study Start Date : November 2003
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : December 2019

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Groups and Cohorts
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Group/Cohort
Cohort 1 - Exposure cohort
Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have used adalimumab in the first trimester of pregnancy for any length of time from the date of conception.
Cohort 2 - Matched Diseased Comparison Cohort
Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have not used adalimumab or any TNF antagonist in pregnancy.
Cohort 3-Non-Diseased Comparison Cohort
Pregnant women without a current diagnosis of an autoimmune disease and who have not used adalimumab or any TNF antagonist at any time in pregnancy nor have they been exposed to any known human teratogen during pregnancy.
Cohort 4 - Registry Group
Pregnant women who have used adalimumab for any length of time following the first day of the last menstrual period until the end of pregnancy who do not meet Cohort 1 inclusionary criteria.


Outcome Measures
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Primary Outcome Measures :
  1. Major malformations [ Time Frame: Throughout 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 of newborns.


Secondary Outcome Measures :
  1. Minor malformations [ Time Frame: At dysmorphological exam ]
    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: Throughout pregnancy ]
    Another objective of the study is to evaluate the effects of certain medications when used during pregnancy with respect to spontaneous abortion, stillbirth, and preterm delivery.

  3. Infant follow-up [ Time Frame: Throughout pregnancy and up to 1 year of life ]
    Pre- and post-natal fetal and infant growth, health and development


Eligibility Criteria
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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, Canada or Puerto Rico.
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): NCT01086059


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92093-0828
Sponsors and Collaborators
University of California, San Diego
The Organization of Teratology Information Specialists
Abbott
Investigators
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Principal Investigator: Kenneth L Jones, MD University of California, San Diego
More Information
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Additional Information:

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Responsible Party: Christina Chambers, Principal Investigator, Professor Department of Pediatrics, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01086059    
Other Study ID Numbers: M03-604
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Keywords provided by Christina Chambers, University of California, San Diego:
Autoimmune diseases
adalimumab
pregnancy
 birth defects
TNF
Tumor necrosis factor
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Crohn Disease
Autoimmune Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases