OTIS Autoimmune Diseases in Pregnancy Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of California, San Diego
Sponsor:
Collaborators:
The Organization of Teratology Information Specialists
Abbott
Information provided by (Responsible Party):
Kenneth Lyons Jone, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01086059
First received: March 11, 2010
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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
Crohn's Disease
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis 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: Throughout 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 of newborns.


Secondary Outcome Measures:
  • Minor malformations [ Time Frame: At dysmorphological exam ] [ 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: Throughout pregnancy ] [ Designated as safety issue: Yes ]
    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.

  • Infant follow-up [ Time Frame: Throughout pregnancy and up to 1 year of life ] [ Designated as safety issue: Yes ]
    Pre- and post-natal fetal and infant growth, health and development


Estimated Enrollment: 554
Study Start Date: November 2003
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  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, Canada or Puerto Rico.

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: NCT01086059

Contacts
Contact: Diana Johnson, MS 858-246-1741 d4johnson@ucsd.edu
Contact: Christina Chambers, PhD, MPH 858-246-1704 chchambers@ucsd.edu

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

Additional Information:
No publications provided

Responsible Party: Kenneth Lyons Jone, Medical Director, Division Chief of Dysmorphology and Teratology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01086059     History of Changes
Other Study ID Numbers: M03-604
Study First Received: March 11, 2010
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Autoimmune diseases
adalimumab
pregnancy
birth defects
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
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 24, 2014