OTIS Autoimmune Diseases in Pregnancy Project

April 1, 2021 updated by: Christina Chambers, University of California, San Diego

Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

944

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093-0828
        • University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women who reside in the United States, Canada or Puerto Rico.

Description

Inclusion Criteria:

  • Currently pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Throughout pregnancy and up to 1 year of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At dysmorphological exam
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.
Throughout pregnancy
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
Throughout pregnancy and up to 1 year of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Abbott
The Organization of Teratology Information Specialists

Investigators

  • Principal Investigator: Kenneth L Jones, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

October 1, 2019

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (ESTIMATE)

March 12, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 1, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M03-604

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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