Overview

This trial is active, not recruiting.

Conditions crohn's disease, rheumatoid arthritis
Sponsor University of California, San Diego
Collaborator The Organization of Teratology Information Specialists
Start date November 2003
End date August 2016
Trial size 554 participants
Trial identifier NCT01086059, M03-604

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have not used adalimumab or any TNF antagonist in pregnancy.
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.
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.

Primary Outcomes

Measure
Major malformations
time frame: Throughout pregnancy and up to 1 year of life

Secondary Outcomes

Measure
Minor malformations
time frame: At dysmorphological exam
Pregnancy outcome
time frame: Throughout pregnancy
Infant follow-up
time frame: Throughout pregnancy and up to 1 year of life

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Currently pregnant

Additional Information

Official title Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project
Principal investigator Kenneth L Jones, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of California, San Diego.