OTIS Autoimmune Diseases in Pregnancy Project

University of California San Diego

Status: Completed

Conditions: Crohn's Disease; Rheumatoid Arthritis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01086059

M03-604

Details and patient eligibility

About

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.

Enrollment: 944 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Currently pregnant

Trial design

944 participants in 4 patient groups

Cohort 1 - Exposure cohort

Description:

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

Description:

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

Description:

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

Description:

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.