OTIS Humira Pregnancy Registry

Completed

• Conditions: Crohn's Disease; Rheumatoid Arthritis

• Registration Number: NCT01086059
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-12
• Primary Completion: 2016-08
• Study Completion: 2019-10
• Status Verified: 2021-04
• Last Update Submitted: 2025-01-26
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 944

Inclusion Criteria

• Currently pregnant

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major malformations	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

Name	Time	Method
Pregnancy outcome	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.
Infant follow-up	Throughout pregnancy and up to 1 year of life	Pre- and post-natal fetal and infant growth, health and development
Minor malformations	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.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States