OTIS Cimzia Pregnancy Registry

Active, not recruiting

• Conditions: Rheumatoid Arthritis; Crohn's Disease; Ankylosing Spondylitis; Psoriatic Arthritis; Psoriasis

• Registration Number: NCT01797224
• Lead Sponsor: University of California, San Diego

Brief Summary

The purpose of the OTIS Autoimmune Diseases 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 five years 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 which 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

The purpose of the OTIS Autoimmune Diseases in Pregnancy Project, Cimzia Pregnancy Exposure Registry is to follow pregnant women with or without a Cimzia approved indication who have or have not been treated with Cimzia during pregnancy to evaluate the possible effect of these diseases, and or this medication on the pregnancy outcome including child development and growth up to five years of age.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-06-16
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-26
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-01
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 925

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	Duration of 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.

Secondary Outcome Measures

Name	Time	Method
Minor malformations	At dysmorphological exam which will occur at one time point between birth and 5 years of age	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	Duration of pregnancy and up to 1 year of life	Another 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
Infant follow-up	Duration of pregnancy and up to 5 years of life	Pre- and post-natal fetal and infant growth, health and development

Trial Locations

Locations (1)

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