NCT01797224

OTIS Cimzia Pregnancy Registry

Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 925 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Crohn's Disease
• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Psoriatic Arthritis
• Psoriasis

Timeline

• Start date: 2012-03-01
• Primary completion: 2026-01-01
• Completion: 2026-03-01
• First posted: 2013-02-22
• Last updated: 2025-01-28

Locations

1 site across 1 country: United States