OTIS Cimzia Pregnancy Registry

Last updated: January 26, 2025
Sponsor: University of California, San Diego
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Crohn's Disease

Scalp Disorders

Rosacea

Treatment

N/A

Clinical Study ID

NCT01797224
RA0023
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Currently pregnant

Study Design

Total Participants: 925
Study Start date:
March 01, 2012
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • University of California, San Diego

    San Diego, California 92093
    United States

    Site Not Available

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