OTIS Autoimmune Diseases in Pregnancy Project

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01797224
• Other study ID #: RA0023
• Status: Recruiting
• Start date: March 2012
• Est. completion date: October 2026

Study information

• Verified date: May 2023
• Source: University of California, San Diego
• Contact: Diana Johnson, MS
• Phone: 877-311-8972
• Email: d4johnson[@]ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 925
• Est. completion date: October 2026
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Currently pregnant

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Autoimmune Diseases
• Crohn Disease
• Crohn's Disease
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	The Organization of Teratology Information Specialists, UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major malformations	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.	Duration of pregnancy and up to 1 year of life
Secondary	Minor malformations	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.	At dysmorphological exam which will occur at one time point between birth and 5 years of age
Secondary	Pregnancy Outcome	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	Duration of pregnancy and up to 1 year of life
Secondary	Infant follow-up	Pre- and post-natal fetal and infant growth, health and development	Duration of pregnancy and up to 5 years of life

External Links

•   Official Research website of the MotherToBaby/OTIS Studies Coordinated at the University of California, San Diego