OTIS Autoimmune Diseases in Pregnancy Project

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 925

Contacts and Locations

• Study Contact: Name: Diana Johnson, MS; Phone Number: 877-311-8972; Email: d4johnson@ucsd.edu
• Study Contact Backup: Name: Christina Chambers, MPH, PhD; Phone Number: 858-246-1740; Email: chchambers@ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • Recruiting
      • University of California, San Diego
      • Contact: Diana Johnson, MS; Phone Number: 877-311-8972; Email: d4johnson@ucsd.edu
      • Principal Investigator: Christina Chambers, MPH, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who reside in the United States or Canada.

Description

Inclusion Criteria:

• Currently pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Cohort 1 - Exposed Cohort; Pregnant women with a current diagnosis of an approved indication who have used Cimzia (certolizumab pegol) in the first trimester of pregnancy for any length of time from the date of conception.
Cohort 2 - Diseased Comparison Cohort; Pregnant women with a current diagnosis of a Cimzia approved indication who have not used Cimzia (certolizumab pegol) during the current pregnancy.
Cohort 3 - Non-Diseased Comparison Cohort; Pregnant women without a current diagnosis of an autoimmune disease and who have not used Cimzia (certolizumab pegol) at any time in pregnancy, nor have they been exposed to any known human teratogen during pregnancy.
Group 4 -Cimzia Registry, Not Qualified for the Cohort Study; Women who have used Cimzia (certolizumab pegol) for any length of time following the first day of the last menstrual period until the end of pregnancy who do not qualify for the prospective cohort study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Infant follow-up	Pre- and post-natal fetal and infant growth, health and development	Duration of pregnancy and up to 5 years of life

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: UCB Pharma; The Organization of Teratology Information Specialists
• Investigators: Principal Investigator: Christina Chambers, PhD, University of California, San Diego

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: June 16, 2012
• First Submitted That Met QC Criteria: February 20, 2013
• First Posted (Estimate): February 22, 2013

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy; Cimzia; Autoimmune disease; TNF; certolizumab pegol; birth outcome; birth defect; Tumor necrosis factor
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Infections; Immune System Diseases; Gastrointestinal Diseases; Joint Diseases; Musculoskeletal Diseases; Gastroenteritis; Intestinal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Inflammatory Bowel Diseases; Spondylarthropathies; Spondylarthritis; Bone Diseases, Infectious; Ankylosis; Axial Spondyloarthritis; Arthritis; Psoriasis; Crohn Disease; Arthritis, Psoriatic; Autoimmune Diseases; Spondylitis; Spondylitis, Ankylosing
• Other Study ID Numbers: RA0023