OTIS Cimzia Pregnancy Registry

NCT01797224 | Active Not Recruiting DMC

• 1 other identifier: RA0023
• Study Type: observational
• Target: 925
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Autoimmune disease; certolizumab pegol; Cimzia; pregnancy; birth defect; birth outcome; TNF; Tumor necrosis factor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Minor malformations

  At dysmorphological exam which will occur at one time point between birth and 5 years of age

• Pregnancy Outcome

  Duration of pregnancy and up to 1 year of life

• Infant follow-up

  Duration of pregnancy and up to 5 years of life

Study Arms (4)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who reside in the United States or Canada.

You may qualify if:

• Currently pregnant

Sponsors & Collaborators

• University of California, San Diego: lead
• The Organization of Teratology Information Specialists: collaborator
• UCB Pharma: collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

Related Links

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

MeSH Terms

Conditions

Crohn Disease; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Autoimmune Diseases; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Skin Diseases, Papulosquamous; Skin Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christina Chambers, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Co-Director Center for Promotion of Maternal Health and Infant Development

Study Record Dates

• First Submitted: June 16, 2012
• First Posted: February 22, 2013
• Study Start: March 1, 2012
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

US (1)