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Active, Not Recruiting

NCT Number: NCT01797224

OTIS Cimzia Pregnancy Registry

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Crohn's Disease Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Rheumatic Diseases Rheumatoid Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Diego

San Diego, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently pregnant

Treatment and study plan

Primary outcomes

  1. Major malformations

    Time frame: Duration of pregnancy and up to 1 year of life

    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.

Secondary outcomes

  1. Minor malformations

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

    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.

  2. Pregnancy Outcome

    Time frame: Duration of pregnancy and up to 1 year of life

    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

  3. Infant follow-up

    Time frame: Duration of pregnancy and up to 5 years of life

    Pre- and post-natal fetal and infant growth, health and development

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • The Organization of Teratology Information Specialists
  • UCB Pharma

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
Feb 22, 2013
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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