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Completed

NCT Number: NCT01086059

OTIS Humira Pregnancy Registry

The purpose of the OTIS Autoimmune disease 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 one year 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 that 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.

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Key information

Conditions

Crohn's Disease Arthritis Arthritis, Rheumatoid Autoimmune 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 Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Diego

La Jolla, California, 92093-0828, United States

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: Throughout 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 of newborns.

Secondary outcomes

  1. Minor malformations

    Time frame: At dysmorphological exam

    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: Throughout pregnancy

    Another objective of the study is to evaluate the effects of certain medications when used during pregnancy with respect to spontaneous abortion, stillbirth, and preterm delivery.

  3. Infant follow-up

    Time frame: Throughout pregnancy and up to 1 year 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

  • Abbott
  • The Organization of Teratology Information Specialists

Registry information

Official study title

Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project

Important dates

Study start
2003
Primary completion
2016
Study completion
2019
First posted
Mar 12, 2010
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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