OTIS Humira Pregnancy Registry

NCT01086059 | Completed DMC

• 1 other identifier: M03-604
• Study Type: observational
• Target: 944
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn's Disease; Rheumatoid Arthritis

Keywords

Autoimmune diseases; adalimumab; pregnancy; birth defects; 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 of newborns.

  Throughout pregnancy and up to 1 year of life

Secondary Outcomes (3)

• Minor malformations

  At dysmorphological exam

• Pregnancy outcome

  Throughout pregnancy

• Infant follow-up

  Throughout pregnancy and up to 1 year of life

Study Arms (4)

Cohort 1 - Exposure cohort

Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have used adalimumab in the first trimester of pregnancy for any length of time from the date of conception.

Cohort 2 - Matched Diseased Comparison Cohort

Pregnant women with a current diagnosis of RA, JRA, or Crohn's disease who have not used adalimumab or any TNF antagonist in pregnancy.

Cohort 3-Non-Diseased Comparison Cohort

Pregnant women without a current diagnosis of an autoimmune disease and who have not used adalimumab or any TNF antagonist at any time in pregnancy nor have they been exposed to any known human teratogen during pregnancy.

Cohort 4 - Registry Group

Pregnant women who have used adalimumab for any length of time following the first day of the last menstrual period until the end of pregnancy who do not meet Cohort 1 inclusionary criteria.

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, Canada or Puerto Rico.

You may qualify if:

• Currently pregnant

Sponsors & Collaborators

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

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093-0828, United States

Location

Related Publications (1)

• Chambers CD, Johnson DL, Xu R, Luo Y, Lopez-Jimenez J, Adam MP, Braddock SR, Robinson LK, Vaux K, Lyons Jones K; OTIS Collaborative Research Group. Birth outcomes in women who have taken adalimumab in pregnancy: A prospective cohort study. PLoS One. 2019 Oct 18;14(10):e0223603. doi: 10.1371/journal.pone.0223603. eCollection 2019.

  PMID: 31626646 BACKGROUND

Related Links

• Official Research Website of the Organization of Teratology Information Specialists, Studies Coordinated at the University of California, San Diego

MeSH Terms

Conditions

Crohn Disease; Arthritis, Rheumatoid; 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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kenneth L Jones, MD

  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: Principal Investigator, Professor Department of Pediatrics

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 12, 2010
• Study Start: November 1, 2003
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2019
• Last Updated: January 28, 2025

Record last verified: 2021-04

Locations

US (1)