OTIS Autoimmune Diseases in Pregnancy Project

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086059
• Other study ID #: M03-604
• Status: Completed
• Start date: November 2003
• Est. completion date: October 2019

Study information

• Verified date: April 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 944
• Est. completion date: October 2019
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Currently pregnant

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Autoimmune Diseases
• Crohn Disease
• Crohn's Disease
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Abbott, The Organization of Teratology Information Specialists

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pregnancy outcome	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.	Throughout pregnancy
Secondary	Infant follow-up	Pre- and post-natal fetal and infant growth, health and development	Throughout pregnancy and up to 1 year of life

External Links

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