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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Major malformations

Outcome Description:

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.

Outcome Time Frame:

Throughout pregnancy and up to 1 year of life

Safety Issue:

Yes

Principal Investigator

Kenneth L Jones, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego

Authority:

United States: Institutional Review Board

Study ID:

M03-604

NCT ID:

NCT01086059

Start Date:

November 2003

Completion Date:

June 2016

Related Keywords:

• Crohn's Disease
• Rheumatoid Arthritis
• Autoimmune diseases
• adalimumab
• pregnancy
• birth defects
• TNF
• Tumor necrosis factor
• Arthritis
• Arthritis, Rheumatoid
• Autoimmune Diseases
• Crohn Disease

Name	Location
University of California, San Diego	La Jolla, California  92037-1709