Expired Study
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San Diego, California


Purpose:

The purpose of the study is to evaluate the effect of etanercept when used in the first trimester of pregnancy with respect to major structural birth defects of newborns. This is an observational study only - no investigational product is used.


Criteria:

Cohort 1 Inclusion Criteria: Eligible subjects will be currently pregnant women residing in the US or Canada who have had any exposure to etanercept for treatment of Rheumatoid Arthritis (RA), Juvenile RA, Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsoA) or Psoriasis (PsO) at any time during the first trimester of pregnancy which is defined as the period between first day of the last menstrual period (i.e., within two weeks of conception) up to and including the 12th week after the first day of the last menstrual period (LMP) - Eligible subjects must have documentation of an exposure to etanercept during the first trimester of pregnancy Cohort 2 Inclusion Criteria: Eligible subjects will be currently pregnant women residing in the US or Canada who have not taken etanercept or any TNF antagonist for treatment of Rheumatoid Arthritis (RA), Juvenile RA, Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsoA) or Psoriasis (PsO) at any time in the current pregnancy or within two months prior to the first day of the last menstrual period (LMP) Cohort 3 Inclusion Criteria: Eligible subjects will be pregnant women who were residing in the US or Canada who had not been diagnosed with Rheumatoid Arthritis (RA), Juvenile RA, Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsoA) or Psoriasis (PsO) and had not been exposed to a known human teratogen during the index pregnancy


NCT ID:

NCT00116272


Primary Contact:

Study Director
MD
Amgen


Backup Contact:

N/A


Location Contact:

San Diego, California
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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