Overview

This trial is active, not recruiting.

Condition pregnancy
Treatments exposure cohort, non-diseased control, matched disease control
Sponsor Amgen
Start date March 2005
End date June 2014
Trial size 837 participants
Trial identifier NCT00116272, 20040246, NCT01017016

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm
Matched diseased control cohort: pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who have not used etanercept or any TNF antagonist in pregnancy
matched disease control
Pregnant women with the disease state that have not used etanercept or any TNF antagonist during pregnancy
Non-Diseased Control Cohort: pregnant women without a current diagnosis of RA, JRA, AS, PsA, or PsO who have not used etanercept or any TNF antagonist at any time in pregnancy nor have been exposed to any known human teratogen during pregnancy
non-diseased control
Pregnant women without the disease state who have not used etanercept or any TNF antagonist during pregnancy and have not been exposed to a known human teratogen during the same pregnancy
Exposure cohort: pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who have used etanercept in the first trimester of pregnancy for any length of time following the first day of the LMP. Women that have used etanercept beginning after 12 weeks from the first day of the LMP will also be included but analyzed separately
exposure cohort
exposure to etanercept at any dose during the pregnancy

Primary Outcomes

Measure
Compare the incidence rates (birth prevalence) of major birth defects
time frame: 8 years

Secondary Outcomes

Measure
Compare the incidence rate of any 3 or more minor birth defects, and the incidence rate of a specific pattern of minor birth defects
time frame: 8 years
Compare the incidence rates of adverse pregnancy events
time frame: 8 years
Compare birth size & in the first year of life, postnatal growth, achievement of infant developmental milestones, incidence rates of malignancies and incidence rates of serious or opportunistic infections.
time frame: 8 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title OTIS Autoimmune Diseases in Pregnancy Project
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Amgen.