Status:
COMPLETED
Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project
Lead Sponsor:
Amgen
Conditions:
Pregnancy
Eligibility:
FEMALE
18+ years
Brief 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 stud...
Detailed Description
This pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS) which is a network of university and health department based telephone informati...
Eligibility Criteria
Inclusion
- 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 RA, JRA, AS, PsoA or 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 RA, JRA, AS, PsoA or PsO and had not been exposed to a known human teratogen during the index pregnancy.
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
830 Patients enrolled
Trial Details
Trial ID
NCT00116272
Start Date
April 1 2005
End Date
June 1 2014
Last Update
October 6 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
San Diego, California, United States