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Autoimmune Diseases (General) |
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Clinical Trial: Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project
This study is currently recruiting patients.
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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.
| Condition | Phase |
|---|---|
| Pregnancy | Phase IV |
MedlinePlus consumer health information
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title: OTIS Autoimmune Diseases in Pregnancy Project
Eligibility
Genders Eligible for Study: Female
Criteria
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00116272
California
Research Site, San Diego, California, United States; Recruiting
Amgen Call Center 866-572-6436 mit@amgen.com
More Information
Study ID Numbers: 20040246
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 28, 2005
ClinicalTrials.gov Identifier: NCT00116272
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 28, 2005
ClinicalTrials.gov Identifier: NCT00116272
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05
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