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Study Complete
Sponsor ID
20040246

Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project

Sponsor ID
20040246
Clinicaltrials.gov ID
NCT00116272
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
etanercept
Type
Observational
Masking
N/A
Enrollment
830
Additional Study Details

Protocol Summary

Primary Outcome Measures

Compare the incidence rates (birth prevalence) of major birth defects

Timeframe: 8 years

Secondary Outcome Measures

Compare the incidence rate of any 3 or more minor birth defects, and the incidence rate of a specific pattern of minor birth defects

Timeframe: 8 years

Compare the incidence rates of adverse pregnancy events

Timeframe: 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.

Timeframe: 8 years

Locations

Location
Status
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Location
Research Site
San Diego, CA, United States
Status
Recruiting
Study Info
Age
N/A
Condition
  • Pregnancy
    • Sex
    N/A
    Trial Dates
    Apr 2005 - Jun 2014
    Inclusion and Exclusion 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 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.