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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00116272
First received: June 28, 2005
Last updated: June 17, 2014
Last verified: June 2014

June 28, 2005
June 17, 2014
March 2005
June 2014   (final data collection date for primary outcome measure)
Compare the incidence rates (birth prevalence) of major birth defects [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00116272 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Compare the incidence rates of adverse pregnancy events [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
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Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project
OTIS Autoimmune Diseases in Pregnancy Project

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.

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Observational
Observational Model: Cohort
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Retention:   None Retained
Description:

This is a prospective & observational, exposure cohort study

Non-Probability Sample

Cohort 1: Exposure Cohort (300 subjects) Cohort 2: Matched diseased control Cohort (300 subjects) Cohort 3: Non-diseased Control Cohort (300 subjects)

Pregnancy
  • Drug: Exposure cohort
    exposure to etanercept at any dose during the pregnancy
  • Other: 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
  • Other: Matched disease control
    Pregnant women with the disease state that have not used etanercept or any TNF antagonist during pregnancy
  • Cohort 2
    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
    Intervention: Other: Matched disease control
  • Cohort 3
    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
    Intervention: Other: Non-Diseased control
  • Cohort 1
    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
    Intervention: Drug: Exposure cohort
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
837
July 2014
June 2014   (final data collection date for primary outcome measure)

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

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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00116272
20040246
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP