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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00116272
First received: June 28, 2005
Last updated: September 29, 2014
Last verified: September 2014
  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 Intervention
Pregnancy
Drug: Exposure cohort
Other: Non-Diseased control
Other: Matched disease control

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: OTIS Autoimmune Diseases in Pregnancy Project

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Compare the incidence rates (birth prevalence) of major birth defects [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]

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 [ 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 ]

Biospecimen Retention:   None Retained

This is a prospective & observational, exposure cohort study


Enrollment: 837
Study Start Date: March 2005
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other: Matched disease control
Pregnant women with the disease state that have not used etanercept or any TNF antagonist during pregnancy
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
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
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
Drug: Exposure cohort
exposure to etanercept at any dose during the pregnancy

  Eligibility

Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116272

Locations
United States, California
Research Site
San Diego, California, United States
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00116272     History of Changes
Obsolete Identifiers: NCT01017016
Other Study ID Numbers: 20040246
Study First Received: June 28, 2005
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
pregnancy
Autoimmune Disease

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014