Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00116272

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: etanercept Other: Control 2 Other: Control 1

MedlinePlus related topics: Autoimmune Diseases

Drug Information available for: Etanercept

U.S. FDA Resources

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

Further study details as provided by Amgen:

Primary Outcome Measures:

Compare the incidence rates (birth prevalence) of major birth defects [ Time Frame: 6 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: 6 years ] [ Designated as safety issue: Yes ]
Compare the incidence rates of adverse pregnancy events [ Time Frame: 6 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: 6 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

This is a prospective & observational, exposure cohort study

Estimated Enrollment:	900
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (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: Control 1 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: Control 2 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: etanercept exposure to etanercept at any dose during the pregnancy

Eligibility

Genders Eligible for Study:	Female
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

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

Contacts

Contact: Amgen Call Center

866-572-6436

Locations

United States, California
Research Site	Recruiting
San Diego, California, United States

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040246
Study First Received:	June 28, 2005
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00116272
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

pregnancy
Autoimmune Disease

Study placed in the following topic categories:

Autoimmune Diseases
TNFR-Fc fusion protein

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009