NCT00116272

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
830

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2005

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 21, 2015

Completed
Last Updated

October 6, 2023

Status Verified

August 1, 2015

Enrollment Period

9.2 years

First QC Date

June 28, 2005

Results QC Date

May 29, 2015

Last Update Submit

October 4, 2023

Conditions

Pregnancy

Keywords

pregnancyAutoimmune Disease

Outcome Measures

Primary Outcomes (2)

  • Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants

    A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.

    From birth through 1 year of age

  • Percentage of Infants With Major Birth Defects in All Pregnancies

    A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.

    From birth through 1 year of age

Secondary Outcomes (20)

  • Percentage of Infants With Any 3 or More Minor Birth Defects

    From birth through 1 year of age

  • Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects

    From birth through 1 year of age

  • Percentage of Pregnancies Ending in Spontaneous Abortion

    9 months

  • Percentage of Participants With Pre-term Delivery

    9 months

  • Gestational Age at Delivery (GAD) of Live Births

    At birth

  • +15 more secondary outcomes

Study Arms (3)

Etanercept-Exposed

Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.

Drug: Etanercept

Diseased Controls

Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.

Non-Diseased Historical Comparison

Pregnant women not diagnosed with RA, JRA, AS, PsoA, or PsO who did not use etanercept or any TNF antagonist at any time in pregnancy and were not exposed to any known human teratogen during pregnancy. This cohort consists of historical controls enrolled in other pregnancy outcome studies selected to match pregnant women in the exposed cohort.

Interventions

EtanerceptDRUG

Pregnant women previously exposed to etanercept during the first trimester. Etanercept was not administered in this non-interventional study.

Also known as: Enbrel
Etanercept-Exposed

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

San Diego, California, United States

Location

Related Links

Biospecimen

Retention: NONE RETAINED

This is a prospective \& observational, exposure cohort study

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2005

First Posted

June 29, 2005

Study Start

April 1, 2005

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 6, 2023

Results First Posted

September 21, 2015

Record last verified: 2015-08

Locations

US(1)