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

October 4, 2023 updated by: Amgen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS) which is a network of university and health department based telephone information centers serving pregnant women and health care providers throughout North America.

Participants in the first two cohorts are recruited concurrently from callers to OTIS centers, from health care providers and through direct to consumer marketing efforts. The source of historical controls is archived data on pregnancies that have been followed through the California Teratogen Information Service's Clinical Research Program located at the University of California San Diego.

Study Type

Observational

Enrollment (Actual)

830

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Pregnant women previously exposed to etanercept during the first trimester. Etanercept was not administered in this non-interventional study.
Other Names:
  • Enbrel
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants
Time Frame: From birth through 1 year of age
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
Time Frame: From birth through 1 year of age
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Infants With Any 3 or More Minor Birth Defects
Time Frame: From birth through 1 year of age
A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). 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 a Specific Pattern of Any 3 or More Minor Birth Defects
Time Frame: From birth through 1 year of age
A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). A pattern is defined as at least the same 3 specific minor malformations occurring in at least two infants in the exposed group.
From birth through 1 year of age
Percentage of Pregnancies Ending in Spontaneous Abortion
Time Frame: 9 months
Computed using Kaplan-Meier estimate at 20 weeks gestation, accounting for left truncation due to varying time in gestation at enrollment. In multiple pregnancies ending in at least 1 live-born infant, the live birth outcome is included in the analysis. In multiples ending in no live birth outcomes, the spontaneous abortion is counted as 1 event.
9 months
Percentage of Participants With Pre-term Delivery
Time Frame: 9 months
A pretem delivery is defined as prior to 37 weeks gestation. Computed using Kaplan-Meier estimate at 37 weeks' gestation, accounting for left truncation due to varying time in gestation at enrollment. Multiple births are excluded.
9 months
Gestational Age at Delivery (GAD) of Live Births
Time Frame: At birth
At birth
Birth Weight Among Full Term Infants
Time Frame: At birth
At birth
Birth Length Among Full Term Infants
Time Frame: At birth
At birth
Birth Head Circumference Among Full Term Infants
Time Frame: At birth
At birth
Percentage of Infants With Small for Gestational Age Birth Weight
Time Frame: At birth
Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.
At birth
Percentage of Infants With Small for Gestational Age Birth Length
Time Frame: At birth
Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.
At birth
Percentage of Infants With Small for Gestational Age Birth Head Circumference
Time Frame: At birth
Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.
At birth
Postnatal Weight Percentile at One Year
Time Frame: 1 year after birth
1 year after birth
Postnatal Length Percentile at One Year
Time Frame: 1 year after birth
1 year after birth
Postnatal Head Circumference Percentile at One Year
Time Frame: 1 year after birth
1 year after birth
Percentage of Infants at One Year of Age With Small for Gestational Age Weight
Time Frame: 1 year after birth
Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.
1 year after birth
Percentage of Infants at One Year of Age With Small for Gestational Age Length
Time Frame: 1 year after birth
Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.
1 year after birth
Percentage of Infants at One Year of Age With Small for Gestational Age Head Circumference
Time Frame: 1 year after birth
Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.
1 year after birth
Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year
Time Frame: From birth to 1 year
From birth to 1 year
Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age
Time Frame: From birth to 1 year
From birth to 1 year
Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ)
Time Frame: 1 year after birth
The ASQ-3 evaluates 5 domains of development: communication, gross motor, fine motor, problem solving, and personal-social. Each domain has a set of 6 items and parents rate the most appropriate answer for the presence of each skill: "Yes," "Sometimes," "Not Yet," with point values of 10, 5, or 0, respectively. Each domain question set is totaled independently and compared against statistically derived cutoffs that are set at 2 standard deviations below the mean. The percentage of infants below the cut-off or close to the cutoff (borderline) is reported.
1 year after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 28, 2005

First Submitted That Met QC Criteria

June 28, 2005

First Posted (Estimated)

June 29, 2005

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

August 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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