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Completed

NCT Number: NCT00116272

Organization of Teratology Information Services (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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Key information

Conditions

Pregnancy Autoimmune Diseases Immune System Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Research Site

San Diego, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etanercept

Drug

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

Other names: Enbrel

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Gestational Age at Delivery (GAD) of Live Births

    Time frame: At birth

  6. Birth Weight Among Full Term Infants

    Time frame: At birth

  7. Birth Length Among Full Term Infants

    Time frame: At birth

  8. Birth Head Circumference Among Full Term Infants

    Time frame: At birth

  9. 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.

  10. 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.

  11. 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.

  12. Postnatal Weight Percentile at One Year

    Time frame: 1 year after birth

  13. Postnatal Length Percentile at One Year

    Time frame: 1 year after birth

  14. Postnatal Head Circumference Percentile at One Year

    Time frame: 1 year after birth

  15. 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.

  16. 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.

  17. 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.

  18. Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year

    Time frame: From birth to 1 year

  19. Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age

    Time frame: From birth to 1 year

  20. 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

OTIS Autoimmune Diseases in Pregnancy Project

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Jun 29, 2005
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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