Clinical trial NCT00116272: Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project
Official title: OTIS Autoimmune Diseases in Pregnancy Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: pregnancy
Autoimmune Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-06-29
Enrollment: 830
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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)

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.

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.

Eligibility 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 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.

Primary outcomes:
measure: Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants
timeFrame: From birth through 1 year of age
measure: Percentage of Infants With Major Birth Defects in All Pregnancies
timeFrame: From birth through 1 year of age
Secondary outcomes:
measure: Percentage of Infants With Any 3 or More Minor Birth Defects
timeFrame: From birth through 1 year of age
measure: Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects
timeFrame: From birth through 1 year of age
measure: Percentage of Pregnancies Ending in Spontaneous Abortion
timeFrame: 9 months
measure: Percentage of Participants With Pre-term Delivery
timeFrame: 9 months
measure: Gestational Age at Delivery (GAD) of Live Births
timeFrame: At birth
measure: Birth Weight Among Full Term Infants
timeFrame: At birth
measure: Birth Length Among Full Term Infants
timeFrame: At birth
measure: Birth Head Circumference Among Full Term Infants
timeFrame: At birth
measure: Percentage of Infants With Small for Gestational Age Birth Weight
timeFrame: At birth
measure: Percentage of Infants With Small for Gestational Age Birth Length
timeFrame: At birth
measure: Percentage of Infants With Small for Gestational Age Birth Head Circumference
timeFrame: At birth
measure: Postnatal Weight Percentile at One Year
timeFrame: 1 year after birth
measure: Postnatal Length Percentile at One Year
timeFrame: 1 year after birth
measure: Postnatal Head Circumference Percentile at One Year
timeFrame: 1 year after birth
measure: Percentage of Infants at One Year of Age With Small for Gestational Age Weight
timeFrame: 1 year after birth
measure: Percentage of Infants at One Year of Age With Small for Gestational Age Length
timeFrame: 1 year after birth
measure: Percentage of Infants at One Year of Age With Small for Gestational Age Head Circumference
timeFrame: 1 year after birth
measure: Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year
timeFrame: From birth to 1 year
measure: Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age
timeFrame: From birth to 1 year
measure: Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ)
timeFrame: 1 year after birth
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research Site
state: California
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: