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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Pregnant women previously exposed to etanercept during the first trimester. Etanercept was not administered in this non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Infants With Any 3 or More Minor Birth Defects | 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. |
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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.
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Cohort 1: Exposure Cohort (300 subjects) Cohort 2: Matched diseased control Cohort (300 subjects) Cohort 3: Non-diseased Control Cohort (300 subjects)
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Diego | California | United States |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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The first participant was recruited in April, 2005 and recruitment continued through March 19, 2012.
Participants were recruited concurrently from callers to Organization of Teratology Information Specialists (OTIS) centers, from health care providers and through direct to consumer marketing efforts.
A third cohort of historical controls including 296 women was also included in the study but are not included in the results of this report.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Maternal Age at Estimated Due Date |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Includes multiple pregnancies ending in at least 1 live-born infant; any 1 or more malformed live-born infants counted as 1 major malformation outcome in the numerator, and 1 pregnancy outcome in the denominator. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort. | Posted | Number | percentage of participants | From birth through 1 year of age |
|
Mothers (enrolled women) were assessed during pregnancy (up to 9 months) and up to 6 weeks after delivery; Infants were assessed for up to 1 year after birth.
Only Serious Adverse Events were collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mothers Diseased Control | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia neonatal | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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This is a prospective & observational, exposure cohort study
|
| From birth through 1 year of age |
| Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects | 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 | 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 | 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 | At birth |
| Birth Weight Among Full Term Infants | At birth |
| Birth Length Among Full Term Infants | At birth |
| Birth Head Circumference Among Full Term Infants | At birth |
| Percentage of Infants With Small for Gestational Age Birth Weight | 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 | 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 | 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 | 1 year after birth |
| Postnatal Length Percentile at One Year | 1 year after birth |
| Postnatal Head Circumference Percentile at One Year | 1 year after birth |
| Percentage of Infants at One Year of Age With Small for Gestational Age Weight | 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 | 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 | 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 | From birth to 1 year |
| Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age | From birth to 1 year |
| Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ) | 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 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Maternal Education | Number | participants |
|
| Hollingshead Socioeconomic Category | Based on four-factor Hollingshead categories incorporating maternal and paternal education and occupation; highest socioeconomic status category = 1; lowest socioeconomic status category = 5. | Number | participants |
|
| Pre-pregnancy Height | Mean | Standard Deviation | cm |
|
| Pre-pregnancy Body Weight | Mean | Standard Deviation | kg |
|
| Gravidity Category | Number | participants |
|
| Parity Category | Number | participants |
|
| Previous Spontaneous Abortion | Number | participants |
|
| Previous Elective Terminations | Number | participants |
|
| Previous Preterm Delivery | Number | participants |
|
| Any Previous Child with Birth Defect | Number | participants |
|
| In Vitro Fertilization (IVF) with This Pregnancy | Number | participants |
|
| Gestational Age at Time of Enrollment | Number | participants |
|
| Referral Source Category | Number | participants |
|
| Geographic Area of Residence | Number | participants |
|
| Maternal Comorbidities | Participants could have more than one comorbidity | Number | participants |
|
| Prenatal Multivitamin or Folic Acid Supplements | Number | participants |
|
| Alcohol Use During Pregnancy | Number | participants |
|
| Tobacco Use During Pregnancy | Number | participants |
|
| Major Known or Suspected Human Teratogens | Number | participants |
|
| Intended Pregnancy | Number | participants |
|
| Primary Disease (RA, JRA, PsA or AS) | Number | participants |
|
| Duration of Disease | Year was known, but month and date were not known for all cases, therefore Jan 1 of the year of diagnosis through the 1st day of the last menstrual period for the index pregnancy was used to calculate duration of disease. In cases where the woman had multiple study diseases, the earliest known year of the "primary disease" diagnosis was used to calculate duration. Five participants in the Etanercept-Exposed Group were missing year of diagnosis. | Mean | Standard Deviation | years |
|
| Prednisone and/or Systemic Oral Corticosteroid | Number | participants |
|
| Disease Severity Score - RA | RA1 disease severity score expressed as the Health Assessment Questionnaire-Disability Index (HAQ-DI) summary score; possible score ranges from 0-3 with higher score representing higher severity/disability. RA1 disease severity score at intake missing for 2 participants in the Etanercept-Exposed Group and 1 participant in the Diseased Controls Group. | Mean | Standard Deviation | units on a scale |
|
| Disease Severity Score - PsO | Maternal rating of overall severity of psoriasis measured using Global Assessment of Psoriasis, possible score 0-5 with higher score indicating more severe disease. | Mean | Standard Deviation | units on a scale |
|
| Exposed to Etanercept | the first trimester of pregnancy is defined as the period between the estimated date of conception (DOC) to the 11th week post-conception. The date of conception is defined as 14 days prior to the next expected menstrual period. | Number | participants |
|
| OG001 | 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. |
|
|
|
| Primary | 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. | Includes multiple pregnancies counted as 1 outcome; any 1 or more malformed infant counted as 1 major malformation in the numerator and 1 outcome in the denominator. Excludes 9 lost-to-follow-up in Etanercept-Exposed and 6 in Diseased Controls cohort. Only women exposed to etanercept in 1st trimester are included in the Etanercept-Exposed cohort. | Posted | Number | percentage of participants | From birth through 1 year of age |
|
|
|
|
| Secondary | Percentage of Infants With Any 3 or More Minor Birth Defects | 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. | Children born to enrolled participants during the study who received the dysmorphological exam. Includes singletons and 1 randomly selected twin from twin pairs. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort. | Posted | Number | percentage of infants | From birth through 1 year of age |
|
|
|
|
| Secondary | Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects | 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. | Children born to enrolled participants who received the dysmorphological exam. Includes multiples who received the exam for consideration of pattern; co-twins with the same 3 or more minor defects could not constitute a pattern on their own. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort. | Posted | Number | percentage of infants | From birth through 1 year of age |
|
|
|
| Secondary | Percentage of Pregnancies Ending in Spontaneous Abortion | 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. | Participants enrolled and exposed to etanercept prior to 20 weeks gestation (Etanercept-Exposed) or enrolled prior to 20 weeks gestation (Diseased Controls). | Posted | Number | 95% Confidence Interval | percentage of pregnancies | 9 months |
|
|
|
|
| Secondary | Percentage of Participants With Pre-term Delivery | 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. | Participants enrolled and exposed to etanercept prior to 37 weeks gestation (Etanercept-Exposed) or enrolled prior to 37 weeks gestation (Diseased Controls), and excluding multiple births. | Posted | Number | 95% Confidence Interval | percentage of participants | 9 months |
|
|
|
|
| Secondary | Gestational Age at Delivery (GAD) of Live Births | Live births in women enrolled and exposed to etanercept prior to 37 weeks' gestation (Etanercept-Exposed) or enrolled prior to 37 weeks gestation (Diseased Controls), excluding multiple births. | Posted | Mean | Standard Deviation | weeks | At birth |
|
|
|
|
| Secondary | Birth Weight Among Full Term Infants | Live birth full-term infants, excluding multiple births, where data were available | Posted | Mean | Standard Deviation | g | At birth |
|
|
|
|
| Secondary | Birth Length Among Full Term Infants | Live birth full-term infants, excluding multiple births, where data were available | Posted | Mean | Standard Deviation | cm | At birth |
|
|
|
|
| Secondary | Birth Head Circumference Among Full Term Infants | Live birth full-term infants, excluding multiple births, where data were available | Posted | Mean | Standard Deviation | cm | At birth |
|
|
|
|
| Secondary | Percentage of Infants With Small for Gestational Age Birth Weight | 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. | Live-born infants, excluding multiple births, where data were available. | Posted | Number | percentage of infants | At birth |
|
|
|
|
| Secondary | Percentage of Infants With Small for Gestational Age Birth Length | 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. | Live-born infants, excluding multiple births, where data were available. | Posted | Number | percentage of infants | At birth |
|
|
|
|
| Secondary | Percentage of Infants With Small for Gestational Age Birth Head Circumference | 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. | Live-born infants, excluding multiple births, where data were available. | Posted | Number | percentage of infants | At birth |
|
|
|
|
| Secondary | Postnatal Weight Percentile at One Year | Live-born infants, excluding multiple births, where 1-year data were available | Posted | Mean | Standard Deviation | percentile | 1 year after birth |
|
|
|
|
| Secondary | Postnatal Length Percentile at One Year | Live-born infants, excluding multiple births, where 1-year data were available | Posted | Mean | Standard Deviation | percentile | 1 year after birth |
|
|
|
|
| Secondary | Postnatal Head Circumference Percentile at One Year | Live-born infants, excluding multiple births, where 1-year data were available | Posted | Mean | Standard Deviation | percentile | 1 year after birth |
|
|
|
|
| Secondary | Percentage of Infants at One Year of Age With Small for Gestational Age Weight | 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. | Live-born infants, excluding multiple births, where data were available. | Posted | Number | percentage of infants | 1 year after birth |
|
|
|
|
| Secondary | Percentage of Infants at One Year of Age With Small for Gestational Age Length | 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. | Live-born infants, excluding multiple births, where data were available. | Posted | Number | percentage of infants | 1 year after birth |
|
|
|
|
| Secondary | Percentage of Infants at One Year of Age With Small for Gestational Age Head Circumference | 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. | Live-born infants, excluding multiple births, where data were available. | Posted | Number | percentage of infants | 1 year after birth |
|
|
|
|
| Secondary | Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year | Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, born to enrolled women exposed to etanercept at any time during pregnancy (Etanercept-Exposed). | Posted | Number | Percentage of infants | From birth to 1 year |
|
|
|
|
| Secondary | Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age | Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, born to enrolled women exposed to etanercept at any time during pregnancy (Etanercept-Exposed). | Posted | Number | Percentage of infants | From birth to 1 year |
|
|
|
| Secondary | Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ) | 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. | Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, where data were available. | Posted | Number | Percentage of infants | 1 year after birth |
|
|
|
|
| 18 |
| 164 |
| 0 |
| 0 |
| EG001 | Mothers 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. | 37 | 370 | 0 | 0 |
| EG002 | Infants Diseased Control | Infants born to 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. | 12 | 146 | 0 | 0 |
| EG003 | Infants Etanercept Exposed | Infants born to 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. | 59 | 352 | 0 | 0 |
| Atrial hypertrophy | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary valve stenosis | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bicuspid aortic valve | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cleft palate | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Congenital aortic valve incompetence | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Congenital cardiovascular anomaly | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Congenital cystic lung | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Congenital eye disorder | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Congenital gastric anomaly | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Congenital mitral valve incompetence | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Developmental hip dysplasia | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Double ureter | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Epispadias | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haemangioma congenital | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Heart block congenital | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypospadias | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Kidney duplex | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Limb reduction defect | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Microcephaly | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Micropenis | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neurofibromatosis | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Noonan syndrome | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Polydactyly | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary artery stenosis congenital | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary valve stenosis congenital | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Transposition of the great vessels | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Trisomy 13 | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Trisomy 21 | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Turner's syndrome | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Necrotising colitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Developmental delay | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Gastroenteritis salmonella | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Group B streptococcus neonatal sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Meningitis neonatal | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Sepsis neonatal | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Uterine infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Blood glucose abnormal | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Hair follicle tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Basal ganglia haemorrhage | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.1 | Systematic Assessment |
|
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 17.1 | Systematic Assessment |
|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA 17.1 | Systematic Assessment |
|
| Reflux nephropathy | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Shortened cervix | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bronchomalacia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Immature respiratory system | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neonatal asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary artery stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
|
| Transplant | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |