ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00116272
Recruitment Status : Completed
First Posted : June 29, 2005
Results First Posted : September 21, 2015
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Observational
Study Design Observational Model: Cohort
Condition Pregnancy
Intervention Drug: Etanercept
Enrollment 830
Recruitment Details

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.

Pre-assignment Details The first participant was recruited in April, 2005 and recruitment continued through March 19, 2012.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 370 164
Completed 359 [1] 158 [1]
Not Completed 11 6
Reason Not Completed
Lost to Follow-up             11             6
[1]
Indicates participants with a known outcome of pregnancy
Arm/Group Title Etanercept-Exposed Diseased Controls Total
Hide Arm/Group Description 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 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. Total of all reporting groups
Overall Number of Baseline Participants 370 164 534
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
< 25 years 21 7 28
25 - 29 years 81 34 115
30 - 34 years 132 48 180
> 34 years 136 75 211
[1]
Measure Description: Maternal Age at Estimated Due Date
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Female
370
 100.0%
164
 100.0%
534
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Non-Hispanic White 292 138 430
Black 14 3 17
Hispanic 42 13 55
Asian/Pacific Islander 18 6 24
Native American 3 4 7
Other 1 0 1
Maternal Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
< 12 years 9 4 13
12 - 15 years 118 42 160
> 15 years 243 118 361
Hollingshead Socioeconomic Category   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
1 134 69 203
2 145 67 212
3 59 19 78
4 23 6 29
5 7 3 10
Missing 2 0 2
[1]
Measure Description: Based on four-factor Hollingshead categories incorporating maternal and paternal education and occupation; highest socioeconomic status category = 1; lowest socioeconomic status category = 5.
Pre-pregnancy Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 370 participants 164 participants 534 participants
164.7  (7.1) 166.7  (7.0) 165.3  (7.1)
Pre-pregnancy Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 370 participants 164 participants 534 participants
70.2  (18.14) 68.3  (16.5) 69.6  (17.8)
Gravidity Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
1 pregnancy 135 62 197
2 -3 pregnancies 163 78 241
4 -5 pregnancies 60 21 81
≥ 6 pregnancies 12 3 15
Parity Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
0 births 193 88 281
1 -2 births 153 69 222
3 - 4 births 22 7 29
≥ 5 births 2 0 2
Previous Spontaneous Abortion  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
0 265 117 382
1 73 30 103
2 22 11 33
≥ 3 10 6 16
Previous Elective Terminations  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
0 314 150 464
1 49 12 61
2 5 1 6
≥ 3 2 1 3
Previous Preterm Delivery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Yes 37 6 43
No 333 158 491
Any Previous Child with Birth Defect  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Yes 20 8 28
No 350 156 506
In Vitro Fertilization (IVF) with This Pregnancy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Yes 27 5 32
No 343 159 502
Gestational Age at Time of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
< 13 weeks 196 84 280
13 - 19.9 weeks 99 58 157
≥ 20 weeks 75 22 97
Referral Source Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Sponsor 37 1 38
Health-care Professional (HCP) 185 53 238
Internet 65 27 92
Patient Support Group 0 4 4
OTIS Member Service 29 69 98
Other 53 10 63
Missing 1 0 1
Geographic Area of Residence  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
United States 338 136 474
Canada 31 27 58
Missing 1 1 2
Maternal Comorbidities   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Thyroid Disease 45 23 68
Asthma 48 33 81
Other Autoimmune Disease 43 17 60
Antidepressant Medication Use in Any Trimester 28 14 42
Pre-gestational Hypertension 19 10 29
Preeclampsia 11 8 19
Other Psychiatric Conditions 64 32 96
Infections 274 114 388
[1]
Measure Description: Participants could have more than one comorbidity
Prenatal Multivitamin or Folic Acid Supplements  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Began Prior to Conception 217 114 331
Post-conception Only 148 50 198
Not Taken at All 5 0 5
Alcohol Use During Pregnancy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Yes 177 80 257
No 193 84 277
Tobacco Use During Pregnancy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Yes 40 17 57
No 330 147 477
Major Known or Suspected Human Teratogens  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Yes 14 11 25
No 356 153 509
Intended Pregnancy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Yes 264 123 387
No 106 41 147
Primary Disease (RA, JRA, PsA or AS)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Yes 311 117 428
No 59 47 106
Duration of Disease   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 370 participants 164 participants 534 participants
9.8  (7.9) 10.0  (9.1) 9.9  (8.3)
[1]
Measure Description: 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.
Prednisone and/or Systemic Oral Corticosteroid  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
Yes 163 65 228
No 207 99 306
Disease Severity Score - RA   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 370 participants 164 participants 534 participants
0.5  (0.6) 0.6  (0.6) 0.5  (0.6)
[1]
Measure Description:

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.

Disease Severity Score - PsO   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 370 participants 164 participants 534 participants
2.0  (1.5) 1.9  (1.1) 1.9  (1.4)
[1]
Measure Description: Maternal rating of overall severity of psoriasis measured using Global Assessment of Psoriasis, possible score 0-5 with higher score indicating more severe disease.
Exposed to Etanercept   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 164 participants 534 participants
First Trimester 344 0 344
Last Menstrual Period to Date of Conception 8 0 8
2nd and/or 3rd Trimester Only 13 0 13
Started Prior to DOC, End Date Unavailable 5 0 5
[1]
Measure Description: 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.
1.Primary Outcome
Title Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants
Hide Description 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.
Time Frame From birth through 1 year of age
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 319 144
Measure Type: Number
Unit of Measure: percentage of participants
9.4 3.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.77
Confidence Interval (2-Sided) 95%
1.04 to 7.35
Estimation Comments Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height
2.Primary Outcome
Title Percentage of Infants With Major Birth Defects in All Pregnancies
Hide Description 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.
Time Frame From birth through 1 year of age
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 335 158
Measure Type: Number
Unit of Measure: percentage of participants
9.9 4.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.37
Confidence Interval (2-Sided) 95%
1.02 to 5.52
Estimation Comments Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height
3.Secondary Outcome
Title Percentage of Infants With Any 3 or More Minor Birth Defects
Hide Description 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.
Time Frame From birth through 1 year of age
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 257 111
Measure Type: Number
Unit of Measure: percentage of infants
25.7 22.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.70 to 2.01
Estimation Comments Unadjusted Odds Ratio computed using logistic regression. No adjusted estimate was computed due to no confirmed confounder.
4.Secondary Outcome
Title Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects
Hide Description 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.
Time Frame From birth through 1 year of age
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 262 113
Measure Type: Number
Unit of Measure: percentage of infants
2.3 0.0
5.Secondary Outcome
Title Percentage of Pregnancies Ending in Spontaneous Abortion
Hide Description 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.
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled and exposed to etanercept prior to 20 weeks gestation (Etanercept-Exposed) or enrolled prior to 20 weeks gestation (Diseased Controls).
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 288 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of pregnancies
14.7
(7.4 to 28.3)
28.8
(16.0 to 48.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
0.20 to 1.12
Estimation Comments Adjusted HR computed using Cox proportional hazards regression adjusted for propensity score comprised of referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other), and maternal height.
6.Secondary Outcome
Title Percentage of Participants With Pre-term Delivery
Hide Description 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.
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 324 142
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.9
(10.5 to 18.2)
10.0
(6.1 to 16.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
0.86 to 2.98
Estimation Comments Adjusted HR computed using Cox proportional hazards regression adjusted for preeclampsia
7.Secondary Outcome
Title Gestational Age at Delivery (GAD) of Live Births
Hide Description [Not Specified]
Time Frame At birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 324 142
Mean (Standard Deviation)
Unit of Measure: weeks
38.6  (2.2) 38.8  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.65 to 0.26
Estimation Comments Computed using linear regression, directly adjusted for referral source (not collapsed), vitamin use (not collapsed), preeclampsia, and asthma because propensity score adjustment was not balanced.
8.Secondary Outcome
Title Birth Weight Among Full Term Infants
Hide Description [Not Specified]
Time Frame At birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live birth full-term infants, excluding multiple births, where data were available
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 282 128
Mean (Standard Deviation)
Unit of Measure: g
3399.1  (434.9) 3380.2  (447.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 21.79
Confidence Interval (2-Sided) 95%
-83.32 to 126.91
Estimation Comments Computed using linear regression, directly adjusted for asthma, RA2 severity score at 32 weeks, and disease severity score imputation indicator because propensity score adjustment was not balanced.
9.Secondary Outcome
Title Birth Length Among Full Term Infants
Hide Description [Not Specified]
Time Frame At birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live birth full-term infants, excluding multiple births, where data were available
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 277 127
Mean (Standard Deviation)
Unit of Measure: cm
50.8  (2.6) 50.7  (2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.44 to 0.63
Estimation Comments Computed using linear regression, adjusted for propensity score comprised of preeclampsia and asthma.
10.Secondary Outcome
Title Birth Head Circumference Among Full Term Infants
Hide Description [Not Specified]
Time Frame At birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live birth full-term infants, excluding multiple births, where data were available
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 253 116
Mean (Standard Deviation)
Unit of Measure: cm
34.4  (1.6) 34.5  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.43 to 0.26
Estimation Comments Computed using linear regression, adjusted for maternal age (categorical).
11.Secondary Outcome
Title Percentage of Infants With Small for Gestational Age Birth Weight
Hide Description 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.
Time Frame At birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live-born infants, excluding multiple births, where data were available.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 324 141
Measure Type: Number
Unit of Measure: percentage of infants
6.8 10.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.22 to 1.05
Estimation Comments Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, & disease severity imputation indicator
12.Secondary Outcome
Title Percentage of Infants With Small for Gestational Age Birth Length
Hide Description 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.
Time Frame At birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live-born infants, excluding multiple births, where data were available.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 317 139
Measure Type: Number
Unit of Measure: percentage of infants
4.7 6.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.31 to 1.68
Estimation Comments Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.
13.Secondary Outcome
Title Percentage of Infants With Small for Gestational Age Birth Head Circumference
Hide Description 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.
Time Frame At birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live-born infants, excluding multiple births, where data were available.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 287 125
Measure Type: Number
Unit of Measure: percentage of infants
17.1 14.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.40 to 1.57
Estimation Comments Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, & disease severity imputation indicator
14.Secondary Outcome
Title Postnatal Weight Percentile at One Year
Hide Description [Not Specified]
Time Frame 1 year after birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live-born infants, excluding multiple births, where 1-year data were available
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 248 108
Mean (Standard Deviation)
Unit of Measure: percentile
45.1  (30.1) 44.1  (28.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-7.59 to 7.99
Estimation Comments Computed using linear regression, adjusted for propensity score comprised of maternal height, vitamin use, primary disease, RA disease severity score at 32 weeks, PsO disease severity score at intake & 32 weeks, disease severity imputation indicators
15.Secondary Outcome
Title Postnatal Length Percentile at One Year
Hide Description [Not Specified]
Time Frame 1 year after birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live-born infants, excluding multiple births, where 1-year data were available
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 251 110
Mean (Standard Deviation)
Unit of Measure: percentile
60.1  (29.7) 62.3  (27.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
-5.76 to 8.81
Estimation Comments Computed using linear regression, adjusted for propensity score comprised of maternal height, maternal age (categorical), and referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other).
16.Secondary Outcome
Title Postnatal Head Circumference Percentile at One Year
Hide Description [Not Specified]
Time Frame 1 year after birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live-born infants, excluding multiple births, where 1-year data were available
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 243 108
Mean (Standard Deviation)
Unit of Measure: percentile
63.9  (28.3) 63.8  (27.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-6.12 to 6.65
Estimation Comments Computed using linear regression. Directly adjusted for infant sex and other autoimmune diseases because propensity score adjustment was not balanced.
17.Secondary Outcome
Title Percentage of Infants at One Year of Age With Small for Gestational Age Weight
Hide Description 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.
Time Frame 1 year after birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live-born infants, excluding multiple births, where data were available.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 248 108
Measure Type: Number
Unit of Measure: percentage of infants
14.5 13.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.37 to 1.62
Estimation Comments Computed using logistic regression, adjusted for propensity score comprised of maternal height, RA disease severity score at 32 weeks, and disease severity score imputation indicator.
18.Secondary Outcome
Title Percentage of Infants at One Year of Age With Small for Gestational Age Length
Hide Description 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.
Time Frame 1 year after birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live-born infants, excluding multiple births, where data were available.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 251 110
Measure Type: Number
Unit of Measure: percentage of infants
7.2 5.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.43 to 3.14
Estimation Comments Computed using logistic regression, adjusted for propensity score comprised of country (U.S., Canada), primary disease, and maternal height.
19.Secondary Outcome
Title Percentage of Infants at One Year of Age With Small for Gestational Age Head Circumference
Hide Description 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.
Time Frame 1 year after birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live-born infants, excluding multiple births, where data were available.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 243 108
Measure Type: Number
Unit of Measure: percentage of infants
4.1 4.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.29 to 2.65
Estimation Comments Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.
20.Secondary Outcome
Title Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year
Hide Description [Not Specified]
Time Frame From birth to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 342 144
Measure Type: Number
Unit of Measure: Percentage of infants
5.3 4.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
0.47 to 4.02
Estimation Comments Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.
21.Secondary Outcome
Title Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age
Hide Description [Not Specified]
Time Frame From birth to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 342 144
Measure Type: Number
Unit of Measure: Percentage of infants
0 0
22.Secondary Outcome
Title Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ)
Hide Description 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.
Time Frame 1 year after birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, where data were available.
Arm/Group Title Etanercept-Exposed Diseased Controls
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 287 117
Measure Type: Number
Unit of Measure: Percentage of infants
28.2 27.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept-Exposed, Diseased Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.65 to 1.69
Estimation Comments Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.
Time Frame 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.
Adverse Event Reporting Description Only Serious Adverse Events were collected for this study.
 
Arm/Group Title Mothers Diseased Control Mothers Etanercept Exposed Infants Diseased Control Infants Etanercept Exposed
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Mothers Diseased Control Mothers Etanercept Exposed Infants Diseased Control Infants Etanercept Exposed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mothers Diseased Control Mothers Etanercept Exposed Infants Diseased Control Infants Etanercept Exposed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/164 (10.98%)   37/370 (10.00%)   12/146 (8.22%)   59/352 (16.76%) 
Blood and lymphatic system disorders         
Neutropenia neonatal  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Cardiac disorders         
Atrial hypertrophy  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Pulmonary valve stenosis  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  2/352 (0.57%) 
Congenital, familial and genetic disorders         
Atrial septal defect  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  9/352 (2.56%) 
Bicuspid aortic valve  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Cleft palate  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Congenital aortic valve incompetence  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Congenital cardiovascular anomaly  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Congenital cystic kidney disease  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  2/352 (0.57%) 
Congenital cystic lung  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Congenital eye disorder  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Congenital gastric anomaly  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  2/352 (0.57%) 
Congenital mitral valve incompetence  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  2/352 (0.57%) 
Developmental hip dysplasia  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  0/352 (0.00%) 
Double ureter  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  1/352 (0.28%) 
Epispadias  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Haemangioma congenital  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Heart block congenital  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Hypospadias  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Kidney duplex  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  0/352 (0.00%) 
Limb reduction defect  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Microcephaly  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  3/352 (0.85%) 
Micropenis  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  0/352 (0.00%) 
Neurofibromatosis  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Noonan syndrome  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Patent ductus arteriosus  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  2/352 (0.57%) 
Polydactyly  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  1/352 (0.28%) 
Pulmonary artery stenosis congenital  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  2/352 (0.57%) 
Pulmonary valve stenosis congenital  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Pyloric stenosis  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  4/352 (1.14%) 
Transposition of the great vessels  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  0/352 (0.00%) 
Trisomy 13  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Trisomy 21  1  0/164 (0.00%)  0/370 (0.00%)  2/146 (1.37%)  1/352 (0.28%) 
Turner's syndrome  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  2/352 (0.57%) 
Ventricular septal defect  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  3/352 (0.85%) 
Endocrine disorders         
Hypothyroidism  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Gastrointestinal disorders         
Food poisoning  1  1/164 (0.61%)  2/370 (0.54%)  0/146 (0.00%)  0/352 (0.00%) 
Necrotising colitis  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Volvulus  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
General disorders         
Death  1  0/164 (0.00%)  1/370 (0.27%)  0/146 (0.00%)  1/352 (0.28%) 
Developmental delay  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Pyrexia  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Immune system disorders         
Allergy to arthropod bite  1  0/164 (0.00%)  1/370 (0.27%)  0/146 (0.00%)  0/352 (0.00%) 
Infections and infestations         
Abscess  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  0/352 (0.00%) 
Bacteraemia  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  1/352 (0.28%) 
Bronchiolitis  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  0/352 (0.00%) 
Cellulitis  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Escherichia urinary tract infection  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Febrile infection  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Gastroenteritis salmonella  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  0/352 (0.00%) 
Gastroenteritis viral  1  1/164 (0.61%)  2/370 (0.54%)  0/146 (0.00%)  0/352 (0.00%) 
Group B streptococcus neonatal sepsis  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Infection  1  0/164 (0.00%)  1/370 (0.27%)  0/146 (0.00%)  0/352 (0.00%) 
Influenza  1  1/164 (0.61%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Kidney infection  1  0/164 (0.00%)  1/370 (0.27%)  0/146 (0.00%)  0/352 (0.00%) 
Meningitis aseptic  1  0/164 (0.00%)  1/370 (0.27%)  0/146 (0.00%)  1/352 (0.28%) 
Meningitis neonatal  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  2/352 (0.57%) 
Pneumonia  1  0/164 (0.00%)  2/370 (0.54%)  1/146 (0.68%)  7/352 (1.99%) 
Pneumonia bacterial  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  2/352 (0.57%) 
Pyelonephritis  1  1/164 (0.61%)  1/370 (0.27%)  0/146 (0.00%)  0/352 (0.00%) 
Respiratory syncytial virus infection  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  3/352 (0.85%) 
Sepsis  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  0/352 (0.00%) 
Sepsis neonatal  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  6/352 (1.70%) 
Septic shock  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  2/352 (0.57%) 
Staphylococcal infection  1  0/164 (0.00%)  1/370 (0.27%)  0/146 (0.00%)  0/352 (0.00%) 
Uterine infection  1  0/164 (0.00%)  1/370 (0.27%)  0/146 (0.00%)  0/352 (0.00%) 
Viral infection  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Investigations         
Blood glucose abnormal  1  0/164 (0.00%)  1/370 (0.27%)  0/146 (0.00%)  0/352 (0.00%) 
White blood cell count increased  1  0/164 (0.00%)  1/370 (0.27%)  0/146 (0.00%)  1/352 (0.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Haemangioma  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Hair follicle tumour benign  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Nervous system disorders         
Basal ganglia haemorrhage  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  13/164 (7.93%)  17/370 (4.59%)  0/146 (0.00%)  0/352 (0.00%) 
Jaundice neonatal  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  3/352 (0.85%) 
Stillbirth  1  0/164 (0.00%)  1/370 (0.27%)  0/146 (0.00%)  0/352 (0.00%) 
Renal and urinary disorders         
Reflux nephropathy  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Reproductive system and breast disorders         
Shortened cervix  1  0/164 (0.00%)  1/370 (0.27%)  0/146 (0.00%)  0/352 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Bronchial hyperreactivity  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  0/352 (0.00%) 
Bronchomalacia  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Bronchopulmonary dysplasia  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Dyspnoea  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Immature respiratory system  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Laryngeal stenosis  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  2/352 (0.57%) 
Neonatal asphyxia  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Neonatal respiratory failure  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Pulmonary artery stenosis  1  0/164 (0.00%)  0/370 (0.00%)  1/146 (0.68%)  0/352 (0.00%) 
Respiratory distress  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Surgical and medical procedures         
Abortion induced  1  1/164 (0.61%)  3/370 (0.81%)  0/146 (0.00%)  0/352 (0.00%) 
Transplant  1  0/164 (0.00%)  0/370 (0.00%)  0/146 (0.00%)  1/352 (0.28%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mothers Diseased Control Mothers Etanercept Exposed Infants Diseased Control Infants Etanercept Exposed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00116272     History of Changes
Obsolete Identifiers: NCT01017016
Other Study ID Numbers: 20040246
First Submitted: June 28, 2005
First Posted: June 29, 2005
Results First Submitted: May 29, 2015
Results First Posted: September 21, 2015
Last Update Posted: September 21, 2015