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    Clinical Trial Results:
    A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis

    Summary
    EudraCT number
    2009-012520-84
    Trial protocol
    HU   DE   BE   CZ   FR   SI   ES   SE   SK   LT   NL   LV   GR   DK   IT   Outside EU/EEA  
    Global end of trial date
    30 Jan 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Jun 2016
    First version publication date
    18 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B1801014
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00962741
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Alias: 0881A1-3338
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000299-PIP01-08
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part 1: To assess the clinical benefit of etanercept in subjects with extended oligoarticular juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA). Part 2: To assess the long-term safety of etnaercept in subjects with extended oligoarticular JIA, ERA, or PsA.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Nov 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    Slovenia: 2
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Czech Republic: 5
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Latvia: 9
    Country: Number of subjects enrolled
    Lithuania: 7
    Country: Number of subjects enrolled
    Serbia: 14
    Country: Number of subjects enrolled
    Australia: 4
    Country: Number of subjects enrolled
    Russian Federation: 11
    Country: Number of subjects enrolled
    Colombia: 3
    Country: Number of subjects enrolled
    Mexico: 2
    Worldwide total number of subjects
    127
    EEA total number of subjects
    93
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    38
    Adolescents (12-17 years)
    89
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Total subjects enrolled were 127 in 19 countries from 23 Novemeber 2009 to 30 January 2013.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Etanercept
    Arm description
    Etanercept was administered 0.8 milligram per kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.

    Number of subjects in period 1
    Etanercept
    Started
    127
    Completed
    119
    Not completed
    8
         Lack of efficacy
    1
         'Failed to return '
    3
         Consent withdrawn by subject
    1
         Lost to follow-up
    2
         'drug ineffective+prohibited drug taken '
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    Etanercept was administered 0.8 milligram per kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.

    Reporting group values
    Etanercept Total
    Number of subjects
    127 127
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    11.7 ± 4.51 -
    Gender categorical
    Units: Subjects
        Female
    72 72
        Male
    55 55

    End points

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    End points reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    Etanercept was administered 0.8 milligram per kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.

    Primary: Percentage of Subjects With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12

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    End point title
    Percentage of Subjects With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12 [1]
    End point description
    ACR Pedi 30 response: greater than or equal to (>=)30 percent (%) improvement from baseline in 3 of 6 criteria with worsening greater than (>)30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Modified Intent-to-Treat (mITT) population included all subjects who received at least 1 dose of the study medication.
    End point type
    Primary
    End point timeframe
    Week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Etanercept
    Number of subjects analysed
    123 [2]
    Units: Percentage of subjects
        number (confidence interval 95%)
    88.6 (81.6 to 93.6)
    Notes
    [2] - ‘N’(Number of subjects analyzed) signified those subjects who were evaluable for measure at week 12.
    No statistical analyses for this end point

    Secondary: Percentage of subjects With an ACR Pedi 30 Response

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    End point title
    Percentage of subjects With an ACR Pedi 30 Response
    End point description
    ACR Pedi 30 response: >=30% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 126)
    71.4 (62.7 to 79.1)
        Week 8 (N = 121)
    88.4 (81.3 to 93.5)
        Week 12 (N = 123)
    88.6 (81.6 to 93.6)
        Week 24 (N = 122)
    94.3 (88.5 to 97.7)
        Week 36 (N = 120)
    95.8 (90.5 to 98.6)
        Week 48 (N = 119)
    94.1 (88.3 to 97.6)
        Week 60 (N = 116)
    95.7 (90.2 to 98.6)
        Week 72 (N = 114)
    96.5 (91.3 to 99)
        Week 84 (N = 113)
    93.8 (87.7 to 97.5)
        Week 96 (N = 108)
    99.1 (94.9 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population
    End point description
    ACR Pedi 30 response: >=30% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 59)
    67.8 (54.4 to 79.4)
        Week 8 (N = 56)
    87.5 (75.9 to 94.8)
        Week 12 (N = 58)
    89.7 (78.8 to 96.1)
        Week 24 (N = 58)
    94.8 (85.6 to 98.9)
        Week 36 (N = 57)
    94.7 (85.4 to 98.9)
        Week 48 (N = 57)
    96.5 (87.9 to 99.6)
        Week 60 (N = 56)
    98.2 (90.4 to 100)
        Week 72 (N = 55)
    98.2 (90.3 to 100)
        Week 84 (N = 55)
    98.2 (90.3 to 100)
        Week 96 (N = 53)
    100 (93.3 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
    End point description
    ACR Pedi 30 response: >=30% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks). ERA: subjects with arthritis (Ar) or (/) enthesitis, any 2: sacroiliac joint tenderness/inflammatory (Ifm) lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6 years; acute anterior uveitis (AAU)/AAU first-degree relative.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 38)
    84.2 (68.7 to 94)
        Week 8 (N = 36)
    91.7 (77.5 to 98.2)
        Week 12 (N = 36)
    83.3 (67.2 to 93.6)
        Week 24 (N = 36)
    91.7 (77.5 to 98.2)
        Week 36 (N = 35)
    97.1 (85.1 to 99.9)
        Week 48 (N = 34)
    91.2 (76.3 to 98.1)
        Week 60 (N = 33)
    90.9 (75.7 to 98.1)
        Week 72 (N = 32)
    93.8 (79.2 to 99.2)
        Week 84 (N = 31)
    90.3 (74.2 to 98)
        Week 96 (N = 30)
    100 (88.4 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
    End point description
    ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 29)
    62.1 (42.3 to 79.3)
        Week 8 (N = 29)
    86.2 (68.3 to 96.1)
        Week 12 (N = 29)
    93.1 (77.2 to 99.2)
        Week 24 (N = 28)
    96.4 (81.7 to 99.9)
        Week 36 (N = 28)
    96.4 (81.7 to 99.9)
        Week 48 (N = 28)
    92.9 (76.5 to 99.1)
        Week 60 (N = 27)
    96.3 (81 to 99.9)
        Week 72 (N = 27)
    96.3 (81 to 99.9)
        Week 84 (N = 27)
    88.9 (70.8 to 97.6)
        Week 96 (N = 25)
    96 (79.6 to 99.9)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 50 Response

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    End point title
    Percentage of Subjects With an ACR Pedi 50 Response
    End point description
    ACR Pedi 50 response: >=50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 125)
    51.2 (42.1 to 60.2)
        Week 8 (N = 121)
    76.9 (68.3 to 84)
        Week 12 (N = 122)
    81.1 (73.1 to 87.7)
        Week 24 (N = 122)
    88.5 (81.5 to 93.6)
        Week 36 (N = 120)
    88.3 (81.2 to 93.5)
        Week 48 (N = 119)
    93.3 (87.2 to 97.1)
        Week 60 (N = 116)
    92.2 (85.8 to 96.4)
        Week 72 (N = 114)
    93.9 (87.8 to 97.5)
        Week 84 (N = 113)
    91.2 (84.3 to 95.7)
        Week 96 (N = 108)
    98.1 (93.5 to 99.8)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 50 Response: eoJIA Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 50 Response: eoJIA Sub-population
    End point description
    ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 58)
    51.7 (38.2 to 65)
        Week 8 (N = 56)
    75 (61.6 to 85.6)
        Week 12 (N = 58)
    79.3 (66.6 to 88.8)
        Week 24 (N = 58)
    86.2 (74.6 to 93.9)
        Week 36 (N = 57)
    91.2 (80.7 to 97.1)
        Week 48 (N = 57)
    94.7 (85.4 to 98.9)
        Week 60 (N = 56)
    92.9 (82.7 to 98)
        Week 72 (N = 55)
    96.4 (87.5 to 99.6)
        Week 84 (N = 55)
    96.4 (87.5 to 99.6)
        Week 96 (N = 53)
    100 (93.3 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 50 Response: ERA Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 50 Response: ERA Sub-population
    End point description
    ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. ERA: subjects with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 38)
    63.2 (46 to 78.2)
        Week 8 (N = 36)
    86.1 (70.5 to 95.3)
        Week 12 (N = 35)
    80 (63.1 to 91.6)
        Week 24 (N = 36)
    86.1 (70.5 to 95.3)
        Week 36 (N = 35)
    82.9 (66.4 to 93.4)
        Week 48 (N = 34)
    91.2 (76.3 to 98.1)
        Week 60 (N = 33)
    87.9 (71.8 to 96.6)
        Week 72 (N = 32)
    90.6 (75 to 98)
        Week 84 (N = 31)
    83.9 (66.3 to 94.5)
        Week 96 (N = 30)
    96.7 (82.8 to 99.9)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 50 Response: PsA Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 50 Response: PsA Sub-population
    End point description
    ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 29)
    34.5 (17.9 to 54.3)
        Week 8 (N = 29)
    69 (49.2 to 84.7)
        Week 12 (N = 29)
    86.2 (68.3 to 96.1)
        Week 24 (N = 28)
    96.4 (81.7 to 99.9)
        Week 36 (N = 28)
    89.3 (71.8 to 97.7)
        Week 48 (N = 28)
    92.9 (76.5 to 99.1)
        Week 60 (N = 27)
    96.3 (81 to 99.9)
        Week 72 (N = 27)
    92.6 (75.7 to 99.1)
        Week 84 (N = 27)
    88.9 (70.8 to 97.6)
        Week 96 (N = 25)
    96 (79.6 to 99.9)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 70 Response

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    End point title
    Percentage of Subjects With an ACR Pedi 70 Response
    End point description
    ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 126)
    26.2 (18.8 to 34.8)
        Week 8 (N = 121)
    47.1 (38 to 56.4)
        Week 12 (N = 122)
    61.5 (52.2 to 70.1)
        Week 24 (N = 122)
    71.3 (62.4 to 79.1)
        Week 36 (N = 120)
    73.3 (64.5 to 81)
        Week 48 (N = 119)
    79.8 (71.5 to 86.6)
        Week 60 (N = 115)
    81.7 (73.5 to 88.3)
        Week 72 (N = 114)
    84.2 (76.2 to 90.4)
        Week 84 (N = 113)
    87.6 (80.1 to 93.1)
        Week 96 (N = 108)
    92.6 (85.9 to 96.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 70 Response: eoJIA Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 70 Response: eoJIA Sub-population
    End point description
    ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 59)
    28.8 (17.8 to 42.1)
        Week 8 (N = 56)
    51.8 (38 to 65.3)
        Week 12 (N = 58)
    63.8 (50.1 to 76)
        Week 24 (N = 58)
    70.7 (57.3 to 81.9)
        Week 36 (N = 57)
    75.4 (62.2 to 85.9)
        Week 48 (N = 57)
    77.2 (64.2 to 87.3)
        Week 60 (N = 55)
    80 (67 to 89.6)
        Week 72 (N = 55)
    85.5 (73.3 to 93.5)
        Week 84 (N = 55)
    90.9 (80 to 97)
        Week 96 (N = 53)
    94.3 (84.3 to 98.8)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 70 Response: ERA Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 70 Response: ERA Sub-population
    End point description
    ACR Pedi 70 response: >=70% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 38)
    28.9 (15.4 to 45.9)
        Week 8 (N = 36)
    52.8 (35.5 to 69.6)
        Week 12 (N = 35)
    71.4 (53.7 to 85.4)
        Week 24 (N = 36)
    80.6 (64 to 91.8)
        Week 36 (N = 35)
    77.1 (59.9 to 89.6)
        Week 48 (N = 34)
    85.3 (68.9 to 95)
        Week 60 (N = 33)
    81.8 (64.5 to 93)
        Week 72 (N = 32)
    81.3 (63.6 to 92.8)
        Week 84 (N = 31)
    80.6 (62.5 to 92.5)
        Week 96 (N = 30)
    86.7 (69.3 to 96.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 70 Response: PsA Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 70 Response: PsA Sub-population
    End point description
    ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 29)
    17.2 (5.8 to 35.8)
        Week 8 (N = 29)
    31 (15.3 to 50.8)
        Week 12 (N = 29)
    44.8 (26.4 to 64.3)
        Week 24 (N = 28)
    60.7 (40.6 to 78.5)
        Week 36 (N = 28)
    64.3 (44.1 to 81.4)
        Week 48 (N = 28)
    78.6 (59 to 91.7)
        Week 60 (N = 27)
    85.2 (66.3 to 95.8)
        Week 72 (N = 27)
    85.2 (66.3 to 95.8)
        Week 84 (N = 27)
    88.9 (70.8 to 97.6)
        Week 96 (N = 25)
    96 (79.6 to 99.9)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 90 Response

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    End point title
    Percentage of Subjects With an ACR Pedi 90 Response
    End point description
    ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 126)
    6.3 (2.8 to 12.1)
        Week 8 (N = 121)
    14.9 (9.1 to 22.5)
        Week 12 (N = 121)
    29.8 (21.8 to 38.7)
        Week 24 (N = 122)
    43.4 (34.5 to 52.7)
        Week 36 (N = 120)
    47.5 (38.3 to 56.8)
        Week 48 (N = 119)
    50.4 (41.1 to 59.7)
        Week 60 (N = 115)
    53 (43.5 to 62.4)
        Week 72 (N = 113)
    60.2 (50.5 to 69.3)
        Week 84 (N = 113)
    64.6 (55 to 73.4)
        Week 96 (N = 107)
    65.4 (55.6 to 74.4)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 90 Response:eoJIA Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 90 Response:eoJIA Sub-population
    End point description
    ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 59)
    6.8 (1.9 to 16.5)
        Week 8 (N = 56)
    16.1 (7.6 to 28.3)
        Week 12 (N = 58)
    27.6 (16.7 to 40.9)
        Week 24 (N = 58)
    53.4 (39.9 to 66.7)
        Week 36 (N = 57)
    49.1 (35.6 to 62.7)
        Week 48 (N = 57)
    52.6 (39 to 66)
        Week 60 (N = 55)
    52.7 (38.8 to 66.3)
        Week 72 (N = 54)
    61.1 (46.9 to 74.1)
        Week 84 (N = 55)
    67.3 (53.3 to 79.3)
        Week 96 (N = 53)
    62.3 (47.9 to 75.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 90 Response: ERA Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 90 Response: ERA Sub-population
    End point description
    ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 38)
    10.5 (2.9 to 24.8)
        Week 8 (N = 36)
    22.2 (10.1 to 39.2)
        Week 12 (N = 35)
    45.7 (28.8 to 63.4)
        Week 24 (N = 36)
    41.7 (25.5 to 59.2)
        Week 36 (N = 35)
    48.6 (31.4 to 66)
        Week 48 (N = 34)
    50 (32.4 to 67.6)
        Week 60 (N = 33)
    57.6 (39.2 to 74.5)
        Week 72 (N = 32)
    71.9 (53.3 to 86.3)
        Week 84 (N = 31)
    64.5 (45.4 to 80.8)
        Week 96 (N = 30)
    66.7 (47.2 to 82.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 90 Response: PsA Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 90 Response: PsA Sub-population
    End point description
    ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 29)
    0 (0 to 11.9)
        Week 8 (N = 29)
    3.4 (0.1 to 17.8)
        Week 12 (N = 28)
    14.3 (4 to 32.7)
        Week 24 (N = 28)
    25 (10.7 to 44.9)
        Week 36 (N = 28)
    42.9 (24.5 to 62.8)
        Week 48 (N = 28)
    46.4 (27.5 to 66.1)
        Week 60 (N = 27)
    48.1 (28.7 to 68.1)
        Week 72 (N = 27)
    44.4 (25.5 to 64.7)
        Week 84 (N = 27)
    59.3 (38.8 to 77.6)
        Week 96 (N = 24)
    70.8 (48.3 to 87.4)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 100 Response

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    End point title
    Percentage of Subjects With an ACR Pedi 100 Response
    End point description
    ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 126)
    3.2 (0.9 to 7.9)
        Week 8 (N = 121)
    6.6 (2.9 to 12.6)
        Week 12 (N = 122)
    23 (15.8 to 31.4)
        Week 24 (N = 122)
    33.6 (25.3 to 42.7)
        Week 36 (N = 120)
    36.7 (28.1 to 45.9)
        Week 48 (N = 119)
    40.3 (31.4 to 49.7)
        Week 60 (N = 114)
    42.1 (32.9 to 51.7)
        Week 72 (N = 113)
    49.6 (40 to 59.1)
        Week 84 (N = 112)
    55.4 (45.7 to 64.8)
        Week 96 (N = 107)
    54.2 (44.3 to 63.9)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 100 Response: eoJIA Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 100 Response: eoJIA Sub-population
    End point description
    ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 59)
    6.8 (1.9 to 16.5)
        Week 8 (N = 56)
    8.9 (3 to 19.6)
        Week 12 (N = 58)
    20.7 (11.2 to 33.4)
        Week 24 (N = 58)
    39.7 (27 to 53.4)
        Week 36 (N = 57)
    42.1 (29.1 to 55.9)
        Week 48 (N = 57)
    47.4 (34 to 61)
        Week 60 (N = 55)
    47.3 (33.7 to 61.2)
        Week 72 (N = 54)
    51.9 (37.8 to 65.7)
        Week 84 (N = 55)
    60 (45.9 to 73)
        Week 96 (N = 53)
    54.7 (40.4 to 68.4)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 100 Response: ERA Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 100 Response: ERA Sub-population
    End point description
    ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA,sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 38)
    0 (0 to 9.3)
        Week 8 (N = 36)
    5.6 (0.7 to 18.7)
        Week 12 (N = 35)
    34.3 (19.1 to 52.2)
        Week 24 (N = 36)
    36.1 (20.8 to 53.8)
        Week 36 (N = 35)
    34.3 (19.1 to 52.2)
        Week 48 (N = 34)
    32.4 (17.4 to 50.5)
        Week 60 (N = 33)
    42.4 (25.5 to 60.8)
        Week 72 (N = 32)
    59.4 (40.6 to 76.3)
        Week 84 (N = 31)
    54.8 (36 to 72.7)
        Week 96 (N = 30)
    50 (31.3 to 68.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an ACR Pedi 100 Response: PsA Sub-population

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    End point title
    Percentage of Subjects With an ACR Pedi 100 Response: PsA Sub-population
    End point description
    ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (N = 29)
    0 (0 to 11.9)
        Week 8 (N = 29)
    3.4 (0.1 to 17.8)
        Week 12 (N = 29)
    13.8 (3.9 to 31.7)
        Week 24 (N = 28)
    17.9 (6.1 to 36.9)
        Week 36 (N = 28)
    28.6 (13.2 to 48.7)
        Week 48 (N = 28)
    35.7 (18.6 to 55.9)
        Week 60 (N = 26)
    30.8 (14.3 to 51.8)
        Week 72 (N = 27)
    33.3 (16.5 to 54)
        Week 84 (N = 26)
    46.2 (36.6 to 66.6)
        Week 96 (N = 24)
    58.3 (36.6 to 77.9)
    No statistical analyses for this end point

    Secondary: Physician's Global Assessment (PGA) of Disease Activity

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    End point title
    Physician's Global Assessment (PGA) of Disease Activity
    End point description
    PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 127)
    5.02 ± 1.75
        Week 4 (N = 126)
    2.78 ± 1.78
        Week 8 (N = 121)
    2 ± 1.55
        Week 12 (N = 123)
    1.5 ± 1.3
        Week 24 (N = 122)
    1.15 ± 1.22
        Week 36 (N = 120)
    1.05 ± 1.17
        Week 48 (N = 119)
    1.03 ± 1.19
        Week 60 (N = 116)
    0.88 ± 0.99
        Week 72 (N = 113)
    0.78 ± 0.97
        Week 84 (N = 113)
    0.78 ± 1.04
        Week 96 (N = 108)
    0.62 ± 0.79
    No statistical analyses for this end point

    Secondary: Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population

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    End point title
    Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population
    End point description
    PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 60)
    4.96 ± 1.76
        Week 4 (N = 59)
    2.73 ± 1.8
        Week 8 (N = 56)
    1.8 ± 1.62
        Week 12 (N = 58)
    1.4 ± 1.3
        Week 24 (N = 58)
    1.03 ± 1.34
        Week 36 (N = 57)
    0.89 ± 1.25
        Week 48 (N = 57)
    0.88 ± 1.2
        Week 60 (N = 56)
    0.83 ± 1.06
        Week 72 (N = 54)
    0.72 ± 0.99
        Week 84 (N = 55)
    0.6 ± 0.86
        Week 96 (N = 53)
    0.59 ± 0.81
    No statistical analyses for this end point

    Secondary: Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population

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    End point title
    Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population
    End point description
    PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity. ERA: subjects with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 38)
    5.39 ± 1.94
        Week 4 (N = 38)
    2.71 ± 1.94
        Week 8 (N = 36)
    2.19 ± 1.5
        Week 12 (N = 36)
    1.53 ± 1.34
        Week 24 (N = 36)
    1.32 ± 1.12
        Week 36 (N = 35)
    1.21 ± 1.1
        Week 48 (N = 34)
    1.16 ± 1.14
        Week 60 (N = 33)
    0.8 ± 0.87
        Week 72 (N = 32)
    0.78 ± 0.98
        Week 84 (N = 31)
    0.84 ± 1.09
        Week 96 (N = 30)
    0.62 ± 0.67
    No statistical analyses for this end point

    Secondary: Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population

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    End point title
    Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population
    End point description
    PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 29)
    4.66 ± 1.42
        Week 4 (N = 29)
    2.98 ± 1.56
        Week 8 (N = 29)
    2.14 ± 1.49
        Week 12 (N = 29)
    1.69 ± 1.28
        Week 24 (N = 28)
    1.18 ± 1.06
        Week 36 (N = 28)
    1.2 ± 1.09
        Week 48 (N = 28)
    1.18 ± 1.22
        Week 60 (N = 27)
    1.06 ± 0.99
        Week 72 (N = 27)
    0.89 ± 0.93
        Week 84 (N = 27)
    1.07 ± 1.25
        Week 96 (N = 25)
    0.66 ± 0.9
    No statistical analyses for this end point

    Secondary: Subject/Parent Global Assessment

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    End point title
    Subject/Parent Global Assessment
    End point description
    Subject/Parent Global Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 127)
    4.96 ± 2.33
        Week 4 (N = 126)
    3.22 ± 2.23
        Week 8 (N = 121)
    2.79 ± 2.1
        Week 12 (N = 123)
    2.21 ± 1.84
        Week 24 (N = 122)
    1.79 ± 1.75
        Week 36 (N = 120)
    1.74 ± 1.97
        Week 48 (N = 119)
    1.65 ± 1.88
        Week 60 (N = 116)
    1.33 ± 1.56
        Week 72 (N = 114)
    1.29 ± 1.63
        Week 84 (N = 113)
    1.17 ± 1.56
        Week 96 (N = 109)
    0.97 ± 1.31
    No statistical analyses for this end point

    Secondary: Subject/Parent Global Assessment: eoJIA Sub-population

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    End point title
    Subject/Parent Global Assessment: eoJIA Sub-population
    End point description
    Subject/Parent Global Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 60)
    4.82 ± 2.44
        Week 4 (N = 59)
    2.82 ± 2.11
        Week 8 (N = 56)
    2.38 ± 2.02
        Week 12 (N = 58)
    1.97 ± 1.81
        Week 24 (N = 58)
    1.51 ± 1.69
        Week 36 (N = 57)
    1.56 ± 2.07
        Week 48 (N = 57)
    1.32 ± 1.82
        Week 60 (N = 56)
    1.29 ± 1.54
        Week 72 (N = 55)
    1.17 ± 1.55
        Week 84 (N = 55)
    0.9 ± 1.21
        Week 96 (N = 54)
    1 ± 1.43
    No statistical analyses for this end point

    Secondary: Subject/Parent Global Assessment: ERA Sub-population

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    End point title
    Subject/Parent Global Assessment: ERA Sub-population
    End point description
    Subject/Parent Global Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 38)
    5.43 ± 2.26
        Week 4 (N = 38)
    3.62 ± 2.43
        Week 8 (N = 36)
    3.19 ± 2.26
        Week 12 (N = 36)
    2.56 ± 2.13
        Week 24 (N = 36)
    2.26 ± 2.03
        Week 36 (N = 35)
    2.04 ± 2.05
        Week 48 (N = 34)
    2.07 ± 2.14
        Week 60 (N = 33)
    1.39 ± 1.74
        Week 72 (N = 32)
    1.39 ± 1.8
        Week 84 (N = 31)
    1.29 ± 1.6
        Week 96 (N = 30)
    0.93 ± 1.19
    No statistical analyses for this end point

    Secondary: Subject/Parent Global Assessment: PsA Sub-population

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    End point title
    Subject/Parent Global Assessment: PsA Sub-population
    End point description
    Subject/Parent Global Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 29)
    4.62 ± 2.17
        Week 4 (N = 29)
    3.5 ± 2.14
        Week 8 (N = 29)
    3.1 ± 1.97
        Week 12 (N = 29)
    2.26 ± 1.46
        Week 24 (N = 28)
    1.75 ± 1.38
        Week 36 (N = 28)
    1.73 ± 1.64
        Week 48 (N = 28)
    1.82 ± 1.61
        Week 60 (N = 27)
    1.33 ± 1.42
        Week 72 (N = 27)
    1.39 ± 1.64
        Week 84 (N = 27)
    1.59 ± 2.05
        Week 96 (N = 25)
    0.96 ± 1.22
    No statistical analyses for this end point

    Secondary: Number of Active Joints

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    End point title
    Number of Active Joints
    End point description
    Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Joints
    arithmetic mean (standard deviation)
        Baseline (N = 127)
    6.74 ± 4.59
        Week 4 (N = 126)
    3.17 ± 3.32
        Week 8 (N = 121)
    2.07 ± 2.67
        Week 12 (N = 123)
    1.72 ± 2.52
        Week 24 (N = 122)
    1.16 ± 2.06
        Week 36 (N = 120)
    0.99 ± 1.86
        Week 48 (N = 119)
    0.88 ± 1.92
        Week 60 (N = 116)
    0.87 ± 1.94
        Week 72 (N = 114)
    0.77 ± 1.97
        Week 84 (N = 113)
    0.81 ± 2.2
        Week 96 (N = 109)
    0.61 ± 2.06
    No statistical analyses for this end point

    Secondary: Number of Active Joints: eoJIA Sub-population

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    End point title
    Number of Active Joints: eoJIA Sub-population
    End point description
    Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Joints
    arithmetic mean (standard deviation)
        Baseline (N = 60)
    7.58 ± 5.09
        Week 4 (N = 59)
    3.95 ± 3.75
        Week 8 (N = 56)
    2.46 ± 2.7
        Week 12 (N = 58)
    2.07 ± 2.77
        Week 24 (N = 58)
    1.34 ± 2.29
        Week 36 (N = 57)
    1.14 ± 1.97
        Week 48 (N = 57)
    1 ± 1.6
        Week 60 (N = 56)
    0.98 ± 1.63
        Week 72 (N = 55)
    0.73 ± 1.21
        Week 84 (N = 55)
    0.65 ± 1.16
        Week 96 (N = 54)
    0.5 ± 0.89
    No statistical analyses for this end point

    Secondary: Number of Active Joints: ERA Sub-population

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    End point title
    Number of Active Joints: ERA Sub-population
    End point description
    Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Joints
    arithmetic mean (standard deviation)
        Baseline (N = 38)
    5.21 ± 3.57
        Week 4 (N = 38)
    2.4 ± 2.62
        Week 8 (N = 36)
    1.47 ± 2.25
        Week 12 (N = 36)
    1.08 ± 1.57
        Week 24 (N = 36)
    0.78 ± 1.07
        Week 36 (N = 35)
    0.74 ± 1.29
        Week 48 (N = 34)
    0.68 ± 1.09
        Week 60 (N = 33)
    0.48 ± 0.94
        Week 72 (N = 32)
    0.59 ± 1.21
        Week 84 (N = 31)
    0.68 ± 1.19
        Week 96 (N = 30)
    0.5 ± 0.94
    No statistical analyses for this end point

    Secondary: Number of Active Joints: PsA Sub-population

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    End point title
    Number of Active Joints: PsA Sub-population
    End point description
    Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Joints
    arithmetic mean (standard deviation)
        Baseline (N = 29)
    7 ± 4.33
        Week 4 (N = 29)
    2.59 ± 2.92
        Week 8 (N = 29)
    2.07 ± 3.05
        Week 12 (N = 29)
    1.79 ± 2.86
        Week 24 (N = 28)
    1.25 ± 2.47
        Week 36 (N = 28)
    1 ± 2.21
        Week 48 (N = 28)
    0.89 ± 3.03
        Week 60 (N = 27)
    1.11 ± 3.11
        Week 72 (N = 27)
    1.08 ± 3.45
        Week 84 (N = 27)
    1.3 ± 4.02
        Week 96 (N = 25)
    0.96 ± 4
    No statistical analyses for this end point

    Secondary: Number of Joints With Limitation of Motion

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    End point title
    Number of Joints With Limitation of Motion
    End point description
    The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Joints
    arithmetic mean (standard deviation)
        Baseline (N = 127)
    5.72 ± 4.22
        Week 4 (N = 126)
    3.2 ± 3.27
        Week 8 (N = 121)
    2.26 ± 3.41
        Week 12 (N = 123)
    1.62 ± 2.31
        Week 24 (N = 122)
    1.43 ± 2.03
        Week 36 (N = 120)
    1.39 ± 2.13
        Week 48 (N = 119)
    1.26 ± 2.51
        Week 60 (N = 116)
    1.41 ± 2.98
        Week 72 (N = 114)
    1.13 ± 2.36
        Week 84 (N = 113)
    1.41 ± 3.05
        Week 96 (N = 109)
    1.06 ± 2.71
    No statistical analyses for this end point

    Secondary: Number of Joints With Limitation of Motion: eoJIA Sub-population

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    End point title
    Number of Joints With Limitation of Motion: eoJIA Sub-population
    End point description
    The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Joints
    arithmetic mean (standard deviation)
        Baseline (N = 60)
    6.33 ± 4.37
        Week 4 (N = 59)
    3.12 ± 2.74
        Week 8 (N = 56)
    2.23 ± 3.47
        Week 12 (N = 58)
    1.78 ± 2.25
        Week 24 (N = 58)
    1.4 ± 1.77
        Week 36 (N = 57)
    1.16 ± 1.54
        Week 48 (N = 57)
    1.05 ± 1.63
        Week 60 (N = 56)
    1.36 ± 2.56
        Week 72 (N = 55)
    0.89 ± 1.58
        Week 84 (N = 55)
    0.98 ± 2.08
        Week 96 (N = 54)
    0.74 ± 1.22
    No statistical analyses for this end point

    Secondary: Number of Joints With Limitation of Motion: ERA Sub-population

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    End point title
    Number of Joints With Limitation of Motion: ERA Sub-population
    End point description
    The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Joints
    arithmetic mean (standard deviation)
        Baseline (N = 38)
    4.84 ± 4
        Week 4 (N = 38)
    2.98 ± 3.73
        Week 8 (N = 36)
    2.28 ± 3.59
        Week 12 (N = 36)
    1.58 ± 2.94
        Week 24 (N = 36)
    1.53 ± 2.8
        Week 36 (N = 35)
    1.55 ± 2.69
        Week 48 (N = 34)
    1.53 ± 2.88
        Week 60 (N = 33)
    1.36 ± 3.26
        Week 72 (N = 32)
    1.19 ± 2.09
        Week 84 (N = 31)
    1.68 ± 3.17
        Week 96 (N = 30)
    1.33 ± 2.89
    No statistical analyses for this end point

    Secondary: Number of Joints With Limitation of Motion: PsA Sub-population

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    End point title
    Number of Joints With Limitation of Motion: PsA Sub-population
    End point description
    The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Joints
    arithmetic mean (standard deviation)
        Baseline (N = 29)
    5.62 ± 4.1
        Week 4 (N = 29)
    3.66 ± 3.66
        Week 8 (N = 29)
    2.28 ± 3.15
        Week 12 (N = 29)
    1.34 ± 1.4
        Week 24 (N = 28)
    1.36 ± 1.31
        Week 36 (N = 28)
    1.64 ± 2.39
        Week 48 (N = 28)
    1.36 ± 3.42
        Week 60 (N = 27)
    1.56 ± 3.51
        Week 72 (N = 27)
    1.56 ± 3.68
        Week 84 (N = 27)
    1.96 ± 4.34
        Week 96 (N = 25)
    1.4 ± 4.39
    No statistical analyses for this end point

    Secondary: C-reactive Protein (CRP)

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    End point title
    C-reactive Protein (CRP)
    End point description
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: mg/Liter (mg/L)
    arithmetic mean (standard deviation)
        Baseline (N = 127)
    8.26 ± 14.7
        Week 4 (N = 125)
    3.29 ± 7.85
        Week 8 (N = 121)
    2.32 ± 3.92
        Week 12 (N = 120)
    2.47 ± 7.19
        Week 24 (N = 120)
    3.54 ± 10.72
        Week 36 (N = 119)
    2.81 ± 5.75
        Week 48 (N = 117)
    2.04 ± 3.94
        Week 60 (N = 110)
    2.16 ± 4.87
        Week 72 (N = 111)
    2.26 ± 4.01
        Week 84 (N = 109)
    3.98 ± 12.51
        Week 96 (N = 103)
    2.76 ± 5.27
    No statistical analyses for this end point

    Secondary: C-reactive Protein (CRP): eoJIA Sub-population

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    End point title
    C-reactive Protein (CRP): eoJIA Sub-population
    End point description
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline (N = 60)
    6.27 ± 10.59
        Week 4 (N = 58)
    3.45 ± 7.79
        Week 8 (N = 56)
    2.66 ± 5.05
        Week 12 (N = 58)
    3.36 ± 10.07
        Week 24 (N = 56)
    5.26 ± 15.34
        Week 36 (N = 57)
    3.25 ± 6.56
        Week 48 (N = 55)
    1.93 ± 4.2
        Week 60 (N = 55)
    2.76 ± 6.52
        Week 72 (N = 55)
    2.42 ± 4.28
        Week 84 (N = 54)
    3.94 ± 9.13
        Week 96 (N = 52)
    3.34 ± 6.62
    No statistical analyses for this end point

    Secondary: C-reactive Protein (CRP): ERA Sub-population

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    End point title
    C-reactive Protein (CRP): ERA Sub-population
    End point description
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline (N = 38)
    15.27 ± 21.52
        Week 4 (N = 38)
    4.37 ± 10.36
        Week 8 (N = 36)
    2.53 ± 3.3
        Week 12 (N = 34)
    1.87 ± 2.84
        Week 24 (N = 36)
    1.96 ± 2.04
        Week 36 (N = 35)
    3.24 ± 6.41
        Week 48 (N = 34)
    2.79 ± 4.89
        Week 60 (N = 30)
    1.99 ± 2.84
        Week 72 (N = 30)
    2.12 ± 4.03
        Week 84 (N = 29)
    6.36 ± 20.81
        Week 96 (N = 27)
    2.68 ± 4.1
    No statistical analyses for this end point

    Secondary: C-reactive Protein (CRP): PsA Sub-population

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    End point title
    C-reactive Protein (CRP): PsA Sub-population
    End point description
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline (N = 29)
    3.19 ± 4.71
        Week 4 (N = 29)
    1.58 ± 1.73
        Week 8 (N = 29)
    1.41 ± 0.98
        Week 12 (N = 28)
    1.36 ± 0.75
        Week 24 (N = 28)
    2.11 ± 3.16
        Week 36 (N = 27)
    1.31 ± 0.81
        Week 48 (N = 28)
    1.35 ± 0.97
        Week 60 (N = 25)
    1.04 ± 0.12
        Week 72 (N = 26)
    2.08 ± 3.51
        Week 84 (N = 26)
    1.44 ± 0.97
        Week 96 (N = 24)
    1.58 ± 2.18
    No statistical analyses for this end point

    Secondary: Pain Assessment

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    End point title
    Pain Assessment
    End point description
    Pain Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 127)
    5.06 ± 2.52
        Week 4 (N = 126)
    3.12 ± 2.25
        Week 8 (N = 121)
    2.58 ± 2.1
        Week 12 (N = 123)
    2.02 ± 1.89
        Week 24 (N = 122)
    1.64 ± 1.74
        Week 36 (N = 120)
    1.63 ± 1.94
        Week 48 (N = 119)
    1.51 ± 1.81
        Week 60 (N = 116)
    1.18 ± 1.46
        Week 72 (N = 114)
    1.14 ± 1.62
        Week 84 (N = 112)
    1.13 ± 1.67
        Week 96 (N = 108)
    0.91 ± 1.42
    No statistical analyses for this end point

    Secondary: Pain Assessment: eoJIA Sub-population

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    End point title
    Pain Assessment: eoJIA Sub-population
    End point description
    Pain Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 60)
    4.81 ± 2.56
        Week 4 (N = 59)
    2.64 ± 2.09
        Week 8 (N = 56)
    2.12 ± 1.97
        Week 12 (N = 58)
    1.69 ± 1.77
        Week 24 (N = 58)
    1.27 ± 1.66
        Week 36 (N = 57)
    1.43 ± 1.98
        Week 48 (N = 57)
    1.19 ± 1.77
        Week 60 (N = 56)
    1.19 ± 1.38
        Week 72 (N = 55)
    1.01 ± 1.52
        Week 84 (N = 54)
    0.91 ± 1.5
        Week 96 (N = 53)
    0.97 ± 1.52
    No statistical analyses for this end point

    Secondary: Pain Assessment: ERA Sub-population

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    End point title
    Pain Assessment: ERA Sub-population
    End point description
    Pain Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 38)
    5.76 ± 2.51
        Week 4 (N = 38)
    3.82 ± 2.59
        Week 8 (N = 36)
    3.13 ± 2.42
        Week 12 (N = 36)
    2.54 ± 2.18
        Week 24 (N = 36)
    2.28 ± 1.89
        Week 36 (N = 35)
    1.87 ± 2.07
        Week 48 (N = 34)
    1.78 ± 1.72
        Week 60 (N = 33)
    1.17 ± 1.69
        Week 72 (N = 32)
    1.17 ± 1.69
        Week 84 (N = 31)
    1.08 ± 1.34
        Week 96 (N = 30)
    0.87 ± 1.21
    No statistical analyses for this end point

    Secondary: Pain Assessment: PsA Sub-population

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    End point title
    Pain Assessment: PsA Sub-population
    End point description
    Pain Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 29)
    4.64 ± 2.31
        Week 4 (N = 29)
    3.19 ± 1.91
        Week 8 (N = 29)
    2.81 ± 1.74
        Week 12 (N = 29)
    2.03 ± 1.65
        Week 24 (N = 28)
    1.61 ± 1.51
        Week 36 (N = 28)
    1.71 ± 1.67
        Week 48 (N = 28)
    1.82 ± 1.95
        Week 60 (N = 27)
    1.19 ± 1.35
        Week 72 (N = 27)
    1.37 ± 1.74
        Week 84 (N = 27)
    1.61 ± 2.2
        Week 96 (N = 25)
    0.84 ± 1.48
    No statistical analyses for this end point

    Secondary: Duration of Morning Stiffness

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    End point title
    Duration of Morning Stiffness
    End point description
    Duration of morning stiffness was defined as the time elapsed when subject woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Minutes
    arithmetic mean (standard deviation)
        Baseline (N = 127)
    73.5 ± 100.61
        Week 4 (N = 126)
    29.86 ± 60
        Week 8 (N = 121)
    25.02 ± 75.32
        Week 12 (N = 123)
    13.29 ± 41.2
        Week 24 (N = 122)
    8.83 ± 23.41
        Week 36 (N = 120)
    6.76 ± 24.41
        Week 48 (N = 119)
    6.01 ± 23.94
        Week 60 (N = 116)
    7.28 ± 30.28
        Week 72 (N = 113)
    8.98 ± 30.67
        Week 84 (N = 112)
    8.4 ± 32.38
        Week 96 (N = 109)
    5.76 ± 21.7
    No statistical analyses for this end point

    Secondary: Duration of Morning Stiffness: eoJIA Sub-population

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    End point title
    Duration of Morning Stiffness: eoJIA Sub-population
    End point description
    Duration of morning stiffness was defined as the time elapsed when subject woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Minutes
    arithmetic mean (standard deviation)
        Baseline (N = 60)
    72.78 ± 97.24
        Week 4 (N = 59)
    20.46 ± 47.37
        Week 8 (N = 56)
    20.18 ± 70.7
        Week 12 (N = 58)
    9.05 ± 24.52
        Week 24 (N = 58)
    5.72 ± 18.85
        Week 36 (N = 57)
    2.49 ± 9.35
        Week 48 (N = 57)
    2.19 ± 6.61
        Week 60 (N = 56)
    2.41 ± 7.32
        Week 72 (N = 54)
    3.89 ± 15.16
        Week 84 (N = 55)
    2.64 ± 8.97
        Week 96 (N = 54)
    2.37 ± 12.42
    No statistical analyses for this end point

    Secondary: Duration of Morning Stiffness: ERA Sub-population

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    End point title
    Duration of Morning Stiffness: ERA Sub-population
    End point description
    Duration of morning stiffness was defined as the time elapsed when subject woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history;human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Minutes
    arithmetic mean (standard deviation)
        Baseline (N = 38)
    89.29 ± 128.94
        Week 4 (N = 38)
    49.34 ± 78.73
        Week 8 (N = 36)
    44.03 ± 102.65
        Week 12 (N = 36)
    25.69 ± 67.57
        Week 24 (N = 36)
    15.69 ± 28.87
        Week 36 (N = 35)
    17.17 ± 41.01
        Week 48 (N = 34)
    13.38 ± 36.88
        Week 60 (N = 33)
    14.09 ± 42.21
        Week 72 (N = 32)
    16.25 ± 42.12
        Week 84 (N = 30)
    12.7 ± 36.16
        Week 96 (N = 30)
    10.67 ± 28.31
    No statistical analyses for this end point

    Secondary: Duration of Morning Stiffness: PsA Sub-population

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    End point title
    Duration of Morning Stiffness: PsA Sub-population
    End point description
    Duration of morning stiffness was defined as the time elapsed when subject woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Minutes
    arithmetic mean (standard deviation)
        Baseline (N = 29)
    54.31 ± 54.16
        Week 4 (N = 29)
    23.45 ± 49.86
        Week 8 (N = 29)
    10.79 ± 24.55
        Week 12 (N = 29)
    6.38 ± 13.42
        Week 24 (N = 28)
    6.43 ± 23.17
        Week 36 (N = 28)
    2.43 ± 11.33
        Week 48 (N = 28)
    4.82 ± 25.51
        Week 60 (N = 27)
    9.07 ± 40.43
        Week 72 (N = 27)
    10.56 ± 36.7
        Week 84 (N = 27)
    15.37 ± 52.05
        Week 96 (N = 25)
    7.2 ± 27.43
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Inactive Disease Per Wallace 2004 Definition

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    End point title
    Percentage of Subjects With Inactive Disease Per Wallace 2004 Definition
    End point description
    Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Percentage of subjects
    number (not applicable)
        Week 4 (N = 126)
    2.4
        Week 8 (N = 121)
    2.5
        Week 12 (N = 123)
    12.2
        Week 24 (N = 121)
    24.8
        Week 36 (N = 120)
    25
        Week 48 (N = 118)
    29.7
        Week 60 (N = 113)
    33.6
        Week 72 (N = 111)
    36
        Week 84 (N = 110)
    34.5
        Week 96 (N = 106)
    34
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population

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    End point title
    Percentage of Subjects With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
    End point description
    Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Percentage of subjects
    number (not applicable)
        Week 4 (N = 59)
    5.1
        Week 8 (N = 56)
    3.6
        Week 12 (N = 58)
    12.1
        Week 24 (N = 57)
    29.8
        Week 36 (N = 57)
    35.1
        Week 48 (N = 56)
    37.5
        Week 60 (N = 56)
    48.2
        Week 72 (N = 54)
    46.3
        Week 84 (N = 54)
    44.4
        Week 96 (N = 53)
    37.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population

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    End point title
    Percentage of Subjects With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
    End point description
    Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter's syndrome history; humanleukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Percentage of subjects
    number (not applicable)
        Week 4 (N = 38)
    0
        Week 8 (N = 36)
    2.8
        Week 12 (N = 36)
    16.7
        Week 24 (N = 36)
    25
        Week 36 (N = 35)
    14.3
        Week 48 (N = 34)
    23.5
        Week 60 (N = 30)
    23.3
        Week 72 (N = 30)
    33.3
        Week 84 (N = 29)
    27.6
        Week 96 (N = 28)
    28.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population

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    End point title
    Percentage of Subjects With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
    End point description
    Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Percentage of subjects
    number (not applicable)
        Week 4 (N = 29)
    0
        Week 8 (N = 29)
    0
        Week 12 (N = 29)
    6.9
        Week 24 (N = 28)
    14.3
        Week 36 (N = 28)
    17.9
        Week 48 (N = 28)
    21.4
        Week 60 (N = 27)
    14.8
        Week 72 (N=27)
    18.5
        Week 84 (N = 27)
    22.2
        Week 96 (N = 25)
    32
    No statistical analyses for this end point

    Secondary: Childhood Health Assessment Questionnaire (CHAQ) Score

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    End point title
    Childhood Health Assessment Questionnaire (CHAQ) Score
    End point description
    CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report subjects’s ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, each, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Highest score reported for domain is score for that domain. Overall score = sum of domain scores divided by number of domains answered. Total score: 0= no difficulty to 3= extreme difficulty. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 127)
    0.8 ± 0.63
        Week 4 (N = 126)
    0.54 ± 0.55
        Week 8 (N = 121)
    0.42 ± 0.45
        Week 12 (N = 123)
    0.32 ± 0.4
        Week 24 (N = 122)
    0.28 ± 0.39
        Week 36 (N = 120)
    0.23 ± 0.39
        Week 48 (N = 119)
    0.24 ± 0.41
        Week 60 (N = 116)
    0.2 ± 0.37
        Week 72 (N = 114)
    0.17 ± 0.32
        Week 84 (N = 113)
    0.17 ± 0.35
        Week 96 (N = 109)
    0.16 ± 0.35
    No statistical analyses for this end point

    Secondary: Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population

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    End point title
    Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
    End point description
    CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report subjects’s ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, each, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0= no difficulty; 1= some difficulty ; 2= much difficulty; 3= unable to do. Highest score reported for domain is score for that domain. Overall score= sum of domain scores divided by number of domains answered. Total score: 0= no difficulty to 3= extreme difficulty. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 60)
    0.9 ± 0.68
        Week 4 (N = 59)
    0.64 ± 0.6
        Week 8 (N = 56)
    0.5 ± 0.54
        Week 12 (N = 58)
    0.4 ± 0.48
        Week 24 (N = 58)
    0.31 ± 0.43
        Week 36 (N = 57)
    0.26 ± 0.46
        Week 48 (N = 57)
    0.27 ± 0.48
        Week 60 (N = 56)
    0.25 ± 0.45
        Week 72 (N = 55)
    0.21 ± 0.37
        Week 84 (N = 55)
    0.21 ± 0.41
        Week 96 (N = 54)
    0.2 ± 0.4
    No statistical analyses for this end point

    Secondary: Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population

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    End point title
    Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
    End point description
    CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report subjects’s ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, each, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3=unable to do. Highest score reported for domain is score for that domain. Overall score = sum of domain scores divided by number of domains answered. Total score: 0= no difficulty to 3= extreme difficulty. ERA: subjects with Ar /enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 38)
    0.72 ± 0.51
        Week 4 (N = 38)
    0.48 ± 0.56
        Week 8 (N = 36)
    0.4 ± 0.34
        Week 12 (N = 36)
    0.23 ± 0.27
        Week 24 (N = 36)
    0.27 ± 0.38
        Week 36 (N = 35)
    0.2 ± 0.32
        Week 48 (N = 34)
    0.18 ± 0.28
        Week 60 (N = 33)
    0.17 ± 0.29
        Week 72 (N = 32)
    0.13 ± 0.27
        Week 84 (N = 31)
    0.1 ± 0.22
        Week 96 (N = 30)
    0.08 ± 0.21
    No statistical analyses for this end point

    Secondary: Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population

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    End point title
    Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
    End point description
    CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report subjects’s ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, each, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Highest score reported for domain is score for that domain. Overall score = sum of domain scores divided by number of domains answered. Total score: 0= no difficulty to 3= extreme difficulty. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 29)
    0.68 ± 0.63
        Week 4 (N = 29)
    0.42 ± 0.41
        Week 8 (N = 29)
    0.3 ± 0.34
        Week 12 (N = 29)
    0.29 ± 0.35
        Week 24 (N = 28)
    0.26 ± 0.32
        Week 36 (N = 28)
    0.21 ± 0.32
        Week 48 (N = 28)
    0.24 ± 0.38
        Week 60 (N = 27)
    0.13 ± 0.25
        Week 72 (N = 27)
    0.15 ± 0.29
        Week 84 (N = 27)
    0.18 ± 0.35
        Week 96 (N = 25)
    0.18 ± 0.36
    No statistical analyses for this end point

    Other pre-specified: Tender Entheseal Assessment for ERA Sub-population

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    End point title
    Tender Entheseal Assessment for ERA Sub-population
    End point description
    Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If >33 tender entheseal counts were missing, total number of tender entheses was defined as missing. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Tender entheses
    arithmetic mean (standard deviation)
        Baseline (N = 38)
    5.87 ± 9.42
        Week 4 (N = 38)
    4.68 ± 11.81
        Week 8 (N = 36)
    2.06 ± 5.79
        Week 12 (N = 36)
    1.81 ± 6.15
        Week 24 (N = 36)
    1.89 ± 6.89
        Week 36 (N = 35)
    2.03 ± 5.7
        Week 48 (N = 34)
    1.32 ± 3.76
        Week 60 (N = 33)
    0.97 ± 2.98
        Week 72 (N = 32)
    0.56 ± 1.29
        Week 84 (N = 31)
    0.77 ± 2
        Week 96 (N = 30)
    0.33 ± 1.03
    No statistical analyses for this end point

    Other pre-specified: Overall Back Pain Score for ERA Sub-population

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    End point title
    Overall Back Pain Score for ERA Sub-population
    End point description
    Overall back pain assessed by subject’s parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: mm
    arithmetic mean (standard deviation)
        Baseline (N = 37)
    25.94 ± 28
        Week 4 (N = 38)
    14.24 ± 19.87
        Week 8 (N = 36)
    12.94 ± 22.6
        Week 12 (N = 36)
    11.83 ± 18.22
        Week 24 (N = 36)
    9.81 ± 17.23
        Week 36 (N = 35)
    10.16 ± 19.2
        Week 48 (N = 34)
    8.62 ± 15.76
        Week 60 (N = 32)
    5.13 ± 12.28
        Week 72 (N = 32)
    6.03 ± 14.67
        Week 84 (N = 31)
    5.03 ± 8.4
        Week 96 (N = 30)
    2.37 ± 4.51
    No statistical analyses for this end point

    Other pre-specified: Nocturnal Back Pain Score for ERA Sub-population

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    End point title
    Nocturnal Back Pain Score for ERA Sub-population
    End point description
    Nocturnal back pain assessed by subject's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: mm
    arithmetic mean (standard deviation)
        Baseline (N = 38)
    16.37 ± 27.76
        Week 4 (N = 38)
    8.58 ± 19.31
        Week 8 (N = 36)
    7.82 ± 18.34
        Week 12 (N = 36)
    5.81 ± 11.74
        Week 24 (N = 36)
    5.31 ± 15.17
        Week 36 (N = 35)
    7.54 ± 17.66
        Week 48 (N = 34)
    5.85 ± 13.82
        Week 60 (N = 32)
    3.34 ± 13.36
        Week 72 (N = 32)
    6.47 ± 19.64
        Week 84 (N = 31)
    2.66 ± 6.86
        Week 96 (N = 30)
    2.17 ± 3.5
    No statistical analyses for this end point

    Other pre-specified: Modified Schober's Test for ERA Sub-population

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    End point title
    Modified Schober's Test for ERA Sub-population
    End point description
    Modified Schober’s Test: A mark was placed in the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 centimeter (cm) above the first. The subject then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: cm
    arithmetic mean (standard deviation)
        Baseline (N = 37)
    5.03 ± 1.94
        Week 4 (N = 38)
    5.24 ± 1.94
        Week 8 (N = 36)
    5.12 ± 2.36
        Week 12 (N = 36)
    5.45 ± 1.98
        Week 24 (N = 36)
    5.35 ± 2.1
        Week 36 (N = 35)
    5.49 ± 2.1
        Week 48 (N = 34)
    5.38 ± 1.59
        Week 60 (N = 33)
    5.33 ± 1.71
        Week 72 (N = 32)
    5.27 ± 1.59
        Week 84 (N = 30)
    5.47 ± 1.68
        Week 96 (N = 30)
    5.33 ± 1.65
    No statistical analyses for this end point

    Other pre-specified: Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population

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    End point title
    Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population
    End point description
    Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the subject’s palm to proximal interphalangeal and thumb= 1% of BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck= 10% (10 palms), upper extremities= 20% (20 palms), Trunk (axillae and groin)= 30% (30 palms), lower extremities (buttocks)= 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Percentage of BSA
    arithmetic mean (standard deviation)
        Baseline (N = 29)
    9.83 ± 13.61
        Week 4 (N = 29)
    6.81 ± 9.02
        Week 8 (N = 29)
    4.67 ± 7.68
        Week 12 (N = 29)
    3.49 ± 5.66
        Week 24 (N = 28)
    2.36 ± 4.24
        Week 36 (N = 28)
    2.91 ± 8.7
        Week 48 (N = 28)
    3.12 ± 8.13
        Week 60 (N = 27)
    1.48 ± 2.38
        Week 72 (N = 27)
    1.53 ± 2.17
        Week 84 (N = 27)
    1.56 ± 2.27
        Week 96 (N = 25)
    1.14 ± 2.12
    No statistical analyses for this end point

    Other pre-specified: Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population

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    End point title
    Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population
    End point description
    PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5. 0 (no psoriasis) to 5 (severe disease). ‘Clear’ and “Almost clear’ includes all subjects who were scored as a 0 or 1. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 29)
    1.76 ± 1.46
        Week 4 (N = 29)
    1.41 ± 1.18
        Week 8 (N = 29)
    1.07 ± 1.03
        Week 12 (N = 28)
    0.82 ± 0.72
        Week 24 (N = 28)
    0.61 ± 0.69
        Week 36 (N = 28)
    0.61 ± 0.88
        Week 48 (N = 28)
    0.75 ± 0.89
        Week 60 (N = 27)
    0.78 ± 0.97
        Week 72 (N = 26)
    0.65 ± 0.94
        Week 84 (N = 27)
    0.56 ± 0.85
        Week 96 (N = 25)
    0.48 ± 0.82
    No statistical analyses for this end point

    Other pre-specified: Number of subjects With Adverse Events (AEs)

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    End point title
    Number of subjects With Adverse Events (AEs)
    End point description
    An AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Number of subjects reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRs), malignancies, AEs, excluding infections and injection site reactions, infections and serious adverse events (SAEs) including infections. Safety population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Week 12, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Subjects
        Medically important infections
    11
        Vaccine preventable infections
    8
        ISRs
    16
        Malignancies
    0
        Infections
    96
        Infection and ISRs excluded
    93
        Serious AE: Infection
    11
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Adverse Events (AEs): eoJIA Subpopulation

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    End point title
    Number of Subjects With Adverse Events (AEs): eoJIA Subpopulation
    End point description
    An AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Number of subjects reporting AEs included medically important infections, infections considered preventable by vaccination, ISRs, malignancies, AEs, excluding infections and injection site reactions, infections and serious adverse events including infections. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Week 12, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Subjects
        Medically important infections
    4
        Vaccine preventable infections
    6
        ISRs
    8
        Malignancies
    0
        Infections
    48
        Infection and ISRs excluded
    44
        Serious AE: Infection
    4
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Adverse Events (AEs): ERA Sub-population

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    End point title
    Number of Subjects With Adverse Events (AEs): ERA Sub-population
    End point description
    An AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Number of subjects reporting AEs included medically important infections, infections considered preventable by vaccination, ISRs, malignancies, AEs, excluding infections and injection site reactions, infections and serious adverse events including infections. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen-B27;Ar in male >6yrs; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Week 12, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Subjects
        Medically important infections
    4
        Vaccine preventable infections
    1
        ISRs
    6
        Malignancies
    0
        Infections
    28
        Infection and ISRs excluded
    30
        Serious AE: Infection
    4
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Adverse Events (AEs): PsA Sub-population

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    End point title
    Number of Subjects With Adverse Events (AEs): PsA Sub-population
    End point description
    An AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Number of subjects reporting AEs included medically important infections, infections considered preventable by vaccination, ISRs, malignancies, AEs, excluding infections and injection site reactions, infections and serious adverse events including infections. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Week 12, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Subjects
        Medically important infections
    3
        Vaccine preventable infections
    1
        ISRs
    2
        Malignancies
    0
        Infections
    20
        Infection and ISRs excluded
    19
        Serious AE: Infection
    3
    No statistical analyses for this end point

    Other pre-specified: Tanner Assessment Score by Age Group

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    End point title
    Tanner Assessment Score by Age Group
    End point description
    Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Safety population: subjects who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 48, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline: 2 to 17 years (N = 126)
    3.08 ± 1.59
        Week 12: 2 to 17 years (N = 122)
    3.18 ± 1.63
        Week 48: 2 to 17 years (N = 118)
    3.34 ± 1.61
        Week 96: 2 to 17 years (N = 106)
    3.57 ± 1.61
    No statistical analyses for this end point

    Other pre-specified: Tanner Assessment Score by Age Group for eoJIA Sub-population

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    End point title
    Tanner Assessment Score by Age Group for eoJIA Sub-population
    End point description
    Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 48, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline: 2 to 4 years (N=14)
    1 ± 0
        Baseline: 5 to 11 years (N=23)
    1.16 ± 0.44
        Baseline: 12 to 17 years (N=22)
    3.94 ± 0.97
        Baseline: 2 to 17 years (N=59)
    2.16 ± 1.53
        Week 12: 2 to 4 years (N=14)
    1 ± 0
        Week 12: 5 to 11 years (N=22)
    1.17 ± 0.45
        Week 12: 12 to 17 years (N=21)
    4.02 ± 0.95
        Week 12: 2 to 17 years (N=57)
    2.18 ± 1.56
        Week 48: 2 to 4 years (n=13)
    1 ± 0
        Week 48: 5 to 11 years (N=22)
    1.3 ± 0.63
        Week 48: 12 to 17 years (N=21)
    4.35 ± 0.83
        Week 48: 2 to 17 years (N=56)
    2.37 ± 1.67
        Week 96: 2 to 4 years (N=13)
    1 ± 0
        Week 96: 5 to 11 years (N=19)
    1.67 ± 1.08
        Week 96: 12 to 17 years (N=20)
    4.53 ± 0.62
        Week 96: 2 to 17 years (N=52)
    2.6 ± 1.73
    No statistical analyses for this end point

    Other pre-specified: Tanner Assessment Score by Age Group for ERA Sub-population

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    End point title
    Tanner Assessment Score by Age Group for ERA Sub-population
    End point description
    Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). ERA: subjects with Ar/enthesitis, any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 48, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline: 12 to 17 years (N = 38)
    3.87 ± 1.07
        Week 12: 12 to 17 years (N = 36)
    4.09 ± 1.04
        Week 48: 12 to 17 years (N = 34)
    4.24 ± 0.84
        Week 96: 12 to 17 years (N = 30)
    4.51 ± 0.66
    No statistical analyses for this end point

    Other pre-specified: Tanner Assessment Score by Age Group for PsA Sub-population

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    End point title
    Tanner Assessment Score by Age Group for PsA Sub-population
    End point description
    Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 48, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline: 12 to 17 years (N = 29)
    3.93 ± 1.22
        Week 12: 12 to 17 years (N = 29)
    4.02 ± 1.19
        Week 48: 12 to 17 years (N = 28)
    4.2 ± 0.95
        Week 96: 12 to 17 years (N = 24)
    4.51 ± 0.69
    No statistical analyses for this end point

    Other pre-specified: Height z-Score by Age Group

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    End point title
    Height z-Score by Age Group
    End point description
    Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. Safety population: subjects who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 48, Week 72, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: z-score
    arithmetic mean (standard deviation)
        Baseline: 2 to 17 years (N = 125)
    0.19 ± 1.07
        Week 12: 2 to 17 years (N = 123)
    0.31 ± 0.98
        Week 48: 2 to 17 years (N = 118)
    0.34 ± 1.02
        Week 72: 2 to 17 years (N = 114)
    0.41 ± 0.97
        Week 96: 2 to 17 years (N = 109)
    0.39 ± 0.99
    No statistical analyses for this end point

    Other pre-specified: Height z-Score by Age Group for eoJIA Sub-population

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    End point title
    Height z-Score by Age Group for eoJIA Sub-population
    End point description
    Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. eoJIA sub-population: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 48, Week 72, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: z-score
    arithmetic mean (standard deviation)
        Baseline: 2 to 4 years (N=15)
    -0.24 ± 1.32
        Baseline: 5 to 11 years (N=22)
    0.2 ± 1.35
        Baseline: 12 to 17 years (N=21)
    0.13 ± 0.84
        Baseline: 2 to 17 years (N=58)
    0.06 ± 1.17
        Week 12: 2 to 4 years (N=15)
    0.17 ± 0.97
        Week 12: 5 to 11 years (N=22)
    0.28 ± 1.23
        Week 12: 12 to 17 years (N=21)
    0.16 ± 0.83
        Week 12: 2 to 17 years (N=58)
    0.21 ± 1.02
        Week 48: 2 to 4 years (N=14)
    0.37 ± 1.06
        Week 48: 5 to 11 years (N=21)
    0.3 ± 1.3
        Week 48: 12 to 17 years (N=21)
    0.18 ± 0.87
        Week 48: 2 to 17 years (N=56)
    0.27 ± 1.08
        Week 72: 2 to 4 years (N=14)
    0.39 ± 0.99
        Week 72: 5 to 11 years (N=21)
    0.43 ± 1.11
        Week 72: 12 to 17 years (N=20)
    0.2 ± 0.87
        Week 72: 2 to 17 years (N=55)
    0.34 ± 0.98
        Week 96: 2 to 4 years (N=14)
    0.34 ± 0.99
        Week 96: 5 to 11 years (N=20)
    0.46 ± 1.15
        Week 96: 12 to 17 years (N=20)
    0.17 ± 0.89
        Week 96: 2 to 17 years (N=54)
    0.32 ± 1.01
    No statistical analyses for this end point

    Other pre-specified: Height z-Score by Age Group for ERA Sub-population

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    End point title
    Height z-Score by Age Group for ERA Sub-population
    End point description
    Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 48, Week 72, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: z-score
    arithmetic mean (standard deviation)
        Baseline: 12 to 17 years (N = 38)
    0.24 ± 0.89
        Week 12: 12 to 17 years (N = 36)
    0.35 ± 0.86
        Week 48: 12 to 17 years (N = 34)
    0.36 ± 0.85
        Week 72: 12 to 17 years (N = 32)
    0.46 ± 0.84
        Week 96: 12 to 17 years (N = 30)
    0.43 ± 0.86
    No statistical analyses for this end point

    Other pre-specified: Height z-Score by Age Group for PsA Sub-population

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    End point title
    Height z-Score by Age Group for PsA Sub-population
    End point description
    Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 48, Week 72, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: z-score
    arithmetic mean (standard deviation)
        Baseline: 12 to 17 years (N = 29)
    0.41 ± 1.06
        Week 12: 12 to 17 years (N = 29)
    0.46 ± 1.05
        Week 48: 12 to 17 years (N = 28)
    0.47 ± 1.11
        Week 72: 12 to 17 years (N = 27)
    0.51 ± 1.1
        Week 96: 12 to 17 years (N = 25)
    0.48 ± 1.11
    No statistical analyses for this end point

    Other pre-specified: Weight z-Scores by Age Group

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    End point title
    Weight z-Scores by Age Group
    End point description
    Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. Safety population: subjects who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96.
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: z-score
    arithmetic mean (standard deviation)
        Baseline: 2 to 17 years (N = 127)
    0.17 ± 1.02
        Week 4: 2 to 17 years (N = 126)
    0.18 ± 1.02
        Week 8: 2 to 17 years (N = 121)
    0.23 ± 1.02
        Week 12: 2 to 17 years (N = 123)
    0.22 ± 1
        Week 24: 2 to 17 years (N = 122)
    0.25 ± 0.99
        Week 36: 2 to 17 years (N = 120)
    0.26 ± 0.97
        Week 48: 2 to 17 years (N = 118)
    0.25 ± 0.97
        Week 60: 2 to 17 years (N = 116)
    0.24 ± 0.95
        Week 72: 2 to 17 years (N = 114)
    0.29 ± 0.91
        Week 84: 2 to 17 years (N = 113)
    0.27 ± 0.93
        Week 96: 2 to 17 years (N = 109)
    0.25 ± 0.93
    No statistical analyses for this end point

    Other pre-specified: Weight z-Scores by Age Group for eoJIA Sub-population

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    End point title
    Weight z-Scores by Age Group for eoJIA Sub-population
    End point description
    Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: z-score
    arithmetic mean (standard deviation)
        Baseline: 2 to 4 years (N=15)
    -0.5 ± 0.98
        Baseline: 5 to 11 years (N=23)
    0.15 ± 1.33
        Baseline: 12 to 17 years (N=22)
    0.4 ± 0.72
        Baseline: 2 to 17 years (N=60)
    0.08 ± 1.1
        Week 4: 2 to 4 years (N=15)
    -0.54 ± 1.13
        Week 4: 5 to 11 years (N=23)
    0.17 ± 1.34
        Week 4: 12 to 17 years (N=21)
    0.38 ± 0.69
        Week 4: 2 to 17 years (N=59)
    0.06 ± 1.13
        Week 8: 2 to 4 years (N=14)
    -0.48 ± 1.25
        Week 8: 5 to 11 years (N=21)
    0.3 ± 1.3
        Week 8: 12 to 17 years (N=21)
    0.4 ± 0.72
        Week 8: 2 to 17 years (N=56)
    0.14 ± 1.14
        Week 12: 2 to 4 years (n=15)
    -0.35 ± 1.09
        Week 12: 5 to 11 years (N=22)
    0.22 ± 1.35
        Week 12: 12 to 17 years (N=21)
    0.41 ± 0.72
        Week 12: 2 to 17 years (N=58)
    0.14 ± 1.11
        Week 24: 2 to 4 years (N=15)
    -0.21 ± 1.1
        Week 24: 5 to 11 years (N=22)
    0.21 ± 1.32
        Week 24: 12 to 17 years (N=21)
    0.46 ± 0.69
        Week 24: 2 to 17 years (N=58)
    0.19 ± 1.08
        Week 36: 2 to 4 years (N=14)
    -0.25 ± 1.14
        Week 36: 5 to 11 years (N=22)
    0.27 ± 1.25
        Week 36: 12 to 17 years (N=21)
    0.39 ± 0.7
        Week 36: 2 to 17 years (N=57)
    0.18 ± 1.06
        Week 48: 2 to 4 years (N=14)
    -0.28 ± 1.15
        Week 48: 5 to 11 years (N=21)
    0.21 ± 1.24
        Week 48: 12 to 17 years (N=21)
    0.4 ± 0.65
        Week 48: 2 to 17 years (N=56)
    0.16 ± 1.05
        Week 60: 2 to 4 years (N=14)
    -0.18 ± 1.15
        Week 60: 5 to 11 years (N=22)
    0.23 ± 1.24
        Week 60: 12 to 17 years (N=20)
    0.31 ± 0.62
        Week 60: 2 to 17 years (N=56)
    0.16 ± 1.04
        Week 72: 2 to 4 years (N=14)
    -0.09 ± 1.12
        Week 72: 5 to 11 years (N=21)
    0.43 ± 1.13
        Week 72: 12 to 17 years (N=20)
    0.29 ± 0.67
        Week 72: 2 to 17 years (N=55)
    0.25 ± 0.99
        Week 84: 2 to 4 years (N=14)
    -0.1 ± 1.13
        Week 84: 5 to 11 years (N=21)
    0.42 ± 1.15
        Week 84: 12 to 17 years (N=20)
    0.23 ± 0.74
        Week 84: 2 to 17 years (N=55)
    0.22 ± 1.02
        Week 96: 2 to 4 years (N=14)
    -0.14 ± 1.18
        Week 96: 5 to 11 years (N=20)
    0.49 ± 1.11
        Week 96: 12 to 17 years (N=20)
    0.16 ± 0.76
        Week 96: 2 to 17 years (N=54)
    0.2 ± 1.03
    No statistical analyses for this end point

    Other pre-specified: Weight z-Scores by Age Group for ERA Sub-population

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    End point title
    Weight z-Scores by Age Group for ERA Sub-population
    End point description
    Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: z-score
    arithmetic mean (standard deviation)
        Baseline: 12 to 17 years (N = 38)
    -0.05 ± 0.74
        Week 4: 12 to 17 years (N = 38)
    0 ± 0.72
        Week 8: 12 to 17 years (N = 36)
    0.04 ± 0.68
        Week 12: 12 to 17 years (N = 36)
    0 ± 0.65
        Week 24: 12 to 17 years (N = 36)
    0.01 ± 0.68
        Week 36: 12 to 17 years (N = 35)
    0.03 ± 0.68
        Week 48: 12 to 17 years (N = 34)
    0.04 ± 0.7
        Week 60: 12 to 17 years (N = 33)
    0.08 ± 0.67
        Week 72: 12 to 17 years (N = 32)
    0.12 ± 0.65
        Week 84: 12 to 17 years (N = 31)
    0.07 ± 0.67
        Week 96: 12 to 17 years (N = 30)
    0.06 ± 0.63
    No statistical analyses for this end point

    Other pre-specified: Weight z-Scores by Age Group for PsA Sub-population

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    End point title
    Weight z-Scores by Age Group for PsA Sub-population
    End point description
    Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: z-score
    arithmetic mean (standard deviation)
        Baseline: 12 to 17 years (N = 29)
    0.63 ± 1.05
        Week 4: 12 to 17 years (N = 29)
    0.66 ± 1.01
        Week 8: 12 to 17 years (N = 29)
    0.64 ± 1.04
        Week 12: 12 to 17 years (N = 29)
    0.63 ± 1.04
        Week 24: 12 to 17 years (N = 28)
    0.66 ± 1.04
        Week 36: 12 to 17 years (N = 28)
    0.69 ± 0.97
        Week 48: 12 to 17 years (N = 28)
    0.7 ± 0.96
        Week 60: 12 to 17 years (N = 27)
    0.61 ± 1
        Week 72: 12 to 17 years (N = 27)
    0.57 ± 0.97
        Week 84: 12 to 17 years (N = 27)
    0.59 ± 0.94
        Week 96: 12 to 17 years (N = 25)
    0.59 ± 0.96
    No statistical analyses for this end point

    Other pre-specified: Body Mass Index (BMI) z-Score by Age Group

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    End point title
    Body Mass Index (BMI) z-Score by Age Group
    End point description
    BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. Safety population: subjects who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 48, Week 72, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: z-score
    arithmetic mean (standard deviation)
        Baseline: 2 to 17 years (N = 125)
    0.03 ± 1.17
        Week 12: 2 to 17 years (N = 123)
    0.03 ± 1.15
        Week 48: 2 to 17 years (N = 118)
    0.05 ± 1.11
        Week 72: 2 to 17 years (N = 114)
    0.07 ± 1.03
        Week 96: 2 to 17 years (N = 109)
    0.04 ± 1.06
    No statistical analyses for this end point

    Other pre-specified: Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population

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    End point title
    Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population
    End point description
    BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 48, Week 72, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: z-score
    arithmetic mean (standard deviation)
        Baseline: 2 to 4 years (N=15)
    -0.6 ± 1.7
        Baseline: 5 to 11 years (N=22)
    0.03 ± 1.28
        Baseline: 12 to 17 years (N=21)
    0.4 ± 0.72
        Baseline: 2 to 17 years (N=58)
    0 ± 1.28
        Week 12: 2 to 4 years (N=15)
    -0.78 ± 1.64
        Week 12: 5 to 11 years (N=22)
    0.21 ± 1.13
        Week 12: 12 to 17 years (N=21)
    0.38 ± 0.73
        Week 12: 2 to 17 years (N=58)
    0.01 ± 1.25
        Week 48: 2 to 4 years (N=14)
    -0.85 ± 1.69
        Week 48: 5 to 11 years (N=21)
    0.18 ± 0.96
        Week 48: 12 to 17 years (N=21)
    0.34 ± 0.68
        Week 48: 2 to 17 years (N=56)
    -0.02 ± 1.19
        Week 72: 2 to 4 years (N=14)
    -0.48 ± 1.46
        Week 72: 5 to 11 years (N=21)
    0.37 ± 0.97
        Week 72: 12 to 17 years (N=20)
    0.2 ± 0.73
        Week 72: 2 to 17 years (N=55)
    0.09 ± 1.08
        Week 96: 2 to 4 years (N=14)
    -0.5 ± 1.55
        Week 96: 5 to 11 years (N=20)
    0.44 ± 0.9
        Week 96: 12 to 17 years (N=20)
    0.05 ± 0.83
        Week 96: 2 to 17 years (N=54)
    0.05 ± 1.13
    No statistical analyses for this end point

    Other pre-specified: Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population

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    End point title
    Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population
    End point description
    BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. ERA: subjects with Ar/enthesitis,any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 48, Week 72, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: z-score
    arithmetic mean (standard deviation)
        Baseline: 12 to 17 years (N = 38)
    -0.29 ± 0.87
        Week 12: 12 to 17 years (N = 36)
    -0.31 ± 0.86
        Week 48: 12 to 17 years (N = 34)
    -0.27 ± 0.91
        Week 72: 12 to 17 years (N = 32)
    -0.23 ± 0.87
        Week 96: 12 to 17 years (N = 30)
    -0.29 ± 0.84
    No statistical analyses for this end point

    Other pre-specified: Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population

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    End point title
    Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population
    End point description
    BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 48, Week 72, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: z-score
    arithmetic mean (standard deviation)
        Baseline: 12 to 17 years (N = 29)
    0.51 ± 1.17
        Week 12: 12 to 17 years (N = 29)
    0.49 ± 1.14
        Week 48: 12 to 17 years (N = 28)
    0.55 ± 1.01
        Week 72: 12 to 17 years (N = 27)
    0.37 ± 1.04
        Week 96: 12 to 17 years (N = 25)
    0.4 ± 1.06
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Anti-etanercept Antibodies

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    End point title
    Number of Subjects With Anti-etanercept Antibodies
    End point description
    Safety population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 12, Week 48, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Subjects
        Overall (N=127)
    26
        Week 12 (N=120)
    6
        Week 48 (N=116)
    14
        Week 96 (N=105)
    14
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Anti-etanercept Antibodies: eoJIA Sub-population

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    End point title
    Number of Subjects With Anti-etanercept Antibodies: eoJIA Sub-population
    End point description
    eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 12, Week 48, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    60
    Units: Subjects
        Overall (N=60)
    11
        Week 12 (N=56)
    0
        Week 48 (N=55)
    7
        Week 96 (N=52)
    7
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Anti-etanercept Antibodies: ERA Sub-population

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    End point title
    Number of Subjects With Anti-etanercept Antibodies: ERA Sub-population
    End point description
    ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 12, Week 48, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    38
    Units: Subjects
        Overall (N=38)
    9
        Week 12 (N=36)
    4
        Week 48 (N=34)
    4
        Week 96 (N=29)
    3
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Anti-etanercept Antibodies: PsA Sub-population

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    End point title
    Number of Subjects With Anti-etanercept Antibodies: PsA Sub-population
    End point description
    PsA: subjects with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 12, Week 48, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    29
    Units: Subjects
        Overall (N=29)
    6
        Week 12 (N=28)
    2
        Week 48 (N=27)
    3
        Week 96 (N=24)
    4
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Neutralizing Anti-etanercept Antibodies

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    End point title
    Number of Subjects With Neutralizing Anti-etanercept Antibodies
    End point description
    Safety population included all subjects who received at least 1 dose of the study medication.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 12, Week 48, Week 96
    End point values
    Etanercept
    Number of subjects analysed
    127
    Units: Subjects
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening up to Week 96
    Adverse event reporting additional description
    The same event may appear as both an AE and a Serious Adverse Event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.

    Serious adverse events
    Etanercept
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 127 (18.90%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Cartilage injury
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fractured coccyx
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tendon injury
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Adenoidectomy
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Phimosis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Juvenile arthritis
         subjects affected / exposed
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Helicobacter gastritis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelocystitis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Etanercept
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    106 / 127 (83.46%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 127 (4.72%)
         occurrences all number
    8
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 127 (4.72%)
         occurrences all number
    6
    Hepatic enzyme increased
         subjects affected / exposed
    5 / 127 (3.94%)
         occurrences all number
    5
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    4 / 127 (3.15%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 127 (5.51%)
         occurrences all number
    7
    Epistaxis
         subjects affected / exposed
    4 / 127 (3.15%)
         occurrences all number
    5
    Rhinitis allergic
         subjects affected / exposed
    4 / 127 (3.15%)
         occurrences all number
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 127 (3.15%)
         occurrences all number
    4
    Leukopenia
         subjects affected / exposed
    7 / 127 (5.51%)
         occurrences all number
    8
    Neutropenia
         subjects affected / exposed
    4 / 127 (3.15%)
         occurrences all number
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    17 / 127 (13.39%)
         occurrences all number
    23
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    5 / 127 (3.94%)
         occurrences all number
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    9 / 127 (7.09%)
         occurrences all number
    12
    Influenza like illness
         subjects affected / exposed
    11 / 127 (8.66%)
         occurrences all number
    14
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 127 (4.72%)
         occurrences all number
    6
    Diarrhoea
         subjects affected / exposed
    10 / 127 (7.87%)
         occurrences all number
    12
    Gastritis
         subjects affected / exposed
    5 / 127 (3.94%)
         occurrences all number
    5
    Nausea
         subjects affected / exposed
    5 / 127 (3.94%)
         occurrences all number
    5
    Vomiting
         subjects affected / exposed
    5 / 127 (3.94%)
         occurrences all number
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 127 (4.72%)
         occurrences all number
    10
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    13 / 127 (10.24%)
         occurrences all number
    19
    Gastroenteritis
         subjects affected / exposed
    18 / 127 (14.17%)
         occurrences all number
    21
    Nasopharyngitis
         subjects affected / exposed
    16 / 127 (12.60%)
         occurrences all number
    19
    Pharyngitis
         subjects affected / exposed
    32 / 127 (25.20%)
         occurrences all number
    50
    Rhinitis
         subjects affected / exposed
    11 / 127 (8.66%)
         occurrences all number
    17
    Upper respiratory tract infection
         subjects affected / exposed
    42 / 127 (33.07%)
         occurrences all number
    84
    Ear infection
         subjects affected / exposed
    9 / 127 (7.09%)
         occurrences all number
    12
    Sinusitis
         subjects affected / exposed
    6 / 127 (4.72%)
         occurrences all number
    6
    Tonsillitis
         subjects affected / exposed
    9 / 127 (7.09%)
         occurrences all number
    11

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Nov 2009
    1.AEs and SAEs were collected until 30 days after the last dose of investigational product for subjects who completed the Week 96 visit and did not consent to participate in the long-term extension study.
    05 May 2011
    1. AEs included progression/worsening of underlying disease. 2. AEs included signs or symptoms resulting from medication errors. 3. Lack of efficacy was reported as an AE when it has been associated with a SAE. 4. Added reporting requirements for Potential Cases of Drug-Induced Liver Injury. 5. Testing for direct and indirect bilirubin added to routine serum chemistry panel. 6. Testing for evaluation of potential Hy’s Law cases added.
    02 Jul 2012
    1. Revised to indicate that the potential exists for a requirement for follow-up of AEs regardless of the investigator’s assessment of causality. 2. Added that any non-serious AE that was determined by the Sponsor to be serious has been reported by the Sponsor as an SAE and that to assist in the determination of case seriousness further information may be requested from the investigator. 3. Revised the active reporting period for SAEs and added the necessity to report all SAEs after the active reporting period regardless of causality. In addition, language regarding the active reporting period and the reporting period for all AEs was revised for clarification.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Results include data for Part 1 (up to Week 12) and Part 2 (up to week 96) of the study.
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