Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36348   clinical trials with a EudraCT protocol, of which   5989   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)

    Summary
    EudraCT number
    2009-013091-40
    Trial protocol
    FR   DE   SE   SK   CZ   DK   Outside EU/EEA  
    Global end of trial date
    21 Mar 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    18 May 2016
    First version publication date
    22 Jul 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Potential category issues

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    M10-444
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00775437
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    1 North Waukegan Road, North Chicago, IL, United States, 60064
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    Aileen L. Pangan MD, AbbVie, aileen.pangan@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000036-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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Mar 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Mar 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to evaluate the safety of adalimumab in patients 2 to < 4 years of age or ≥ 4 years of age weighing < 15 kg, with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) or polyarticular course JIA.
    Protection of trial subjects
    Parent or legal guardian read and understood the information provided about the study and gave written permission. An assent form was not used in this study due to the young age of children being studied.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Mar 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 9
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    32
    EEA total number of subjects
    17
    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)
    32
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Subjects were enrolled at 14 investigative sites in the Czech Republic, France, Germany, and the United States.

    Pre-assignment
    Screening details
    Subjects age 2 to < 4 years or ≥ 4 years and under 15 kg with moderately to severely active polyarticular or polyarticular-course JIA with a parent/guardian to administer injections. The screening visit occurred between Day -28 and Day 0.

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

    Arms
    Arm title
    Adalimumab
    Arm description
    Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Subjects could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those subjects who continued in the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira, ABT-D2E7
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab administered by parent or designee as a single dose via subcutaneous injection at approximately the same time of day

    Number of subjects in period 1
    Adalimumab
    Started
    32
    Completed
    26
    Not completed
    6
         Loss of efficacy
    2
         Consent withdrawn by subject
    3
         Lost to follow-up
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Subjects could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those subjects who continued in the study.

    Reporting group values
    Adalimumab Total
    Number of subjects
    32 32
    Age categorical
    Units: Subjects
        < 4 years
    28 28
        ≥ 4 years
    4 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    3.04 ± 0.723 -
    Gender categorical
    Units: Subjects
        Female
    28 28
        Male
    4 4
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    13.4 ± 1.96 -

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Subjects could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those subjects who continued in the study.

    Primary: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs)

    Close Top of page
    End point title
    Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) [1]
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an AE meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent a serious outcome. A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a subject from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration (total of 32.5 months).
    End point type
    Primary
    End point timeframe
    TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months).
    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: Descriptive data were summarized for this endpoint per protocol.
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: Subjects
        Any Treatment-emergent AE
    29
        Any Treatment-emergent SAE
    5
    No statistical analyses for this end point

    Secondary: Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24

    Close Top of page
    End point title
    Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24
    End point description
    Adalimumab concentrations in serum were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method. The lower limit of quantitation (LLOQ) for adalimumab is 3.13 ng/mL.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 12, and 24
    End point values
    Adalimumab
    Number of subjects analysed
    15 [2]
    Units: µg/mL
    arithmetic mean (standard deviation)
        Week 0
    0 ± 0
        Week 12
    6.97 ± 5.69
        Week 24
    7.78 ± 5.85
    Notes
    [2] - All subjects who had samples for pharmacokinetic analysis
    No statistical analyses for this end point

    Secondary: Hemoglobin: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Hemoglobin: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    31
    Units: g/L
    arithmetic mean (standard deviation)
        Week 12 (n=29)
    6.7 ± 7.32
        Week 24 (n=29)
    6.7 ± 9.76
        Week 36 (n=25)
    5.5 ± 9.31
        Week 48 (n=24)
    5.3 ± 10.68
        Week 60 (n=21)
    6 ± 10.96
        Week 72 (n=17)
    9.5 ± 10.65
        Week 84 (n=16)
    10.5 ± 13.69
        Week 96 (n=11)
    8.6 ± 9.99
        Week 108 (n=9)
    7.7 ± 8.08
        Week 120 (n=3)
    4.7 ± 2.89
    No statistical analyses for this end point

    Secondary: Hematocrit: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Hematocrit: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    31
    Units: Fraction
    arithmetic mean (standard deviation)
        Week 12 (n=29)
    0.018 ± 0.0206
        Week 24 (n=29)
    0.016 ± 0.0289
        Week 36 (n=25)
    0.017 ± 0.0292
        Week 48 (n=24)
    0.011 ± 0.0288
        Week 60 (n=21)
    0.009 ± 0.0275
        Week 72 (n=17)
    0.024 ± 0.0264
        Week 84 (n=16)
    0.026 ± 0.0366
        Week 96 (n=11)
    0.023 ± 0.0319
        Week 108 (n=9)
    0.018 ± 0.0273
        Week 120 (n=3)
    0.008 ± 0.0082
    No statistical analyses for this end point

    Secondary: Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    31
    Units: x10˄12/L
    arithmetic mean (standard deviation)
        Week 12 (n=29)
    0.15 ± 0.231
        Week 24 (n=29)
    0.08 ± 0.308
        Week 36 (n=25)
    0.098 ± 0.277
        Week 48 (n=24)
    0.05 ± 0.213
        Week 60 (n=21)
    0.07 ± 0.296
        Week 72 (n=17)
    0.1 ± 0.187
        Week 84 (n=16)
    0.06 ± 0.228
        Week 96 (n=11)
    0.08 ± 0.343
        Week 108 (n=9)
    0.1 ± 0.32
        Week 120 (n=3)
    0.03 ± 0.153
    No statistical analyses for this end point

    Secondary: Platelets: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Platelets: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    31
    Units: x10˄9/L
    arithmetic mean (standard deviation)
        Week 12 (n=29)
    -35 ± 145.44
        Week 24 (n=29)
    -57.7 ± 140.82
        Week 36 (n=25)
    -75.2 ± 148.51
        Week 48 (n=23)
    -21 ± 174.17
        Week 60 (n=21)
    -46.7 ± 125.71
        Week 72 (n=17)
    -51.1 ± 111.11
        Week 84 (n=15)
    -58.5 ± 127.29
        Week 96 (n=11)
    -49.2 ± 142.73
        Week 108 (n=9)
    -30.4 ± 137.84
        Week 120 (n=3)
    20 ± 185.95
    No statistical analyses for this end point

    Secondary: White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    31
    Units: x10^9/L
    arithmetic mean (standard deviation)
        Week 12 (n=29)
    0.19 ± 3.959
        Week 24 (n=29)
    -0.25 ± 3.756
        Week 36 (n=25)
    -0.42 ± 4.632
        Week 48 (n=24)
    0.3 ± 4.804
        Week 60 (n=21)
    0.25 ± 2.183
        Week 72 (n=17)
    0.66 ± 3.225
        Week 84 (n=16)
    0.18 ± 2.944
        Week 96 (n=11)
    0.55 ± 2.757
        Week 108 (n=9)
    -0.76 ± 4.166
        Week 120 (n=3)
    1.8 ± 3.651
    No statistical analyses for this end point

    Secondary: Neutrophils: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Neutrophils: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    31
    Units: x10˄9/L
    arithmetic mean (standard deviation)
        Week 12 (n=29)
    -0.138 ± 2.9819
        Week 24 (n=29)
    -0.619 ± 3.0082
        Week 36 (n=25)
    -0.586 ± 3.7363
        Week 48 (n=24)
    0.065 ± 3.4433
        Week 60 (n=21)
    0.222 ± 2.0937
        Week 72 (n=17)
    -0.169 ± 2.6167
        Week 84 (n=16)
    -0.206 ± 2.0077
        Week 96 (n=11)
    0.293 ± 2.511
        Week 108 (n=9)
    -0.39 ± 3.1702
        Week 120 (n=3)
    2.47 ± 3.2658
    No statistical analyses for this end point

    Secondary: Lymphocytes: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Lymphocytes: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    31
    Units: x10˄9/L
    arithmetic mean (standard deviation)
        Week 12 (n=29)
    0.371 ± 2.3523
        Week 24 (n=29)
    0.292 ± 1.9345
        Week 36 (n=25)
    0.176 ± 1.962
        Week 48 (n=24)
    0.186 ± 1.9584
        Week 60 (n=21)
    -0.034 ± 1.6129
        Week 72 (n=17)
    0.636 ± 1.7404
        Week 84 (n=16)
    0.306 ± 1.5143
        Week 96 (n=11)
    0.006 ± 1.9402
        Week 108 (n=9)
    -0.46 ± 2.4315
        Week 120 (n=3)
    -0.67 ± 1.8041
    No statistical analyses for this end point

    Secondary: Monocytes: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Monocytes: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    31
    Units: x10^9/L
    arithmetic mean (standard deviation)
        Week 12 (n=29)
    -0.032 ± 0.3051
        Week 24 (n=29)
    0.081 ± 0.4547
        Week 36 (n=25)
    0.028 ± 0.2978
        Week 48 (n=24)
    -0.006 ± 0.2718
        Week 60 (n=21)
    0.08 ± 0.1831
        Week 72 (n=17)
    0.113 ± 0.2054
        Week 84 (n=16)
    0.061 ± 0.2594
        Week 96 (n=11)
    0.089 ± 0.2295
        Week 108 (n=9)
    0.096 ± 0.3248
        Week 120 (n=3)
    0.057 ± 0.0777
    No statistical analyses for this end point

    Secondary: Eosinophils: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Eosinophils: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    31
    Units: x10^9/L
    arithmetic mean (standard deviation)
        Week 12 (n=29)
    -0.004 ± 0.1771
        Week 24 (n=29)
    -0.006 ± 0.1545
        Week 36 (n=25)
    -0.052 ± 0.1374
        Week 48 (n=24)
    0.056 ± 0.2773
        Week 60 (n=21)
    -0.015 ± 0.1363
        Week 72 (n=17)
    0.069 ± 0.1886
        Week 84 (n=16)
    0.016 ± 0.1631
        Week 96 (n=11)
    0.158 ± 0.3207
        Week 108 (n=9)
    -0.002 ± 0.0864
        Week 120 (n=3)
    -0.063 ± 0.0929
    No statistical analyses for this end point

    Secondary: Basophils: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Basophils: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    31
    Units: x10^9/L
    arithmetic mean (standard deviation)
        Week 12 (n=29)
    -0.012 ± 0.0299
        Week 24 (n=29)
    -0.002 ± 0.0272
        Week 36 (n=25)
    0.003 ± 0.0244
        Week 48 (n=24)
    0.005 ± 0.0412
        Week 60 (n=21)
    -0.003 ± 0.0256
        Week 72 (n=17)
    0.007 ± 0.031
        Week 84 (n=16)
    -0.001 ± 0.0171
        Week 96 (n=11)
    -0.003 ± 0.0205
        Week 108 (n=9)
    -0.001 ± 0.0117
        Week 120 (n=3)
    0.003 ± 0.0306
    No statistical analyses for this end point

    Secondary: Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    30
    Units: U/L
    arithmetic mean (standard deviation)
        Week 12 (n=27)
    0.5 ± 9.96
        Week 24 (n=28)
    -1.1 ± 17.13
        Week 36 (n=25)
    0 ± 29.82
        Week 48 (n=24)
    -4.5 ± 24.81
        Week 60 (n=21)
    -2 ± 10.25
        Week 72 (n=16)
    -1.8 ± 10.1
        Week 84 (n=16)
    -0.5 ± 14.56
        Week 96 (n=11)
    -3.9 ± 15.4
        Week 108 (n=9)
    -2.4 ± 6.31
        Week 120 (n=3)
    -14.3 ± 23.12
    No statistical analyses for this end point

    Secondary: Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    30
    Units: U/L
    arithmetic mean (standard deviation)
        Week 12 (n=26)
    2.8 ± 7.56
        Week 24 (n=28)
    -0.6 ± 8.82
        Week 36 (n=25)
    2 ± 23.26
        Week 48 (n=24)
    -0.7 ± 16.13
        Week 60 (n=21)
    -0.4 ± 7.63
        Week 72 (n=16)
    0.3 ± 7.36
        Week 84 (n=16)
    -0.4 ± 6.89
        Week 96 (n=10)
    1.5 ± 11.48
        Week 108 (n=9)
    0.4 ± 6.21
        Week 120 (n=3)
    -8.3 ± 11.93
    No statistical analyses for this end point

    Secondary: Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    30
    Units: U/L
    arithmetic mean (standard deviation)
        Week 12 (n=27)
    15.7 ± 64.65
        Week 24 (n=28)
    10.6 ± 68.75
        Week 36 (n=25)
    23.2 ± 73.28
        Week 48 (n=24)
    21.7 ± 73.03
        Week 60 (n=21)
    17.9 ± 85.55
        Week 72 (n=16)
    17.9 ± 83.52
        Week 84 (n=16)
    31.5 ± 89.3
        Week 96 (n=11)
    59.4 ± 57.65
        Week 108 (n=9)
    -6.3 ± 100.72
        Week 120 (n=3)
    -72.3 ± 169.19
    No statistical analyses for this end point

    Secondary: Creatine Phosphokinase: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Creatine Phosphokinase: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    30
    Units: U/L
    arithmetic mean (standard deviation)
        Week 12 (n=27)
    17.2 ± 50.48
        Week 24 (n=27)
    7 ± 30.79
        Week 36 (n=25)
    24.8 ± 44.5
        Week 48 (n=24)
    18.4 ± 54.02
        Week 60 (n=21)
    26.6 ± 65.48
        Week 72 (n=16)
    41.6 ± 40.63
        Week 84 (n=16)
    36.4 ± 53.64
        Week 96 (n=11)
    28.7 ± 41.79
        Week 108 (n=9)
    7.2 ± 22.97
        Week 120 (n=3)
    14 ± 40.73
    No statistical analyses for this end point

    Secondary: Total Bilirubin: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Total Bilirubin: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    30
    Units: µmol/L
    arithmetic mean (standard deviation)
        Week 12 (n=27)
    1.2 ± 2.42
        Week 24 (n=28)
    0.6 ± 1.59
        Week 36 (n=25)
    0.6 ± 1.61
        Week 48 (n=24)
    0.9 ± 2.4
        Week 60 (n=21)
    1 ± 2.09
        Week 72 (n=16)
    0.2 ± 1.25
        Week 84 (n=16)
    0.5 ± 2.36
        Week 96 (n=11)
    0.7 ± 1.62
        Week 108 (n=9)
    1.1 ± 2.71
        Week 120 (n=3)
    2.3 ± 0.58
    No statistical analyses for this end point

    Secondary: Creatinine: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Creatinine: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    30
    Units: µmol/L
    arithmetic mean (standard deviation)
        Week 12 (n=27)
    1.7 ± 5.98
        Week 24 (n=28)
    0.5 ± 5.3
        Week 36 (n=25)
    0.3 ± 5.84
        Week 48 (n=24)
    2.5 ± 7.8
        Week 60 (n=21)
    2.8 ± 5.79
        Week 72 (n=16)
    3.4 ± 6.96
        Week 84 (n=16)
    4 ± 6.37
        Week 96 (n=11)
    3.2 ± 5.53
        Week 108 (n=9)
    6.2 ± 6.7
        Week 120 (n=3)
    8.7 ± 5.51
    No statistical analyses for this end point

    Secondary: Uric Acid: Mean Change From Baseline to Each Visit

    Close Top of page
    End point title
    Uric Acid: Mean Change From Baseline to Each Visit
    End point description
    Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    30
    Units: µmol/L
    arithmetic mean (standard deviation)
        Week 12 (n=27)
    1.7 ± 48.24
        Week 24 (n=27)
    6.5 ± 47.93
        Week 36 (n=25)
    2.5 ± 41.77
        Week 48 (n=24)
    5.6 ± 45.62
        Week 60 (n=21)
    1.9 ± 30.86
        Week 72 (n=16)
    -0.9 ± 43.53
        Week 84 (n=16)
    -4.5 ± 46.76
        Week 96 (n=11)
    13.3 ± 36.39
        Week 108 (n=9)
    -10.1 ± 33.55
        Week 120 (n=3)
    -7 ± 27.78
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 30% Response (PedACR30)

    Close Top of page
    End point title
    Percentage of Subjects Achieving Pediatric American College of Rheumatology 30% Response (PedACR30)
    End point description
    The PedACR30 response is defined by the Pediatric American College of Rheumatology as ≥30% improvement in ≥3 of 6 JIA core set criteria, and ≥30% worsening in ≤1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria are Physician's Global Assessment (PGA) of subject's disease activity, Parent's Global Assessment of subject's disease activity, number of active joints (joints with swelling not due to deformity or joints with loss of passive motion [LOM] and joints with pain on passive motion [POM], tenderness, or both), number of joints with LOM, Disability Index of Child Health Assessment Questionnaire (DICHAQ), and C-reactive protein (CRP). Baseline=last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using last observation carried forward (LOCF) and non-responder imputation (NRI); observed values are presented for timepoints past Week 60. n=number of subjects for either observed or imputed methods at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: percentage of subjects
    number (not applicable)
        Week 12 Observed (n=31)
    93.5
        Week 12 NRI (n=32)
    90.6
        Week 12 LOCF (n=31)
    93.5
        Week 24 Observed (n=30)
    90
        Week 24 NRI (n=32)
    84.4
        Week 24 LOCF (n=31)
    90.3
        Week 36 Observed (n=27)
    92.6
        Week 36 NRI (n=32)
    78.1
        Week 36 LOCF (n=31)
    93.5
        Week 48 Observed (n=24)
    83.3
        Week 48 NRI (n=32)
    62.5
        Week 48 LOCF (n=31)
    83.9
        Week 60 Observed (n=20)
    90
        Week 60 NRI (n=32)
    56.3
        Week 60 LOCF (n=31)
    87.1
        Week 72 Observed (n=17)
    100
        Week 84 Observed (n=17)
    100
        Week 96 Observed (n=13)
    92.3
        Week 108 Observed (n=9)
    88.9
        Week 120 Observed (n=3)
    100
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 50% Response (PedACR50)

    Close Top of page
    End point title
    Percentage of Subjects Achieving Pediatric American College of Rheumatology 50% Response (PedACR50)
    End point description
    The PedACR50 response is defined by the Pediatric American College of Rheumatology as ≥ 50% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of subject's disease activity, Parent's Global Assessment of subject's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of subjects for either observed or imputed methods at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: percentage of subjects
    number (not applicable)
        Week 12 Observed (n=31)
    90.3
        Week 12 NRI (n=32)
    87.5
        Week 12 LOCF (n=31)
    90.3
        Week 24 Observed (n=30)
    83.3
        Week 24 NRI (n=32)
    78.1
        Week 24 LOCF (n=31)
    83.9
        Week 36 Observed (n=27)
    88.9
        Week 36 NRI (n=32)
    75
        Week 36 LOCF (n=31)
    90.3
        Week 48 Observed (n=24)
    79.2
        Week 48 NRI (n=32)
    59.4
        Week 48 LOCF (n=31)
    80.6
        Week 60 Observed (n=20)
    80
        Week 60 NRI (n=32)
    50
        Week 60 LOCF (n=31)
    80.6
        Week 72 Observed (n=17)
    100
        Week 84 Observed (n=17)
    94.1
        Week 96 Observed (n=13)
    92.3
        Week 108 Observed (n=9)
    88.9
        Week 120 Observed (n=3)
    100
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 70% Response (PedACR70)

    Close Top of page
    End point title
    Percentage of Subjects Achieving Pediatric American College of Rheumatology 70% Response (PedACR70)
    End point description
    The PedACR70 response is defined by the Pediatric American College of Rheumatology as ≥ 70% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of subject's disease activity, Parent's Global Assessment of subject's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of subjects for either observed or imputed methods at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: percentage of subjects
    number (not applicable)
        Week 12 Observed (n=31)
    61.3
        Week 12 NRI (n=32)
    59.4
        Week 12 LOCF (n=31)
    61.3
        Week 24 Observed (n=30)
    73.3
        Week 24 NRI (n=32)
    68.8
        Week 24 LOCF (n=31)
    74.2
        Week 36 Observed (n=27)
    66.7
        Week 36 NRI (n=32)
    56.3
        Week 36 LOCF (n=31)
    67.7
        Week 48 Observed (n=24)
    75
        Week 48 NRI (n=32)
    56.3
        Week 48 LOCF (n=31)
    74.2
        Week 60 Observed (n=20)
    70
        Week 60 NRI (n=32)
    43.8
        Week 60 LOCF (n=31)
    71
        Week 72 Observed (n=17)
    76.5
        Week 84 Observed (n=17)
    82.4
        Week 96 Observed (n=13)
    76.9
        Week 108 Observed (n=9)
    77.8
        Week 120 Observed (n=3)
    100
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 90% Response (PedACR90)

    Close Top of page
    End point title
    Percentage of Subjects Achieving Pediatric American College of Rheumatology 90% Response (PedACR90)
    End point description
    The PedACR90 response is defined by the Pediatric American College of Rheumatology as ≥ 90% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of subject's disease activity, Parent's Global Assessment of subject's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of subjects for either observed or imputed methods at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: percentage of subjects
    number (not applicable)
        Week 12 Observed (n=31)
    38.7
        Week 12 NRI (n=32)
    37.5
        Week 12 LOCF (n=31)
    38.7
        Week 24 Observed (n=30)
    36.7
        Week 24 NRI (n=32)
    34.4
        Week 24 LOCF (n=31)
    35.5
        Week 36 Observed (n=27)
    51.9
        Week 36 NRI (n=32)
    43.8
        Week 36 LOCF (n=31)
    51.6
        Week 48 Observed (n=24)
    62.5
        Week 48 NRI (n=32)
    46.9
        Week 48 LOCF (n=31)
    58.1
        Week 60 Observed (n=20)
    50
        Week 60 NRI (n=32)
    31.3
        Week 60 LOCF (n=31)
    51.6
        Week 72 Observed (n=17)
    64.7
        Week 84 Observed (n=17)
    64.7
        Week 96 Observed (n=13)
    61.5
        Week 108 Observed (n=9)
    66.7
        Week 120 Observed (n=3)
    100
    No statistical analyses for this end point

    Secondary: Physician's Global Assessment of Disease Activity: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Physician's Global Assessment of Disease Activity: Mean Change from Baseline to Each Visit
    End point description
    The physician’s assessment of subject’s overall disease activity on a visual analog scale (VAS). The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=31)
    -41.4 ± 21.2
        Week 24 (n=30)
    -45.3 ± 21.32
        Week 36 (n=28)
    -43 ± 23.9
        Week 48 (n=24)
    -46.5 ± 18.35
        Week 60 (n=21)
    -42.7 ± 28.17
        Week 72 (n=17)
    -51.1 ± 19.53
        Week 84 (n=17)
    -50.5 ± 16.77
        Week 96 (n=13)
    -47.5 ± 24.42
        Week 108 (n=9)
    -48.3 ± 28.24
        Week 120 (n=3)
    -56.3 ± 5.13
    No statistical analyses for this end point

    Secondary: Parent's Global Assessment of Disease Activity: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Parent's Global Assessment of Disease Activity: Mean Change from Baseline to Each Visit
    End point description
    The parent’s assessment of how the subject’s arthritis is doing overall on a VAS. The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=31)
    -28.1 ± 29.91
        Week 24 (n=30)
    -32.2 ± 29.74
        Week 36 (n=27)
    -35.1 ± 27.42
        Week 48 (n=24)
    -35.6 ± 32.19
        Week 60 (n=21)
    -34.5 ± 33.31
        Week 72 (n=17)
    -43.8 ± 25.58
        Week 84 (n=17)
    -42.6 ± 28.62
        Week 96 (n=13)
    -45.8 ± 29.1
        Week 108 (n=9)
    -39.9 ± 37.54
        Week 120 (n=3)
    -47.7 ± 34.96
    No statistical analyses for this end point

    Secondary: Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change from Baseline to Each Visit
    End point description
    The DICHAQ is a self-reported subject-oriented outcome measure, calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The score of each category is calculated as the maximum of the scores for the questions within that category. If aids and devices and/or help from another person are used for a category, a lower category score is adjusted to 2 for that category. A subject must have scores for at least 6 categories in order to compute the DICHAQ score. Total score is derived as average of all categories: 0 (no disability) to 3 (complete disability). Baseline is the last value prior to the first dose of study drug. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=31)
    -0.5 ± 0.64
        Week 24 (n=30)
    -0.5 ± 0.69
        Week 36 (n=27)
    -0.6 ± 0.7
        Week 48 (n=24)
    -0.6 ± 0.68
        Week 60 (n=21)
    -0.6 ± 0.71
        Week 72 (n=16)
    -0.9 ± 0.64
        Week 84 (n=17)
    -0.9 ± 0.68
        Week 96 (n=13)
    -0.8 ± 0.56
        Week 108 (n=9)
    -0.8 ± 0.63
        Week 120 (n=3)
    -0.8 ± 1.09
    No statistical analyses for this end point

    Secondary: Active Joint Counts (AJC73): Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Active Joint Counts (AJC73): Mean Change from Baseline to Each Visit
    End point description
    A joint assessment was recorded at all study visits to assess the number of active joints, with a total possible score of 0 (no active joints) to 73 (all active joints). Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 2 (n=32)
    -5 ± 6.58
        Week 4 (n=32)
    -6.1 ± 6.69
        Week 8 (n=32)
    -7 ± 5.24
        Week 12 (n=31)
    -7.3 ± 4.52
        Week 16 (n=31)
    -7.1 ± 5.87
        Week 20 (n=29)
    -8 ± 5.68
        Week 24 (n=30)
    -7.2 ± 5.6
        Week 36 (n=28)
    -7.3 ± 5.21
        Week 48 (n=24)
    -8 ± 5.5
        Week 60 (n=20)
    -9.5 ± 7.5
        Week 72 (n=17)
    -10.2 ± 6.64
        Week 84 (n=17)
    -10.4 ± 7.57
        Week 96 (n=13)
    -8.9 ± 7.04
        Week 108 (n=9)
    -5.9 ± 3.33
        Week 120 (n=3)
    -7.3 ± 2.08
    No statistical analyses for this end point

    Secondary: Limitation of Passive Motion (LOM69) Joint Count: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Limitation of Passive Motion (LOM69) Joint Count: Mean Change from Baseline to Each Visit
    End point description
    Sixty-nine joints were assessed by physical examination. The joints to be examined for LOM were the same as those examined for tenderness, except that the sacroiliac, sternoclavicular, and acromio clavicular joints were excluded. LOM of the joint was classified as present ("1"), absent ("0"), or replaced/injected ("9"). Scores range from 0 to 621, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 2 (n=32)
    -4.5 ± 7.14
        Week 4 (n=32)
    -5.4 ± 6.48
        Week 8 (n=32)
    -5.3 ± 5.02
        Week 12 (n=31)
    -5.6 ± 4.8
        Week 16 (n=31)
    -6.3 ± 6.31
        Week 20 (n=29)
    -6.8 ± 6.63
        Week 24 (n=30)
    -5.6 ± 5.54
        Week 36 (n=28)
    -5.1 ± 5.29
        Week 48 (n=24)
    -5.5 ± 7.06
        Week 60 (n=20)
    -5.5 ± 8.31
        Week 72 (n=17)
    -6.9 ± 7.84
        Week 84 (n=17)
    -8.4 ± 6.9
        Week 96 (n=13)
    -7.5 ± 6.73
        Week 108 (n=9)
    -5.2 ± 3.96
        Week 120 (n=3)
    -6 ± 2.65
    No statistical analyses for this end point

    Secondary: C-reactive Protein (CRP): Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    C-reactive Protein (CRP): Mean Change from Baseline to Each Visit
    End point description
    CRP is a laboratory parameter and considered as an efficacy variable. CRP is a general marker of inflammation that is sensitive to acute changes in inflammatory response. CRP is reported using mg/dL. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: mg/dL
    arithmetic mean (standard deviation)
        Week 12 (n=28)
    -0.6 ± 2.65
        Week 24 (n=28)
    -0.2 ± 3.2
        Week 36 (n=25)
    -0.4 ± 3.08
        Week 48 (n=23)
    0.4 ± 2.68
        Week 60 (n=20)
    -0.3 ± 1.83
        Week 72 (n=17)
    -0.7 ± 1.25
        Week 84 (n=17)
    -0.7 ± 1.47
        Week 96 (n=12)
    0.1 ± 1.6
        Week 108 (n=9)
    0.2 ± 1.93
        Week 120 (n=3)
    0.3 ± 0.28
    No statistical analyses for this end point

    Secondary: Tender Joint Count (TJC75): Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Tender Joint Count (TJC75): Mean Change from Baseline to Each Visit
    End point description
    Seventy-five joints or regions were assessed by pressure and joint manipulation on physical examination. Joint tenderness was classified as either present ("1"), absent ("0") or replaced/injected ("9"). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 2 (n=32)
    -2.3 ± 4.62
        Week 4 (n=32)
    -2.8 ± 4.48
        Week 8 (n=32)
    -3.1 ± 4.31
        Week 12 (n=31)
    -2.7 ± 5.09
        Week 16 (n=31)
    -3.5 ± 4.77
        Week 20 (n=29)
    -3.9 ± 5.09
        Week 24 (n=30)
    -3 ± 5.54
        Week 36 (n=28)
    -2.9 ± 5.65
        Week 48 (n=24)
    -4.4 ± 4.85
        Week 60 (n=20)
    -4.5 ± 5.85
        Week 72 (n=17)
    -5.3 ± 5.53
        Week 84 (n=17)
    -4.8 ± 5.2
        Week 96 (n=13)
    -4 ± 5.46
        Week 108 (n=9)
    -1.1 ± 4.73
        Week 120 (n=3)
    -1.3 ± 2.31
    No statistical analyses for this end point

    Secondary: Swollen Joint Count (SJC66): Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Swollen Joint Count (SJC66): Mean Change from Baseline to Each Visit
    End point description
    Sixty-six joints were assessed by physical examination. The joints to be examined for swelling were the same as those examined for tenderness, except that the hip, subtalar, sacroiliac, lumbar spine, thoracic spine, and cervical spine joints were excluded. Joint swelling was classified as present ("1"), absent ("0") or replaced/injected ("9"). Scores range from 0 to 594, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 2 (n=32)
    -4.5 ± 6.46
        Week 4 (n=32)
    -5.3 ± 6.63
        Week 8 (n=32)
    -6 ± 5.32
        Week 12 (n=31)
    -6.2 ± 4.24
        Week 16 (n=31)
    -6.1 ± 6.59
        Week 20 (n=29)
    -6.9 ± 5.62
        Week 24 (n=30)
    -6.3 ± 5.83
        Week 36 (n=28)
    -6.2 ± 4.73
        Week 48 (n=24)
    -6.7 ± 5.34
        Week 60 (n=20)
    -8.4 ± 7.15
        Week 72 (n=17)
    -8.9 ± 6.06
        Week 84 (n=17)
    -9.4 ± 7.15
        Week 96 (n=13)
    -8.5 ± 6.89
        Week 108 (n=9)
    -5.8 ± 3.31
        Week 120 (n=3)
    -7.3 ± 2.08
    No statistical analyses for this end point

    Secondary: Pain on Passive Motion (POM75) Joint Count: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Pain on Passive Motion (POM75) Joint Count: Mean Change from Baseline to Each Visit
    End point description
    Seventy-five joints were assessed by physical examination. The joints to be examined for POM were the same as those examined for tenderness. POM of the joint was classified as present ("1"), absent ("0"), or replaced/injected ("9"). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 2 (n=32)
    -3.3 ± 4.5
        Week 4 (n=32)
    -4 ± 4.01
        Week 8 (n=32)
    -4.6 ± 5.17
        Week 12 (n=31)
    -4.9 ± 4.59
        Week 16 (n=31)
    -4.9 ± 4.6
        Week 20 (n=29)
    -5.4 ± 4.81
        Week 24 (n=30)
    -4.1 ± 7.32
        Week 36 (n=28)
    -4.3 ± 7.34
        Week 48 (n=24)
    -5.8 ± 4.42
        Week 60 (n=20)
    -5.9 ± 5.25
        Week 72 (n=17)
    -6.4 ± 5.41
        Week 84 (n=17)
    -6.1 ± 5.34
        Week 96 (n=13)
    5.7 ± 5.12
        Week 108 (n=9)
    -3.6 ± 5.85
        Week 120 (n=3)
    -5.3 ± 1.53
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=29)
    17.1 ± 29.48
        Week 24 (n=28)
    24.3 ± 25.77
        Week 36 (n=24)
    25 ± 27.27
        Week 48 (n=22)
    30.9 ± 23.79
        Week 60 (n=19)
    21.8 ± 27.35
        Week 72 (n=17)
    31.5 ± 24.86
        Week 84 (n=17)
    26.2 ± 25.89
        Week 96 (n=11)
    32.7 ± 20.66
        Week 108 (n=8)
    36.9 ± 19.99
        Week 120 (n=3)
    45 ± 17.32
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=31)
    30.6 ± 32.14
        Week 24 (n=30)
    31.6 ± 31.91
        Week 36 (n=27)
    36.4 ± 31.26
        Week 48 (n=23)
    31.5 ± 28.39
        Week 60 (n=21)
    29 ± 32.3
        Week 72 (n=16)
    40.6 ± 27
        Week 84 (n=17)
    40 ± 30.44
        Week 96 (n=13)
    34.3 ± 27.88
        Week 108 (n=9)
    37 ± 27.92
        Week 120 (n=3)
    53.7 ± 8.49
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=23)
    20.8 ± 32.53
        Week 24 (n=22)
    17.7 ± 29.43
        Week 36 (n=20)
    17.2 ± 25.86
        Week 48 (n=18)
    16 ± 27.28
        Week 60 (n=16)
    20.8 ± 31.91
        Week 72 (n=13)
    26.5 ± 32.25
        Week 84 (n=13)
    20.5 ± 33.29
        Week 96 (n=9)
    30.9 ± 32.76
        Week 108 (n=7)
    23.8 ± 25.2
        Week 120 (n=2)
    33.3 ± 47.14
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations – Physical Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations – Physical Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=21)
    28.6 ± 32.97
        Week 24 (n=20)
    31.7 ± 35
        Week 36 (n=18)
    30.6 ± 39.3
        Week 48 (n=17)
    27.5 ± 37.24
        Week 60 (n=15)
    34.4 ± 39.07
        Week 72 (n=12)
    36.1 ± 41.34
        Week 84 (n=12)
    34.7 ± 43.5
        Week 96 (n=8)
    41.7 ± 37.8
        Week 108 (n=6)
    47.2 ± 37.14
        Week 120 (n=1)
    66.7 ± 0
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=30)
    35 ± 30.6
        Week 24 (n=29)
    36.2 ± 32.99
        Week 36 (n=26)
    38.8 ± 27.76
        Week 48 (n=23)
    41.7 ± 29.64
        Week 60 (n=20)
    39 ± 34.78
        Week 72 (n=17)
    48.2 ± 20.38
        Week 84 (n=17)
    41.2 ± 25.47
        Week 96 (n=13)
    42.3 ± 23.51
        Week 108 (n=9)
    41.1 ± 37.56
        Week 120 (n=3)
    50 ± 17.32
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=29)
    5.6 ± 15.78
        Week 24 (n=28)
    4.2 ± 13.58
        Week 36 (n=27)
    0.4 ± 16.87
        Week 48 (n=24)
    3.6 ± 17.04
        Week 60 (n=21)
    -0.3 ± 13.95
        Week 72 (n=17)
    0.1 ± 16.44
        Week 84 (n=17)
    1.5 ± 13.97
        Week 96 (n=13)
    7.1 ± 11.81
        Week 108 (n=9)
    8.9 ± 10.46
        Week 120 (n=3)
    -6.1 ± 31.28
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=19)
    4.5 ± 18.17
        Week 24 (n=19)
    10.8 ± 17.66
        Week 36 (n=18)
    9.2 ± 25.04
        Week 48 (n=16)
    4.1 ± 18.55
        Week 60 (n=13)
    -3.5 ± 20.35
        Week 72 (n=10)
    2 ± 15.31
        Week 84 (n=11)
    -5 ± 14.32
        Week 96 (n=9)
    0 ± 17.68
        Week 108 (n=6)
    -4.2 ± 10.21
        Week 120 (n=1)
    -25 ± 0
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=31)
    3.5 ± 11.12
        Week 24 (n=30)
    3.5 ± 10.76
        Week 36 (n=27)
    4.1 ± 14.01
        Week 48 (n=24)
    5.4 ± 11.88
        Week 60 (n=21)
    2.1 ± 14.02
        Week 72 (n=17)
    5 ± 12.37
        Week 84 (n=17)
    2.6 ± 8.5
        Week 96 (n=13)
    4.2 ± 11.88
        Week 108 (n=9)
    -0.8 ± 15
        Week 120 (n=3)
    -3.3 ± 20.21
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=23)
    10.6 ± 23.91
        Week 24 (n=22)
    10.5 ± 24.75
        Week 36 (n=19)
    16.8 ± 22.02
        Week 48 (n=16)
    15.2 ± 22.6
        Week 60 (n=14)
    10.2 ± 22.53
        Week 72 (n=13)
    -2.8 ± 31.78
        Week 84 (n=13)
    9.4 ± 18.52
        Week 96 (n=9)
    6.9 ± 19.87
        Week 108 (n=6)
    -4.2 ± 10.87
        Week 120 (n=1)
    4.2 ± 0
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=26)
    0.7 ± 14.27
        Week 24 (n=25)
    3.8 ± 14.98
        Week 36 (n=22)
    6.2 ± 15.99
        Week 48 (n=19)
    7.2 ± 13.36
        Week 60 (n=18)
    0.7 ± 10.65
        Week 72 (n=15)
    9.1 ± 10.1
        Week 84 (n=15)
    7.2 ± 13.03
        Week 96 (n=11)
    10.9 ± 16
        Week 108 (n=7)
    9 ± 16.61
        Week 120 (n=3)
    4.7 ± 12.92
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=30)
    1.4 ± 1.75
        Week 24 (n=29)
    1.7 ± 1.67
        Week 36 (n=25)
    1.7 ± 1.8
        Week 48 (n=22)
    1.7 ± 2.4
        Week 60 (n=20)
    1.3 ± 2.57
        Week 72 (n=16)
    1.6 ± 2.13
        Week 84(n=16)
    1.3 ± 1.98
        Week 96 (n=12)
    1.5 ± 2.02
        Week 108 (n=8)
    0.9 ± 2.7
        Week 120 (n=3)
    2.3 ± 0.58
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=30)
    11.4 ± 26.12
        Week 24 (n=28)
    19 ± 28.59
        Week 36 (n=26)
    29.2 ± 33.1
        Week 48 (n=23)
    34.1 ± 33.98
        Week 60 (n=20)
    31.7 ± 32.4
        Week 72 (n=16)
    34.4 ± 36.37
        Week 84 (n=16)
    27.6 ± 41.69
        Week 96 (n=11)
    43.9 ± 40.15
        Week 108 (n=8)
    46.9 ± 40.81
        Week 120 (n=2)
    62.5 ± 41.25
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=30)
    4.6 ± 24.5
        Week 24 (n=28)
    13.5 ± 28.59
        Week 36 (n=26)
    21.8 ± 24.24
        Week 48 (n=23)
    18.4 ± 24.76
        Week 60 (n=20)
    13.3 ± 31.55
        Week 72 (n=16)
    22.2 ± 30.09
        Week 84 (n=16)
    17.4 ± 35.13
        Week 96 (n=12)
    20.4 ± 27.15
        Week 108 (n=8)
    15.3 ± 25.85
        Week 120 (n=2)
    55.6 ± 62.85
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=30)
    8.3 ± 28.41
        Week 24 (n=28)
    17.6 ± 24.15
        Week 36 (n=26)
    20 ± 28.5
        Week 48 (n=23)
    16.8 ± 26.43
        Week 60 (n=20)
    14.8 ± 30.9
        Week 72 (n=16)
    17.2 ± 31.43
        Week 84 (n=16)
    18.2 ± 30.27
        Week 96 (n=12)
    19.4 ± 27.6
        Week 108 (n=8)
    20.8 ± 29.38
        Week 120 (n=2)
    68.8 ± 20.62
    No statistical analyses for this end point

    Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change from Baseline to Each Visit

    Close Top of page
    End point title
    Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change from Baseline to Each Visit
    End point description
    The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
    End point values
    Adalimumab
    Number of subjects analysed
    32
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=30)
    2.5 ± 14
        Week 24 (n=28)
    4.3 ± 23.28
        Week 36 (n=26)
    5.6 ± 20.66
        Week 48 (n=23)
    3.7 ± 15.61
        Week 60 (n=20)
    4.8 ± 16.66
        Week 72 (n=16)
    7.2 ± 29.15
        Week 84 (n=16)
    8.4 ± 39.19
        Week 96 (n=12)
    18.8 ± 35.36
        Week 108 (n=8)
    19.4 ± 35.3
        Week 120 (n=2)
    -27.5 ± 38.89
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months)
    Adverse event reporting additional description
    A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a subject from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the subject.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Subjects could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU).Visits beyond Week 24 occurred every 12 weeks for those subjects who continued in the study.

    Serious adverse events
    Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 32 (15.63%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Juvenile arthritis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 32 (84.38%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    3
    Investigations
    Body temperature increased
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 32 (18.75%)
         occurrences all number
    11
    Rhinorrhoea
         subjects affected / exposed
    6 / 32 (18.75%)
         occurrences all number
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Eye disorders
    Uveitis
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    7 / 32 (21.88%)
         occurrences all number
    11
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    4
    Vomiting
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    5
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Juvenile arthritis
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    9
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    4
    Bronchitis
         subjects affected / exposed
    6 / 32 (18.75%)
         occurrences all number
    7
    Cystitis
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Ear infection
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    4
    Gastroenteritis
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    4
    Gastroenteritis viral
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    H1N1 influenza
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    8 / 32 (25.00%)
         occurrences all number
    11
    Otitis media
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    9
    Pharyngitis
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    6
    Pharyngitis streptococcal
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Pneumonia
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Rhinitis
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    5
    Sinusitis
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 32 (18.75%)
         occurrences all number
    11

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Aug 2008
    To add study visits to gather additional safety data and to shorten the intervals between visits, and change study duration from based on age (10 years) to based on age and weight.
    08 Jan 2009
    To clarify and update study procedures; include BSA dosing and dosing diaries; and update criteria for JIA diagnosis to include International League of Associations for Rheumatology (ILAR) classification.
    06 Jul 2009
    To extend the study population to include children in the EU who meet the study criteria; update the classification of JIA to add back in ‘moderately to severely’ in the description and to include polyarticular course JIA; revise inclusion exclusion criteria for safety reasons (eg, normal cardiopulmonary and neurological exams, parent/legal guardian responsible for storage and handling of study drug, procedures following positive purified protein derivative [PPD] test, and exclusionary concomitant medications); update conditions in which a subject should be withdrawn; and include (EU) and update (US) injection instructions for adalimumab.
    29 Oct 2009
    To extend the study for subjects in the EU who have reached 4 years of age and weight ≥ 15 kg for up to 1 additional year to allow time for transition to an appropriate treatment.
    23 Aug 2010
    To add anti-adalimumab antibody (AAA) assay; clarify that subjects beginning commercial adalimumab immediately after the trial will not be required to have a 70-day follow-up call; expand anti-nuclear antibody (ANA)/double-stranded DNA (dsDNA) test to include US subjects; and include previous Disease-Modifying Anti-Rheumatic Drug (DMARD) failure as part of inclusion criteria for subjects in the EU.
    01 May 2012
    To include annual tuberculosis tests.

    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.
    None reported
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA