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    Clinical Trial Results:
    A long-term, open-label study of TNR-001 in Japanese Juvenile Idiopathic Arthritis Subjects.

    Summary
    EudraCT number
    		 2014-004103-73
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Sep 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    16 Mar 2016
    First version publication date
    24 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    MeDRA version correction

    Trial information

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    Trial identification
    Sponsor protocol code
    0881A1-207
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias: B1801001
    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)
    No
    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
    19 Apr 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess the safety of the long-term administration of TNR-001 in subjects with active polyarticular-course Juvenile Idiopathic Arthritis (JIA).
    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
    25 Aug 2005
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 1 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    0
    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)
    6
    Adolescents (12-17 years)
    22
    Adults (18-64 years)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Study was conducted in Japan from 25 August 2005 to 3 September 2009.

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

    Arms
    Arm title
    		 Etanercept
    Arm description
    		 Etanercept administered to subjects subcutaneously by self-injection or by his or her guardian.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    TNR- 001
    Other name
    Enbrel
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Etanercept administered at a dose of 0.2 or 0.4 milligram per kilogram (mg/kg) (up to a maximum of 12.5 or 25 mg) twice weekly up to Week 216.

    Number of subjects in period 1
    		Etanercept
    Started
    32
    Completed
    18
    Not completed
    14
         Adverse events
    2
         No efficacy
    2
         Subject refusal
    7
         Lack of efficacy
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    		 Etanercept administered to subjects subcutaneously by self-injection or by his or her guardian.

    Reporting group values
    		 Etanercept Total
    Number of subjects
    		 32 32
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.7 ( 3.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 28
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    		 Etanercept administered to subjects subcutaneously by self-injection or by his or her guardian.

    Primary: Physician’s Global Assessment of Disease Activity

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    End point title
    		 Physician’s Global Assessment of Disease Activity [1]
    End point description
    Physician Global Assessment of Disease Activity was measured on a 0 to 10 centimeter (cm) Visual Analog Scale (VAS), with 0 cm = no symptoms and 10 cm = severe symptoms. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 Juvenile Rheumatoid Arthritis (JRA) core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Primary
    End point timeframe
    Baseline, Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    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 end point.
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: cm
    arithmetic mean (standard deviation)
        Baseline (n=32)
    6.08 ( 1.82 )
        Week 0 (n=32)
    1.03 ( 1.86 )
        Week 12 (n=32)
    1.47 ( 2.25 )
        Week 24 (n=31)
    1 ( 1.66 )
        Week 36 (n=31)
    0.53 ( 0.72 )
        Week 48 (n=28)
    0.47 ( 0.6 )
        Week 72 (n=28)
    0.52 ( 0.8 )
        Week 96 (n=27)
    0.57 ( 1.59 )
        Week 120 (n=26)
    0.67 ( 1.17 )
        Week 144 (n=26)
    0.71 ( 1.47 )
        Week 168 (n=20)
    0.53 ( 0.89 )
        Week 192 (n=19)
    0.57 ( 0.81 )
        Week 216 (n=2)
    0.05 ( 0.07 )
    No statistical analyses for this end point

    Primary: Subject or Guardians Global Assessment of Overall Well-being

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    End point title
    		 Subject or Guardians Global Assessment of Overall Well-being [2]
    End point description
    Face scale composed with 11 check boxes was used to asssess subject's overall well-being. "Laughing face" located left of scale is most good condition as "0", and "Crying face" located right of scale is worst condition as "10". Subject or subject's guardian selected and marked one of eleven check boxes for a question: "How your or his /her usual activities were over the past week on average, considering only those difficulties or limitations that are due to the illness?". Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Primary
    End point timeframe
    Baseline, 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    Notes
    [2] - 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 end point.
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=32)
    5.3 ( 2.1 )
        Week 0 (n=32)
    2.4 ( 1.9 )
        Week 12 (n=32)
    2.2 ( 2.4 )
        Week 24 (n=31)
    2.3 ( 2.3 )
        Week 36 (n=31)
    1.8 ( 1.9 )
        Week 48 (n=28)
    2 ( 2.1 )
        Week 72 (n=28)
    1.8 ( 2 )
        Week 96 (n=27)
    1.6 ( 1.8 )
        Week 120 (n=26)
    1.6 ( 1.6 )
        Week 144 (n=26)
    1.7 ( 2 )
        Week 168 (n=20)
    2 ( 2.1 )
        Week 192 (n=19)
    1.8 ( 1.7 )
        Week 216 (n=3)
    1.3 ( 1.2 )
    No statistical analyses for this end point

    Primary: Number of Active Joints

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    End point title
    		 Number of Active Joints [3]
    End point description
    Following 73 joints were observed, and presence/absence of swollen joints not due to deformity and of joints with limitation of motion accompanied by pain or tenderness was recorded; 2 jaw joints, 2 shoulder joints, 2 elbow joints, 2 wrist joints, 10 metacarpophalangeal joints, 10 proximal interphalangeal joints, 8 distal interphalangeal joints, 2 sternoclavicular joints, 2 acromioclavicular joints, 1 neck joint, 1 chest joint, 1 lumbar joint, 2 hip joints, 2 knee joints, 2 ankle joints, 2 subtalar joints, 2 tarsal joints, 10 metatarsophalangeal joints, 10 proximal interphalangeal joints of the feet. Efficacy population:subjects who consented to participate in the study except those who violated GCP, never received administration of test article, had no data on 6 JRA core set variables at baseline, had missing data on 3 or more of the 6 JRA core set variables at baseline. Here,'n' signifies subjects evaluable for this end point at specified time points for given arm.
    End point type
    Primary
    End point timeframe
    Baseline, Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    Notes
    [3] - 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 end point.
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: Active joints
    arithmetic mean (standard deviation)
        Baseline (n=32)
    19 ( 15 )
        Week 0 (n=32)
    3 ( 5.7 )
        Week 12 (n=32)
    4.3 ( 9.6 )
        Week 24 (n=31)
    2.7 ( 6.3 )
        Week 36 (n=31)
    1.9 ( 4.9 )
        Week 48 (n=28)
    1 ( 1.6 )
        Week 72 (n=28)
    0.6 ( 0.8 )
        Week 96 (n=27)
    0.9 ( 1.6 )
        Week 120 (n=26)
    0.9 ( 1.8 )
        Week 144 (n=26)
    0.8 ( 1.9 )
        Week 168 (n=20)
    1.4 ( 3 )
        Week 192 (n=19)
    1.4 ( 4 )
        Week 216 (n=3)
    1 ( 1.7 )
    No statistical analyses for this end point

    Primary: Number of Painful Joints on Pressure or Motion

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    End point title
    		 Number of Painful Joints on Pressure or Motion [4]
    End point description
    Following 71 joints were observed, and presence/absence of a joint with limitation of motion accompanied by pain or tenderness was recorded; 2 jaw joints, 2 shoulder joints, 2 elbow joints, 2 wrist joints, 10 metacarpophalangeal joints, 10 proximal interphalangeal joints, 8 distal interphalangeal joints, 2 acromioclavicular joints, 1 neck joint, 1 chest joint, 1 lumbar joint, 2 hip joints, 2 knee joints, 2 ankle joint, 2 subtalar joints, 2 tarsal joints, 10 metatarsophalangeal joints, 10 proximal interphalangeal joints of the feet. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Primary
    End point timeframe
    Baseline, Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    Notes
    [4] - 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 end point.
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: Painful joints
    arithmetic mean (standard deviation)
        Baseline (n=32)
    14.4 ( 13.5 )
        Week 0 (n=32)
    0.9 ( 3.1 )
        Week 12 (n=32)
    2.9 ( 9.1 )
        Week 24 (n=31)
    1.4 ( 4.3 )
        Week 36 (n=31)
    1 ( 4.7 )
        Week 48 (n=28)
    0.2 ( 0.4 )
        Week 72 (n=28)
    0.1 ( 0.4 )
        Week 96 (n=27)
    0.3 ( 1 )
        Week 120 (n=26)
    0.2 ( 0.5 )
        Week 144 (n=26)
    0.2 ( 0.8 )
        Week 168 (n=20)
    0.2 ( 0.4 )
        Week 192 (n=19)
    0.1 ( 0.2 )
        Week 216 (n=3)
    1 ( 1.7 )
    No statistical analyses for this end point

    Primary: Childhood Health Assessment Questionnaire (CHAQ) Score

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    End point title
    		 Childhood Health Assessment Questionnaire (CHAQ) Score [5]
    End point description
    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 and grooming,arising,eating,walking,hygiene, reach,grip,common activities(errands,chores and play). 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.Total Score =average of domain scores divided by number of domains answered: 0 = no difficulty to 3 = extreme difficulty. Efficacy population:subjects who consented to participate in study except those who violated GCP,never received administration of test article, had no data on 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here,'n' signifies subjects evaluable for this end point at specified time points for given arm.
    End point type
    Primary
    End point timeframe
    Baseline, Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    Notes
    [5] - 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 end point.
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=32)
    1.207 ( 0.906 )
        Week 0 (n=32)
    0.492 ( 0.62 )
        Week 12 (n=32)
    0.512 ( 0.693 )
        Week 24 (n=31)
    0.476 ( 0.615 )
        Week 36 (n=31)
    0.399 ( 0.574 )
        Week 48 (n=28)
    0.429 ( 0.589 )
        Week 72 (n=28)
    0.375 ( 0.575 )
        Week 96 (n=27)
    0.347 ( 0.627 )
        Week 120 (n=26)
    0.264 ( 0.555 )
        Week 144 (n=26)
    0.269 ( 0.492 )
        Week 168 (n=20)
    0.213 ( 0.391 )
        Week 192 (n=19)
    0.217 ( 0.365 )
        Week 216 (n=3)
    0 ( 0 )
    No statistical analyses for this end point

    Primary: Erythrocyte Sedimentation Rate (ESR)

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    End point title
    		 Erythrocyte Sedimentation Rate (ESR) [6]
    End point description
    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hr). A higher rate is consistent with inflammation. ESR was measured using the standard international Westergren method. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Primary
    End point timeframe
    Baseline, Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    Notes
    [6] - 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 end point.
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: mm/hr
    arithmetic mean (standard deviation)
        Baseline (n=32)
    38.7 ( 27.7 )
        Week 0 (n=32)
    26.6 ( 27.8 )
        Week 12 (n=32)
    24.4 ( 25.3 )
        Week 24 (n=31)
    21.4 ( 15.6 )
        Week 36 (n=31)
    19.6 ( 16.1 )
        Week 48 (n=28)
    21.5 ( 14.2 )
        Week 72 (n=28)
    19.9 ( 14.4 )
        Week 96 (n=25)
    18.7 ( 13.5 )
        Week 120 (n=26)
    17.7 ( 14.2 )
        Week 144 (n=24)
    21.2 ( 18.2 )
        Week 168 (n=20)
    15.4 ( 10.5 )
        Week 192 (n=19)
    16.5 ( 11.8 )
        Week 216 (n=3)
    28.7 ( 31 )
    No statistical analyses for this end point

    Primary: Subject or Guardians Pain Evaluation

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    End point title
    		 Subject or Guardians Pain Evaluation [7]
    End point description
    Face scale composed with 11 check boxes was used for pain evaluation ."Laughing face" located left of scale is most good condition as "0", and "Crying face" located right of scale is worst condition as "10".Subject or guardian answered "How much pain do you think you or your child experienced because of the illness in the past week?" Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Primary
    End point timeframe
    Baseline, Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    Notes
    [7] - 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 end point.
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=32)
    5.5 ( 2.4 )
        Week 0 (n=32)
    2.4 ( 2.1 )
        Week 12 (n=32)
    2.3 ( 2.4 )
        Week 24 (n=31)
    2.7 ( 2.8 )
        Week 36 (n=31)
    2.1 ( 2.4 )
        Week 48 (n=28)
    2.3 ( 2.4 )
        Week 72 (n=28)
    1.9 ( 2.2 )
        Week 96 (n=27)
    1.9 ( 2.1 )
        Week 120 (n=26)
    1.5 ( 1.8 )
        Week 144 (n=26)
    2.1 ( 2.3 )
        Week 168 (n=20)
    2 ( 1.9 )
        Week 192 (n=19)
    1.9 ( 1.9 )
        Week 216 (n=3)
    1.3 ( 1.2 )
    No statistical analyses for this end point

    Primary: Duration of Morning Stiffness

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    End point title
    		 Duration of Morning Stiffness [8]
    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 hours. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Primary
    End point timeframe
    Baseline, Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    Notes
    [8] - 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 end point.
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: hours
    median (full range (min-max))
        Baseline (n=32)
    1 (0 to 5)
        Week 0 (n=32)
    0 (0 to 2)
        Week 12 (n=31)
    0 (0 to 6)
        Week 24 (n=31)
    0 (0 to 5.5)
        Week 36 (n=31)
    0 (0 to 3)
        Week 48 (n=28)
    0 (0 to 3)
        Week 72 (n=28)
    0 (0 to 4)
        Week 96 (n=27)
    0 (0 to 2)
        Week 120 (n=26)
    0 (0 to 5)
        Week 144 (n=26)
    0 (0 to 1)
        Week 168 (n=20)
    0 (0 to 2)
        Week 192 (n=19)
    0 (0 to 2)
        Week 216 (n=3)
    0 (0 to 0.5)
    No statistical analyses for this end point

    Primary: C-Reactive Protein (CRP)

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    End point title
    		 C-Reactive Protein (CRP) [9]
    End point description
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Primary
    End point timeframe
    Baseline, Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    Notes
    [9] - 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 end point.
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: milligram per deciliter (mg/dL)
    arithmetic mean (standard deviation)
        Baseline (n=32)
    2.223 ( 2.309 )
        Week 0 (n=32)
    0.846 ( 1.836 )
        Week 12 (n=31)
    0.585 ( 0.905 )
        Week 24 (n=31)
    0.632 ( 1.083 )
        Week 36 (n=30)
    0.593 ( 0.968 )
        Week 48 (n=28)
    0.856 ( 1.458 )
        Week 72 (n=28)
    0.585 ( 1.113 )
        Week 96 (n=27)
    0.33 ( 0.505 )
        Week 120 (n=26)
    0.403 ( 0.906 )
        Week 144 (n=26)
    0.502 ( 0.876 )
        Week 168 (n=20)
    0.282 ( 0.567 )
        Week 192 (n=19)
    0.353 ( 0.724 )
        Week 216 (n=3)
    0.98 ( 1.037 )
    No statistical analyses for this end point

    Primary: Rheumatoid factor

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    End point title
    		 Rheumatoid factor [10]
    End point description
    Rheumatoid factor is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Primary
    End point timeframe
    Baseline, Week 0, 24, 48, 72, 96, 120, 144, 168, 192, 216
    Notes
    [10] - 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 end point.
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: IU/mL
    arithmetic mean (standard deviation)
        Baseline (n=32)
    427.4 ( 1616.2 )
        Week 0 (n=32)
    509.7 ( 1897.5 )
        Week 24 (n=32)
    457.2 ( 1396.7 )
        Week 48 (n=30)
    367.1 ( 959 )
        Week 72 (n=28)
    370.4 ( 881.9 )
        Week 96 (n=27)
    355.5 ( 1004.4 )
        Week 120 (n=26)
    427.1 ( 1575.7 )
        Week 144 (n=26)
    377.6 ( 1323.1 )
        Week 168 (n=20)
    110.6 ( 141.1 )
        Week 192 (n=19)
    111.4 ( 141 )
        Week 216 (n=3)
    16.3 ( 20.8 )
    No statistical analyses for this end point

    Secondary: Numbers of Subjects Who Achieved Juvenile Rheumatoid Arthritis (JRA) 30 Percent (%) Definition of Improvement (DOI), 50 % DOI And 70 % DOI

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    End point title
    		 Numbers of Subjects Who Achieved Juvenile Rheumatoid Arthritis (JRA) 30 Percent (%) Definition of Improvement (DOI), 50 % DOI And 70 % DOI
    End point description
    JRA 30% DOI, defined as a 30% improvement from baseline in 3 of 6 response variables used to assess disease activity, with no more than 1 variable worsening by more than 30%. JRA 50% DOI, defined as a 50% improvement from baseline in 3 of 6 response variables used to assess disease activity, with no more than 1 variable worsening by more than 50%. JRA 70% DOI, defined as a 70% improvement from baseline in 3 of 6 response variables used to assess disease activity, with no more than 1 variable worsening by more than 70%. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: Subjects
        30% DOI: Week 0 (n=32)
    31
        30% DOI: Week 12 (n=32)
    29
        30% DOI: Week 24 (n=31)
    29
        30% DOI: Week 36 (n=31)
    30
        30% DOI: Week 48 (n=28)
    28
        30% DOI: Week 72 (n=28)
    27
        30% DOI: Week 96 (n=27)
    26
        30% DOI: Week 120 (n=26)
    25
        30% DOI: Week 144 (n=26)
    24
        30% DOI: Week 168 (n=20)
    20
        30% DOI: Week 192 (n=19)
    18
        30% DOI: Week 216 (n=3)
    3
        50% DOI: Week 0 (n=32)
    30
        50% DOI: Week 12 (n=32)
    29
        50% DOI: Week 24 (n=31)
    28
        50% DOI: Week 36 (n=31)
    30
        50% DOI: Week 48 (n=28)
    28
        50% DOI: Week 72 (n=28)
    27
        50% DOI: Week 96 (n=27)
    26
        50% DOI: Week 120 (n=26)
    25
        50% DOI: Week 144 (n=26)
    24
        50% DOI: Week 168 (n=20)
    20
        50% DOI: Week 192 (n=19)
    18
        50% DOI: Week 216 (n=3)
    3
        70% DOI: Week 0 (n=32)
    27
        70% DOI: Week 12 (n=32)
    26
        70% DOI: Week 24 (n=31)
    25
        70% DOI: Week 36 (n=31)
    29
        70% DOI: Week 48 (n=28)
    26
        70% DOI: Week 72 (n=28)
    26
        70% DOI: Week 96 (n=27)
    24
        70% DOI: Week 120 (n=26)
    24
        70% DOI: Week 144 (n=26)
    23
        70% DOI: Week 168 (n=20)
    20
        70% DOI: Week 192 (n=19)
    17
        70% DOI: Week 216 (n=3)
    2
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Physicians Global Assessment of Disease Activity at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, and 216

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    End point title
    		 Percent Change From Baseline in Physicians Global Assessment of Disease Activity at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, and 216
    End point description
    Physician Global Assessment of Disease Activity was measured on a 0 to 10 cm VAS, with 0 cm = no symptoms and 10 cm = severe symptoms. Change from baseline was reported in percentage. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: percent change
    arithmetic mean (standard deviation)
        Week 0 (n=32)
    72.81 ( 72.48 )
        Week 12 (n=32)
    78.32 ( 31.01 )
        Week 24 (n=31)
    82.48 ( 30.2 )
        Week 36 (n=31)
    88.05 ( 20.88 )
        Week 48 (n=28)
    92.48 ( 9.68 )
        Week 72 (n=28)
    91.64 ( 12.75 )
        Week 96 (n=27)
    90.22 ( 25.99 )
        Week 120 (n=26)
    87.57 ( 22.41 )
        Week 144 (n=26)
    87.46 ( 26.42 )
        Week 168 (n=20)
    91.39 ( 15.21 )
        Week 192 (n=19)
    90.7 ( 12.74 )
        Week 216 (n=2)
    99.38 ( 0.88 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Subject or Guardians Global Assessment at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216

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    End point title
    		 Percent Change From Baseline in Subject or Guardians Global Assessment at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216
    End point description
    Face scale composed with 11 check boxes was used to asssess subject's overall well-being. "Laughing face" located left of scale is most good condition as "0", and "Crying face" located right of scale is worst condition as "10". Subject or subject's guardian selected and marked one of eleven check boxes for a question: "How your or his /her usual activities were over the past week on average, considering only those difficulties or limitations that are due to the illness?". Change from baseline was reported in percentage. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: percent change
    arithmetic mean (standard deviation)
        Week 0 (n=32)
    46.73 ( 43.08 )
        Week 12 (n=32)
    48.64 ( 82.02 )
        Week 24 (n=31)
    54.73 ( 39.3 )
        Week 36 (n=31)
    59.26 ( 57.82 )
        Week 48 (n=28)
    58.29 ( 37.82 )
        Week 72 (n=28)
    65.48 ( 35.67 )
        Week 96 (n=27)
    64.13 ( 36.51 )
        Week 120 (n=26)
    62.18 ( 39.25 )
        Week 144 (n=26)
    61.01 ( 48.81 )
        Week 168 (n=20)
    44.71 ( 87.31 )
        Week 192 (n=19)
    54.07 ( 49.82 )
        Week 216 (n=3)
    72.22 ( 25.46 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Number of Active Joints at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216

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    End point title
    		 Percent Change From Baseline in Number of Active Joints at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216
    End point description
    Following 73 joints were observed, and presence/absence of swollen joints not due to deformity and of joints with limitation of motion accompanied by pain or tenderness was recorded; 2 jaw joints, 2 shoulder joints, 2 elbow joints, 2 wrist joints, 10 metacarpophalangeal joints, 10 proximal interphalangeal joints, 8 distal interphalangeal joints, 2 sternoclavicular joints, 2 acromioclavicular joints, 1 neck joint, 1 chest joint, 1 lumbar joint, 2 hip joints, 2 knee joints, 2 ankle joints, 2 subtalar joints, 2 tarsal joints, 10 metatarsophalangeal joints, 10 proximal interphalangeal joints of the feet. Efficacy population:subjects who consented to participate in the study except those who violated GCP, never received administration of test article, had no data on 6 JRA core set variables at baseline, had missing data on 3 or more of the 6 JRA core set variables at baseline. Here,'n' signifies subjects evaluable for this end point at specified time points for given arm.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: percent change
    arithmetic mean (standard deviation)
        Week 0 (n=32)
    85.46 ( 20.24 )
        Week 12 (n=32)
    84.63 ( 22.83 )
        Week 24 (n=31)
    86.84 ( 21.4 )
        Week 36 (n=31)
    91.16 ( 12.08 )
        Week 48 (n=28)
    91.64 ( 14.2 )
        Week 72 (n=28)
    93.99 ( 10.67 )
        Week 96 (n=27)
    91.89 ( 20.28 )
        Week 120 (n=26)
    93.54 ( 10.98 )
        Week 144 (n=26)
    91.25 ( 27.89 )
        Week 168 (n=20)
    94.83 ( 7.7 )
        Week 192 (n=19)
    95.14 ( 10.76 )
        Week 216 (n=3)
    91.67 ( 14.43 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Number of Painful Joints on Pressure or Motion at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216

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    End point title
    		 Percent Change From Baseline in Number of Painful Joints on Pressure or Motion at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216
    End point description
    Following 71 joints were observed, and presence/absence of a joint with limitation of motion accompanied by pain or tenderness was recorded; 2 jaw joints, 2 shoulder joints, 2 elbow joints, 2 wrist joints, 10 metacarpophalangeal joints, 10 proximal interphalangeal joints, 8 distal interphalangeal joints, 2 acromioclavicular joints, 1 neck joint, 1 chest joint, 1 lumbar joint, 2 hip joints, 2 knee joints, 2 ankle joint, 2 subtalar joints, 2 tarsal joints, 10 metatarsophalangeal joints, 10 proximal interphalangeal joints of the feet. Change from baseline was reported in percentage. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at pecified time points for given arm.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: percent change
    arithmetic mean (standard deviation)
        Week 0 (n=32)
    91.83 ( 24.45 )
        Week 12 (n=32)
    88.53 ( 24.13 )
        Week 24 (n=31)
    87.73 ( 37.74 )
        Week 36 (n=31)
    96.62 ( 10.08 )
        Week 48 (n=28)
    97.91 ( 4.87 )
        Week 72 (n=28)
    98.56 ( 4.24 )
        Week 96 (n=27)
    96.02 ( 14.08 )
        Week 120 (n=26)
    98.08 ( 5.92 )
        Week 144 (n=26)
    97.86 ( 7.71 )
        Week 168 (n=20)
    98.04 ( 5 )
        Week 192 (n=19)
    99.12 ( 3.82 )
        Week 216 (n=3)
    83.33 ( 28.87 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216

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    End point title
    		 Percent Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216
    End point description
    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,grooming,arising,eating,walking,hygiene, reach,grip,common activities(errands,chores and play). 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. Total Score =average of domain scores divided by number of domains answered: 0 = no difficulty to 3 = extreme difficulty. Change from baseline was reported in percentage. Efficacy population:subjects who consented to participate in study except those who violated GCP,never received administration of test article, had no data on 6 JRA core set variables at baseline,had missing data on 3 or more of the 6 JRA core set variables at baseline. Here,'n' signifies subjects evaluable for this end point at specified time points.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: percent change
    arithmetic mean (standard deviation)
        Week 0 (n=28)
    58.97 ( 35.47 )
        Week 12 (n=28)
    63.15 ( 33.65 )
        Week 24 (n=27)
    61.58 ( 48.6 )
        Week 36 (n=27)
    69.75 ( 36.44 )
        Week 48 (n=25)
    71.6 ( 31.42 )
        Week 72 (n=25)
    73.46 ( 34.85 )
        Week 96 (n=24)
    73.83 ( 40.51 )
        Week 120 (n=23)
    84.05 ( 22.49 )
        Week 144 (n=23)
    81.29 ( 24.82 )
        Week 168 (n=17)
    85.09 ( 21.1 )
        Week 192 (n=16)
    84.56 ( 19.75 )
        Week 216 (n=3)
    100 ( 0 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216

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    End point title
    		 Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216
    End point description
    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation. ESR was measured using the standard international Westergren method. Change from baseline was reported in percentage. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: percent change
    arithmetic mean (standard deviation)
        Week 0 (n=32)
    26.22 ( 47.99 )
        Week 12 (n=32)
    34.44 ( 39.68 )
        Week 24 (n=31)
    32.69 ( 46.3 )
        Week 36 (n=31)
    28.4 ( 86.21 )
        Week 48 (n=28)
    8.1 ( 133.23 )
        Week 72 (n=28)
    24.05 ( 88.16 )
        Week 96 (n=27)
    36.68 ( 60.57 )
        Week 120 (n=26)
    42.38 ( 48.48 )
        Week 144 (n=24)
    42.78 ( 40.44 )
        Week 168 (n=20)
    47.32 ( 48.24 )
        Week 192 (n=19)
    41.83 ( 49.2 )
        Week 216 (n=3)
    45.88 ( 32.91 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Subject or Guardians Pain Evaluation at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216

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    End point title
    		 Percent Change From Baseline in Subject or Guardians Pain Evaluation at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216
    End point description
    Face scale composed with 11 check boxes was used for pain evaluation ."Laughing face" located left of scale is most good condition as "0", and "Crying face" located right of scale is worst condition as "10". Subject or guardian answered "How much pain do you think you or your child experienced because of the illness in the past week?". Change from baseline was reported in percentage. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: percent change
    arithmetic mean (standard deviation)
        Week 0 (n=31)
    55.89 ( 37.68 )
        Week 12 (n=31)
    54.89 ( 47.9 )
        Week 24 (n=30)
    46.6 ( 50.98 )
        Week 36 (n=30)
    52.92 ( 67.64 )
        Week 48 (n=27)
    48.44 ( 54.04 )
        Week 72 (n=27)
    58.95 ( 46.26 )
        Week 96 (n=26)
    55.76 ( 51.82 )
        Week 120 (n=25)
    61.35 ( 54.5 )
        Week 144 (n=25)
    49.76 ( 55.14 )
        Week 168 (n=19)
    61.02 ( 35.9 )
        Week 192 (n=18)
    46.66 ( 70.95 )
        Week 216 (n=3)
    72.22 ( 25.46 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Duration of Morning Stiffness at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216

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    End point title
    		 Percent Change From Baseline in Duration of Morning Stiffness at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216
    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 hours. Change from baseline was reported in percentage. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: percent change
    median (full range (min-max))
        Week 0 (n=26)
    94.84 (0 to 100)
        Week 12 (n=25)
    93.8 (-200 to 100)
        Week 24 (n=25)
    94.4 (-100 to 100)
        Week 36 (n=25)
    100 (25 to 100)
        Week 48 (n=22)
    100 (25 to 100)
        Week 72 (n=22)
    100 (0 to 100)
        Week 96 (n=21)
    100 (27.3 to 100)
        Week 120 (n=21)
    100 (-25 to 100)
        Week 144 (n=21)
    100 (0 to 100)
        Week 168 (n=15)
    100 (27.3 to 100)
        Week 192 (n=15)
    100 (27.3 to 100)
        Week 216 (n=3)
    100 (75 to 100)
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in C-Reactive Protein at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216

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    End point title
    		 Percent Change From Baseline in C-Reactive Protein at Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216
    End point description
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change from baseline was reported in percentage. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: percent change
    arithmetic mean (standard deviation)
        Week 0 (n=32)
    32.76 ( 143.29 )
        Week 12 (n=31)
    43.65 ( 81.27 )
        Week 24 (n=31)
    35.6 ( 115.53 )
        Week 36 (n=30)
    -112.34 ( 592.41 )
        Week 48 (n=28)
    -110.2 ( 605.58 )
        Week 72 (n=28)
    -46.96 ( 444.64 )
        Week 96 (n=27)
    39.11 ( 107.63 )
        Week 120 (n=26)
    61.72 ( 61.11 )
        Week 144 (n=26)
    50.09 ( 89.15 )
        Week 168 (n=20)
    55.16 ( 71.8 )
        Week 192 (n=19)
    52.91 ( 85.17 )
        Week 216 (n=3)
    52.62 ( 54.53 )
    No statistical analyses for this end point

    Secondary: Serum Cytokine Concentration

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    End point title
    		 Serum Cytokine Concentration
    End point description
    Serum collected from subjects was analyzed and concentration of cytokines interleukin - 1 beta (IL-1β), interleukin-6 (IL-6) and Tumor Necrosis Factor-alpha (TNF-α) was determined. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 0, 12, 24, 36, 48
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: picogram per millilter (pg/mL)
    arithmetic mean (standard deviation)
        IL-1β: Baseline (n=32)
    28.7 ( 82 )
        IL-1β: Week 0 (n=32)
    26.2 ( 65.1 )
        IL-1β: Week 12 (n=32)
    10.3 ( 1 )
        IL-1β: Week 24 (n=31)
    11.6 ( 4 )
        IL-1β: Week 36 (n=30)
    14.7 ( 19.1 )
        IL-1β: Week 48 (n=28)
    17.8 ( 13.2 )
        IL-6: Baseline (n=32)
    30.26 ( 41.67 )
        IL-6: Week 0 (n=32)
    7.5 ( 11.72 )
        IL-6: Week 12 (n=32)
    7.3 ( 14.63 )
        IL-6: Week 24 (n=31)
    8.95 ( 22.88 )
        IL-6: Week 36 (n=30)
    12.37 ( 34.4 )
        IL-6: Week 48 (n=28)
    7.9 ( 22.7 )
        TNF-α: Baseline (n=32)
    6.1 ( 5.7 )
        TNF-α: Week 0 (n=32)
    119.8 ( 47.6 )
        TNF-α: Week 12 (n=32)
    135.5 ( 53 )
        TNF-α: Week 24 (n=31)
    153.1 ( 60.7 )
        TNF-α: Week 36 (n=30)
    162.5 ( 52.1 )
        TNF-α: Week 48 (n=28)
    160 ( 71.4 )
    No statistical analyses for this end point

    Secondary: Serum Soluble TNF Receptor Concentration

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    End point title
    		 Serum Soluble TNF Receptor Concentration
    End point description
    Serum concentrations of soluble tumor necrosis factor receptor 1 (sTNFR I) and receptor II (sTNFR II) was determined over time. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 0, 12, 24, 36, 48
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: pg/mL
    arithmetic mean (standard deviation)
        sTNFR I (p55): Baseline (n=32)
    1020 ( 302.4 )
        sTNFR I (p55): Week 0 (n=32)
    942.2 ( 229.9 )
        sTNFR I (p55): Week 12 (n=32)
    947.8 ( 176.2 )
        sTNFR I (p55): Week 24 (n=31)
    1003.1 ( 243.3 )
        sTNFR I (p55): Week 36 (n=30)
    977.7 ( 217.3 )
        sTNFR I (p55): Week 48 (n=28)
    1099.7 ( 229.9 )
        sTNFR II (p75): Baseline (n=32)
    2095.9 ( 741.2 )
        sTNFR II (p75): Week 0 (n=32)
    5000 ( 0 )
        sTNFR II (p75): Week 12 (n=32)
    5000 ( 0 )
        sTNFR II (p75): Week 24 (n=31)
    5000 ( 0 )
        sTNFR II (p75): Week 36 (n=30)
    5000 ( 0 )
        sTNFR II (p75): Week 48 (n=28)
    4937.9 ( 328.8 )
    No statistical analyses for this end point

    Secondary: Disease Activity Score 28 (DAS28)

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    End point title
    		 Disease Activity Score 28 (DAS28)
    End point description
    DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and Face scale score (subject rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=32)
    5.73 ( 1.24 )
        Week 0 (n=32)
    2.96 ( 1.49 )
        Week 12 (n=32)
    2.95 ( 1.57 )
        Week 24 (n=31)
    2.74 ( 1.41 )
        Week 36 (n=31)
    2.47 ( 1.38 )
        Week 48 (n=28)
    2.52 ( 1.28 )
        Week 72 (n=28)
    2.33 ( 1.01 )
        Week 96 (n=27)
    2.17 ( 1.13 )
        Week 120 (n=26)
    2.22 ( 0.94 )
        Week 144 (n=24)
    2.33 ( 1.15 )
        Week 168 (n=19)
    2.48 ( 1.19 )
        Week 192 (n=19)
    2.35 ( 1.34 )
        Week 216 (n=3)
    2.55 ( 1.48 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With European League Against Rheumatism (EULAR) Response Based on DAS28

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    End point title
    		 Percentage of Subjects With European League Against Rheumatism (EULAR) Response Based on DAS28
    End point description
    The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 =>3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Efficacy population: population of all the subjects who consented to participate in the study except those who violated the GCP, never received administration of the test article, had no data on the 6 JRA core set variables at baseline and had missing data on 3 or more of the 6 JRA core set variables at baseline. Here, 'n' signifies subjects evaluable for this end point at the specified time points for the given arm.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216
    End point values
    		 Etanercept
    Number of subjects analysed
    32
    Units: Percentage of Subjects
    number (not applicable)
        Good Response: Week 0 (n=32)
    59.4
        Good Response: Week 12 (n=32)
    65.6
        Good Response: Week 24 (n=31)
    61.3
        Good Response: Week 36 (n=31)
    67.7
        Good Response: Week 48 (n=28)
    75
        Good Response: Week 72 (n=28)
    75
        Good Response: Week 96 (n=27)
    85.2
        Good Response: Week 120 (n=26)
    84.6
        Good Response: Week 144 (n=24)
    79.2
        Good Response: Week 168 (n=19)
    84.2
        Good Response: Week 192 (n=19)
    78.9
        Good Response: Week 216 (n=3)
    66.7
        Moderate Response: Week 0 (n=32)
    37.5
        Moderate Response: Week 12 (n=32)
    28.1
        Moderate Response: Week 24 (n=31)
    32.3
        Moderate Response: Week 36 (n=31)
    25.8
        Moderate Response: Week 48 (n=28)
    21.4
        Moderate Response: Week 72 (n=28)
    25
        Moderate Response: Week 96 (n=27)
    11.1
        Moderate Response: Week 120 (n=26)
    15.4
        Moderate Response: Week 144 (n=24)
    16.7
        Moderate Response: Week 168 (n=19)
    15.8
        Moderate Response: Week 192 (n=19)
    15.8
        Moderate Response: Week 216 (n=3)
    33.3
        No Response: Week 0 (n=32)
    3.1
        No Response: Week 12 (n=32)
    6.3
        No Response: Week 24 (n=31)
    6.5
        No Response: Week 36 (n=31)
    6.5
        No Response: Week 48 (n=28)
    3.6
        No Response: Week 72 (n=28)
    0
        No Response: Week 96 (n=27)
    3.7
        No Response: Week 120 (n=26)
    0
        No Response: Week 144 (n=24)
    4.2
        No Response: Week 168 (n=19)
    0
        No Response: Week 192 (n=19)
    5.3
        No Response: Week 216 (n=3)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) and Serious AEs were reported from baseline up to follow­ up visit (4 weeks after the last dose of study drug)
    Adverse event reporting additional description
    The same event may appear as both an AE and a 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
    17.1
    Reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    		 Etanercept administered to subjects subcutaneously at a dose of 0.2 or 0.4 mg/kg (up to a maximum of 12.5 or 25 mg) twice weekly up to Week 216.

    Serious adverse events
    		 Etanercept
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 32 (18.75%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    Feeling abnormal
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Etanercept
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 32 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Haemorrhage
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Internal haemorrhage
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Pallor
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    General disorders and administration site conditions
    Administration site pain
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    13
    Administration site reaction
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Chest pain
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    4
    Chest discomfort
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    3
    Chills
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Injection site erythema
         subjects affected / exposed
    6 / 32 (18.75%)
         occurrences all number
    22
    Injection site pain
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Injection site haemorrhage
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    5
    Injection site swelling
         subjects affected / exposed
    7 / 32 (21.88%)
         occurrences all number
    21
    Injection site pruritus
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    22
    Malaise
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Oedema
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    2
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Breast enlargement
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Menstruation irregular
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Dysmenorrhoea
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Allergic bronchitis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Asthma
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    6
    Cough
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Rhinitis allergic
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    4
    Oropharyngeal pain
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Rhinorrhoea
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Vocal cord polyp
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    9 / 32 (28.13%)
         occurrences all number
    10
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Investigations
    Bacterial test
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Blood urea increased
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    4
    Eosinophil count increased
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Haematocrit decreased
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Granulocyte count decreased
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Lymphocyte count increased
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Haemoglobin decreased
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Red blood cell count decreased
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Platelet count increased
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    White blood cell count increased
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    4
    Weight increased
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    White blood cells urine positive
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Chillblains
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Arthropod sting
         subjects affected / exposed
    8 / 32 (25.00%)
         occurrences all number
    8
    Contusion
         subjects affected / exposed
    10 / 32 (31.25%)
         occurrences all number
    16
    Foot fracture
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Frostbite
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Heat stroke
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Injury
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Injury corneal
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Limb injury
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    5
    Ligament sprain
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    5
    Skin abrasion
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Sunburn
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Thermal burn
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Congenital, familial and genetic disorders
    Talipes
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    3
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Cerebral infarction
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Dizziness postural
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    12 / 32 (37.50%)
         occurrences all number
    17
    Hypoaesthesia
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Migraine
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    2
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Lymphadenitis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Eye disorders
    Asthenopia
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Chalazion
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Conjunctivitis allergic
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    4
    Eye pruritus
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Glaucoma
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    2
    Iritis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    2
    Ocular hyperaemia
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Papilloedema
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Uveitis
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    3
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    4
    Abdominal pain
         subjects affected / exposed
    9 / 32 (28.13%)
         occurrences all number
    12
    Abdominal pain upper
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Chapped lips
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    7
    Cheilitis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Dental caries
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    5
    Diarrhoea
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    4
    Faeces soft
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Gastric ulcer
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Lip oedema
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Toothache
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Alopecia
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Dermatitis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Dermatitis atopic
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    4
    Erythema
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Hyperkeratosis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Palmar erythema
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Prurigo
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    10 / 32 (31.25%)
         occurrences all number
    13
    Skin erosion
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    4
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Arthralgia
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Monarthritis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Musculoskeletal stiffness
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Musculoskeletal pain
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Myalgia
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    6
    Pain in extremity
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    3
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Synovial cyst
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    6
    Tenosynovitis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis bacterial
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    4 / 32 (12.50%)
         occurrences all number
    4
    Bronchitis fungal
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Bronchitis viral
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Candida infection
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    6 / 32 (18.75%)
         occurrences all number
    9
    Gastroenteritis viral
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    2
    Hordeolum
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Herpes zoster
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Impetigo
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Infection
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    29 / 32 (90.63%)
         occurrences all number
    157
    Influenza
         subjects affected / exposed
    7 / 32 (21.88%)
         occurrences all number
    8
    Onychomycosis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    4
    Periodontitis
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Otitis media
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    10
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Skin candida
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Skin infection
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Tinea versicolour
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Subcutaneous abscess
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    4
    Urinary tract infection
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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