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    Clinical Trial Results:
    An Open-label Extension Study to Evaluate the Safety of Etanercept in Pediatric Subjects With Plaque Psoriasis

    Summary
    EudraCT number
    		 2012-001186-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Mar 2018
    First version publication date
    02 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20050111
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00141921
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen, Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000299-PIP01-08
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Dec 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/ guidelines. Written informed consent and verbal/written assent, if applicable, had to be obtained from each subject (if he or she has attained the legal age for consent) or the subject’s parents or legal guardian before performing any procedures, including screening. The study protocol, amendments, and the informed consent form (ICF) were reviewed by the Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Aug 2005
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 56
    Country: Number of subjects enrolled
    United States: 126
    Worldwide total number of subjects
    182
    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)
    63
    Adolescents (12-17 years)
    119
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was designed to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe plaque psoriasis who participated in Study 20030211 (2012-001186-33). The study was conducted at 38 sites in the United States and Canada.

    Pre-assignment
    Screening details
    		 Results reported below are from the main analysis performed at year 5 (264 weeks). After the final analysis data cutoff date (22 February 2012), 28 subjects continued protocol specified treatment until they reached 18 years of age.

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

    Arms
    Arm title
    		 Etanercept
    Arm description
    		 Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    Other name
    Enbrel®
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection

    Number of subjects in period 1
    		Etanercept
    Started
    182
    Received Treatment
    181
    Completed
    41
    Not completed
    141
         Consent withdrawn by subject
    42
         Disease progression
    7
         Ineligibility Determined
    2
         Adverse event, non-fatal
    5
         Administrative decision
    2
         Other
    8
         Protocol deviation
    7
         Pregnancy
    4
         Lost to follow-up
    19
         Remained on study
    28
         Noncompliance
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    		 Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.

    Reporting group values
    		 Etanercept Total
    Number of subjects
    		 182 182
    Age Categorical
    Units: Subjects
        4 - 11 years
    		 63 63
        12 - 17 years
    		 119 119
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.8 ( 3.5 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 90 90
        Male
    		 92 92
    Race/Ethnicity
    Units: Subjects
        White or Caucasian
    		 138 138
        Black or African American
    		 10 10
        Hispanic or Latino
    		 17 17
        Asian
    		 13 13
        Native Hawaiian or Other Pacific Islander
    		 1 1
        Other
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    		 Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.

    Primary: Number of Participants With Adverse Events

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    End point title
    		 Number of Participants With Adverse Events [1]
    End point description
    A serious adverse events is any AE that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity). An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
    End point type
    Primary
    End point timeframe
    264 Weeks
    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: A formal hypothesis was not tested in this study, no formal statistical testing was done.
    End point values
    		 Etanercept
    Number of subjects analysed
    181 [2]
    Units: participants
        Any adverse event
    161
        Non-infectious adverse events
    149
        Infections
    140
        Grade 3 non-infectious adverse events
    14
        Grade 3 infections
    5
        Serious non-infectious adverse events
    5
        Serious infections
    2
        Non-infectious AEs leading to study withdrawal
    5
        Infections leading to withdrawal from study
    1
        Injection site reactions
    16
        Deaths
    0
    Notes
    [2] - Participants who received at least one dose of investigational product.
    No statistical analyses for this end point

    Secondary: Number of Participants With Injection Site Reactions

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    End point title
    		 Number of Participants With Injection Site Reactions
    End point description
    An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
    End point type
    Secondary
    End point timeframe
    264 weeks
    End point values
    		 Etanercept
    Number of subjects analysed
    181 [3]
    Units: participants
        Any injection site reaction
    16
        Injection site erythema
    6
        Injection site reaction
    4
        Injection site pruritus
    3
        Injection site haematoma
    2
        Injection site swelling
    2
        Injection site discolouration
    1
        Injection site irritation
    1
        Injection site pain
    1
    Notes
    [3] - Participants who received at least one dose of investigational product.
    No statistical analyses for this end point

    Secondary: Exposure-adjusted Adverse Event Rates

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    End point title
    		 Exposure-adjusted Adverse Event Rates
    End point description
    The exposure adjusted event rate for a given event in a given time period is defined as the number of events reported in the given time period divided by total patient-years on investigational product during the period. Exposure-adjusted event rate per 100 patient years = total number of events / patient years * 100. Multiple occurrences of the same event for a participant were counted as multiple events.
    End point type
    Secondary
    End point timeframe
    264 weeks
    End point values
    		 Etanercept
    Number of subjects analysed
    181 [4]
    Units: events per 100 patient years
    number (not applicable)
        All adverse events
    215.8
        Non-infectious Adverse Events
    115.9
        Infections
    97.3
        Injection Site Reactions
    2.6
    Notes
    [4] - Participants who received at least one dose of investigational product.
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinically Significant Changes in Vital Signs

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    End point title
    		 Number of Participants With Clinically Significant Changes in Vital Signs
    End point description
    End point type
    Secondary
    End point timeframe
    264 weeks
    End point values
    		 Etanercept
    Number of subjects analysed
    181 [5]
    Units: participants
    0
    Notes
    [5] - Participants who received at least one dose of investigational product.
    No statistical analyses for this end point

    Secondary: Number of Participants With Grade 3 and 4 Laboratory Toxicities

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    End point title
    		 Number of Participants With Grade 3 and 4 Laboratory Toxicities
    End point description
    The severity assessment for adverse events and infections (not including injection site reaction) used the Common Toxicity Criteria (CTC) Version 2.0, where Grade 1= Mild - aware of sign or symptom, but easily tolerated; Grade 2= Moderate - discomfort enough to cause interference with usual activity; Grade 3 = Severe - incapacitating with inability to work or do usual activity; Grade 4= Life-threatening - refers to an event in which the patient was, in the view of the investigator, at risk of immediate death at the time of event; Grade 5 = Fatal.
    End point type
    Secondary
    End point timeframe
    264 weeks
    End point values
    		 Etanercept
    Number of subjects analysed
    181 [6]
    Units: participants
        Grade 3 high creatinine
    1
        Grade 3 high hemoglobin
    1
        Grade 3 low hemoglobin
    1
        Grade 3 high alanine aminotransferase
    1
        Grade 3 high white blood cells
    1
        Any grade 4 toxicity
    0
    Notes
    [6] - Participants who received at least one dose of investigational product.
    No statistical analyses for this end point

    Secondary: Number of Participants Who Developed Anti-etanercept Antibodies

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    End point title
    		 Number of Participants Who Developed Anti-etanercept Antibodies
    End point description
    Binding antibodies to etanercept were detected using an anti-etanercept immunoassay. The positive samples in the immunoassay were further analyzed for the presence of neutralizing antibodies using a bioassay. Participants who developed anti-etanercept antibodies are those who were antibody positive post-baseline with a negative or no result at baseline.
    End point type
    Secondary
    End point timeframe
    264 weeks
    End point values
    		 Etanercept
    Number of subjects analysed
    169 [7]
    Units: participants
        Binding antibody positive
    18
        Neutralizing antibody positive
    0
    Notes
    [7] - Subjects who received at least 1 dose of investigational product with post-baseline antibody data.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)

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    End point title
    		 Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)
    End point description
    A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    181 [8]
    Units: percentage of participants
    number (not applicable)
        Week 12 (N = 181)
    89.5
        Week 48 (N = 168)
    89.3
        Week 96 (N = 138)
    89.1
        Week 144 (N = 114)
    88.6
        Week 192 (n = 92)
    87.0
        Week 240 (N = 74)
    91.9
        Week 264 (N = 66)
    87.9
    Notes
    [8] - Participants who received at least one dose of investigational product.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a PASI 75 Response

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    End point title
    		 Percentage of Participants With a PASI 75 Response
    End point description
    A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    181 [9]
    Units: percentage of participants
    number (not applicable)
        Week 12 (N = 181)
    67.4
        Week 48 (N = 168)
    67.3
        Week 96 (N = 138)
    60.9
        Week 144 (N = 114)
    62.3
        Week 192 (n = 92)
    69.6
        Week 240 (N = 74)
    64.9
        Week 264 (N = 66)
    63.6
    Notes
    [9] - Participants who received at least one dose of investigational product.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a PASI 90 Response

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    End point title
    		 Percentage of Participants With a PASI 90 Response
    End point description
    A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    181 [10]
    Units: percentage of participants
    number (not applicable)
        Week 12 (N = 181)
    35.4
        Week 48 (N = 168)
    32.7
        Week 96 (N = 138)
    29.7
        Week 144 (N = 114)
    28.1
        Week 192 (N = 92)
    35.9
        Week 240 (N = 74)
    36.5
        Week 264 (N = 66)
    28.8
    Notes
    [10] - Participants who received at least one dose of investigational product.
    No statistical analyses for this end point

    Secondary: Percent Improvement From Study 20030211 Baseline in PASI Score

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    End point title
    		 Percent Improvement From Study 20030211 Baseline in PASI Score
    End point description
    The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
    End point type
    Secondary
    End point timeframe
    Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    181 [11]
    Units: percent improvement
    arithmetic mean (standard deviation)
        Study 20050111 baseline (N = 179)
    74.429 ( 22.146 )
        Week 12 (N = 181)
    78.286 ( 21.079 )
        Week 48 (N = 168)
    77.546 ( 20.682 )
        Week 96 (N = 138)
    75.355 ( 24.139 )
        Week 144 (N = 114)
    75.052 ( 23.839 )
        Week 192 (N = 92)
    77.815 ( 23.965 )
        Week 240 (N = 74)
    78.924 ( 23.497 )
        Week 264 (N = 66)
    74.605 ( 29.327 )
    Notes
    [11] - Participants who received at least one dose of investigational product.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Clear (0) or Almost Clear (1)

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    End point title
    		 Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Clear (0) or Almost Clear (1)
    End point description
    The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
    End point type
    Secondary
    End point timeframe
    Weeks 12, 48, 96, 144, 192, 240 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    181 [12]
    Units: percentage of participants
    number (not applicable)
        Week 12 (N = 181)
    53.6
        Week 48 (N = 168)
    48.8
        Week 96 (N = 139)
    47.5
        Week 144 (N = 114)
    45.6
        Week 192 (N = 92)
    47.8
        Week 240 (N = 74)
    50.0
        Week 264 (N = 66)
    37.9
    Notes
    [12] - Participants who received at least one dose of investigational product.
    No statistical analyses for this end point

    Secondary: Percent Improvement From Study 20030211 Baseline in Children’s Dermatology Life Quality Index (CDLQI) Total Score

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    End point title
    		 Percent Improvement From Study 20030211 Baseline in Children’s Dermatology Life Quality Index (CDLQI) Total Score
    End point description
    The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. If participants were ≥ 13 years old, the text instrument was completed by the participants themselves. Participants ≥ 8 but < 13 years old used the cartoon version of the instrument and participants ≤ 7 years old used the cartoon version of the instrument completed with help from the parents or caregivers. Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
    End point type
    Secondary
    End point timeframe
    Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    173 [13]
    Units: percent improvement
    arithmetic mean (standard deviation)
        Study 20050111 baseline (N = 164)
    59.492 ( 73.501 )
        Week 24 (N = 155)
    54.978 ( 69.744 )
        Week 48 (N = 148)
    59.229 ( 65.259 )
        Week 72 (N = 136)
    57.549 ( 79.389 )
        Week 96 (N = 127)
    61.084 ( 66.169 )
        Week 120 (N = 105)
    64.059 ( 75.298 )
        Week 144 (N = 103)
    69.732 ( 42.008 )
        Week 168 (N = 93)
    67.531 ( 42.261 )
        Week 192 (N = 81)
    65.622 ( 53.359 )
        Week 216 (N = 70)
    76.121 ( 43.217 )
        Week 240 (N = 64)
    73.631 ( 54.704 )
        Week 264 (N = 56)
    63.291 ( 63.555 )
    Notes
    [13] - Participants who received at least one dose of investigational product with baseline data.
    No statistical analyses for this end point

    Secondary: Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score

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    End point title
    		 Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
    End point description
    The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Symptoms and Feelings Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
    End point type
    Secondary
    End point timeframe
    Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    173 [14]
    Units: percent improvement
    arithmetic mean (standard deviation)
        Study 20050111 baseline (N = 165)
    54.869 ( 56.213 )
        Week 24 (N = 155)
    55.366 ( 64.039 )
        Week 48 (N = 149)
    53.792 ( 65.857 )
        Week 72 (N = 136)
    51.005 ( 68.117 )
        Week 96 (N = 128)
    55.430 ( 57.430 )
        Week 120 (N = 105)
    53.302 ( 67.555 )
        Week 144 (N = 104)
    56.250 ( 58.194 )
        Week 168 (N = 94)
    58.901 ( 49.431 )
        Week 192 (N = 81)
    55.700 ( 56.352 )
        Week 216 (N = 71)
    71.056 ( 41.396 )
        Week 240 (N = 65)
    67.538 ( 43.418 )
        Week 264 (N = 57)
    56.725 ( 52.965 )
    Notes
    [14] - Participants who received at least one dose of investigational product with baseline data.
    No statistical analyses for this end point

    Secondary: Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score

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    End point title
    		 Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
    End point description
    The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Leisure Score includes 3 questions and ranges from 0 to 9, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
    End point type
    Secondary
    End point timeframe
    Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    173 [15]
    Units: percent improvement
    arithmetic mean (standard deviation)
        Study 20050111 baseline (N = 165)
    51.088 ( 52.612 )
        Week 24 (N = 156)
    50.546 ( 58.606 )
        Week 48 (N = 148)
    51.792 ( 61.204 )
        Week 72 (N = 136)
    50.792 ( 70.769 )
        Week 96 (N = 129)
    48.686 ( 68.482 )
        Week 120 (N = 105)
    59.031 ( 49.472 )
        Week 144 (N = 104)
    57.125 ( 54.284 )
        Week 168 (N = 94)
    55.198 ( 52.141 )
        Week 192 (N = 81)
    47.989 ( 72.947 )
        Week 216 (N = 71)
    58.545 ( 60.440 )
        Week 240 (N = 64)
    55.727 ( 64.420 )
        Week 264 (N = 56)
    50.072 ( 62.049 )
    Notes
    [15] - Participants who received at least one dose of investigational product with baseline data.
    No statistical analyses for this end point

    Secondary: Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score

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    End point title
    		 Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
    End point description
    The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI School or Holidays Score includes 1 question (How much did your skin problem effect your school work/holiday plans over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
    End point type
    Secondary
    End point timeframe
    Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    173 [16]
    Units: percent improvement
    arithmetic mean (standard deviation)
        Study 20050111 baseline (N = 165)
    31.616 ( 51.981 )
        Week 24 (N = 156)
    32.585 ( 52.750 )
        Week 48 (N = 148)
    36.149 ( 51.778 )
        Week 72 (N = 133)
    29.825 ( 53.025 )
        Week 96 (N = 129)
    29.547 ( 55.085 )
        Week 120 (N = 105)
    32.063 ( 55.166 )
        Week 144 (N = 105)
    33.333 ( 48.371 )
        Week 168 (N = 94)
    32.979 ( 50.563 )
        Week 192 (N = 81)
    31.070 ( 52.886 )
        Week 216 (N = 71)
    35.211 ( 48.103 )
        Week 240 (N = 65)
    26.923 ( 56.649 )
        Week 264 (N = 57)
    27.193 ( 51.815 )
    Notes
    [16] - Participants who received at least one dose of investigational product with baseline data.
    No statistical analyses for this end point

    Secondary: Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score

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    End point title
    		 Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
    End point description
    The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Personal Relationships Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
    End point type
    Secondary
    End point timeframe
    Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    173 [17]
    Units: percent improvement
    arithmetic mean (standard deviation)
        Study 20050111 baseline (N = 166)
    45.452 ( 65.038 )
        Week 24 (N = 156)
    49.797 ( 59.328 )
        Week 48 (N = 149)
    50.895 ( 60.179 )
        Week 72 (N = 136)
    54.669 ( 54.519 )
        Week 96 (N = 129)
    48.346 ( 60.414 )
        Week 120 (N = 105)
    51.206 ( 54.435 )
        Week 144 (N = 105)
    50.365 ( 49.636 )
        Week 168 (N = 94)
    44.557 ( 72.287 )
        Week 192 (N = 81)
    52.284 ( 56.125 )
        Week 216 (N = 71)
    61.737 ( 48.255 )
        Week 240 (N = 65)
    56.282 ( 52.042 )
        Week 264 (N = 57)
    56.140 ( 52.481 )
    Notes
    [17] - Participants who received at least one dose of investigational product with baseline data.
    No statistical analyses for this end point

    Secondary: Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score

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    End point title
    		 Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
    End point description
    The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Sleep Score includes 1 question (How much has your sleep been affected by your skin problems over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
    End point type
    Secondary
    End point timeframe
    Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    171 [18]
    Units: percent improvement
    arithmetic mean (standard deviation)
        Study 20050111 baseline (N = 161)
    36.646 ( 56.851 )
        Week 24 (N = 153)
    36.057 ( 60.349 )
        Week 48 (N = 144)
    31.597 ( 56.329 )
        Week 72 (N = 132)
    34.596 ( 57.390 )
        Week 96 (N = 127)
    32.940 ( 55.216 )
        Week 120 (N = 101)
    29.538 ( 61.503 )
        Week 144 (N = 102)
    41.013 ( 50.229 )
        Week 168 (N = 93)
    37.814 ( 49.888 )
        Week 192 (N = 81)
    34.774 ( 54.658 )
        Week 216 (N = 71)
    35.681 ( 50.811 )
        Week 240 (N = 65)
    39.231 ( 48.808 )
        Week 264 (N = 56)
    36.012 ( 57.890 )
    Notes
    [18] - Participants who received at least one dose of investigational product with baseline data.
    No statistical analyses for this end point

    Secondary: Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score

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    End point title
    		 Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
    End point description
    The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Treatment Satisfaction Score includes 1 question (How much of a problem has the treatment for your skin been over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life. Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
    End point type
    Secondary
    End point timeframe
    Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    169 [19]
    Units: percent improvement
    arithmetic mean (standard deviation)
        Study 20050111 baseline (N = 161)
    23.085 ( 64.713 )
        Week 24 (N = 152)
    13.268 ( 74.987 )
        Week 48 (N = 144)
    18.634 ( 67.750 )
        Week 72 (N = 134)
    23.383 ( 73.210 )
        Week 96 (N = 128)
    17.969 ( 72.561 )
        Week 120 (N = 105)
    17.778 ( 65.709 )
        Week 144 (N = 104)
    21.795 ( 62.924 )
        Week 168 (N = 93)
    20.430 ( 73.849 )
        Week 192 (N = 81)
    26.955 ( 68.443 )
        Week 216 (N = 71)
    31.455 ( 59.598 )
        Week 240 (N = 65)
    30.513 ( 57.703 )
        Week 264 (N = 56)
    37.500 ( 64.842 )
    Notes
    [19] - Participants who received at least one dose of investigational product with baseline data.
    No statistical analyses for this end point

    Secondary: Improvement From Study 20030211 Baseline in Joint Pain

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    End point title
    		 Improvement From Study 20030211 Baseline in Joint Pain
    End point description
    Participants were asked to indicate how much joint pain they had experienced in the last 7 days on a visual analog scale (VAS) from no pain on the left end of the line (score = 0) to severe pain on the right side of the line (score = 10). Improvement from baseline = (Baseline Value – Post-baseline Value).
    End point type
    Secondary
    End point timeframe
    Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264
    End point values
    		 Etanercept
    Number of subjects analysed
    41 [20]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Study 20050111 baseline (N = 31)
    1.5 ( 2.7 )
        Week 12 (N = 29)
    2.3 ( 2.5 )
        Week 24 (N = 22)
    2.4 ( 3.2 )
        Week 36 (N = 22)
    1.5 ( 3.2 )
        Week 48 (N = 24)
    1.5 ( 3.5 )
        Week 60 (N = 14)
    1.3 ( 3.2 )
        Week 72 (N = 16)
    2.1 ( 3.6 )
        Week 84 (N = 14)
    2.9 ( 3.0 )
        Week 96 (N = 16)
    2.0 ( 2.7 )
        Week 108 (N = 14)
    2.4 ( 3.4 )
        Week 120 (N = 12)
    2.4 ( 2.9 )
        Week 132 (N = 15)
    1.9 ( 3.7 )
        Week 144 (N = 12)
    1.8 ( 4.3 )
        Week 156 (N = 12)
    2.5 ( 3.8 )
        Week 168 (N = 10)
    2.2 ( 4.0 )
        Week 180 (N = 11)
    2.7 ( 3.3 )
        Week 192 (N = 11)
    2.5 ( 4.2 )
        Week 204 (N = 11)
    2.8 ( 3.6 )
        Week 216 (N = 9)
    2.9 ( 3.4 )
        Week 228 (N = 10)
    2.8 ( 3.6 )
        Week 240 (N = 9)
    2.7 ( 3.4 )
        Week 252 (N = 8)
    3.9 ( 3.7 )
        Week 264 (N = 8)
    3.9 ( 3.3 )
    Notes
    [20] - Participants who received at least one dose of investigational product with baseline data
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Through the End of Treatment (Week 264 or the first quarterly visit after the subject's 18th birthday, whichever comes last) or Early Termination Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    		 Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.

    Serious adverse events
    		 Etanercept
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 181 (6.08%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Joint dislocation
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Intracranial mass
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Premature separation of placenta
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intentional self-injury
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary bladder rupture
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Thyroid cyst
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 181 (0.55%)
         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
    		 Etanercept
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    149 / 181 (82.32%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    24 / 181 (13.26%)
         occurrences all number
    36
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    11 / 181 (6.08%)
         occurrences all number
    13
    Procedural pain
         subjects affected / exposed
    12 / 181 (6.63%)
         occurrences all number
    16
    Nervous system disorders
    Headache
         subjects affected / exposed
    40 / 181 (22.10%)
         occurrences all number
    65
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    17 / 181 (9.39%)
         occurrences all number
    28
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    11 / 181 (6.08%)
         occurrences all number
    21
    Diarrhoea
         subjects affected / exposed
    11 / 181 (6.08%)
         occurrences all number
    13
    Nausea
         subjects affected / exposed
    13 / 181 (7.18%)
         occurrences all number
    17
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    22 / 181 (12.15%)
         occurrences all number
    29
    Nasal congestion
         subjects affected / exposed
    17 / 181 (9.39%)
         occurrences all number
    29
    Oropharyngeal pain
         subjects affected / exposed
    20 / 181 (11.05%)
         occurrences all number
    34
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    33 / 181 (18.23%)
         occurrences all number
    36
    Dermatitis contact
         subjects affected / exposed
    11 / 181 (6.08%)
         occurrences all number
    17
    Psoriasis
         subjects affected / exposed
    14 / 181 (7.73%)
         occurrences all number
    19
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    14 / 181 (7.73%)
         occurrences all number
    18
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    18 / 181 (9.94%)
         occurrences all number
    22
    Ear infection
         subjects affected / exposed
    12 / 181 (6.63%)
         occurrences all number
    18
    Gastroenteritis
         subjects affected / exposed
    14 / 181 (7.73%)
         occurrences all number
    14
    Gastroenteritis viral
         subjects affected / exposed
    14 / 181 (7.73%)
         occurrences all number
    15
    Influenza
         subjects affected / exposed
    21 / 181 (11.60%)
         occurrences all number
    28
    Pharyngitis
         subjects affected / exposed
    15 / 181 (8.29%)
         occurrences all number
    21
    Pharyngitis streptococcal
         subjects affected / exposed
    27 / 181 (14.92%)
         occurrences all number
    37
    Sinusitis
         subjects affected / exposed
    25 / 181 (13.81%)
         occurrences all number
    36
    Upper respiratory tract infection
         subjects affected / exposed
    69 / 181 (38.12%)
         occurrences all number
    154
    Viral upper respiratory tract infection
         subjects affected / exposed
    54 / 181 (29.83%)
         occurrences all number
    116
    Urinary tract infection
         subjects affected / exposed
    12 / 181 (6.63%)
         occurrences all number
    16

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jul 2005
    • Per US Food and Drug Administration request, the discontinuation and dose adjustment criteria were amended to require that subjects with a systemic infection that required intravenous antibiotic use or hospitalization be removed from the study. • Etanercept dose wording was changed to correctly reflect that an exact 0.8 mg/kg dose is not always possible using 2 vials of lyophilized investigational product as the subject’s body weight approaches 62 kg.
    19 Oct 2006
    • Extended length of study for an additional 18 months • Included the option for investigators to stop treatment with investigational product for subjects with a Static Physician Global Assessment score of clear (0) or almost clear (1) at week 96, 108, 120, 132, 144, or 156
    10 Sep 2008
    • Extended length of the study to 5 years • Subjects were no longer required to permanently discontinue treatment if therapy was temporarily withheld more than once because of clearing of psoriasis or if more than 3 consecutive doses were withheld because of an adverse event or surgical procedure • Removed 30 day follow-up visit • Removed collection of Harter’s Self-Perception Profile in Children and Adolescents
    26 Jul 2010
    • Allowed for the collection of additional safety data (assessments of adverse events and concomitant medication use) on subjects who were under the age of 18. After week 264, only serious adverse events were to be collected. • Subjects were allowed to continue on this study until they reached 18 years of age. • Added a second planned interim analysis (a “week 264 analysis”) after all subjects remaining in the study completed the week 264 assessments. This comprises the main comprehensive, integrated analysis of Study 20050111 data.

    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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