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    Clinical Trial Results:
    A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis

    Summary
    EudraCT number
    		 2012-003486-18
    Trial protocol
    		 DE   IT   GB   ES   PL   Outside EU/EEA  
    Global end of trial date
    19 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Feb 2017
    First version publication date
    09 Feb 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    WA28117
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01904279
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Acronym: JIGSAW 117
    Sponsors
    Sponsor organisation name
    Hoffmann-La Roche
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH­4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche Ltd, +41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche Ltd, +41 61 6878333, global.trial_information@roche.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 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize the pharmacokinetics of subcutaneous tocilizumab (SC TCZ) in participants with polyarticular juvenile idiopathic arthritis (pJIA).
    Protection of trial subjects
    The study was conducted in full conformance with the principles of the “Declaration of Helsinki” or with the laws and regulations of the country in which the research was conducted, whichever affords the greater protection to the individual. The study fully adhered to the principles outlined in “Guideline for Good Clinical Practice (GCP)” International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Tripartite Guideline and ensured compliance with the EU Clinical Trial Directive [2001/20/EC]. Approval from the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) and the relevant Competent Authority was obtained before study start.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jul 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Russian Federation: 2
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    Argentina: 4
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    United States: 11
    Worldwide total number of subjects
    52
    EEA total number of subjects
    24
    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)
    1
    Children (2-11 years)
    30
    Adolescents (12-17 years)
    21
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 52 participants were enrolled in the study. Study included a 21-day screening period.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TCZ SC 162 mg Q3W
    Arm description
    		 Participants with body weight less than (<) 30 kilograms (kg) were administered 162 milligrams (mg) of TCZ as an subcutaneous (SC) injection every 3 weeks (Q3W) for 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tocilizumab (TCZ)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks.

    Arm title
    		 TCZ SC 162 mg Q2W
    Arm description
    		 Participants with body weight greater than or equal to (>/=) 30 kg were administered 162 mg of TCZ as an SC injection every 2 weeks (Q2W) for 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tocilizumab (TCZ)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks.

    Number of subjects in period 1
    		TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
    Started
    27
    25
    Completed
    24
    22
    Not completed
    3
    3
         Consent withdrawn by subject
    1
    -
         Lack of efficacy
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TCZ SC 162 mg Q3W
    Reporting group description
    		 Participants with body weight less than (<) 30 kilograms (kg) were administered 162 milligrams (mg) of TCZ as an subcutaneous (SC) injection every 3 weeks (Q3W) for 52 weeks.

    Reporting group title
    TCZ SC 162 mg Q2W
    Reporting group description
    		 Participants with body weight greater than or equal to (>/=) 30 kg were administered 162 mg of TCZ as an SC injection every 2 weeks (Q2W) for 52 weeks.

    Reporting group values
    		 TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W Total
    Number of subjects
    		 27 25 52
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 5.5 ( 2.1 ) 13.9 ( 2.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 18 36
        Male
    		 9 7 16

    End points

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    End points reporting groups
    Reporting group title
    TCZ SC 162 mg Q3W
    Reporting group description
    		 Participants with body weight less than (<) 30 kilograms (kg) were administered 162 milligrams (mg) of TCZ as an subcutaneous (SC) injection every 3 weeks (Q3W) for 52 weeks.

    Reporting group title
    TCZ SC 162 mg Q2W
    Reporting group description
    		 Participants with body weight greater than or equal to (>/=) 30 kg were administered 162 mg of TCZ as an SC injection every 2 weeks (Q2W) for 52 weeks.

    Primary: Minimum Serum Concentration (Cmin) of TCZ at Steady State

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    End point title
    		 Minimum Serum Concentration (Cmin) of TCZ at Steady State [1]
    End point description
    Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose. The analysis was performed in pharmacokinetic population. Pharmacokinetic population included all enrolled participants who were adherent to the protocol.
    End point type
    Primary
    End point timeframe
    Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
    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 presented for the endpoint.
    End point values
    		 TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
    Number of subjects analysed
    27
    25
    Units: Micrograms per milliliter (mcg/mL)
        median (full range (min-max))
    13.35 (0.21 to 52.25)
    12.71 (0.19 to 23.75)
    No statistical analyses for this end point

    Primary: Area Under the Curve From Time 0 to 12 Weeks (AUC12weeks) of TCZ Treatment

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    End point title
    		 Area Under the Curve From Time 0 to 12 Weeks (AUC12weeks) of TCZ Treatment [2]
    End point description
    Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose. The analysis was performed in pharmacokinetic population.
    End point type
    Primary
    End point timeframe
    Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
    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 presented for the endpoint.
    End point values
    		 TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
    Number of subjects analysed
    27
    25
    Units: Mcg/mL*day
        median (full range (min-max))
    2998 (1465 to 7708)
    1933 (324 to 3098)
    No statistical analyses for this end point

    Primary: Maximum Serum Concentration (Cmax) of TCZ at Steady State

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    End point title
    		 Maximum Serum Concentration (Cmax) of TCZ at Steady State [3]
    End point description
    Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.The analysis was performed in pharmacokinetic Population.
    End point type
    Primary
    End point timeframe
    Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
    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 presented for the endpoint.
    End point values
    		 TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
    Number of subjects analysed
    27
    25
    Units: mcg/mL
        median (full range (min-max))
    62.44 (39.37 to 121.13)
    29.74 (7.56 to 50.3)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Serum Interleukin-6 (IL-6) Levels

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    End point title
    		 Change From Baseline in Serum Interleukin-6 (IL-6) Levels
    End point description
    IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the pJIA subset. It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity. Here n refers to the number of participants analyzed at specific time point. The analysis was performed in safety population. Safety population included all participants who received at least one dose of treatment and who had at least one post-dose safety assessment. Here number of subjects analyzed represents participants evaluable for this outcome measure and "n" represents participants evaluable for the specified category. 99999 represented data not analysed as no participants were evaluable. 9999 represented data was not available as only single participant was evaluated.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
    End point values
    		 TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
    Number of subjects analysed
    18
    23
    Units: picograms per milliliter(pg/mL)
    arithmetic mean (standard deviation)
        Baseline (n=18, 23)
    77.569 ( 278.376 )
    10.567 ( 11.24 )
        Day 0.25 (n=18, 23)
    -15.309 ( 108.157 )
    4.575 ( 7.555 )
        Day 0.5 (n=15, 23)
    -16.181 ( 116.587 )
    11.932 ( 13.33 )
        Day 2 (n=18, 23)
    17.998 ( 157.295 )
    23.223 ( 23.935 )
        Day 4 (n= 0, 0)
    99999 ( 99999 )
    99999 ( 99999 )
        Day 5 (n= 17, 23)
    17.265 ( 186.212 )
    35.263 ( 64.907 )
        Week 2 (n= 0, 23)
    99999 ( 99999 )
    21.751 ( 49.964 )
        Week 3 (n=18, 0)
    -12.801 ( 198.038 )
    99999 ( 99999 )
        Week 4 (n=0, 22)
    99999 ( 99999 )
    15.944 ( 26.322 )
        Week 6 (n=18, 23)
    -0.412 ( 271.409 )
    17.841 ( 34.515 )
        Week 12 (n=16, 21)
    -45.569 ( 294.169 )
    17.236 ( 28.727 )
        Day 84.25 (n= 14, 21)
    32.644 ( 65.094 )
    14.66 ( 24.026 )
        Day 84.5 (n=13, 20)
    -46.575 ( 318.217 )
    24.478 ( 31.747 )
        Day 85 (n=0, 22)
    99999 ( 99999 )
    27.934 ( 53.23 )
        Day 86 (n=16, 21)
    -53.35 ( 285.831 )
    36.06 ( 82.547 )
        Day 88 (n=17, 21)
    -42.836 ( 280.041 )
    19.397 ( 22.712 )
        Day 90 (n=15, 19)
    -51.899 ( 299.59 )
    20.642 ( 20.247 )
        Week 14 (n=0, 23)
    99999 ( 99999 )
    11.958 ( 16.665 )
        Week 15 (n=17, 1)
    -21.565 ( 312.758 )
    122.88 ( 9999 )
        Week 27 (n=18, 0)
    -16.408 ( 293.156 )
    99999 ( 99999 )
        Week 28 (n= 0, 20)
    99999 ( 99999 )
    14.206 ( 20.762 )
        Week 36 (n=16, 16)
    -38.921 ( 303.851 )
    13.273 ( 24.814 )
        Week 44 (n=0, 20)
    99999 ( 99999 )
    14.765 ( 18.458 )
        Week 52 (n=17, 20)
    -44.611 ( 289.698 )
    10.401 ( 18.455 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Soluble IL-6 Receptor Levels

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    End point title
    		 Change From Baseline in Soluble IL-6 Receptor Levels
    End point description
    The analysis was performed in safety population. 99999 represented data not analysed as no participants were evaluable. 9999 represented data was not available as only single participant was evaluated. Here number of subjects analyzed represents participants evaluable for this outcome measure and "n" represents participants evaluable for the specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
    End point values
    		 TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
    Number of subjects analysed
    20
    23
    Units: nanograms per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        Baseline (n=20, 23)
    140.4 ( 225.72 )
    206.7 ( 241.69 )
        Day 0.25 (n= 19, 23)
    -4.04 ( 41.14 )
    1.78 ( 29.68 )
        Day 0.5 (n=16, 22)
    -1.45 ( 53.39 )
    4.58 ( 51.71 )
        Day 2 (n=19, 23)
    89.72 ( 75.29 )
    68.9 ( 66.75 )
        Day 4 (n=1, 0)
    323.4 ( 9999 )
    99999 ( 99999 )
        Day 5 (n=19, 23)
    194.46 ( 143.28 )
    124.65 ( 100.58 )
        Week 2 (n=0, 23)
    99999 ( 99999 )
    193.25 ( 158.69 )
        Week 3 (n=20, 0)
    418.54 ( 237.02 )
    99999 ( 99999 )
        Week 4 (n=0, 23)
    99999 ( 99999 )
    239.86 ( 194.47 )
        Week 6 (n=20, 23)
    407.36 ( 344.44 )
    233.82 ( 234.92 )
        Week 12 (n=17, 21)
    464.77 ( 317.77 )
    286.06 ( 260.33 )
        Day 84.25 (n= 17, 23)
    461.85 ( 280.99 )
    245.05 ( 253.45 )
        Day 84.5 (17, 22)
    482.55 ( 299.43 )
    274.85 ( 230.86 )
        Day 85 (n=0, 22)
    99999 ( 99999 )
    268.72 ( 254.46 )
        Day 86 (n=19, 22)
    461.19 ( 345.97 )
    244.53 ( 257.08 )
        Day 88 (n=19, 21)
    514.89 ( 303.29 )
    256.47 ( 234.7 )
        Day 90 (n=19, 20)
    494.05 ( 276.35 )
    292.29 ( 229.2 )
        Week 14 (n=0, 23)
    99999 ( 99999 )
    272.93 ( 241.9 )
        Week 15 (n=20, 1)
    497.21 ( 295.29 )
    200 ( 9999 )
        Week 27 (n= 20, 0)
    532.81 ( 270.07 )
    99999 ( 99999 )
        Week 28 (n=0, 21)
    99999 ( 99999 )
    295.28 ( 286.78 )
        Week 36 (n=18, 18)
    416.02 ( 305.07 )
    269.32 ( 276.03 )
        Week 44 (n=0, 21)
    99999 ( 99999 )
    243.93 ( 299.72 )
        Week 52 (n=20, 22)
    470.6 ( 263.38 )
    209.51 ( 318.38 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in C-Reactive Protein (CRP) Levels

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    End point title
    		 Change From Baseline in C-Reactive Protein (CRP) Levels
    End point description
    The analysis was performed in safety population. Here "n" represents participants evaluable for the specified category. Here 99999 represented data not analysed as no participants were evaluable.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
    End point values
    		 TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
    Number of subjects analysed
    27
    25
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline (n=27, 25)
    3.391 ( 5.27 )
    3.356 ( 6.908 )
        Week 4 (n=0, 25)
    99999 ( 99999 )
    -2.187 ( 5.27 )
        Week 6 (n=27, 25)
    -3 ( 5.21 )
    -2.368 ( 5.735 )
        Week 9 (n=27, 0)
    -3.069 ( 5.346 )
    99999 ( 99999 )
        Week 12 (n=27, 24)
    -3.16 ( 5.285 )
    -1.783 ( 4.559 )
        Week 18 (n=26, 0)
    -3.213 ( 5.377 )
    99999 ( 99999 )
        Week 20 (n=0, 25)
    99999 ( 99999 )
    -1.336 ( 6.158 )
        Week 27 (n=27, 0)
    -3.122 ( 5.279 )
    99999 ( 99999 )
        Week 28 (n=0, 25)
    99999 ( 99999 )
    -2.467 ( 6.455 )
        Week 36 (n=25, 22)
    -3.254 ( 5.492 )
    -2.209 ( 5.316 )
        Week 44 (n=0, 22)
    99999 ( 99999 )
    -2.039 ( 5.47 )
        Week 45 (n=26, 0)
    -3.153 ( 5.385 )
    99999 ( 99999 )
        Week 51 (n=25, 0)
    -3.344 ( 5.453 )
    99999 ( 99999 )
        Week 52 (n=0, 22)
    99999 ( 99999 )
    -2.225 ( 5.285 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

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    End point title
    		 Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
    End point description
    The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement. The analysis was performed in safety population. 99999 represented data not analysed as no participants were evaluable. Here "n" represents participants evaluable for the specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
    End point values
    		 TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
    Number of subjects analysed
    27
    25
    Units: millimeters per hour (mm/h)
    arithmetic mean (standard deviation)
        Baseline (n=27, 25)
    15.9 ( 14.2 )
    13 ( 13.1 )
        Week 4 (n=0, 25)
    99999 ( 99999 )
    -7 ( 9 )
        Week 6 (n= 26, 25)
    -10.6 ( 12.8 )
    -7.2 ( 10.5 )
        Week 9 (n=25, 0)
    -9.9 ( 10.9 )
    99999 ( 99999 )
        Week 12 (n=26, 25)
    -9.8 ( 12.4 )
    -6.8 ( 13 )
        Week 18 (n=26, 0)
    -11.8 ( 12.3 )
    99999 ( 99999 )
        Week 20 (n=0, 25)
    99999 ( 99999 )
    -7.9 ( 11.2 )
        Week 27 (n=27,0)
    -11.9 ( 12.2 )
    99999 ( 99999 )
        Week 28 (n=0, 23)
    99999 ( 99999 )
    -8 ( 14.2 )
        Week 36 (n=26, 21)
    -11.8 ( 12.8 )
    -8 ( 13.1 )
        Week 44 (n=0, 21)
    99999 ( 99999 )
    -10.2 ( 13 )
        Week 45 (n=26, 0)
    -12 ( 12.2 )
    99999 ( 99999 )
        Week 51 (n=25,0)
    -12.2 ( 13 )
    99999 ( 99999 )
        Week 52 (n=0, 22)
    99999 ( 99999 )
    -8.5 ( 13.2 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential

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    End point title
    		 Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential
    End point description
    The analysis was performed in safety population.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 52
    End point values
    		 TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
    Number of subjects analysed
    27
    25
    Units: Percentage of Participants
        number (not applicable)
    3.7
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 56
    Adverse event reporting additional description
    Safety population.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    TCZ SC 162 mg Q2W
    Reporting group description
    		 Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.

    Reporting group title
    TCZ SC 162 mg Q3W
    Reporting group description
    		 Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.

    Serious adverse events
    		 TCZ SC 162 mg Q2W TCZ SC 162 mg Q3W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 27 (3.70%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Varicella
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TCZ SC 162 mg Q2W TCZ SC 162 mg Q3W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 25 (88.00%)
    23 / 27 (85.19%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    Vascular disorders
    Haematoma
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
         occurrences all number
    6
    0
    Injection site erythema
         subjects affected / exposed
    6 / 25 (24.00%)
    4 / 27 (14.81%)
         occurrences all number
    18
    9
    Injection site haematoma
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Injection site pain
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Injection site pruritus
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
         occurrences all number
    4
    0
    Injection site swelling
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 27 (3.70%)
         occurrences all number
    5
    1
    Pyrexia
         subjects affected / exposed
    4 / 25 (16.00%)
    2 / 27 (7.41%)
         occurrences all number
    4
    2
    Vessel puncture site haematoma
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Cough
         subjects affected / exposed
    3 / 25 (12.00%)
    10 / 27 (37.04%)
         occurrences all number
    5
    15
    Oropharyngeal pain
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 27 (3.70%)
         occurrences all number
    5
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 27 (7.41%)
         occurrences all number
    2
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 25 (24.00%)
    1 / 27 (3.70%)
         occurrences all number
    9
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 27 (11.11%)
         occurrences all number
    1
    9
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 25 (12.00%)
    3 / 27 (11.11%)
         occurrences all number
    4
    3
    Constipation
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Aphthous ulcer
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 27 (3.70%)
         occurrences all number
    5
    2
    Diarrhoea
         subjects affected / exposed
    4 / 25 (16.00%)
    1 / 27 (3.70%)
         occurrences all number
    4
    1
    Nausea
         subjects affected / exposed
    5 / 25 (20.00%)
    1 / 27 (3.70%)
         occurrences all number
    8
    1
    Vomiting
         subjects affected / exposed
    5 / 25 (20.00%)
    4 / 27 (14.81%)
         occurrences all number
    7
    8
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Dermatitis Atopic
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    2
    Eczema
         subjects affected / exposed
    3 / 25 (12.00%)
    2 / 27 (7.41%)
         occurrences all number
    3
    3
    Rash
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 27 (11.11%)
         occurrences all number
    2
    3
    Arthralgia
         subjects affected / exposed
    4 / 25 (16.00%)
    5 / 27 (18.52%)
         occurrences all number
    10
    6
    Joint Swelling
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
         occurrences all number
    4
    0
    Juvenile idiopathic arthritis
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    Neck Pain
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 27 (7.41%)
         occurrences all number
    3
    2
    Pain in extremity
         subjects affected / exposed
    4 / 25 (16.00%)
    1 / 27 (3.70%)
         occurrences all number
    6
    2
    Infections and infestations
    Ear Infection
         subjects affected / exposed
    0 / 25 (0.00%)
    4 / 27 (14.81%)
         occurrences all number
    0
    4
    Bronchitis
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Impetigo
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    3
    Gastrointeritis
         subjects affected / exposed
    2 / 25 (8.00%)
    4 / 27 (14.81%)
         occurrences all number
    2
    7
    Nasopharyngitis
         subjects affected / exposed
    7 / 25 (28.00%)
    11 / 27 (40.74%)
         occurrences all number
    8
    18
    Influenza
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    2
    Otitis media
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 27 (11.11%)
         occurrences all number
    0
    3
    Rhinitis
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 27 (3.70%)
         occurrences all number
    4
    1
    Paronychia
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 25 (16.00%)
    1 / 27 (3.70%)
         occurrences all number
    6
    1
    Viral infection
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Mar 2013
    1) Removal of the Juvenile Arthritis Multidimensional Assessment Report (JAMAR) as a patient-reported outcome (PRO) tool and replacement with child health assessment questionnaire (CHAQ) functional ability instrument 2) The immunogenicity testing requirements were updated for participants who withdrew due to hypersensitivity or anaphylaxis 3)The dose interval changes for participants whose body weight increased or decreased above or below the 30 kg threshold were clarified
    01 Aug 2013
    The number of participants switching from TCZ intravenous to TCZ SC was limited to no more than 50 percent of the total number of participants and to include the request to collect information on the prior four intravenous infusions for participants switching.

    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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