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    Clinical Trial Results:
    A Phase IV Study to Evaluate Decreased Dose Frequency in Patients with Systemic Juvenile Arthritis (SJIA) who Experience Laboratory Abnormalities During Treatment with Tocilizumab

    Summary
    EudraCT number
    		 2012-000444-10
    Trial protocol
    		 GB   ES   NO   DE   SE   IT  
    Global end of trial date
    09 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2020
    First version publication date
    25 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    WA28029
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01734382
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to explore the efficacy of tocilizumab (TCZ) in reduced dosing frequency regimens (every 3 weeks [Q3W] and every 4 weeks [Q4W], as appropriate) using Juvenile Arthritis Disease Activity Score (JADAS)-71, JIA flare, and fever (attributable to sJIA) and to describe the pharmacodynamics, using soluble interleukin-6 receptor (sIL-6R) and C-reactive protein (CRP), and immunogenicity of TCZ in reduced dosing frequency regimens.
    Protection of trial subjects
    All participants or their guardians signed informed consent form (ICF).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jun 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Russian Federation: 5
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    35
    EEA total number of subjects
    12
    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)
    25
    Adolescents (12-17 years)
    10
    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
    		 Participants with systemic juvenile idiopathic arthritis (sJIA) were recruited at study sites in 8 countries. The study consisted of two parts: Part 1 was a 24-week Run-in period and Part 2 was a 52-week Main study.

    Pre-assignment
    Screening details
    		 Part 1 enrolled 19. Patients treated with tocilizumab (TCZ) every other week (Q2W) either during Part 1 or prior to the study, who experienced laboratory abnormalities and which had resolved, were allowed to enroll into Part 2. Part 2 enrolled 22 with 6 from Part 1 and 16 directly enrolled into Part 2.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Part 1: Tocilizumab (TCZ) Q2W
    Arm description
    		 Participants received tocilizumab intravenous (IV) infusions (12 mg/kg for participants < 30 kg; 8 mg/kg for participants >/= 30 kg) once every other week (Q2W) up to 24 weeks or until occurrence of a protocol defined laboratory abnormality in Part 1 of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tocilizumab (TCZ)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    TCZ dosed by body weight (12 mg/kg for participants < 30 kg; 8 mg/kg for participants ≥ 30 kg) by IV infusion Q2W for up to 24 weeks or until they experience a laboratory abnormality of neutropenia, thrombocytopenia, or liver enzyme abnormality as per the protocol criteria.

    Arm title
    		 Part 2: TCZ IV 12 mg/kg Q3W/Q4W
    Arm description
    		 Participants with weight < 30 kg received tocilizumab IV infusions of 12 mg/kg once every three weeks (Q3W) up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 12 mg/kg once every four weeks (Q4W) up to Week 52 in Part 2 of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tocilizumab (TCZ)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switiched to tocilizumab IV infusions of 12 mg/kg Q4W up to 52 weeks.

    Arm title
    		 Part 2: TCZ IV 8 mg/kg Q3W/Q4W
    Arm description
    		 Participants with weight >/= 30 kg received tocilizumab IV infusions of 8 mg/kg Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tocilizumab (TCZ)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switiched to tocilizumab IV infusions of 8 mg/kg Q4W up to 52 weeks.

    Number of subjects in period 1
    		Part 1: Tocilizumab (TCZ) Q2W Part 2: TCZ IV 12 mg/kg Q3W/Q4W Part 2: TCZ IV 8 mg/kg Q3W/Q4W
    Started
    19
    7
    15
    Completed
    17
    5
    8
    Not completed
    2
    2
    7
         Physician decision
    -
    -
    3
         Consent withdrawn by subject
    -
    -
    1
         Adverse event, non-fatal
    2
    -
    1
         Not Specified
    -
    -
    1
         Lack of efficacy
    -
    1
    1
         Protocol deviation
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: Tocilizumab (TCZ) Q2W
    Reporting group description
    		 Participants received tocilizumab intravenous (IV) infusions (12 mg/kg for participants < 30 kg; 8 mg/kg for participants >/= 30 kg) once every other week (Q2W) up to 24 weeks or until occurrence of a protocol defined laboratory abnormality in Part 1 of the study.

    Reporting group title
    Part 2: TCZ IV 12 mg/kg Q3W/Q4W
    Reporting group description
    		 Participants with weight < 30 kg received tocilizumab IV infusions of 12 mg/kg once every three weeks (Q3W) up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 12 mg/kg once every four weeks (Q4W) up to Week 52 in Part 2 of the study.

    Reporting group title
    Part 2: TCZ IV 8 mg/kg Q3W/Q4W
    Reporting group description
    		 Participants with weight >/= 30 kg received tocilizumab IV infusions of 8 mg/kg Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.

    Reporting group values
    		 Part 1: Tocilizumab (TCZ) Q2W Part 2: TCZ IV 12 mg/kg Q3W/Q4W Part 2: TCZ IV 8 mg/kg Q3W/Q4W Total
    Number of subjects
    		 19 7 15 41
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.5 ± 3.6 6.7 ± 1.8 11.7 ± 2.8 -
    Sex: Female, Male
    Units: participants
        Female
    		 9 4 10 23
        Male
    		 10 3 5 18

    End points

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    End points reporting groups
    Reporting group title
    Part 1: Tocilizumab (TCZ) Q2W
    Reporting group description
    		 Participants received tocilizumab intravenous (IV) infusions (12 mg/kg for participants < 30 kg; 8 mg/kg for participants >/= 30 kg) once every other week (Q2W) up to 24 weeks or until occurrence of a protocol defined laboratory abnormality in Part 1 of the study.

    Reporting group title
    Part 2: TCZ IV 12 mg/kg Q3W/Q4W
    Reporting group description
    		 Participants with weight < 30 kg received tocilizumab IV infusions of 12 mg/kg once every three weeks (Q3W) up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 12 mg/kg once every four weeks (Q4W) up to Week 52 in Part 2 of the study.

    Reporting group title
    Part 2: TCZ IV 8 mg/kg Q3W/Q4W
    Reporting group description
    		 Participants with weight >/= 30 kg received tocilizumab IV infusions of 8 mg/kg Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.

    Subject analysis set title
    Part 2: TCZ IV 12 mg/kg Q3W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received tocilizumab 12 mg/kg IV infusions Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria.

    Subject analysis set title
    Part 2: TCZ IV 8 mg/kg Q3W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received tocilizumab 8 mg/kg IV infusions Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria.

    Subject analysis set title
    Part 2: TCZ IV 12 mg/kg Q4W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switiched to tocilizumab IV infusions of 12 mg/kg Q4W up to Week 52 in Part 2 of the study.

    Subject analysis set title
    Part 2: TCZ IV 8 mg/kg Q4W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switiched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.

    Subject analysis set title
    Part 2: TCZ 12 mg/kg Q3W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received tocilizumab 12 mg/kg IV infusions Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria.

    Subject analysis set title
    Part 2: TCZ IV 12 mg/kg Q4W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switiched to tocilizumab IV infusions of 12 mg/kg Q4W up to Week 52 in Part 2 of the study.

    Subject analysis set title
    Part 2: TCZ IV 12 mg/kg Q3W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received tocilizumab 12 mg/kg IV infusions Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria.

    Subject analysis set title
    Part 2: TCZ IV 8 mg/kg Q3W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received tocilizumab 8 mg/kg IV infusions Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality.

    Subject analysis set title
    Part 2: TCZ IV 12 mg/kg Q4W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switiched to tocilizumab IV infusions of 12 mg/kg Q4W up to Week 52 in Part 2 of the study.

    Subject analysis set title
    Part 2: TCZ IV 8 mg/kg Q4W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switiched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.

    Subject analysis set title
    Part 2: TCZ IV 8 mg/kg Q4W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switiched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.

    Subject analysis set title
    Part 2: TCZ IV 12 mg/kg Q4W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switiched to tocilizumab IV infusions of 12 mg/kg Q4W up to Week 52 in Part 2 of the study.

    Subject analysis set title
    Part 2: TCZ IV 12 mg/kg Q4W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switiched to tocilizumab IV infusions of 12 mg/kg Q4W up to Week 52 in Part 2 of the study.

    Subject analysis set title
    Part 2: TCZ IV 8 mg/kg Q4W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switiched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.

    Subject analysis set title
    Part 2: TCZ IV 8 mg/kg Q4W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switiched to tocilizumab IV infusions of 8 mg/kg Q4W up to 52 weeks.

    Subject analysis set title
    TCZ Q2W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    IV infusions of tocilizumab once every other week (Q2W). Participants weighing < 30 kg received 8 mg/kg and participants weighing >/= 30 kg received 12 mg/kg.

    Subject analysis set title
    TCZ Q3W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    IV infusions of tocilizumab once every three weeks (Q3W). Participants weighing < 30 kg received 8 mg/kg and participants weighing >/= 30 kg received 12 mg/kg.

    Subject analysis set title
    TCZ Q4W
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    IV infusions of tocilizumab once every four weeks (Q4W). Participants weighing < 30 kg received 8 mg/kg and participants weighing >/= 30 kg received 12 mg/kg.

    Primary: Juvenile Arthritis Disease Activity Score (JADAS-71) at the End of Part 2 of the Study

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    End point title
    		 Juvenile Arthritis Disease Activity Score (JADAS-71) at the End of Part 2 of the Study [1]
    End point description
    JADAS-71 has 4 components:Physician global assessment of disease activity on visual analog scale (VAS) (range=0-10, 0=arthritis inactive, 10=very poor), patient/parent global assessment of overall well-being on VAS (range=0-10, 0=very well, 10=very poor), normalized erythrocyte sedimentation rate (ESR) (range=0-10, If ESR is ≤20 mm/h, set to 0. If ≥120 mm/h, set to 10 mm/h. If > 20 mm/h and < 120 mm/h, apply formula:[ESR−20 mm/h]/10 mm/h), count of active arthritis (swelling present/pain present and limitation of motion) in 71 selected joints (range=0-71). Total score=sum of 4 component scores,range=0-101. Higher score=more arthritis. Data was collected: Part 2:Q3W Baseline, Weeks 3,6,9,12,24,36,48 and 51; Q4W-Baseline, Weeks 0,4,8,12,24,36 and 40. All TCZ population, participants who received at least 1 dose of study drug. n=participants with data at given timepoint. 9999=Not available; No participant analysed at given timepoint. 99999=SD was not estimable for 1 participant.
    End point type
    Primary
    End point timeframe
    Part 2: Up to 52 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: Only descriptive statistics were planned to be reported for this endpoint. No formal assessment of treatment group comparability was planned to be performed.
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=7,15,1,6)
    0.60 ± 0.839
    0.21 ± 0.247
    0.00 ± 99999
    0.35 ± 0.295
        Week 0 (n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    0.00 ± 99999
    0.13 ± 0.242
        Week 3 (n=7,15,0,0)
    1.60 ± 2.474
    0.61 ± 0.913
    9999 ± 9999
    9999 ± 9999
        Week 4 (n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    0.00 ± 99999
    0.17 ± 0.266
        Week 6 (n=7,15,0,0)
    0.54 ± 0.812
    0.39 ± 0.498
    9999 ± 9999
    9999 ± 9999
        Week 8 (n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    0.00 ± 99999
    0.20 ± 0.490
        Week 9 (n=7,15,0,0)
    2.59 ± 5.402
    0.33 ± 0.420
    9999 ± 9999
    9999 ± 9999
        Week 12 (n=6,14,1,6)
    0.30 ± 0.600
    0.84 ± 2.318
    0.00 ± 99999
    0.13 ± 0.327
        Week 24 (n=5,6,1,5)
    0.42 ± 0.576
    0.05 ± 0.084
    0.00 ± 99999
    0.20 ± 0.346
        Week 36 (n=4,4,1,4)
    0.48 ± 0.950
    0.08 ± 0.150
    0.00 ± 99999
    0.00 ± 0.000
        Week 40 (n=0,0,0,4)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    0.00 ± 0.000
        Week 48 (n=4,3,0,0)
    0.00 ± 0.000
    0.17 ± 0.289
    9999 ± 9999
    9999 ± 9999
        Week 51 (n=4,3,0,0)
    0.00 ± 0.000
    0.17 ± 0.208
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Primary: Number of Participants With Juvenile Idiopathic Arthritis (JIA) Disease Flare as Determined by JIA Core Variables in Part 2 of the Study

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    End point title
    		 Number of Participants With Juvenile Idiopathic Arthritis (JIA) Disease Flare as Determined by JIA Core Variables in Part 2 of the Study [2]
    End point description
    JIA flare was defined as any 3 of 6 core outcome variables worsening by at least 30% relative to baseline visit of Part 2, with no >1 of remaining variables improving by >30%. For number of joints with active arthritis/limitation of motion a minimum worsening of at least 2 joints had to be present. If physician global assessment (PGA)/parent/patient global assessment were used a minimum worsening of at least 2 units on a scale=0-10 had to be present. For ESR, a worsening of at least 30% was not considered if within normal ranges. The 6 core outcome variables: PGA of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis/limitation of movement, ESR (measure of acute phase reaction) and functional ability determined by CHAQ Disability Index. All TCZ population, all participants who received at least one dose of study drug. Number of participants analyzed=participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    Part 2: Up to 52 weeks
    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 statistics were planned to be reported for this endpoint. No formal assessment of treatment group comparability was planned to be performed.
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: participants
    3
    1
    0
    1
    No statistical analyses for this end point

    Primary: Number of Participants With Fever Attributable to Systemic Juvenile Idiopathic Arthritis (sJIA) in Part 2 of the Study

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    End point title
    		 Number of Participants With Fever Attributable to Systemic Juvenile Idiopathic Arthritis (sJIA) in Part 2 of the Study [3]
    End point description
    Absence of fever at screening visit was defined as a temperature measurement < 38 degree centigrades (C). Presence of fever at each study visit was defined as a temperature measurement ≥ 38 C. All TCZ population, all participants who have received at least one dose of study drug
    End point type
    Primary
    End point timeframe
    Part 2: Up to 52 weeks
    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 statistics were planned to be reported for this endpoint. No formal assessment of treatment group comparability was planned to be performed.
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With at Least One Adverse Event

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    End point title
    		 Number of Participants With at Least One Adverse Event
    End point description
    An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Safety population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of safety.
    End point type
    Secondary
    End point timeframe
    Part 1 - Baseline up to 24 weeks plus 12 weeks of safety follow up; Part 2 - Baseline up to 52 weeks plus 12 weeks of safety follow up
    End point values
    		 Part 1: Tocilizumab (TCZ) Q2W Part 2: TCZ IV 12 mg/kg Q3W/Q4W Part 2: TCZ IV 8 mg/kg Q3W/Q4W
    Number of subjects analysed
    19
    7
    15
    Units: participants
    16
    7
    14
    No statistical analyses for this end point

    Secondary: Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study

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    End point title
    		 Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study
    End point description
    Pharmacodynamic (PD) population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of PD. 'n' is the number of participants with data available at the given timepoint. 9999=0 participants. 99999=Not available (NA) i.e. SD was not estimable for 1 participant.
    End point type
    Secondary
    End point timeframe
    Part 2: Q3W arms - Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms - Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: pg/mL
    arithmetic mean (standard deviation)
        Baseline (n=5,14,1,6)
    36.340 ± 19.2413
    23.453 ± 12.1440
    51.500 ± 99999
    25.415 ± 15.0174
        Week 0 (n=0,0,0,4)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    33.000 ± 23.3195
        Week 3 (n=6,11,0,0)
    61.617 ± 75.5724
    22.727 ± 7.0321
    9999 ± 9999
    9999 ± 9999
        Week 4 (n=0,0,1,5)
    9999 ± 9999
    9999 ± 9999
    13.700 ± 99999
    28.364 ± 24.8937
        Week 6 (n=6,13,0,0)
    46.698 ± 50.7148
    82.995 ± 216.2854
    9999 ± 9999
    9999 ± 9999
        Week 8 (n=0,0,1,5)
    9999 ± 9999
    9999 ± 9999
    14.300 ± 99999
    30.580 ± 22.0335
        Week 9 (n=5,11,0,0)
    45.231 ± 46.2539
    47.582 ± 37.2259
    9999 ± 9999
    9999 ± 9999
        Week 12 (n=4,12,1,5)
    84.100 ± 57.8972
    71.867 ± 156.4710
    11.600 ± 99999
    29.662 ± 26.0053
        Week 24 (n=3,5,1,3)
    79.200 ± 44.8853
    23.420 ± 14.5520
    45.000 ± 99999
    29.393 ± 19.2760
        Week 36 (n=3,4,1,2)
    67.467 ± 84.7317
    30.025 ± 16.5470
    14.100 ± 9999
    21.500 ± 15.8392
        Week 40 (n=0,0,0,2)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    22.820 ± 24.0133
        Week 48 (n=3,3,0,0)
    14.533 ± 1.4154
    15.400 ± 10.0936
    9999 ± 9999
    9999 ± 9999
        Week 51 (n=3,1,0,0)
    17.523 ± 9.2077
    5.060 ± 99999
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Secondary: Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study

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    End point title
    		 Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study
    End point description
    PD population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of PD. 'n' is the number of participants with data available at the given timepoint. 9999=0 participants. 99999= NA i.e. SD was not estimable for 1 participant.
    End point type
    Secondary
    End point timeframe
    Part 2: Q3W arms - Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms - Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: ngEq/mL
    arithmetic mean (standard deviation)
        Baseline (n=7,14,1,6)
    621.04 ± 443.779
    735.16 ± 310.983
    447.00 ± 99999
    855.00 ± 325.572
        Week 0 (n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    72.50 ± 99999
    722.83 ± 229.530
        Week 3 (n=7,14,0,0)
    632.43 ± 261.172
    707.73 ± 291.228
    9999 ± 9999
    9999 ± 9999
        Week 4 (n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    379.00 ± 99999
    653.00 ± 143.386
        Week 6 (n=6,15,0,0)
    518.67 ± 272.217
    721.73 ± 253.114
    9999 ± 9999
    9999 ± 9999
        Week 8 (n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    434.00 ± 99999
    628.50 ± 145.891
        Week 9 (n=6,13,0,0)
    596.58 ± 318.685
    646.92 ± 174.932
    9999 ± 9999
    9999 ± 9999
        Week 12 (n=5,12,1,6)
    656.80 ± 123.611
    666.75 ± 144.510
    411.00 ± 99999
    645.33 ± 106.952
        Week 24 (n=5,6,1,4)
    574.54 ± 347.127
    554.33 ± 124.498
    519.00 ± 99999
    546.25 ± 330.265
        Week 36 (n=4,4,1,4)
    492.50 ± 258.445
    646.00 ± 198.499
    439.00 ± 99999
    599.75 ± 122.200
        Week 40 (n=0,0,0,4)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    609.50 ± 115.613
        Week 48 (n=3,3,0,0)
    551.00 ± 91.000
    391.00 ± 220.293
    9999 ± 9999
    9999 ± 9999
        Week 51 (n=2,2,0,0)
    651.00 ± 135.765
    517.00 ± 140.007
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Secondary: C-reactive Protein (CRP) Concentration in Part 2 of the Study

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    End point title
    		 C-reactive Protein (CRP) Concentration in Part 2 of the Study
    End point description
    PD population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of PD. 'n' is the number of participants with data available at the given timepoint. 9999=0 participants. 99999=NA i.e. SD was not estimable for 1 participant.
    End point type
    Secondary
    End point timeframe
    Part 2: Q3W arms - Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms - Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline (n=7,15,1,6)
    4.844 ± 12.2832
    2.309 ± 6.9847
    0.200 ± 99999
    0.958 ± 1.8575
        Week 0 (n=0,0,1,4)
    9999 ± 9999
    9999 ± 9999
    0.610 ± 99999
    0.200 ± 0.0000
        Week 3 (n=7,13,1,2)
    0.223 ± 0.0427
    0.216 ± 0.0407
    0.200 ± 99999
    0.200 ± 0.0000
        Week 4 (n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    0.200 ± 99999
    0.200 ± 0.0000
        Week 6 (n=7,14,0,0)
    0.291 ± 0.1499
    0.526 ± 1.0163
    9999 ± 9999
    9999 ± 9999
        Week 8 (n=0,0,1,5)
    9999 ± 9999
    9999 ± 9999
    0.200 ± 99999
    0.200 ± 0.0000
        Week 9 (n=5,11,1,3)
    0.208 ± 0.0179
    0.255 ± 0.1250
    0.200 ± 99999
    0.200 ± 0.0000
        Week 12 (n=5,11,1,6)
    0.200 ± 0.0000
    0.238 ± 0.1201
    0.200 ± 99999
    0.203 ± 0.0082
        Week 24 (n=5,5,1,5)
    0.280 ± 0.1789
    0.254 ± 0.1207
    0.200 ± 99999
    4.040 ± 8.5865
        Week 36 (n=4,4,1,4)
    0.225 ± 0.0500
    0.200 ± 0.0000
    0.200 ± 99999
    0.200 ± 0.0000
        Week 40 (n=0,0,0,4)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    0.200 ± 0.0000
        Week 48 (n=4,3,0,0)
    0.200 ± 0.0000
    0.820 ± 1.0739
    9999 ± 9999
    9999 ± 9999
        Week 51 (n=4,3,0,0)
    0.318 ± 0.2350
    0.200 ± 0.0000
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Secondary: Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study

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    End point title
    		 Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study
    End point description
    PD population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of PD. 'n' is the number of participants with data available at the given timepoint. 9999=0 participants. 99999=NA i.e. SD was not estimable for 1 participant.
    End point type
    Secondary
    End point timeframe
    Part 2: Q3W arms - Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms - Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: mm/h
    arithmetic mean (standard deviation)
        Baseline (n=7,15,1,6)
    3.43 ± 5.192
    3.00 ± 1.852
    1.00 ± 99999
    3.17 ± 1.602
        Week 0 (n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    4.00 ± 99999
    2.67 ± 1.633
        Week 3 (n=7,14,1,4)
    2.86 ± 2.035
    3.57 ± 2.709
    2.00 ± 99999
    2.75 ± 0.957
        Week 4 (n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    1.00 ± 99999
    3.17 ± 1.722
        Week 6 (n=7,15,0,0)
    4.14 ± 4.598
    4.13 ± 3.681
    9999 ± 9999
    9999 ± 9999
        Week 8 (n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    1.00 ± 99999
    3.33 ± 2.160
        Week 9 (n=6,13,1,4)
    2.50 ± 2.510
    3.23 ± 2.204
    3.00 ± 99999
    2.25 ± 0.957
        Week 12 (n=5,12,1,6)
    2.20 ± 1.789
    3.92 ± 3.315
    1.00 ± 99999
    4.50 ± 3.209
        Week 24 (n=5,6,1,5)
    2.80 ± 1.304
    3.17 ± 2.137
    1.00 ± 99999
    2.80 ± 1.789
        Week 36 (n=4,4,1,4)
    2.25 ± 2.217
    4.50 ± 2.646
    1.00 ± 99999
    2.25 ± 1.893
        Week 40 (n=0,0,0,4)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    2.25 ± 1.893
        Week 48 (n=4,3,0,0)
    3.00 ± 0.816
    4.67 ± 1.528
    9999 ± 9999
    9999 ± 9999
        Week 51 (n=4,3,0,0)
    1.75 ± 1.708
    6.00 ± 3.000
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Secondary: Number of Participants With Anti-TCZ Antibodies in Part 2 of the Study

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    End point title
    		 Number of Participants With Anti-TCZ Antibodies in Part 2 of the Study
    End point description
    Safety population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of safety.
    End point type
    Secondary
    End point timeframe
    Part 2: Up to Week 52
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Serum TCZ Concentration in Part 2 of the Study

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    End point title
    		 Serum TCZ Concentration in Part 2 of the Study
    End point description
    All TCZ population in Part 2, all participants who have received at least one dose of study drug in Part 2. 'n' analyzed is the number of participants with data available at the given timepoint. 9999=0 participants. 99999=NA, i.e. SD was not estimable for 1 participant.
    End point type
    Secondary
    End point timeframe
    Part 2: Q3W arms - Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms - Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: ug/mL
    arithmetic mean (standard deviation)
        Baseline (n=6,13,1,6)
    29.916 ± 35.8002
    44.210 ± 33.2547
    9.520 ± 99999
    53.622 ± 48.5163
        Week 0 (n=0,0,0,6)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    24.212 ± 13.1659
        Week 3 (n=7,13,0,0)
    26.420 ± 21.1844
    37.239 ± 21.8192
    9999 ± 9999
    9999 ± 9999
        Week 4 (n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    11.100 ± 99999
    17.718 ± 11.1580
        Week 6 (n=5,14,1,0)
    28.636 ± 13.5744
    30.482 ± 19.2402
    9999 ± 9999
    9999 ± 9999
        Week 8 (n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    22.800 ± 99999
    17.578 ± 13.0611
        Week 9 (n=5,13,0,0)
    32.020 ± 6.3739
    26.962 ± 17.9122
    9999 ± 9999
    9999 ± 9999
        Week 12 (n=4,12,1,6)
    37.600 ± 20.5254
    44.763 ± 77.1798
    23.800 ± 99999
    15.442 ± 11.0714
        Week 24 (n=4,5,1,3)
    24.363 ± 20.3686
    20.842 ± 25.9417
    30.300 ± 99999
    16.030 ± 14.2124
        Week 36 (n=3,4,1,4)
    30.517 ± 18.6058
    19.733 ± 8.2218
    19.800 ± 99999
    12.903 ± 11.1808
        Week 40 (n=0,0,0,4)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    28.778 ± 16.0031
        Week 48 (n=3,2,0,0)
    25.433 ± 34.3053
    22.950 ± 0.9192
    9999 ± 9999
    9999 ± 9999
        Week 51 (n=3,2,0,0)
    12.207 ± 8.5862
    10.945 ± 14.6449
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Secondary: Baseline Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study

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    End point title
    		 Baseline Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study
    End point description
    CHAQ- Disability Index consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on 4-point scale with range 0=no difficulty to 3=unable to do. To calculate overall score, participant must have a domain score in at least 6 of 8 domains. Scores were averaged to calculate CHAQ disability index, range is 0=no/minimal physical dysfunction)-3=very severe physical dysfunction, higher score indicates more disability. All TCZ population, all participants who received at least one dose of study drug. 99999=NA i.e. SD was not estimable for 1 participant.
    End point type
    Secondary
    End point timeframe
    Baseline of Part 2
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.0000 ± 0.00000
    0.0417 ± 0.09047
    0.0000 ± 99999
    0.0000 ± 0.00000
    No statistical analyses for this end point

    Secondary: Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study

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    End point title
    		 Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study
    End point description
    CHAQ- Disability Index consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on 4-point scale with range 0=no difficulty to 3=unable to do. To calculate overall score, participant must have a domain score in at least 6 of 8 domains. Scores were averaged to calculate CHAQ disability index, range is 0=no/minimal physical dysfunction)-3=very severe physical dysfunction, higher score indicates more disability. Negative change from baseline indicates an improvement. All TCZ population, all participants who received at least 1 dose of study.'n'= participants with data available at given timepoint. 9999=0 participants. 99999=NA i.e. SD was not estimable for 1 participant.
    End point type
    Secondary
    End point timeframe
    Baseline; Part 2: Q3W arms - Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 and 51; Q4W arms - Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: score on a scale
    arithmetic mean (standard deviation)
        Change from Baseline at Week 0(n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    0.0000 ± 99999
    0.0000 ± 0.00000
        Change from Baseline at Week 3(n=7,15,0,0)
    0.2500 ± 0.66144
    0.0167 ± 0.25384
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 4(n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    0.0000 ± 99999
    0.0000 ± 0.00000
        Change from Baseline at Week 6(n=7,15,0,0)
    0.1071 ± 0.28347
    -0.0083 ± 0.07420
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 8(n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    0.0000 ± 99999
    0.0000 ± 0.00000
        Change from Baseline at Week 9(n=7,14,0,0)
    0.2500 ± 0.51539
    -0.0268 ± 0.10022
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 12(n=5,13,1,6)
    0.1250 ± 0.27951
    -0.0481 ± 0.09599
    0.0000 ± 99999
    0.0000 ± 0.00000
        Change from Baseline at Week 15(n=6,12,0,0)
    0.1458 ± 0.35722
    0.1771 ± 0.54994
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 16(n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    0.0000 ± 99999
    0.0000 ± 0.00000
        Change from Baseline at Week 18(n=5,9,0,0)
    0.1000 ± 0.22361
    0.2500 ± 0.85009
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 20(n=0,0,1,5)
    9999 ± 9999
    9999 ± 99999999
    0.0000 ± 99999
    0.0000 ± 0.00000
        Change from Baseline at Week 21(n=4,8,0,0)
    0.0000 ± 0.00000
    0.2656 ± 0.90740
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 24(n=5,5,1,5)
    0.1250 ± 0.27951
    -0.0750 ± 0.11180
    0.0000 ± 99999
    0.0000 ± 0.00000
        Change from Baseline at Week 27(n=4,4,0,0)
    0.0000 ± 0.00000
    0.0000 ± 0.10206
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 28(n=0,0,1,5)
    9999 ± 9999
    9999 ± 9999
    0.0000 ± 99999
    0.0000 ± 0.00000
        Change from Baseline at Week 30(n=4,3,0,0)
    0.0000 ± 0.00000
    0.0000 ± 0.00000
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 32(n=0,0,1,5)
    9999 ± 9999
    9999 ± 9999
    0.0000 ± 99999
    0.0000 ± 0.00000
        Change from Baseline at Week 33(n=4,3,0,0)
    0.0000 ± 0.00000
    -0.0417 ± 0.07217
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 36(n=4,3,1,4)
    0.0000 ± 0.00000
    0.0417 ± 0.07217
    0.0000 ± 99999
    0.0000 ± 0.00000
        Change from Baseline at Week 39(n=4,3,0,0)
    0.0000 ± 0.00000
    -0.0417 ± 0.07217
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 40(n=0,0,0,3)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    0.0000 ± 0.00000
        Change from Baseline at Week 42(n=3,3,0,0)
    0.0000 ± 0.00000
    -0.0417 ± 0.07217
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 45(n=4,3,0,0)
    0.0000 ± 0.00000
    -0.0417 ± 0.07217
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 48(n=4,3,0,0)
    0.0000 ± 0.00000
    -0.0417 ± 0.07217
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 51(n=4,3,0,0)
    0.0000 ± 0.00000
    -0.0417 ± 0.07217
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Secondary: Baseline Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study

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    End point title
    		 Baseline Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study
    End point description
    Participant's/parent's global assessment of overall well-being was determined on a VAS (range = 0-100, left end of the line = very well, i.e., symptom-free and no arthritis disease activity; right end = very poor, i.e., maximum arthritis disease activity). All TCZ population, all participants who have received at least one dose of study drug. 99999=NA i.e. SD was not estimable for 1 participant.
    End point type
    Secondary
    End point timeframe
    Baseline of Part 2
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: score on a scale
        arithmetic mean (standard deviation)
    2.3 ± 3.95
    1.6 ± 2.29
    0.0 ± 99999
    2.5 ± 3.21
    No statistical analyses for this end point

    Secondary: Change from Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study

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    End point title
    		 Change from Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study
    End point description
    Participant's/Parent's global assessment of overall well-being was determined on a VAS (range = 0-100, left end of the line = very well, i.e., symptom-free and no arthritis disease activity; right end = very poor, i.e., maximum arthritis disease activity). Reported is the change from baseline in VAS score with a negative change from baseline indicating an improvement. All TCZ population, all participants who have received at least one dose of study drug.'n' is the number of participants with data available at the given timepoint. 9999=0 participants. 99999=NA i.e. SD was not estimable for 1 participant.
    End point type
    Secondary
    End point timeframe
    Baseline; Part 2: Q3W arms - Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 and 51; Q4W arms - Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
    End point values
    		 Part 2: TCZ IV 12 mg/kg Q3W Part 2: TCZ IV 8 mg/kg Q3W Part 2: TCZ IV 12 mg/kg Q4W Part 2: TCZ IV 8 mg/kg Q4W
    Number of subjects analysed
    7
    15
    1
    6
    Units: score on a scale
    arithmetic mean (standard deviation)
        Change from Baseline at Week 0(n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    0.0 ± 99999
    -1.2 ± 1.60
        Change from Baseline at Week 3(n=7,15,0,0)
    -0.3 ± 2.36
    2.0 ± 6.12
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 4(n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    0.0 ± 99999
    -1.2 ± 1.26
        Change from Baseline at Week 6(n=7,15,0,0)
    -1.6 ± 3.51
    2.2 ± 4.55
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 8(n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    0.0 ± 99999
    -0.5 ± 3.56
        Change from Baseline at Week 9(n=7,14,0,0)
    8.4 ± 26.48
    0.1 ± 2.62
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 12(n=5,13,1,6)
    -1.6 ± 3.58
    -0.7 ± 2.32
    0.0 ± 99999
    -1.2 ± 2.56
        Change from Baseline at Week 15(n=6,12,0,0)
    -1.5 ± 3.67
    7.1 ± 29.34
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 16(n=0,0,1,6)
    9999 ± 9999
    9999 ± 9999
    0.0 ± 99999
    -1.5 ± 1.97
        Change from Baseline at Week 18(n=5,9,0,0)
    -1.4 ± 3.71
    6.9 ± 23.26
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 20(n=0,0,1,5)
    9999 ± 9999
    9999 ± 9999
    0.0 ± 99999
    -1.6 ± 2.61
        Change from Baseline at Week 21(n=4,8,0,0)
    0.0 ± 0.00
    9.9 ± 30.02
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 24(n=5,5,1,5)
    -1.8 ± 4.02
    -0.8 ± 2.17
    0.0 ± 99999
    -1.0 ± 2.00
        Change from Baseline at Week 27(n=4,4,0,0)
    0.0 ± 0.00
    0.3 ± 2.87
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 28(n=0,0,1,5)
    9999 ± 9999
    9999 ± 9999
    0.0 ± 99999
    -1.2 ± 2.39
        Change from Baseline at Week 30(n=4,3,0,0)
    0.0 ± 0.00
    -0.3 ± 2.52
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 32(n=0,0,1,5)
    9999 ± 9999
    9999 ± 9999
    0.0 ± 99999
    5.4 ± 14.35
        Change from Baseline at Week 33(n=4,3,0,0)
    25.0 ± 50.00
    0.0 ± 3.00
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 36(n=4,3,1,4)
    0.3 ± 0.50
    0.0 ± 3.00
    0.0 ± 99999
    -2.0 ± 2.83
        Change from Baseline at Week 39(n=4,3,0,0)
    0.3 ± 0.50
    -1.0 ± 1.73
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 40(n=0,0,0,3)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    -2.7 ± 3.06
        Change from Baseline at Week 42(n=3,3,0,0)
    0.0 ± 0.00
    -0.7 ± 2.08
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 45(n=4,3,0,0)
    0.0 ± 0.00
    0.3 ± 3.51
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 48(n=4,3,0,0)
    0.0 ± 0.00
    0.7 ± 4.04
    9999 ± 9999
    9999 ± 9999
        Change from Baseline at Week 51(n=4,3,0,0)
    0.0 ± 0.00
    0.3 ± 3.51
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Part 1 - Baseline up to 24 weeks plus 12 weeks of safety follow up; Part 2 - Baseline up to 52 weeks plus 12 weeks of safety follow up
    Adverse event reporting additional description
    Safety population, all participants who received at least one dose of study drug and who had at least one post-baseline assessment of safety.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Part 1: Tocilizumab (TCZ) Q2W
    Reporting group description
    		 Participants received tocilizumab intravenous (IV) infusions (12 mg/kg for participants < 30 kg; 8 mg/kg for participants >/= 30 kg) once every other week (Q2W) up to 24 weeks or until occurrence of laboratory abnormalities in Part 1 of the study.

    Reporting group title
    Part 2: TCZ IV 12 mg/kg Q3W/Q4W
    Reporting group description
    		 Participants with weight < 30 kg received tocilizumab IV infusions of 12 mg/kg once every three weeks (Q3W) up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 12 mg/kg once every four weeks (Q4W) up to Week 52 in Part 2 of the study.

    Reporting group title
    Part 2: TCZ IV 8 mg/kg Q3W/Q4W
    Reporting group description
    		 Participants with weight >/= 30 kg received tocilizumab IV infusions of 8 mg/kg Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who completed 5 consecutive infusions of Q3W and had a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality switched to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.

    Serious adverse events
    		 Part 1: Tocilizumab (TCZ) Q2W Part 2: TCZ IV 12 mg/kg Q3W/Q4W Part 2: TCZ IV 8 mg/kg Q3W/Q4W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 7 (14.29%)
    1 / 15 (6.67%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Immune system disorders
    HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    HYPERTRANSAMINASAEMIA
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    PNEUMONIA
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part 1: Tocilizumab (TCZ) Q2W Part 2: TCZ IV 12 mg/kg Q3W/Q4W Part 2: TCZ IV 8 mg/kg Q3W/Q4W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 19 (84.21%)
    7 / 7 (100.00%)
    14 / 15 (93.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    SKIN PAPILLOMA
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    ***NO CODING AVAILABLE***
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    PYREXIA
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    2
    FATIGUE
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    SEASONAL ALLERGY
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    HYPERSENSITIVITY
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    DYSMENORRHOEA
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    CATARRH
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    COUGH
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 7 (14.29%)
    2 / 15 (13.33%)
         occurrences all number
    3
    1
    2
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    1
    0
    2
    RHINORRHOEA
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    TONSILLAR HYPERTROPHY
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    FEAR OF INJECTION
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Investigations
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 7 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    2
    0
    2
    COMPLEMENT FACTOR C4 DECREASED
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    2 / 15 (13.33%)
         occurrences all number
    0
    1
    2
    EOSINOPHIL COUNT INCREASED
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    LIVER FUNCTION TEST INCREASED
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    LYMPHOCYTE MORPHOLOGY ABNORMAL
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    LIVER FUNCTION TEST ABNORMAL
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    ROSEOLOVIRUS TEST POSITIVE
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    VITAMIN D DECREASED
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    ARTHROPOD BITE
         subjects affected / exposed
    3 / 19 (15.79%)
    2 / 7 (28.57%)
    0 / 15 (0.00%)
         occurrences all number
    4
    2
    0
    CONTUSION
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    FALL
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    HEAD INJURY
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    JOINT INJURY
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    LIGAMENT SPRAIN
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    RADIUS FRACTURE
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    SKIN ABRASION
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    2
    TRAUMATIC HAEMATOMA
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    SYNCOPE
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    LEUKOPENIA
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    0
    0
    7
    NEUTROPENIA
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 7 (14.29%)
    3 / 15 (20.00%)
         occurrences all number
    1
    1
    4
    THROMBOCYTOPENIA
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    EAR PAIN
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    EAR SWELLING
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    VERTIGO
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    CATARACT SUBCAPSULAR
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    EYE PAIN
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    VISION BLURRED
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    DIARRHOEA
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 7 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    1
    VOMITING
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    ANAL FISSURE
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    NAUSEA
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatobiliary disorders
    HEPATIC STEATOSIS
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    BLISTER
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    INGROWING NAIL
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    PETECHIAE
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    PRURITUS
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    2
    RASH
         subjects affected / exposed
    3 / 19 (15.79%)
    2 / 7 (28.57%)
    0 / 15 (0.00%)
         occurrences all number
    3
    2
    0
    RASH PAPULAR
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    SKIN EXFOLIATION
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    PRURIGO
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    PAIN IN EXTREMITY
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    POLYARTHRITIS
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    STILL'S DISEASE
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    2 / 15 (13.33%)
         occurrences all number
    0
    1
    2
    SYNOVIAL CYST
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    CONJUNCTIVITIS
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    CYSTITIS
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    3
    0
    1
    EAR INFECTION
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    ENTEROBIASIS
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    2
    2
    0
    INFLUENZA
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    MYCOPLASMA INFECTION
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    NASOPHARYNGITIS
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 7 (14.29%)
    3 / 15 (20.00%)
         occurrences all number
    2
    1
    7
    PARONYCHIA
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    2
    PHARYNGITIS
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 7 (28.57%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    PNEUMONIA
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    3
    1
    0
    RHINITIS
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 7 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    2
    TONSILLITIS
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    3 / 19 (15.79%)
    0 / 7 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    4
    0
    5
    URINARY TRACT INFECTION
         subjects affected / exposed
    2 / 19 (10.53%)
    2 / 7 (28.57%)
    2 / 15 (13.33%)
         occurrences all number
    2
    3
    2
    VIRAL RASH
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    ASYMPTOMATIC BACTERIURIA
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    FUNGAL SKIN INFECTION
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    GASTROENTERITIS
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    IMPETIGO
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    OTITIS EXTERNA
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    OTITIS MEDIA
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    PNEUMONIA MYCOPLASMAL
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    TONSILLITIS STREPTOCOCCAL
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    IRON DEFICIENCY
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    2
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Mar 2013
    In Protocol WA28029 version 2 the Patient-reported outcome measures section was updated to use Child Health Assessment Questionnaire (CHAQ) instead of Juvenile Arthritis Multidimensional Assessment Report (JAMAR). Physician global assessment of disease activity and parent/patient global assessment of overall well-being were updated to use 100 mm horizontal visual analogue scale (VAS).
    07 Jan 2016
    Protocol WA28029 version 3 included the addition of a preliminary screening assessment (Screening Evaluation 1) and a run-in phase of ≤ 24 weeks (Part 1). The proposed modifications were intended to increase enrollment by helping to identify participants with resolved laboratory abnormalities as per protocol criteria in Part 1 on the TCZ Q2W regimen who were eligible to participate in the decreased dose frequency phase (Part 2).

    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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