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    Clinical Trial Results:
    A Multicenter, Double-Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Humanized Anti-TNFa Antibody, in Subjects With Active Polyarticular Juvenile Idiopathic Arthritis (JIA) Despite Standard Therapy

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2009-015019-42
    Trial protocol
    		 DE   AT   BE   LT   FI   Outside EU/EEA  
    Global end of trial date
    27 May 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Jul 2016
    First version publication date
    29 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CNTO148JIA3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01230827
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Biologics B.V.
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands,
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, +31 71 524 2166, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, +31 71 524 2166, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000265-PIP01-08
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the clinical efficacy of subcutaneous (SC) administration of golimumab in pediatric subjects (ages 2 to less than [<]18 years) with polyarticular juvenile idiopathic arthritis (pJIA) manifested by more than equal to (>=)5 joints with active arthritis despite methotrexate (MTX) therapy for >=3 months.
    Protection of trial subjects
    In this study, safety evaluations included monitoring of adverse events (AEs), clinical laboratory tests, vital sign measurements and injection-site reaction evaluations. Tuberculosis evaluations, including QuantiFERON-TB Gold test and Mantoux tuberculin skin test were performed. Serum samples for the determination of the presence of antinuclear antibodies/anti-double-stranded DNA antibodies were also collected.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Brazil: 8
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    Germany: 49
    Country: Number of subjects enrolled
    Finland: 1
    Country: Number of subjects enrolled
    Lithuania: 10
    Country: Number of subjects enrolled
    Mexico: 22
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Poland: 7
    Country: Number of subjects enrolled
    Russian Federation: 29
    Country: Number of subjects enrolled
    United States: 21
    Worldwide total number of subjects
    173
    EEA total number of subjects
    86
    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)
    83
    Adolescents (12-17 years)
    90
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted between 01 December 2010 to 27 May 2014 and 173 subjects were enrolled in the study.

    Pre-assignment
    Screening details
    		 In this study, 173 enrolled subjects received golimumab 30 milligram per square meter (mg/m^2) + MTX at Week 0. A total of 154 subjects were randomized to treatment at Week 16; 76 were randomized to receive placebo + MTX and 78 were randomized to receive golimumab 30 mg/m^2 + methotrexate (MTX).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group I: Enrolled subjects who did not enter RW period
    Arm description
    		 Enrolled subjects who did not enter randomized withdrawal period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an ACR Ped 30 response) at Week 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    CNTO148
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Enrolled subjects who did not enter randomized withdrawal period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an ACR Ped 30 response) at Week 16.

    Arm title
    		 Group II: Placebo SC + MTX
    Arm description
    		 Subjects who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + MTX at Week 16 and continued on placebo + MTX after Week 48 through the final DBL (Data Base Lock).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + MTX at Week 16 and continued on placebo + MTX after Week 48 through the final DBL (Data Base Lock).

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + MTX at Week 16 and continued on placebo + MTX after Week 48 through the final DBL (Data Base Lock).

    Arm title
    		 Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX
    Arm description
    		 Subjects who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study after Week 48 through the final DBL (Data Base Lock).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    CNTO148
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study after Week 48 through the final DBL (Data Base Lock).

    Investigational medicinal product name
    Methotrextae
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study after Week 48 through the final DBL (Data Base Lock).

    Arm title
    		 Group IV: Golimumab + MTX
    Arm description
    		 Subjects were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX after Week 48 through the final DBL (Data Base Lock).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    CNTO148
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX after Week 48 through the final DBL (Data Base Lock).

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX after Week 48 through the final DBL (Data Base Lock).

    Number of subjects in period 1
    		Group I: Enrolled subjects who did not enter RW period Group II: Placebo SC + MTX Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX Group IV: Golimumab + MTX
    Started
    19
    11
    65
    78
    Completed
    0
    0
    0
    0
    Not completed
    19
    11
    65
    78
         Consent withdrawn by subject
    1
    -
    3
    2
         Recovery
    -
    6
    -
    -
         Adverse event
    4
    2
    3
    7
         Study terminated by sponsor
    -
    2
    56
    63
         Lost to follow-up
    -
    -
    1
    3
         Lack of efficacy
    14
    1
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group I: Enrolled subjects who did not enter RW period
    Reporting group description
    		 Enrolled subjects who did not enter randomized withdrawal period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an ACR Ped 30 response) at Week 16.

    Reporting group title
    Group II: Placebo SC + MTX
    Reporting group description
    		 Subjects who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + MTX at Week 16 and continued on placebo + MTX after Week 48 through the final DBL (Data Base Lock).

    Reporting group title
    Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX
    Reporting group description
    		 Subjects who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study after Week 48 through the final DBL (Data Base Lock).

    Reporting group title
    Group IV: Golimumab + MTX
    Reporting group description
    		 Subjects were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX after Week 48 through the final DBL (Data Base Lock).

    Reporting group values
    		 Group I: Enrolled subjects who did not enter RW period Group II: Placebo SC + MTX Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX Group IV: Golimumab + MTX Total
    Number of subjects
    		 19 11 65 78 173
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 8 2 34 39 83
        Adolescents (12-17 years)
    		 11 9 31 39 90
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65 to 84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.8 ± 4.4 13.6 ± 2.2 10.7 ± 4.66 11.1 ± 4.43 -
    Title for Gender
    Units: subjects
        Female
    		 15 6 51 59 131
        Male
    		 4 5 14 19 42

    End points

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    End points reporting groups
    Reporting group title
    Group I: Enrolled subjects who did not enter RW period
    Reporting group description
    		 Enrolled subjects who did not enter randomized withdrawal period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an ACR Ped 30 response) at Week 16.

    Reporting group title
    Group II: Placebo SC + MTX
    Reporting group description
    		 Subjects who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + MTX at Week 16 and continued on placebo + MTX after Week 48 through the final DBL (Data Base Lock).

    Reporting group title
    Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX
    Reporting group description
    		 Subjects who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study after Week 48 through the final DBL (Data Base Lock).

    Reporting group title
    Group IV: Golimumab + MTX
    Reporting group description
    		 Subjects were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX after Week 48 through the final DBL (Data Base Lock).

    Subject analysis set title
    Participants Allocated to Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16.

    Subject analysis set title
    Participants Allocated to Golimumab
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16.

    Primary: Percentage of Participants With American College of Rheumatology (ACR Ped) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48

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    End point title
    		 Percentage of Participants With American College of Rheumatology (ACR Ped) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48
    End point description
    Percentage of participants with ACR Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Ped Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate. ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.
    End point type
    Primary
    End point timeframe
    Week 16 through Week 48
    End point values
    		 Participants Allocated to Placebo Participants Allocated to Golimumab
    Number of subjects analysed
    76
    78
    Units: percentage of participants
        number (not applicable)
    52.6
    59
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Participants Allocated to Placebo v Participants Allocated to Golimumab
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.414
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Participants With American College of Rheumatology (ACR Ped) 30 Response at Week 48

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    End point title
    		 Percentage of Participants With American College of Rheumatology (ACR Ped) 30 Response at Week 48
    End point description
    Percentage of participants with ACR Ped 30 response at Week 48 was calculated as number of participants with ACR 30 response at Week 48 divided by number of participants randomized. ACR Ped 30 response was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire and erythrocyte sedimentation rate. ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.
    End point type
    Secondary
    End point timeframe
    Week 16 through Week 48
    End point values
    		 Participants Allocated to Placebo Participants Allocated to Golimumab
    Number of subjects analysed
    76
    78
    Units: percentage of participants
        number (not applicable)
    55.3
    52.6
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Participants Allocated to Placebo v Participants Allocated to Golimumab
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.751
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Participants With American College of Rheumatology (ACR Ped) 30 Response Who Had Inactive Disease at Week 48

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    End point title
    		 Percentage of Participants With American College of Rheumatology (ACR Ped) 30 Response Who Had Inactive Disease at Week 48
    End point description
    Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; normal erythrocyte sedimentation rate or C-reactive protein, no active uveitis (eye disease); physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes. ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.
    End point type
    Secondary
    End point timeframe
    Week 16 through Week 48
    End point values
    		 Participants Allocated to Placebo Participants Allocated to Golimumab
    Number of subjects analysed
    76
    78
    Units: Percentage of Participants
        number (not applicable)
    27.6
    39.7
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Participants Allocated to Placebo v Participants Allocated to Golimumab
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.119
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48

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    End point title
    		 Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48
    End point description
    Clinical remission while on medication for JIA is defined as inactive disease at each visit for a period of 6 months or more while on medication. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes. ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.
    End point type
    Secondary
    End point timeframe
    Week 16 through Week 48
    End point values
    		 Participants Allocated to Placebo Participants Allocated to Golimumab
    Number of subjects analysed
    76
    78
    Units: percentage of participants
        number (not applicable)
    11.8
    12.8
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Participants Allocated to Golimumab v Participants Allocated to Placebo
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.848
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to Database Lock (DBL) (approximately Week 184)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Group I: Enrolled subjects who did not enter RW period
    Reporting group description
    		 Enrolled subjects who did not enter randomized withdrawal period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an ACR Ped 30 response) at Week 16.

    Reporting group title
    Group II: Placebo SC + MTX
    Reporting group description
    		 Subjects who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + MTX at Week 16 and continued on placebo + MTX after Week 48 through the final DBL (Data Base Lock).

    Reporting group title
    Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX
    Reporting group description
    		 Subjects who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study after Week 48 through the final DBL (Data Base Lock).

    Reporting group title
    Group IV: Golimumab + MTX
    Reporting group description
    		 Subjectswere treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX after Week 48 through the final DBL (Data Base Lock).

    Serious adverse events
    		 Group I: Enrolled subjects who did not enter RW period Group II: Placebo SC + MTX Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX Group IV: Golimumab + MTX
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 19 (21.05%)
    2 / 10 (20.00%)
    15 / 66 (22.73%)
    18 / 78 (23.08%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somatoform disorder neurologic
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Demyelination
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Immune thrombocytopenic purpura
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoid tissue hyperplasia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Eye pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Gallbladder oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    1 / 66 (1.52%)
    2 / 78 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Juvenile idiopathic arthritis
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 10 (10.00%)
    6 / 66 (9.09%)
    8 / 78 (10.26%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendiceal abscess
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scarlet fever
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin bacterial infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group I: Enrolled subjects who did not enter RW period Group II: Placebo SC + MTX Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX Group IV: Golimumab + MTX
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 19 (73.68%)
    9 / 10 (90.00%)
    60 / 66 (90.91%)
    68 / 78 (87.18%)
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    2 / 78 (2.56%)
         occurrences all number
    1
    0
    1
    2
    Influenza like illness
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    8 / 66 (12.12%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    8
    0
    Injection site reaction
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    15 / 66 (22.73%)
    9 / 78 (11.54%)
         occurrences all number
    0
    0
    24
    10
    Serositis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    3 / 66 (4.55%)
    10 / 78 (12.82%)
         occurrences all number
    1
    0
    6
    14
    Dyspnoea
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    2 / 66 (3.03%)
    2 / 78 (2.56%)
         occurrences all number
    1
    0
    2
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 10 (20.00%)
    7 / 66 (10.61%)
    2 / 78 (2.56%)
         occurrences all number
    1
    2
    11
    2
    Rhinorrhoea
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    3
    1
    Upper respiratory tract congestion
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    3 / 78 (3.85%)
         occurrences all number
    1
    0
    0
    3
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Emotional distress
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    3 / 66 (4.55%)
    8 / 78 (10.26%)
         occurrences all number
    1
    0
    3
    9
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    7 / 78 (8.97%)
         occurrences all number
    0
    0
    1
    8
    C-reactive protein increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    1
    0
    0
    3
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    3 / 66 (4.55%)
    6 / 78 (7.69%)
         occurrences all number
    0
    1
    4
    6
    Neutrophil count increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    0
    1
    Transaminases increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Clavicle fracture
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Contusion
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    3 / 66 (4.55%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    3
    2
    Foot fracture
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    1 / 66 (1.52%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    1
    1
    Ligament sprain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    2 / 66 (3.03%)
    2 / 78 (2.56%)
         occurrences all number
    0
    1
    3
    2
    Injury
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Traumatic fracture
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    10 / 66 (15.15%)
    15 / 78 (19.23%)
         occurrences all number
    1
    0
    20
    21
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    4 / 78 (5.13%)
         occurrences all number
    0
    0
    1
    5
    Neutropenia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    4 / 66 (6.06%)
    3 / 78 (3.85%)
         occurrences all number
    0
    0
    4
    4
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    5 / 66 (7.58%)
    7 / 78 (8.97%)
         occurrences all number
    1
    0
    7
    13
    Erythema of eyelid
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Visual impairment
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eyelid oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 10 (20.00%)
    8 / 66 (12.12%)
    7 / 78 (8.97%)
         occurrences all number
    0
    3
    11
    8
    Abdominal pain upper
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    10 / 66 (15.15%)
    2 / 78 (2.56%)
         occurrences all number
    0
    0
    13
    3
    Aphthous stomatitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    4 / 66 (6.06%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    5
    0
    Constipation
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    5 / 66 (7.58%)
    2 / 78 (2.56%)
         occurrences all number
    0
    0
    5
    2
    Diarrhoea
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    9 / 66 (13.64%)
    7 / 78 (8.97%)
         occurrences all number
    0
    0
    16
    9
    Dental caries
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    4 / 78 (5.13%)
         occurrences all number
    0
    0
    1
    4
    Haemorrhoids
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    2 / 19 (10.53%)
    2 / 10 (20.00%)
    7 / 66 (10.61%)
    11 / 78 (14.10%)
         occurrences all number
    2
    3
    8
    12
    Peptic ulcer
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    13 / 66 (19.70%)
    12 / 78 (15.38%)
         occurrences all number
    0
    0
    18
    15
    Hepatobiliary disorders
    Hepatomegaly
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 10 (10.00%)
    3 / 66 (4.55%)
    2 / 78 (2.56%)
         occurrences all number
    1
    1
    4
    2
    Alopecia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    2 / 78 (2.56%)
         occurrences all number
    1
    0
    1
    2
    Dermatitis atopic
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    4 / 78 (5.13%)
         occurrences all number
    0
    0
    1
    5
    Eczema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    4 / 78 (5.13%)
         occurrences all number
    0
    0
    1
    4
    Pruritus
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Urticaria
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 10 (0.00%)
    4 / 66 (6.06%)
    6 / 78 (7.69%)
         occurrences all number
    2
    0
    4
    8
    Rash generalised
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    3 / 78 (3.85%)
         occurrences all number
    1
    0
    1
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    6 / 66 (9.09%)
    8 / 78 (10.26%)
         occurrences all number
    0
    2
    6
    9
    Arthritis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    2 / 66 (3.03%)
    3 / 78 (3.85%)
         occurrences all number
    1
    0
    2
    8
    Foot deformity
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    1
    0
    0
    2
    Back pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    2 / 66 (3.03%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    2
    1
    Juvenile idiopathic arthritis
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 10 (10.00%)
    11 / 66 (16.67%)
    18 / 78 (23.08%)
         occurrences all number
    2
    1
    12
    27
    Muscle spasms
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    1 / 66 (1.52%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    1
    1
    Pain in extremity
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 10 (10.00%)
    3 / 66 (4.55%)
    6 / 78 (7.69%)
         occurrences all number
    1
    2
    3
    6
    Synovitis
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 10 (20.00%)
    1 / 66 (1.52%)
    1 / 78 (1.28%)
         occurrences all number
    0
    2
    1
    1
    Tenosynovitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tendon pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    4 / 66 (6.06%)
    6 / 78 (7.69%)
         occurrences all number
    1
    0
    4
    10
    Acute tonsillitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    3 / 66 (4.55%)
    2 / 78 (2.56%)
         occurrences all number
    0
    1
    5
    2
    Gastroenteritis
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 10 (10.00%)
    6 / 66 (9.09%)
    8 / 78 (10.26%)
         occurrences all number
    3
    1
    6
    10
    Gastroenteritis viral
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    6 / 66 (9.09%)
    2 / 78 (2.56%)
         occurrences all number
    0
    0
    6
    2
    Gingivitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    1 / 66 (1.52%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Influenza
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    2 / 66 (3.03%)
    7 / 78 (8.97%)
         occurrences all number
    0
    0
    2
    10
    Laryngitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 10 (10.00%)
    0 / 66 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    0
    1
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 19 (10.53%)
    3 / 10 (30.00%)
    18 / 66 (27.27%)
    21 / 78 (26.92%)
         occurrences all number
    2
    3
    39
    35
    Otitis media
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    5 / 66 (7.58%)
    6 / 78 (7.69%)
         occurrences all number
    0
    0
    9
    12
    Paronychia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    2 / 66 (3.03%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    2
    1
    Pharyngitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    6 / 66 (9.09%)
    9 / 78 (11.54%)
         occurrences all number
    0
    0
    7
    10
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    1
    0
    0
    2
    Respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    9 / 66 (13.64%)
    10 / 78 (12.82%)
         occurrences all number
    1
    0
    13
    14
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    4 / 66 (6.06%)
    2 / 78 (2.56%)
         occurrences all number
    0
    0
    4
    3
    Rhinitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    4 / 66 (6.06%)
    10 / 78 (12.82%)
         occurrences all number
    0
    0
    10
    15
    Sinusitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    7 / 66 (10.61%)
    8 / 78 (10.26%)
         occurrences all number
    0
    0
    8
    10
    Tonsillitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    6 / 66 (9.09%)
    8 / 78 (10.26%)
         occurrences all number
    0
    0
    8
    12
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 10 (30.00%)
    25 / 66 (37.88%)
    20 / 78 (25.64%)
         occurrences all number
    1
    4
    47
    46
    Urinary tract infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    1 / 66 (1.52%)
    4 / 78 (5.13%)
         occurrences all number
    0
    0
    1
    4
    Viral infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 10 (0.00%)
    4 / 66 (6.06%)
    2 / 78 (2.56%)
         occurrences all number
    0
    0
    6
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 10 (0.00%)
    0 / 66 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Apr 2010
    The first amendment included the following changes: 1) At the time of the Week 48 database lock (DBL) subjects randomized to placebo who were not in clinical remission began receiving golimumab 30 mg/m^2 SC and subjects randomized to placebo who were already in clinical remission, were discontinued from the study; 2) only the 1 milliliter (mL) single-use prefilled syringe (PFS) for SC administration was supplied and not the 0.5 mL PFS containing 50 mg of golimumab; 3) text was clarified to indicate that the determination of flare of disease (according to JIA pediatric criteria for flare) was based on comparison of criteria with Week 16 values; 4) a change from independent joint assessor (IJA) to consistent joint assessor was necessary as the Sponsor was unable to obtain IJAs for all sites in a timely manner.
    10 Jun 2010
    The second amendment included that the total maximum blood volume (mL) to be collected from each subject per visit was appropriately adjusted for a 2.5 mL serum separator tube due to the lack of availability of 2.0 mL serum separator tubes.
    03 Aug 2010
    The third amendment included the following key changes: The consistent joint assessor’s responsibilities were clarified.
    28 Oct 2010
    The fourth amendment included the following key changes: 1) Routine laboratory analyses and ESR evaluations were rescheduled; 2) ESR evaluations, routine laboratory analyses and QuantiFERON Gold TB tests were rescheduled; 3) amended description of interim analyses (Response at Week 8); 4) revised inclusion criteria for the use of MTX (dosage), immunizations, and previous use of anti-TNFα agents, and clarified TB screening criteria; 5) revised exclusion criteria for chest radiographs and history of hepatitis B infection, and added additional exclusion criteria for hepatitis B testing and the use of anti-TNFα agents; 6) the use of MTX (dosage) during the course of the study was clarified and added additional text regarding the use of intramuscular administration of corticosteroids; 7) revised total blood volume to be collected; 8) clarified inactive diseases and added serum hepatitis B virus testing; 9) revised statistical rules for the determination of treatment failures.
    23 Nov 2010
    The fifth amendment included the following key changes: 1) The numbering for inclusion criterion 8 was revised. Inclusion criterion 26 was deleted, but the content was retained under criterion 20c; 2) revised the total blood volume to be collected.
    07 Mar 2011
    The sixth amendment included the following key changes: 1) Revised the chest x-ray schedule from Week 108 to Week 104 to correct an inadvertent check mark 2) text was added to indicate how concomitant medication would be adjusted for subjects with a worsening of clinical status between Weeks 0 and 16; 3) the sponsor clarified that golimumab dose would be adjusted by BSA for each subject for all q4w doses and also clarified that golimumab dose decreases or increases below or above 30 mg/m^2 based upon BSA will not be permitted; 4) listed the evaluations to be performed and the forms that need to be filled at every unscheduled visit; 5) subjects who developed study agent-related bronchospasm requiring bronchodilator treatment were to be permanently discontinued from further treatment with study agent; 6) clarified evaluation of uveitis; 7) clarified efficacy evaluations conducted at all times and at screening.
    31 May 2012
    The seventh amendment included the following changes: 1) The name of the sponsor for this protocol was changed to Janssen Research & Development; 2) added clarification of the minimum weekly dosage of MTX for subjects who were ≥1.67 m^2; 3) made clarification on the use of corticosteroids and MTX after Week 16 or in the event of a flare; 4) the number of joints to be evaluated was revised to include subtalar joints (1 in each foot) on the advice of the Pediatric Rheumatology International Trials Organisation/Pediatric Rheumatology Collaborative Study Group; 5) subjects were to be observed for at least 30 minutes after the SC administration of study agent for symptoms of injection-site reaction; 6) corrections were made to the PK sampling schedule for consistency; 7) The Annual Safety Report was replaced by the Development Safety Update Report per Health Authority direction; 8) subjects were identified by subject ID and date of birth in addition to anonymous initials.
    20 Feb 2013
    The eighth amendment included the following key changes: 1) The use of DMARDs, corticosteroids, and NSAIDs between Weeks 16 and 48 was clarified; 2) the weekly commercial MTX dosage to be administered was clarified.
    18 Jun 2013
    The ninth amendment included the following key changes: 1) The long-term extension of this study was extended by 104 weeks; 2) updated the total volume of blood to be collected; 3) updated the list regarding inactive disease was updated; 4) minor editorial changes were made.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    27 May 2014
    Trial was discontinued since the primary and major secondary endpoints were not met.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was planned to continue to Week 256; however, the primary and major secondary efficacy endpoints at Week 48 were not met and the sponsor decided to discontinue the study prematurely.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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