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    Clinical Trial Results:
    A Phase 2b Randomized, Double-blind, Multicenter, Placebo controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Participants with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2011-002840-29
    Trial protocol
    		 HU   CZ   LV   RO  
    Global end of trial date
    03 Jul 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Jul 2016
    First version publication date
    16 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    38518168ARA2002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01679951
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Antwerpseweg 15-17, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research and Development, ClinicalTrialsEU@its.jnj.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
    03 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the efficacy {as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA)} of JNJ-38518168 at doses of 3, 10, and 30 milligram/day (mg/d) compared with placebo in subjects with active RA despite concomitant methotrexate (MTX) therapy.
    Protection of trial subjects
    Safety assessments include vital signs, general physical examination, adverse events, concomitant medication review, electrocardiograms (ECGs), pregnancy testing, routine laboratory testing, ferritin test, and fasting lipid measurements.
    Background therapy
    		 Stable dose of MTX.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Oct 2012
    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
    Argentina: 4
    Country: Number of subjects enrolled
    Chile: 13
    Country: Number of subjects enrolled
    Colombia: 20
    Country: Number of subjects enrolled
    Czech Republic: 11
    Country: Number of subjects enrolled
    Hungary: 25
    Country: Number of subjects enrolled
    Japan: 31
    Country: Number of subjects enrolled
    Latvia: 13
    Country: Number of subjects enrolled
    Mexico: 42
    Country: Number of subjects enrolled
    Poland: 23
    Country: Number of subjects enrolled
    Romania: 2
    Country: Number of subjects enrolled
    Russian Federation: 42
    Country: Number of subjects enrolled
    Thailand: 16
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    Ukraine: 19
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    272
    EEA total number of subjects
    74
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    236
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted from 31 October 2012 to 03 July 2014.

    Pre-assignment
    Screening details
    		 A total of 649 participants were screened, of which, 272 subjects were randomized.

    Period 1
    Period 1 title
    24 weeks Placebo Controlled Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Daily Placebo from Week 0 to Week 24 (unless early escape at week 16); if early escape, 30 mg/day JNJ-38518168 from Week 16 up to Week 24.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with two placebo tablets, one matching the 3 and 10 mg size, one matching the 30 mg size, daily with or without food.

    Arm title
    		 JNJ–38518168 3 mg
    Arm description
    		 JNJ-38518168 3 mg/day from Week 0 to Week 24 (unless early escape at week 16); if early escape, 30 mg/day JNJ-38518168 from Week 16 up to Week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-38518168 3 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with one JNJ-38518168 3 mg tablet and one placebo tablet daily with or without food.

    Arm title
    		 JNJ-38518168 10 mg
    Arm description
    		 JNJ-38518168 10 mg/day from Week 0 to Week 24 (unless early escape at week 16); if early escape, 30 mg/day JNJ-38518168 from Week 16 up to Week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-38518168 10 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participant administered with one JNJ-38518168 10 mg tablet and one placebo tablet daily with or without food.

    Arm title
    		 JNJ-38518168 30 mg
    Arm description
    		 JNJ-38518168 30 mg/day from Week 0 to Week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-38518168 30 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with one JNJ-38518168 30 mg tablet, one placebo tablet daily with or without food.

    Number of subjects in period 1
    		Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Started
    68
    68
    68
    68
    Completed
    57
    50
    57
    53
    Not completed
    11
    18
    11
    15
         Consent withdrawn by subject
    -
    2
    -
    2
         Physician decision
    -
    -
    -
    1
         Adverse event, non-fatal
    5
    7
    3
    3
         Other
    4
    6
    5
    3
         Lost to follow-up
    -
    -
    -
    1
         Lack of efficacy
    2
    3
    3
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Daily Placebo from Week 0 to Week 24 (unless early escape at week 16); if early escape, 30 mg/day JNJ-38518168 from Week 16 up to Week 24.

    Reporting group title
    JNJ–38518168 3 mg
    Reporting group description
    		 JNJ-38518168 3 mg/day from Week 0 to Week 24 (unless early escape at week 16); if early escape, 30 mg/day JNJ-38518168 from Week 16 up to Week 24.

    Reporting group title
    JNJ-38518168 10 mg
    Reporting group description
    		 JNJ-38518168 10 mg/day from Week 0 to Week 24 (unless early escape at week 16); if early escape, 30 mg/day JNJ-38518168 from Week 16 up to Week 24.

    Reporting group title
    JNJ-38518168 30 mg
    Reporting group description
    		 JNJ-38518168 30 mg/day from Week 0 to Week 24.

    Reporting group values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg Total
    Number of subjects
    		 68 68 68 68 272
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 62 59 60 55 236
        From 65 to 84 years
    		 6 9 8 13 36
        85 years and over
    		 0 0 0 0 0
    Title for AgeContinuous
    Units: Years
        arithmetic mean (standard deviation)
    		 51.5 ( 11.44 ) 52.8 ( 11.39 ) 49.5 ( 13.24 ) 53.8 ( 12.55 ) -
    Title for Gender
    Units: subjects
        Female
    		 57 60 52 51 220
        Male
    		 11 8 16 17 52

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Daily Placebo from Week 0 to Week 24 (unless early escape at week 16); if early escape, 30 mg/day JNJ-38518168 from Week 16 up to Week 24.

    Reporting group title
    JNJ–38518168 3 mg
    Reporting group description
    		 JNJ-38518168 3 mg/day from Week 0 to Week 24 (unless early escape at week 16); if early escape, 30 mg/day JNJ-38518168 from Week 16 up to Week 24.

    Reporting group title
    JNJ-38518168 10 mg
    Reporting group description
    		 JNJ-38518168 10 mg/day from Week 0 to Week 24 (unless early escape at week 16); if early escape, 30 mg/day JNJ-38518168 from Week 16 up to Week 24.

    Reporting group title
    JNJ-38518168 30 mg
    Reporting group description
    		 JNJ-38518168 30 mg/day from Week 0 to Week 24.

    Subject analysis set title
    Modified intent to treat (m-ITT) population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Modified intent-to-treat (m-ITT) population included all the randomized participants who received at least 1 dose of study drug.

    Primary: Change From Baseline in Disease Activity Index Score (DAS28) Using C-Reactive Protein (CRP) at Week 12

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    End point title
    		 Change From Baseline in Disease Activity Index Score (DAS28) Using C-Reactive Protein (CRP) at Week 12
    End point description
    The Disease Activity Index Score (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP (mg/L) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. Modified intent-to-treat (m-ITT) population included all the randomized participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    67
    67
    68
    66
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -1.346 ( 1.45853 )
    -1.2108 ( 1.03667 )
    -1.0509 ( 1.24138 )
    -1.2933 ( 1.20112 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    JNJ–38518168 3 mg v Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.537
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    JNJ-38518168 10 mg v Placebo
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.207
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    JNJ-38518168 30 mg v Placebo
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.82
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Disease Activity Index Score (DAS28) Using C-Reactive Protein (CRP) at Week 24

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    End point title
    		 Change From Baseline in Disease Activity Index Score (DAS28) Using C-Reactive Protein (CRP) at Week 24
    End point description
    The Disease Activity Index Score (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP (mg/L) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. Modified intent-to-treat (m-ITT) population included all the randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    64
    62
    64
    63
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -1.4856 ( 1.37984 )
    -1.3912 ( 1.26788 )
    -1.2642 ( 1.32334 )
    -1.3581 ( 1.30176 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    JNJ–38518168 3 mg v Placebo
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.69
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    JNJ-38518168 10 mg v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.356
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    JNJ-38518168 30 mg v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.593
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from baseline in DAS28 (using Erythrocyte Sedimentation Rate [ESR]) at Week 12 and Week 24

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    End point title
    		 Change from baseline in DAS28 (using Erythrocyte Sedimentation Rate [ESR]) at Week 12 and Week 24
    End point description
    The Disease Activity Index Score (DAS28) based on ESR is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities.The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure & 'n' signifies those participants who were evaluated for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: Unit on a scale
    least squares mean (standard error)
        Change at Week 12 (n=66, 65, 66, 63)
    -1.4075 ( 0.14945 )
    -1.2149 ( 0.15092 )
    -1.205 ( 0.15018 )
    -1.3545 ( 0.15341 )
        Change at Week 24 (n=63, 60, 62, 61)
    -1.6447 ( 0.16111 )
    -1.567 ( 0.1655 )
    -1.5501 ( 0.16369 )
    -1.5638 ( 0.16431 )
    No statistical analyses for this end point

    Secondary: DAS28 (using CRP) response rates at Week 12 and Week 24

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    End point title
    		 DAS28 (using CRP) response rates at Week 12 and Week 24
    End point description
    The Disease Activity Index Score (DAS28) response using C-Reactive Protein (CRP) is a statistically derived index based on both DAS28 score at the visit and improvement from baseline. When DAS28 is <=3.2 and improvement is >1.2, it is considered as "good response". A "moderate" response is defined as improvement >1.2 or improvement is between 0.6 to 1.2 but DAS28 score is <5.1. Otherwise, it is considered as "no response". The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: percentage of participants
    number (not applicable)
        Week 12 (n=67, 67, 68, 66)
    56.7
    61.2
    52.9
    66.7
        Week 24 (n=64, 62, 64, 63)
    67.2
    58.1
    62.5
    58.7
    No statistical analyses for this end point

    Secondary: DAS28 (using ESR) response rates at Week 12 and Week 24

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    End point title
    		 DAS28 (using ESR) response rates at Week 12 and Week 24
    End point description
    The Disease Activity Index Score (DAS28) response using ESR is a statistically derived index based on both DAS28 score at the visit and improvement from baseline. When DAS28 is <=3.2 and improvement is >1.2, it is considered as "good response". A "moderate" response is defined as improvement >1.2 or improvement is between 0.6 to 1.2 but DAS28 score is <5.1. Otherwise, it is considered as "no response". The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: Percentage of participants
    number (not applicable)
        Week 12 (n=66, 65, 66, 63)
    53
    49.2
    57.6
    63.5
        Week 24 (n=63, 60, 62, 61)
    66.7
    61.7
    67.7
    60.7
    No statistical analyses for this end point

    Secondary: DAS28 (using CRP) remission rates at Week 12 and Week 24

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    End point title
    		 DAS28 (using CRP) remission rates at Week 12 and Week 24
    End point description
    DAS28 remission is defined as a DAS28 value of < 2.6 at a visit. The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: percentage of participants
    number (not applicable)
        Week 12 (n=68, 67, 68, 68)
    5.9
    11.9
    10.3
    5.9
        Week 24 (n=64, 62, 64, 65)
    7.8
    9.7
    12.5
    10.8
    No statistical analyses for this end point

    Secondary: DAS28 (using ESR) remission rates at Week 12 and Week 24

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    End point title
    		 DAS28 (using ESR) remission rates at Week 12 and Week 24
    End point description
    DAS28 remission is defined as a DAS28 value of < 2.6 at a visit. The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: percentage of participants
    number (not applicable)
        Week 12 (n=68, 67, 68, 67)
    4.4
    4.5
    4.4
    1.5
        Week 24 (n=64, 62, 64, 64)
    4.7
    6.5
    7.8
    3.1
    No statistical analyses for this end point

    Secondary: American College of Rheumatology (ACR) 20/50/70 response rates at Week 12 and Week 24

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    End point title
    		 American College of Rheumatology (ACR) 20/50/70 response rates at Week 12 and Week 24
    End point description
    An ACR 20/50/70 response is defined as a greater than or equal to 20/50/70 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 20/50/70 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C- reactive protein (CRP). The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: percentage of participants
    number (not applicable)
        Week 12: ACR 20 (n=68, 67, 68, 68)
    36.8
    35.8
    47.1
    36.8
        Week 12: ACR 50 (n=68, 67, 68, 68)
    22.1
    11.9
    16.2
    14.7
        Week 12: ACR 70 (n=68, 67, 68, 68)
    8.8
    6
    2.9
    5.9
        Week 24: ACR 20 (n=64, 62, 64, 65)
    50
    48.4
    51.6
    43.1
        Week 24: ACR 50 (n=64, 62, 64, 65)
    23.4
    22.6
    20.3
    13.8
        Week 24: ACR 70 (n=64, 62, 64, 65)
    7.8
    11.3
    12.5
    4.6
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Statistical analysis for Week 12: ACR 20
    Comparison groups
    JNJ–38518168 3 mg v Placebo
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.909
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Statistical analysis for Week 12: ACR 20
    Comparison groups
    JNJ-38518168 10 mg v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.224
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Statistical analysis for Week 12: ACR 20
    Comparison groups
    JNJ-38518168 30 mg v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Hybrid ACR response at Week 12 and Week 24

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    End point title
    		 Hybrid ACR response at Week 12 and Week 24
    End point description
    The hybrid ACR response is a continuous variable of mean % change in ACR response measures that is limited to an overall score of -100 (maximal worsening) to +100 (maximal improvement) after taking into consideration of ACR20/50/70 response. The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: unit on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=67, 60, 65, 64)
    22.33 ( 32.341 )
    25.72 ( 25.824 )
    23.52 ( 30.933 )
    25.5 ( 27.57 )
        Week 24 (n=61, 53, 61, 57)
    29.82 ( 29.112 )
    31.76 ( 33.49 )
    25.54 ( 35.877 )
    24.04 ( 31.905 )
    No statistical analyses for this end point

    Secondary: ACR/European League Against Rheumatism (EULAR) remission rates at Week 12 and Week 24

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    End point title
    		 ACR/European League Against Rheumatism (EULAR) remission rates at Week 12 and Week 24
    End point description
    ACR/EULAR remission is defined as scores on the tender joint count, swollen joint count, CRP (in mg/dL), and patient global assessment (0-10 scale) are all less than or equal to 1 . The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: percentage of participants
    number (not applicable)
        Week 12 (n=68, 67, 68, 68)
    0
    1.5
    2.9
    2.9
        Week 12 (n=64, 62, 64, 65)
    1.6
    3.2
    4.7
    3.1
    No statistical analyses for this end point

    Secondary: Change from baseline in Simplified Disease Activity Index (SDAI) at Week 12 and Week 24

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    End point title
    		 Change from baseline in Simplified Disease Activity Index (SDAI) at Week 12 and Week 24
    End point description
    The SDAI is the numerical sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment of disease activity (PGA VAS in cm), physician global assessment of disease activity (MDGA VAS in cm) and C-reactive protein (CRP in mg/dL). The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=66, 65, 68, 62)
    -18.0532 ( 18.07508 )
    -15.5735 ( 11.46746 )
    -13.5475 ( 13.89626 )
    -17.1179 ( 15.04138 )
        Week 24 (n=63, 60, 64, 59)
    -19.0301 ( 16.63858 )
    -17.9037 ( 15.00419 )
    -15.4572 ( 15.4755 )
    -17.7375 ( 14.65954 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Clinical Disease Activity Index (CDAI) at Week 12 and Week 24

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    End point title
    		 Change from baseline in Clinical Disease Activity Index (CDAI) at Week 12 and Week 24
    End point description
    The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA, and MDGA. The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: unit on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=66, 65, 68, 62)
    -17.84 ( 17.798 )
    -15.06 ( 11.485 )
    -13.31 ( 13.174 )
    -16.9 ( 14.61 )
        Week 24 (n=63, 60, 64, 59)
    -18.78 ( 16.04 )
    -17.43 ( 14.511 )
    -15.36 ( 15.165 )
    -17.33 ( 14.177 )
    No statistical analyses for this end point

    Secondary: Health Assessment Questionnaire - Disability Index (HAQ-DI) response rate at Week 12 and Week 24

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    End point title
    		 Health Assessment Questionnaire - Disability Index (HAQ-DI) response rate at Week 12 and Week 24
    End point description
    The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). HAQ responders are those subjects who achieve a > 0.22 improvement in HAQ from baseline. The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: Percentage of participants
    number (not applicable)
        Week 12 (n=67, 67, 68, 66)
    53.7
    49.3
    52.9
    60.6
        Week 24 (n=64, 63, 64, 63)
    62.5
    57.1
    57.8
    49.2
    No statistical analyses for this end point

    Secondary: Change from baseline in HAQ-DI score at Week 12 and Week 24

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    End point title
    		 Change from baseline in HAQ-DI score at Week 12 and Week 24
    End point description
    The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    67
    67
    68
    66
    Units: unit on scale
    least squares mean (standard error)
        Week 12 (n=67, 67, 68, 66)
    -0.2322 ( 0.06359 )
    -0.2338 ( 0.06352 )
    -0.2466 ( 0.06329 )
    -0.3674 ( 0.06424 )
        Week 24 (n=64, 63, 64, 63)
    -0.2892 ( 0.06969 )
    -0.3167 ( 0.07043 )
    -0.2823 ( 0.07023 )
    -0.2516 ( 0.07068 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Statistical analysis for Week 12
    Comparison groups
    JNJ–38518168 3 mg v Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.988
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Statistical analysis for Week 12
    Comparison groups
    JNJ-38518168 10 mg v Placebo
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.874
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Statistical analysis for Week 12
    Comparison groups
    JNJ-38518168 30 mg v Placebo
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.136
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percent change from baseline in ESR levels at Week 12 and Week 24

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    End point title
    		 Percent change from baseline in ESR levels at Week 12 and Week 24
    End point description
    Erythrocyte sedimentation rate (ESR) is a lab test that measures overall inflammation level. The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n=67, 65, 66, 64)
    -2.65 ( 61.922 )
    -0.51 ( 60.462 )
    -12.1 ( 42.836 )
    -15.11 ( 34.324 )
        Week 24 (n=63, 61, 62, 62)
    -6.83 ( 61.901 )
    -16.98 ( 42.513 )
    -4.12 ( 111.822 )
    -12.37 ( 46.144 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline in ACR components at Week 12 and Week 24

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    End point title
    		 Percent change from baseline in ACR components at Week 12 and Week 24
    End point description
    The ACR components include tender (of 68 joints) and swollen (of 66 joints) joint counts, patient's assessment of pain (PAP) (0-10 cm VAS), patient's global assessment of disease activity (Patients GADA) (0-10 cm VAS), physician's global assessment of disease activity (Physicians GADA) (0-10 cm VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). The m-ITT population included all the randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 Placebo JNJ–38518168 3 mg JNJ-38518168 10 mg JNJ-38518168 30 mg
    Number of subjects analysed
    68
    67
    68
    68
    Units: percent change
    arithmetic mean (standard deviation)
        W-12: Swollen Joints (n=68, 67, 68, 68)
    -47.09 ( 41.962 )
    -42.61 ( 38.549 )
    -38.45 ( 42.792 )
    -49.16 ( 36.086 )
        W-24: Swollen Joints (n=64, 63, 64, 65)
    -46.57 ( 46.368 )
    -47.18 ( 44.745 )
    -43.83 ( 50.12 )
    -49.19 ( 40.676 )
        W-12: Tender Joint (n=68, 67, 68, 68)
    -42.01 ( 38.653 )
    -39.34 ( 40.908 )
    -34.08 ( 52.916 )
    -42.8 ( 46.532 )
        W-24: Tender Joint (n=64, 63, 64, 65)
    -49.16 ( 37.893 )
    -43.63 ( 45.341 )
    -42.85 ( 57.755 )
    -37.6 ( 59.481 )
        W-12: PAP (67, 67,68,66)
    -3.77 ( 69.675 )
    -20.87 ( 68.219 )
    -11.05 ( 90.822 )
    -14.34 ( 86.633 )
        W-24: PAP (64,63,64,63)
    -18.68 ( 58.988 )
    -25.35 ( 62.807 )
    -12.09 ( 87.988 )
    -9.75 ( 84.198 )
        W-12: Patients-GADA (67, 67,68,66)
    -6.83 ( 65.368 )
    5.34 ( 163.888 )
    -21.56 ( 41.004 )
    -24.48 ( 43.78 )
        W-24: Patients-GADA (64,63,64,63)
    -19.22 ( 64.002 )
    1.64 ( 157.848 )
    -19.39 ( 52.087 )
    -19.42 ( 59.116 )
        W-12: Physicians-GADA (66, 65,68,62)
    -35.76 ( 40.718 )
    -37.16 ( 37.12 )
    -38.5 ( 35.633 )
    -42.83 ( 34.837 )
        W-24: Physicians-GADA (63,61,64,59)
    -38 ( 38.64 )
    -39.91 ( 40.962 )
    -39.91 ( 40.301 )
    -40.86 ( 39.112 )
        W-12: HAQ-DI (67,65,66,64)
    -6.56 ( 53.466 )
    -9.1 ( 66.147 )
    -19.01 ( 39.831 )
    -21.13 ( 40.729 )
        W-24: HAQ-DI (64,61,62,61)
    -6.23 ( 92.169 )
    -11.73 ( 100.462 )
    -18.22 ( 55.337 )
    -12.31 ( 47.954 )
        W-12: CRP (68,67,68,68)
    89.62 ( 447.216 )
    44.41 ( 356.124 )
    83.54 ( 477.163 )
    4.61 ( 86.846 )
        W-24: CRP (64,63,64,65)
    50.11 ( 393.99 )
    44.48 ( 360.594 )
    52.03 ( 309.206 )
    0.92 ( 74.172 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through week 28
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    JNJ-38518168 3 mg
    Reporting group description
    		 Participants received JNJ-38518168 3 mg/day from Week 0 to Week 24 (unless early escape at week 16).

    Reporting group title
    JNJ-38518168 10 mg
    Reporting group description
    		 Participants received JNJ-38518168 10 mg once daily from week 0 to week 24 (unless early escape at week 16).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo daily from Week 0 to Week 24 (unless early escape at week 16).

    Reporting group title
    Early escape to JNJ- 38518168 30 mg
    Reporting group description
    		 Subjects who entered early escape at week 16 and received JNJ-38518168 dose of 30 mg per day from week 16 to week 24.

    Reporting group title
    JNJ-38518168 30 mg
    Reporting group description
    		 Participants received JNJ-38518168 30 mg once daily from week 0 to week 24.

    Serious adverse events
    		 JNJ-38518168 3 mg JNJ-38518168 10 mg Placebo Early escape to JNJ- 38518168 30 mg JNJ-38518168 30 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 67 (4.48%)
    5 / 68 (7.35%)
    5 / 68 (7.35%)
    0 / 19 (0.00%)
    2 / 68 (2.94%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Lipase Increased
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Papilloma
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle Fracture
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibula Fracture
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive Crisis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis Superficial
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric Ulcer Haemorrhage
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis Chronic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 68 (1.47%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic Ketoacidosis
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
    0 / 19 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 JNJ-38518168 3 mg JNJ-38518168 10 mg Placebo Early escape to JNJ- 38518168 30 mg JNJ-38518168 30 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 67 (32.84%)
    22 / 68 (32.35%)
    24 / 68 (35.29%)
    6 / 19 (31.58%)
    27 / 68 (39.71%)
    Injury, poisoning and procedural complications
    Tendon Rupture
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 19 (5.26%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 67 (1.49%)
    6 / 68 (8.82%)
    2 / 68 (2.94%)
    0 / 19 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    1
    6
    2
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 67 (1.49%)
    3 / 68 (4.41%)
    3 / 68 (4.41%)
    0 / 19 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    1
    3
    3
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 68 (2.94%)
    1 / 68 (1.47%)
    1 / 19 (5.26%)
    3 / 68 (4.41%)
         occurrences all number
    1
    2
    1
    1
    1
    Diarrhoea
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 68 (1.47%)
    1 / 68 (1.47%)
    0 / 19 (0.00%)
    8 / 68 (11.76%)
         occurrences all number
    2
    1
    1
    0
    8
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 19 (5.26%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 19 (5.26%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 19 (5.26%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle Spasms
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    0 / 19 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    2
    0
    0
    0
    3
    Rheumatoid Arthritis
         subjects affected / exposed
    3 / 67 (4.48%)
    4 / 68 (5.88%)
    2 / 68 (2.94%)
    0 / 19 (0.00%)
    2 / 68 (2.94%)
         occurrences all number
    3
    4
    2
    0
    2
    Rheumatoid Nodule
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 19 (5.26%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 67 (5.97%)
    3 / 68 (4.41%)
    2 / 68 (2.94%)
    0 / 19 (0.00%)
    4 / 68 (5.88%)
         occurrences all number
    4
    3
    2
    0
    4
    Influenza
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 68 (1.47%)
    1 / 68 (1.47%)
    1 / 19 (5.26%)
    0 / 68 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 67 (2.99%)
    5 / 68 (7.35%)
    7 / 68 (10.29%)
    0 / 19 (0.00%)
    8 / 68 (11.76%)
         occurrences all number
    2
    5
    7
    0
    8
    Pharyngitis
         subjects affected / exposed
    3 / 67 (4.48%)
    1 / 68 (1.47%)
    1 / 68 (1.47%)
    0 / 19 (0.00%)
    2 / 68 (2.94%)
         occurrences all number
    3
    1
    1
    0
    2
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    3 / 68 (4.41%)
    0 / 19 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    0
    3
    0
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    5 / 67 (7.46%)
    4 / 68 (5.88%)
    3 / 68 (4.41%)
    0 / 19 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    5
    4
    3
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    4 / 67 (5.97%)
    4 / 68 (5.88%)
    2 / 68 (2.94%)
    0 / 19 (0.00%)
    5 / 68 (7.35%)
         occurrences all number
    4
    4
    2
    0
    5
    Viral Pharyngitis
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 19 (5.26%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 68 (0.00%)
    1 / 68 (1.47%)
    1 / 19 (5.26%)
    1 / 68 (1.47%)
         occurrences all number
    0
    0
    1
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2013
    The amendment updated information regarding drug-drug interactions (DDIs), criteria for subject enrollment, and the list of prohibited medications, based on preliminary PK results from the 38518168ARA1003 DDI study with ketoconazole. In addition, editorial changes were also made for clarity throughout the protocol.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    03 Jul 2014
    The decision was made to prematurely discontinue this trial due to lack of efficacy.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The trial was discontinued due to lack of efficacy.
    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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