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    Clinical Trial Results:
    A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy.

    Summary
    EudraCT number
    		 2012-003629-40
    Trial protocol
    		 CZ  
    Global end of trial date
    26 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 May 2016
    First version publication date
    25 May 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CNTO6785ARA2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01909427
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janseen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, BEERSE, Belgium, 2340
    Public contact
    Clinical Registry Group, Janseen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janseen-Cilag International NV, 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
    26 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the efficacy of CNTO6785 on the signs and symptoms in subjects with active Rheumatoid Arthritis (RA) compared with Placebo despite concomitant Methotrexate (MTX) Therapy
    Protection of trial subjects
    To protect the subjects in the study, a series of risk management actions were considered, excluding subjects with potential risks entering into the study, designed the discontinuation criteria during the study, applying for the comprehensive medical monitoring of clinical data on an ongoing basis and an internal Data Reviewing Committee to review unblinded data during the study ongoing. Safety monitoring also include assessing Adverse Events, brief physical examinations, vital signs measurements, electrocardiogram (ECG) measurements, signs and symptoms of active tuberculosis (TB), laboratory assessments including chemistry, hematology and urinalysis during the study.
    Background therapy
    		 Methotrexate
    Evidence for comparator
    		 Placebo
    Actual start date of recruitment
    09 May 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 47
    Country: Number of subjects enrolled
    Colombia: 23
    Country: Number of subjects enrolled
    Czech Republic: 18
    Country: Number of subjects enrolled
    Philippines: 20
    Country: Number of subjects enrolled
    Poland: 62
    Country: Number of subjects enrolled
    Russian Federation: 73
    Country: Number of subjects enrolled
    Thailand: 14
    Worldwide total number of subjects
    257
    EEA total number of subjects
    80
    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)
    228
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 257 male and female subjects with active Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy were enrolled in the study.

    Pre-assignment
    Screening details
    		 This study consist of Screening phase from Week -6 to Week 0 followed by treatment phase from Week 0 to Week 28, and follow up phase from Week 28 to Week 38.

    Period 1
    Period 1 title
    Double Blind Treatment Phase (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
    		 Subjects received Placebo as Subcutaneous injection (SC) at Week 0, 4, 8 and 12. From Week 16, subjects started to receive 200 mg of CNTO6785 SC every 4 weeks through week 28 named as Placebo-CNTO6785 200 mg group thereafter in this report.
    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 administered with Placebo subcutaneous injections (SC) every 4 weeks through Week 12. From Week 16, subjects started receiving CNTO6785 200 mg SC every 4 weeks through Week 28, also named the arm title as Placebo-CNTO6785 200 mg.

    Arm title
    		 CNTO6785, 15 mg
    Arm description
    		 Subjects received 15 mg of CNTO6785 as SC every 4 weeks through Week 28.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CNTO6785 15 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects administered with CNTO6785 15 mg SC every 4 weeks through Week 28.

    Arm title
    		 CNTO6785, 50 mg
    Arm description
    		 Subjects received 50 mg of CNTO6785 as SC every 4 weeks through Week 28.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CNTO6785 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects administered with CNTO6785 50 mg SC every 4 weeks through Week 28.

    Arm title
    		 CNTO6785,100mg
    Arm description
    		 Subjects received 100 mg of CNTO6785 as SC every 4 weeks through Week 28.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CNTO6785 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects administered with CNTO6785 100 mg SC every 4 weeks through Week 28.

    Arm title
    		 CNTO6785, 200mg
    Arm description
    		 Subjects received 200 mg of CNTO6785 as SC every 4 weeks through Week 28.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CNTO6785 200mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects administered with CNTO 6785 200 mg SC every 4 weeks through Week 28.

    Number of subjects in period 1
    		Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg
    Started
    51
    52
    51
    51
    52
    Completed
    48
    50
    48
    48
    48
    Not completed
    3
    2
    3
    3
    4
         Consent withdrawn by subject
    1
    -
    1
    -
    2
         Physician decision
    -
    1
    1
    1
    1
         Adverse event, non-fatal
    -
    1
    1
    1
    1
         Other
    2
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received Placebo as Subcutaneous injection (SC) at Week 0, 4, 8 and 12. From Week 16, subjects started to receive 200 mg of CNTO6785 SC every 4 weeks through week 28 named as Placebo-CNTO6785 200 mg group thereafter in this report.

    Reporting group title
    CNTO6785, 15 mg
    Reporting group description
    		 Subjects received 15 mg of CNTO6785 as SC every 4 weeks through Week 28.

    Reporting group title
    CNTO6785, 50 mg
    Reporting group description
    		 Subjects received 50 mg of CNTO6785 as SC every 4 weeks through Week 28.

    Reporting group title
    CNTO6785,100mg
    Reporting group description
    		 Subjects received 100 mg of CNTO6785 as SC every 4 weeks through Week 28.

    Reporting group title
    CNTO6785, 200mg
    Reporting group description
    		 Subjects received 200 mg of CNTO6785 as SC every 4 weeks through Week 28.

    Reporting group values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Total
    Number of subjects
    		 51 52 51 51 52 257
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 48 44 44 46 46 228
        From 65 to 84 years
    		 3 8 7 5 6 29
        85 years and over
    		 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.8 ± 11.63 49.5 ± 14.33 52.3 ± 10.83 52.3 ± 11.91 52.9 ± 9.68 -
    Title for Gender
    Units: subjects
        Female
    		 45 40 45 46 40 216
        Male
    		 6 12 6 5 12 41

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received Placebo as Subcutaneous injection (SC) at Week 0, 4, 8 and 12. From Week 16, subjects started to receive 200 mg of CNTO6785 SC every 4 weeks through week 28 named as Placebo-CNTO6785 200 mg group thereafter in this report.

    Reporting group title
    CNTO6785, 15 mg
    Reporting group description
    		 Subjects received 15 mg of CNTO6785 as SC every 4 weeks through Week 28.

    Reporting group title
    CNTO6785, 50 mg
    Reporting group description
    		 Subjects received 50 mg of CNTO6785 as SC every 4 weeks through Week 28.

    Reporting group title
    CNTO6785,100mg
    Reporting group description
    		 Subjects received 100 mg of CNTO6785 as SC every 4 weeks through Week 28.

    Reporting group title
    CNTO6785, 200mg
    Reporting group description
    		 Subjects received 200 mg of CNTO6785 as SC every 4 weeks through Week 28.

    Subject analysis set title
    Placebo-CNTO6785 200mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects received placebo through Week 12 and then switched to receive CNTO6785 200 mg from Week 16 and every 4 weeks thereafter up to Week 28 .

    Primary: Percentage of Subjects who Achieved an American College of Rheumatology (ACR 20) Response at Week 16

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    End point title
    		 Percentage of Subjects who Achieved an American College of Rheumatology (ACR 20) Response at Week 16
    End point description
    The ACR 20 response is a greater than or equal to (>=) 20 percentage improvement in rheumatoid arthritis (RA) signs and symptoms. Modified intent to treat (mITT) analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg
    Number of subjects analysed
    51
    52
    51
    51
    52
    Units: Percentage of subjects
        number (not applicable)
    41.2
    51.9
    47.1
    37.3
    40.4
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v CNTO6785, 15 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2718
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v CNTO6785, 50 mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5629
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v CNTO6785,100mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6862
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v CNTO6785, 200mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9516
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Change From Baseline in Disease Activity Score 28 (DAS 28 [C-reactive protein {CRP}]) at Week 16

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    End point title
    		 Change From Baseline in Disease Activity Score 28 (DAS 28 [C-reactive protein {CRP}]) at Week 16
    End point description
    The DAS28 based on CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and subjects global assessment of disease activity. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg
    Number of subjects analysed
    51
    52
    51
    51
    51
    Units: units on scale
        least squares mean (standard error)
    -1.3255 ± 0.17361
    -1.7519 ± 0.17215
    -1.7176 ± 0.17422
    -1.5836 ± 0.17352
    -1.4565 ± 0.17349
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v CNTO6785, 15 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0748
    Method
    		 ANCOVA
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.0356
         upper limit
    		 -1.4681
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v CNTO6785, 50 mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.103
    Method
    		 ANCOVA
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.0047
         upper limit
    		 -1.4304
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v CNTO6785,100mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2825
    Method
    		 ANCOVA
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.8696
         upper limit
    		 -1.2976
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v CNTO6785, 200mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5853
    Method
    		 ANCOVA
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.7425
         upper limit
    		 -1.1706

    Secondary: Percentage of Subjects who Achieved ACR 50 Response at Week 16

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    End point title
    		 Percentage of Subjects who Achieved ACR 50 Response at Week 16
    End point description
    The ACR 50 response is a >=50% improvement in RA signs and symptoms. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg
    Number of subjects analysed
    51
    52
    51
    51
    52
    Units: Percentage of subjects
        number (not applicable)
    19.6
    25
    19.6
    11.8
    17.3
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v CNTO6785, 15 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5003
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v CNTO6785, 50 mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9763
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v CNTO6785,100mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2721
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v CNTO6785, 200mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7721
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Subjects who Achieved ACR 20 Response Through Week 32

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    End point title
    		 Percentage of Subjects who Achieved ACR 20 Response Through Week 32
    End point description
    The ACR 20 response is a >=20% improvement in RA signs and symptoms. mITT analysis set included all subjects who received at least a partial dose of the study drug. Here, 99999 signifies that no subjects were in Placebo group after Week 16 and in Placebo-CNTO6785 200 mg group till Week 16.
    End point type
    Secondary
    End point timeframe
    Up to Week 32
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    51
    52
    51
    51
    52
    51
    Units: Percentage of subjects
    number (not applicable)
        Week 2
    19.6
    21.2
    35.3
    25.5
    30.8
    99999
        Week 4
    35.3
    17.3
    35.3
    31.4
    28.8
    99999
        Week 8
    35.3
    34.6
    41.2
    45.1
    30.8
    99999
        Week 12
    43.1
    44.2
    52.9
    35.3
    42.3
    99999
        Week 16
    41.2
    51.9
    47.1
    37.3
    40.4
    99999
        Week 20
    99999
    50
    47.1
    33.3
    46.2
    51
        Week 24
    99999
    48.1
    37.3
    45.1
    48.1
    64.7
        Week 28
    99999
    46.2
    60.8
    37.3
    50
    64.7
        Week 32
    99999
    46.2
    56.9
    47.1
    57.7
    54.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved ACR 50 Response Through Week 32

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    End point title
    		 Percentage of Subjects who Achieved ACR 50 Response Through Week 32
    End point description
    The ACR 50 response is a >=50% improvement in RA signs and symptoms. mITT analysis set included all subjects who received at least a partial dose of the study drug. Here, 99999 signifies that no subjects were in Placebo group after Week 16 and in Placebo-CNTO6785 200 mg group till Week 16.
    End point type
    Secondary
    End point timeframe
    Up to Week 32
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    51
    52
    51
    51
    52
    51
    Units: Percentage of subjects
    number (not applicable)
        Week 2
    0
    1.9
    2
    3.9
    5.8
    99999
        Week 4
    7.8
    7.7
    5.9
    7.8
    3.8
    99999
        Week 8
    11.8
    7.7
    9.8
    13.7
    13.5
    99999
        Week 12
    13.7
    21.2
    11.8
    11.8
    15.4
    99999
        Week 16
    19.6
    25
    19.6
    11.8
    17.3
    99999
        Week 20
    99999
    25
    29.4
    7.8
    19.2
    37.3
        Week 24
    99999
    28.8
    23.5
    7.8
    25
    29.4
        Week 28
    99999
    23.1
    29.4
    15.7
    25
    39.2
        Week 32
    99999
    34.6
    31.4
    19.6
    30.8
    37.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved ACR 70 Response Through Week 32

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    End point title
    		 Percentage of Subjects who Achieved ACR 70 Response Through Week 32
    End point description
    ACR 70 response is a >=70% improvement in RA signs and symptoms. mITT analysis set included all subjects who received at least a partial dose of the study drug. Here, 99999 signifies that no subjects were in Placebo group after Week 16 and in Placebo-CNTO6785 200 mg group till Week 16.
    End point type
    Secondary
    End point timeframe
    Up to Week 32
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    51
    52
    51
    51
    52
    51
    Units: Percentage of subjects
    number (not applicable)
        Week 2
    0
    0
    0
    0
    0
    99999
        Week 4
    2
    1.9
    0
    2
    0
    99999
        Week 8
    2
    0
    0
    5.9
    0
    99999
        Week 12
    3.9
    5.8
    2
    2
    3.8
    99999
        Week 16
    7.8
    9.6
    9.8
    5.9
    1.9
    99999
        Week 20
    99999
    11.5
    11.8
    3.9
    9.6
    13.7
        Week 24
    99999
    15.4
    15.7
    3.9
    11.5
    19.6
        Week 28
    99999
    13.5
    21.6
    5.9
    9.6
    17.6
        Week 32
    99999
    23.1
    23.5
    11.8
    15.4
    17.6
    No statistical analyses for this end point

    Secondary: Change From Baseline in DAS28 (CRP) Through Week 32

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    End point title
    		 Change From Baseline in DAS28 (CRP) Through Week 32
    End point description
    The DAS28 based on CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and subjects global assessment of disease activity. mITT analysis set included all subjects who received at least a partial dose of the study drug. Here, 99999 signifies that no subjects were in Placebo group after Week 16 and in Placebo-CNTO6785 200 mg group till Week 16. Here, ‘n’ signifies number of subjects analyzed for this endpoint at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 32
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    51
    52
    51
    51
    52
    51
    Units: units on scale
    least squares mean (standard error)
        Change at Week 2 (n= 51, 51, 51, 50, 51, 0)
    -0.5833 ± 0.11967
    -0.8358 ± 0.12017
    -0.8834 ± 0.1201
    -0.7587 ± 0.12063
    -0.8708 ± 0.11958
    99999 ± 99999
        Change at Week 4 (n= 51, 52, 51, 50, 51, 0)
    -0.7356 ± 0.13715
    -0.8687 ± 0.136
    -0.9805 ± 0.13763
    -0.9781 ± 0.13826
    -0.9602 ± 0.13705
    99999 ± 99999
        Change at Week 8 (n= 51, 52, 51, 51, 51, 0)
    -0.9657 ± 0.14857
    -1.229 ± 0.14733
    -1.303 ± 0.14909
    -1.3166 ± 0.14849
    -1.0021 ± 0.14847
    99999 ± 99999
        Change at Week 12 (n= 51, 52, 51, 51, 51, 0)
    -1.2594 ± 0.16009
    -1.3984 ± 0.15874
    -1.5975 ± 0.16065
    -1.321 ± 0.16
    -1.3586 ± 0.15998
    99999 ± 99999
        Change at Week 16 (n= 51, 52, 51, 51, 51, 0)
    -1.3255 ± 0.17361
    -1.7519 ± 0.17215
    -1.7176 ± 0.17422
    -1.5836 ± 0.17352
    -1.4565 ± 0.17349
    99999 ± 99999
        Change at Week 20 (n= 0, 52, 51, 51, 51, 51)
    99999 ± 99999
    -1.7754 ± 0.17468
    -1.8309 ± 0.17674
    -1.4073 ± 0.1761
    -1.5692 ± 0.17608
    -1.8127 ± 0.17618
        Change at Week 24 (n= 0, 52, 51, 51, 51, 51)
    99999 ± 99999
    -1.835 ± 0.18912
    -1.8298 ± 0.19135
    -1.6945 ± 0.19066
    -1.6848 ± 0.19063
    -2.0472 ± 0.19074
        Change at Week 28 (n= 0, 52, 51, 51, 51, 51)
    99999 ± 99999
    -1.7537 ± 0.18084
    -2.1819 ± 0.18298
    -1.8096 ± 0.18232
    -1.8364 ± 0.18229
    -2.1183 ± 0.1824
        Change at Week 32 (n= 0, 52, 51, 51, 51, 51)
    99999 ± 99999
    -1.9354 ± 0.1887
    -2.2117 ± 0.19093
    -2.0158 ± 0.19023
    -2.0259 ± 0.19021
    -2.2459 ± 0.19032
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With DAS28 (CRP) Response Through Week 32

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    End point title
    		 Percentage of Subjects With DAS28 (CRP) Response Through Week 32
    End point description
    The DAS28 (using CRP) response is improvement from baseline, with >1.2 indicating a good or moderate response, and between 0.6 and 1.2 inclusive indicating moderate response if DAS28 at the visit is <=5.1 or no response if DAS28 at the visit is >5.1 and <=0.6 indicating no response. mITT analysis set included all subjects who received at least a partial dose of the study drug. Here, 99999 signifies that no subjects were in Placebo group after Week 16 and in Placebo-CNTO6785 200 mg group till Week 16. Here, ‘n’ signifies number of subjects analyzed for this endpoint at given timepoint.
    End point type
    Secondary
    End point timeframe
    Up to Week 32
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    51
    52
    51
    51
    52
    51
    Units: Percentage of subjects
    number (not applicable)
        Week 2 (n= 51, 51, 51, 50, 51, 0)
    31.4
    44.2
    39.2
    35.3
    32.7
    99999
        Week 4 (n= 51, 52, 51, 50, 51, 0)
    43.1
    42.3
    45.1
    56.9
    48.1
    99999
        Week 8 (n= 51, 52, 51, 51, 51, 0)
    54.9
    59.6
    62.7
    64.7
    51.9
    99999
        Week 12 (n= 51, 52, 51, 51, 51, 0)
    62.7
    65.4
    72.5
    60.8
    61.5
    99999
        Week 16 (n= 51, 52, 51, 51, 51, 0)
    62.7
    75
    72.5
    66.7
    53.8
    99999
        Week 20 (n= 0, 52, 51, 51, 51, 51)
    99999
    71.2
    72.5
    64.7
    57.7
    72.5
        Week 24 (n= 0, 52, 51, 51, 51, 51)
    99999
    71.2
    62.7
    66.7
    65.4
    78.4
        Week 28 (n= 0, 52, 51, 51, 51, 51)
    99999
    63.5
    76.5
    66.7
    67.3
    76.5
        Week 32 (n= 0, 52, 51, 51, 51, 51)
    99999
    69.2
    84.3
    76.5
    71.2
    78.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With DAS28 (CRP) Remission at Week 16

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    End point title
    		 Percentage of Subjects With DAS28 (CRP) Remission at Week 16
    End point description
    The DAS28 (using CRP) remission is defined as a value of <2.6 on the disease activity score, a measure of tender and swollen joints and the subjects assessment of disease activity. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg
    Number of subjects analysed
    51
    52
    51
    51
    52
    Units: Percentage of subjects
        number (not applicable)
    7.8
    17.3
    19.6
    9.8
    13.5
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v CNTO6785, 15 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1502
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v CNTO6785, 50 mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0915
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v CNTO6785,100mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7304
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v CNTO6785, 200mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3601
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Subjects With DAS28 (CRP) Remission at Week 32

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    End point title
    		 Percentage of Subjects With DAS28 (CRP) Remission at Week 32 [1]
    End point description
    The DAS28 (using CRP) remission is defined as a value of less than (<) 2.6 on the disease activity score, a measure of tender and swollen joints and the subject's assessment of disease activity. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 32
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was reported for the specific arms.
    End point values
    		 CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    52
    51
    51
    52
    51
    Units: Percentage of subjects
        number (not applicable)
    19.2
    19.6
    19.6
    23.1
    25.5
    No statistical analyses for this end point

    Secondary: Change From Baseline in DAS28 (Erythrocyte sedimentation rate [ESR]) at Week 16

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    End point title
    		 Change From Baseline in DAS28 (Erythrocyte sedimentation rate [ESR]) at Week 16
    End point description
    The DAS28 based on ESR is defined as a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), ESR, and patient’s global assessment of disease activity (GH). mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg
    Number of subjects analysed
    51
    52
    51
    51
    51
    Units: units on scale
        least squares mean (standard error)
    -1.4717 ± 0.18222
    -1.8829 ± 0.18068
    -1.7996 ± 0.18291
    -1.671 ± 0.18214
    -1.6757 ± 0.18214
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v CNTO6785, 15 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1016
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v CNTO6785, 50 mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1937
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v CNTO6785,100mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4293
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v CNTO6785, 200mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4187
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in DAS28 (ESR) at Week 32

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    End point title
    		 Change From Baseline in DAS28 (ESR) at Week 32 [2]
    End point description
    The DAS28 based on ESR is defined as a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), ESR, and patient’s global assessment of disease activity (GH). mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 32
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was reported for the specific arms.
    End point values
    		 CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    52
    51
    51
    51
    51
    Units: units on scale
        least squares mean (standard error)
    -2.2022 ± 0.19439
    -2.3277 ± 0.19675
    -2.0893 ± 0.196
    -2.2871 ± 0.19602
    -2.4823 ± 0.19606
    No statistical analyses for this end point

    Secondary: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 32

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    End point title
    		 Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 32
    End point description
    The HAQ-DI assesses the degree of difficulty a subject has in accomplishing tasks in 8 functional areas, each scored from 0 (no difficulty) to 3 (inability to perform a task). mITT analysis set included all subjects who received at least a partial dose of the study drug. Here, 99999 signifies that no subjects were in Placebo group after Week 16 and in Placebo-CNTO6785 200 mg group till Week 16. Here, ‘n’ signifies number of subjects analyzed for this endpoint at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 32
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    51
    52
    51
    51
    52
    51
    Units: units on scale
    arithmetic mean (standard deviation)
        Baseline (n= 51, 52, 51, 51, 52, 0)
    1.56 ± 0.545
    1.43 ± 0.756
    1.54 ± 0.62
    1.49 ± 0.736
    1.44 ± 0.706
    99999 ± 99999
        Change at Week 2 (n= 51, 51, 51, 50, 51, 0)
    -0.19 ± 0.45
    -0.13 ± 0.409
    -0.34 ± 0.469
    -0.14 ± 0.412
    -0.14 ± 0.326
    99999 ± 99999
        Change at Week 4 (n= 51, 52, 51, 50, 52, 0)
    -0.24 ± 0.527
    -0.16 ± 0.458
    -0.28 ± 0.54
    -0.14 ± 0.485
    -0.15 ± 0.383
    99999 ± 99999
        Change at Week 8 (n= 51, 52, 51, 51, 52, 0)
    -0.27 ± 0.569
    -0.22 ± 0.559
    -0.32 ± 0.52
    -0.23 ± 0.537
    -0.16 ± 0.446
    99999 ± 99999
        Change at Week 12 (n= 51, 52, 51, 51, 52, 0)
    -0.33 ± 0.673
    -0.3 ± 0.655
    -0.42 ± 0.645
    -0.26 ± 0.452
    -0.24 ± 0.523
    99999 ± 99999
        Change at Week 16 (n= 51, 52, 51, 51, 52, 0)
    -0.38 ± 0.738
    -0.38 ± 0.657
    -0.41 ± 0.6
    -0.26 ± 0.512
    -0.25 ± 0.498
    99999 ± 99999
        Change at Week 20 (n= 0, 52, 51, 51, 52, 51)
    99999 ± 99999
    -0.34 ± 0.685
    -0.42 ± 0.668
    -0.22 ± 0.499
    -0.27 ± 0.518
    -0.51 ± 0.722
        Change at Week 24 (n= 0, 52, 51, 51, 52, 51)
    99999 ± 99999
    -0.3 ± 0.714
    -0.42 ± 0.689
    -0.21 ± 0.509
    -0.27 ± 0.585
    -0.52 ± 0.723
        Change at Week 28 (n= 0, 52, 51, 51, 52, 51)
    99999 ± 99999
    -0.35 ± 0.717
    -0.57 ± 0.723
    -0.23 ± 0.544
    -0.27 ± 0.618
    -0.5 ± 0.786
        Change at Week 32 (n= 0, 52, 51, 51, 52, 51)
    99999 ± 99999
    -0.37 ± 0.714
    -0.55 ± 0.725
    -0.35 ± 0.596
    -0.38 ± 0.696
    -0.55 ± 0.729
    No statistical analyses for this end point

    Secondary: Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 16

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    End point title
    		 Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 16
    End point description
    The SF-36 is a medical outcome study health measure and consists of 8 multi-item scales that are scored from 0 to 100, with higher scores indicating better health. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg
    Number of subjects analysed
    49
    49
    46
    47
    47
    Units: units on scale
    arithmetic mean (standard deviation)
        Mental Component Score (MCS)
    5.91 ± 11.543
    6.18 ± 12.059
    4.42 ± 9.651
    4.05 ± 12.323
    4.99 ± 11.149
        Physical Component Score (PCS)
    5.68 ± 8.279
    5.11 ± 9.434
    5.33 ± 9.191
    2.71 ± 7.592
    3.99 ± 7.749
    Statistical analysis title
    		 Statistical analysis 1 (MCS)
    Comparison groups
    Placebo v CNTO6785, 15 mg
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2637
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2 (MCS)
    Comparison groups
    Placebo v CNTO6785, 50 mg
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5981
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3 (MCS)
    Comparison groups
    Placebo v CNTO6785,100mg
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7214
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4 (MCS)
    Comparison groups
    Placebo v CNTO6785, 200mg
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5225
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 5 (PCS)
    Comparison groups
    Placebo v CNTO6785, 15 mg
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3045
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 6 (PCS)
    Comparison groups
    Placebo v CNTO6785, 50 mg
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6525
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 7 (PCS)
    Comparison groups
    Placebo v CNTO6785,100mg
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1843
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 8 (PCS)
    Comparison groups
    Placebo v CNTO6785, 200mg
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3753
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in SF-36 at Week 32

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    End point title
    		 Change From Baseline in SF-36 at Week 32 [3]
    End point description
    The SF-36 is a medical outcome study health measure and consists of 8 multi-item scales that are scored from 0 to 100, with higher scores indicating better health. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 32
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was reported for the specific arms.
    End point values
    		 CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    46
    44
    39
    45
    45
    Units: units on scale
    arithmetic mean (standard deviation)
        MCS
    4.24 ± 12.685
    6.62 ± 8.163
    6.1 ± 12.067
    5.48 ± 11.347
    8.14 ± 10.831
        PCS
    5.48 ± 9.098
    6.83 ± 8.612
    2.92 ± 9.193
    6.92 ± 9.097
    8.66 ± 9.867
    No statistical analyses for this end point

    Secondary: Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16

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    End point title
    		 Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16
    End point description
    The CDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg
    Number of subjects analysed
    51
    51
    51
    51
    50
    Units: units on scale
        arithmetic mean (standard deviation)
    -16.09 ± 15.944
    -18.58 ± 13.274
    -19.78 ± 11.392
    -17.94 ± 15.578
    -18.41 ± 15.621
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v CNTO6785, 15 mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3159
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v CNTO6785, 50 mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2466
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v CNTO6785,100mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5866
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v CNTO6785, 200mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6545
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in CDAI at Week 32

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    End point title
    		 Change From Baseline in CDAI at Week 32 [4]
    End point description
    The CDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 32
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was reported for the specific arms.
    End point values
    		 CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    51
    51
    51
    50
    51
    Units: units on scale
        arithmetic mean (standard deviation)
    -19.05 ± 16.452
    -23.94 ± 14.124
    -20.56 ± 16.112
    -22.93 ± 15.75
    -22.93 ± 14.89
    No statistical analyses for this end point

    Secondary: Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 16

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    End point title
    		 Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 16
    End point description
    The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg
    Number of subjects analysed
    51
    51
    50
    51
    50
    Units: units on scale
        arithmetic mean (standard deviation)
    -16.12 ± 16.458
    -19.39 ± 13.535
    -19.78 ± 11.508
    -18.35 ± 15.447
    -19.2 ± 15.739
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v CNTO6785, 15 mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2167
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v CNTO6785, 50 mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2289
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v CNTO6785,100mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4918
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v CNTO6785, 200mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.449
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in SDAI at Week 32

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    End point title
    		 Change From Baseline in SDAI at Week 32 [5]
    End point description
    SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 32
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was reported for the specific arms.
    End point values
    		 CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    51
    50
    51
    50
    51
    Units: units on scale
        arithmetic mean (standard deviation)
    -19.78 ± 16.985
    -24.09 ± 14.291
    -21.24 ± 16.411
    -23.41 ± 15.888
    -23.62 ± 15.133
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With SDAI-Based ACR/European League Against Rheumatism (EULAR) Remission at Week 16

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    End point title
    		 Percentage of Subjects With SDAI-Based ACR/European League Against Rheumatism (EULAR) Remission at Week 16
    End point description
    The SDAI-based ACR/EULAR remission is defined as a SDAI value of <=3.3 at a visit. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg
    Number of subjects analysed
    51
    52
    51
    51
    52
    Units: Percentage of subjects
        number (not applicable)
    3.9
    5.8
    5.9
    5.9
    1.9
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v CNTO6785, 15 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6527
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v CNTO6785, 50 mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6651
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v CNTO6785,100mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6512
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v CNTO6785, 200mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5487
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Subjects With SDAI-Based ACR/EULAR Remission at Week 32

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    End point title
    		 Percentage of Subjects With SDAI-Based ACR/EULAR Remission at Week 32 [6]
    End point description
    SDAI-based ACR/EULAR remission is defined as a SDAI value of <=3.3 at a visit. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 32
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was reported for the specific arms.
    End point values
    		 CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    52
    51
    51
    52
    51
    Units: Percentage of subjects
        number (not applicable)
    13.5
    13.7
    11.8
    15.4
    7.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Boolean-Based ACR/EULAR Remission at Week 16

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    End point title
    		 Percentage of Subjects With Boolean-Based ACR/EULAR Remission at Week 16
    End point description
    The Boolean-based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) <=1 on a 0 to 10 scale. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg
    Number of subjects analysed
    51
    52
    51
    51
    52
    Units: Percentage of subjects
        number (not applicable)
    3.9
    5.8
    5.9
    3.9
    1.9
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v CNTO6785, 15 mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6394
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v CNTO6785, 50 mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.657
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v CNTO6785,100mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v CNTO6785, 200mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5524
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Subjects With Boolean-Based ACR/EULAR Remission at Week 32

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    End point title
    		 Percentage of Subjects With Boolean-Based ACR/EULAR Remission at Week 32 [7]
    End point description
    The Boolean-based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 mg/dL; and patient's global assessment of disease activity on VAS <=1 on a 0 to 10 scale. mITT analysis set included all subjects who received at least a partial dose of the study drug.
    End point type
    Secondary
    End point timeframe
    Week 32
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data was reported for the specific arms.
    End point values
    		 CNTO6785, 15 mg CNTO6785, 50 mg CNTO6785,100mg CNTO6785, 200mg Placebo-CNTO6785 200mg
    Number of subjects analysed
    52
    51
    51
    52
    51
    Units: Percentage of subjects
        number (not applicable)
    11.5
    9.8
    5.9
    7.7
    3.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to follow-up (Week 38)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo (Week 0-Week 16)
    Reporting group description
    		 Subject administered with Placebo subcutaneous injections (SC) every 4 weeks through Week 12.

    Reporting group title
    Placebo->200 mg (Week 16-Week 38)
    Reporting group description
    		 Patients receiving Placebo at Week 0, 4,8,12 --> receiving 200 mg CNTO6785 at Week 16 and every 4 weeks (q4w) thereafter through Week 28

    Reporting group title
    CNTO6785, 15 mg (Week 0-Week 38)
    Reporting group description
    		 Subjects received 15 mg of CNTO6785 as SC every 4 weeks through Week 28.

    Reporting group title
    CNTO6785, 50 mg (Week 0-Week 38)
    Reporting group description
    		 Subjects received 50 mg of CNTO6785 as SC every 4 weeks through Week 28.

    Reporting group title
    CNTO6785, 100 mg (Week 0-Week 38)
    Reporting group description
    		 Subjects received 100 mg of CNTO6785 as SC every 4 weeks through Week 28.

    Reporting group title
    CNTO6785, 200 mg (Week 0-Week 38)
    Reporting group description
    		 Subjects received 200 mg of CNTO6785 as SC every 4 weeks through Week 28.

    Serious adverse events
    		 Placebo (Week 0-Week 16) Placebo->200 mg (Week 16-Week 38) CNTO6785, 15 mg (Week 0-Week 38) CNTO6785, 50 mg (Week 0-Week 38) CNTO6785, 100 mg (Week 0-Week 38) CNTO6785, 200 mg (Week 0-Week 38)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 48 (2.08%)
    2 / 52 (3.85%)
    2 / 51 (3.92%)
    5 / 51 (9.80%)
    0 / 52 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast Cancer Stage Iii
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Joint Injury
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Prerenal Failure
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid Arthritis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal Pain
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo (Week 0-Week 16) Placebo->200 mg (Week 16-Week 38) CNTO6785, 15 mg (Week 0-Week 38) CNTO6785, 50 mg (Week 0-Week 38) CNTO6785, 100 mg (Week 0-Week 38) CNTO6785, 200 mg (Week 0-Week 38)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 51 (11.76%)
    17 / 48 (35.42%)
    19 / 52 (36.54%)
    21 / 51 (41.18%)
    28 / 51 (54.90%)
    20 / 52 (38.46%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 48 (2.08%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    4 / 51 (7.84%)
    5 / 52 (9.62%)
         occurrences all number
    1
    1
    1
    0
    4
    6
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 48 (2.08%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    5 / 52 (9.62%)
         occurrences all number
    1
    1
    1
    0
    1
    5
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 48 (2.08%)
    3 / 52 (5.77%)
    3 / 51 (5.88%)
    3 / 51 (5.88%)
    2 / 52 (3.85%)
         occurrences all number
    3
    1
    3
    3
    4
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    Leukocytosis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    3 / 51 (5.88%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 48 (4.17%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    4 / 51 (7.84%)
    2 / 52 (3.85%)
         occurrences all number
    0
    4
    1
    1
    15
    12
    Injection Site Pain
         subjects affected / exposed
    1 / 51 (1.96%)
    6 / 48 (12.50%)
    8 / 52 (15.38%)
    11 / 51 (21.57%)
    8 / 51 (15.69%)
    9 / 52 (17.31%)
         occurrences all number
    1
    11
    23
    35
    22
    38
    Musculoskeletal and connective tissue disorders
    Rheumatoid Arthritis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    4 / 52 (7.69%)
    1 / 51 (1.96%)
    3 / 51 (5.88%)
    3 / 52 (5.77%)
         occurrences all number
    0
    1
    5
    1
    3
    4
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    2 / 52 (3.85%)
    2 / 51 (3.92%)
    3 / 51 (5.88%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    2
    2
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    3 / 51 (5.88%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    0
    3
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 48 (6.25%)
    4 / 52 (7.69%)
    4 / 51 (7.84%)
    2 / 51 (3.92%)
    1 / 52 (1.92%)
         occurrences all number
    0
    3
    4
    4
    2
    1
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    3 / 51 (5.88%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    0
    1
    3
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
    2 / 51 (3.92%)
    5 / 51 (9.80%)
    3 / 52 (5.77%)
         occurrences all number
    3
    1
    0
    4
    5
    4
    Urinary Tract Infection
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 48 (4.17%)
    5 / 52 (9.62%)
    2 / 51 (3.92%)
    3 / 51 (5.88%)
    2 / 52 (3.85%)
         occurrences all number
    2
    2
    5
    2
    5
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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