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    Clinical Trial Results:
    Phase 2, Randomized, Multi-Center, Double-blind, Dose-ranging, Placebo-controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors

    Summary
    EudraCT number
    		 2015-002887-17
    Trial protocol
    		 ES   AT   BE   FR   NL  
    Global end of trial date
    03 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Sep 2019
    First version publication date
    22 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IM006-016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02638948
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb Study Director
    Sponsor organisation address
    3401 Princeton Pike, Lawrenceville, United States, NJ 08543
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb Study Director, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb Study Director, clinical.trials@bms.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 May 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of the study was to compare the efficacy of BMS-986142 versus placebo on a background of methotrexate (MTX) as assessed by American College of Rheumatology (ACR)20 and ACR70 response rates at Week 12.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Feb 2016
    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: 15
    Country: Number of subjects enrolled
    Brazil: 42
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Japan: 50
    Country: Number of subjects enrolled
    Mexico: 96
    Country: Number of subjects enrolled
    Poland: 27
    Country: Number of subjects enrolled
    Russian Federation: 44
    Country: Number of subjects enrolled
    South Africa: 61
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    United States: 152
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Worldwide total number of subjects
    508
    EEA total number of subjects
    36
    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)
    367
    From 65 to 84 years
    139
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Out of 508 subjects who signed the informed consent form and were enrolled in the study; 248 subjects were randomized, and 247 subjects were administered study drug (1 subject decided after randomization to initiate treatment with a different medication instead).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching Placebo for BMS-986142
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral dose

    Arm title
    		 BMS 100mg
    Arm description
    		 Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986142
    Investigational medicinal product code
    BMS-986142-01
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral dose

    Arm title
    		 BMS 200mg
    Arm description
    		 Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986142
    Investigational medicinal product code
    BMS-986142-01
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral dose

    Arm title
    		 BMS 350mg
    Arm description
    		 Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986142
    Investigational medicinal product code
    BMS-986142-01
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral dose

    Number of subjects in period 1 [1]
    		Placebo BMS 100mg BMS 200mg BMS 350mg
    Started
    75
    73
    73
    26
    Completed
    66
    62
    66
    18
    Not completed
    9
    11
    7
    8
         Other than specified above
    4
    1
    1
    1
         Consent withdrawn by subject
    4
    5
    2
    1
         Poor/Non-Compliance
    -
    2
    1
    -
         Adverse event, non-fatal
    -
    -
    1
    1
         Lost to follow-up
    -
    -
    1
    1
         Subject no longer meets study criteria
    -
    1
    -
    -
         Administrative Reason by Sponsor
    -
    1
    -
    4
         Subject requested to discontinue study treatment
    -
    -
    1
    -
         Lack of efficacy
    1
    1
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 508 subjects who signed the informed consent form and were enrolled in the study; 248 subjects were randomized, and 247 subjects were administered study drug.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.

    Reporting group title
    BMS 100mg
    Reporting group description
    		 Oral dose of BMS-986142 100mg was administered daily for 12 weeks.

    Reporting group title
    BMS 200mg
    Reporting group description
    		 Oral dose of BMS-986142 200mg was administered daily for 12 weeks.

    Reporting group title
    BMS 350mg
    Reporting group description
    		 Oral dose of BMS-986142 350mg was administered daily for 12 weeks.

    Reporting group values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg Total
    Number of subjects
    		 75 73 73 26 247
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 51 51 57 21 180
        From 65-84 years
    		 24 22 16 5 67
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 58.6 ( 11.61 ) 57.6 ( 13.01 ) 55.2 ( 13.13 ) 52.9 ( 13.16 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 64 67 62 21 214
        Male
    		 11 6 11 5 33
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 52 54 58 24 188
        Black or African American
    		 6 9 5 1 21
        Asian
    		 14 8 8 1 31
        Other
    		 3 2 2 0 7
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 22 24 28 10 84
        Not Hispanic or Latino
    		 27 24 25 8 84
        Unknown or Not Reported
    		 26 25 20 8 79

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.

    Reporting group title
    BMS 100mg
    Reporting group description
    		 Oral dose of BMS-986142 100mg was administered daily for 12 weeks.

    Reporting group title
    BMS 200mg
    Reporting group description
    		 Oral dose of BMS-986142 200mg was administered daily for 12 weeks.

    Reporting group title
    BMS 350mg
    Reporting group description
    		 Oral dose of BMS-986142 350mg was administered daily for 12 weeks.

    Primary: Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

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    End point title
    		 Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
    End point description
    ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant C-reactive Protein levels (CRP); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by health assessment questionnaire disability index (HAQ-DI). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. Analysis was performed on efficacy population which excluded subjects who were randomized to a treatment arm and discontinued based on the interim analysis (IA).
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Percentage of Subjects
    number (confidence interval 95%)
        % of Subjects Achieving ACR20 Response at Week 12
    30.7 (20.2 to 41.1)
    35.6 (24.6 to 46.6)
    42.5 (31.1 to 53.8)
    30.8 (13.0 to 48.5)
    Statistical analysis title
    		 BMS-986142 100 mg vs Placebo
    Comparison groups
    Placebo v BMS 100mg
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5224 [1]
    Method
    		 Chi-squared
    Parameter type
    		 Estimate of Difference (%)
    Point estimate
    4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.2
         upper limit
    		 20.1
    Notes
    [1] - Threshold for significance = 0.05
    Statistical analysis title
    		 BMS-986142 200 mg vs Placebo
    Comparison groups
    Placebo v BMS 200mg
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.136 [2]
    Method
    		 Chi-squared
    Parameter type
    		 Estimate of Difference (%)
    Point estimate
    11.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 27.2
    Notes
    [2] - Threshold for significance = 0.05
    Statistical analysis title
    		 BMS-986142 350 mg vs Placebo
    Comparison groups
    Placebo v BMS 350mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9922 [3]
    Method
    		 Chi-squared
    Parameter type
    		 Estimate of Difference (%)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.5
         upper limit
    		 20.7
    Notes
    [3] - Threshold for significance = 0.05

    Primary: Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12

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    End point title
    		 Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
    End point description
    ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant' assessment of pain; particpant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ-­DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. Analysis was performed on efficacy population.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Percentage of Subjects
    number (confidence interval 95%)
        % of Subjects Achieving ACR70 Response at Week 12
    4.0 (0.8 to 11.2)
    4.1 (0.9 to 11.5)
    9.6 (2.8 to 16.3)
    3.8 (0.1 to 19.6)
    Statistical analysis title
    		 BMS-986142 100 mg vs Placebo
    Comparison groups
    Placebo v BMS 100mg
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1 [4]
    Method
    		 Chi-squared
    Parameter type
    		 Estimate of Difference (%)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16
         upper limit
    		 16.5
    Notes
    [4] - Threshold for significance = 0.05
    Statistical analysis title
    		 BMS-986142 200 mg vs Placebo
    Comparison groups
    Placebo v BMS 200mg
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2058 [5]
    Method
    		 Chi-squared
    Parameter type
    		 Estimate of Difference (%)
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.5
         upper limit
    		 21.9
    Notes
    [5] - Threshold for significance = 0.05
    Statistical analysis title
    		 BMS-986142 350 mg vs Placebo
    Comparison groups
    Placebo v BMS 350mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 1 [6]
    Method
    		 Chi-squared
    Parameter type
    		 Estimate of Difference (%)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.5
         upper limit
    		 22.2
    Notes
    [6] - Threshold for significance = 0.05

    Secondary: Percentage of Subjects Achieving American College of Rheumatology 20% Response Over Time From Baseline to Week 12

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    End point title
    		 Percentage of Subjects Achieving American College of Rheumatology 20% Response Over Time From Baseline to Week 12
    End point description
    ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant C-reactive Protein levels (CRP); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by health assessment questionnaire disability index (HAQ-DI). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. Analysis was performed on efficacy population.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 15
    10.7 (3.7 to 17.7)
    13.7 (5.8 to 21.6)
    24.7 (14.8 to 34.5)
    15.4 (4.4 to 34.9)
        Day 29
    18.7 (9.8 to 27.5)
    23.3 (13.6 to 33)
    21.9 (12.4 to 31.4)
    26.9 (9.9 to 44)
        Day 57
    28 (17.8 to 38.2)
    41.1 (29.8 to 52.4)
    39.7 (28.5 to 51)
    15.4 (4.4 to 34.9)
        Day 87
    30.7 (20.2 to 41.1)
    35.6 (24.6 to 46.6)
    42.5 (31.1 to 53.8)
    30.8 (13 to 48.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 12

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    End point title
    		 Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 12
    End point description
    ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); subject's assessment of pain; subject's global assessment of disease activity; physician's global assessment of disease activity; subject's assessment of physical function by HAQ-­DI. ACR70 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. Analysis was performed on efficacy population.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Day 15
    2.7 (0.3 to 9.3)
    4.1 (0.9 to 11.5)
    5.5 (1.5 to 13.4)
    3.8 (0.1 to 19.6)
        Day 29
    2.7 (0.3 to 9.3)
    4.1 (0.9 to 11.5)
    6.8 (1.1 to 12.6)
    7.7 (0.9 to 25.1)
        Day 57
    9.3 (2.7 to 15.9)
    12.3 (4.8 to 19.9)
    13.7 (5.8 to 21.6)
    7.7 (0.9 to 25.1)
        Day 85
    9.3 (2.7 to 15.9)
    13.7 (5.8 to 21.6)
    16.4 (7.9 to 24.9)
    11.5 (2.4 to 30.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving American College of Rheumatology 70% Response Over Time From Baseline to Week 12

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    End point title
    		 Percentage of Subjects Achieving American College of Rheumatology 70% Response Over Time From Baseline to Week 12
    End point description
    CR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ-­DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. Analysis was performed on efficacy population.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 15
    1.3 (0 to 7.2)
    0 (0 to 4.9)
    1.4 (0 to 7.4)
    0 (0 to 13.2)
        Day 29
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Day 57
    1.3 (0 to 7.2)
    5.5 (1.5 to 13.4)
    5 (1.5 to 13.4)
    3.8 (0.1 to 19.6)
        Day 85
    4 (0.8 to 11.2)
    4.1 (0.9 to 11.5)
    9.6 (2.8 to 16.3)
    3.8 (0.1 to 19.6)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving < 2.6 Response in Disease Activity Score for 28 Joints ­C-Reactive Protein (DAS28-­CRP) Score at Week 12

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    End point title
    		 Percentage of Subjects Achieving < 2.6 Response in Disease Activity Score for 28 Joints ­C-Reactive Protein (DAS28-­CRP) Score at Week 12
    End point description
    DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the subjects assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. Analysis was performed on efficacy population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Percentage of Subjects
    number (confidence interval 95%)
        % of Subjects Achieving < 2.6 in DAS28-CRP Score
    6.7 (1.0 to 12.3)
    9.6 (2.8 to 16.3)
    11.0 (3.8 to 18.1)
    0.0 (0.0 to 13.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving < 2.6 Response in Disease Activity Score for 28 Joints Erythrocyte Sedimentation Rate (DAS28-­ESR) Score at Week 12

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    End point title
    		 Percentage of Subjects Achieving < 2.6 Response in Disease Activity Score for 28 Joints Erythrocyte Sedimentation Rate (DAS28-­ESR) Score at Week 12
    End point description
    DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the subject assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Analysis was performed on efficacy population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Percentage of Subjects
    number (confidence interval 95%)
        % of Subjects Achieving < 2.6 in DAS28-­ESR Score
    0.0 (0.0 to 4.8)
    6.8 (1.1 to 12.6)
    1.4 (0.0 to 7.4)
    0.0 (0.0 to 13.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving <= 2.8 Response in Clinical Disease Activity Index (CDAI) Score at Week 12

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    End point title
    		 Percentage of Subjects Achieving <= 2.8 Response in Clinical Disease Activity Index (CDAI) Score at Week 12
    End point description
    CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. Analysis was performed on efficacy population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Percentage of Subjects
    number (confidence interval 95%)
        % of Subjects Achieving <= 2.8 in CDAI Score
    0.0 (0.0 to 4.8)
    6.8 (1.1 to 12.6)
    6.8 (1.1 to 12.6)
    0.0 (0.0 to 13.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving <= 3.3 Response in Simple Disease Activity Index (SDAI) Score at Week 12

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    End point title
    		 Percentage of Subjects Achieving <= 3.3 Response in Simple Disease Activity Index (SDAI) Score at Week 12
    End point description
    The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a VAS scale ranging from 0 to 10 cm, where higher scores indicate greater affection due to disease activity, and CRP measured in terms of milligram per deciliter (mg/dL). SDAI total score ranges from 0 to 86. SDAI <= 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. Analysis was performed on efficacy population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Percentage of Subjects
    number (confidence interval 95%)
        % of Subjects Achieving <= 3.3 in SDAI Score
    0.0 (0.0 to 4.8)
    6.8 (1.1 to 12.6)
    6.8 (1.1 to 12.6)
    0.0 (0.0 to 13.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Boolean Remission Criteria at Week 12

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    End point title
    		 Percentage of Subjects Achieving Boolean Remission Criteria at Week 12
    End point description
    Boolean remission criteria was defined as: TJC28 <= 1; SJC28 <= 1; physician’s global assessment <= 1; and CRP <= 1 mg/dL. Analysis was performed on efficacy population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Percentage of Subjects
    number (confidence interval 95%)
        % of Subjects Achieving Boolean Remission Criteria
    1.3 (0.0 to 7.2)
    4.1 (0.9 to 11.5)
    4.1 (0.9 to 11.5)
    0.0 (0.0 to 13.2)
    No statistical analyses for this end point

    Secondary: Change From Baseline in DAS28-CRP Score Over Time up to Week 12

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    End point title
    		 Change From Baseline in DAS28-CRP Score Over Time up to Week 12
    End point description
    DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the subject assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. Analysis was performed on efficacy population. Here 'N' signifies number of subjects analyzed who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    64
    63
    64
    15
    Units: Units on a scale
    arithmetic mean (standard error)
        CFB in DAS28-CRP Score Over Time up to Week 12
    -1.1 ( 0.141 )
    -1.1 ( 0.176 )
    -1.4 ( 0.168 )
    -1.4 ( 0.194 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in DAS28-ESR Score Over Time up to Week 12

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    End point title
    		 Change From Baseline in DAS28-ESR Score Over Time up to Week 12
    End point description
    DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the subject assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Analysis was performed on efficacy population. Here 'N' signifies number of subjects analyzed who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    64
    63
    65
    14
    Units: Units on a scale
    arithmetic mean (standard error)
        CFB in DAS28-ESR Score Over Time up to Week 12
    -1.1 ( 0.149 )
    -1.1 ( 0.166 )
    -1.4 ( 0.161 )
    -1.5 ( 0.247 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in CDAI Score Over Time up to Week 12

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    End point title
    		 Change From Baseline in CDAI Score Over Time up to Week 12
    End point description
    CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. Analysis was performed on efficacy population. Here 'N' signifies number of subjects analyzed who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    65
    61
    68
    16
    Units: Units on a scale
    arithmetic mean (standard error)
        CFB in CDAI Score Over Time up to Week 12
    -14.9 ( 1.591 )
    -13.6 ( 2.030 )
    -16 ( 1.828 )
    -17.6 ( 2.519 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in SDAI Score Over Time up to Week 12

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    End point title
    		 Change From Baseline in SDAI Score Over Time up to Week 12
    End point description
    The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores indicate greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score ranges from 0 to 86. SDAI <= 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. Analysis was performed on efficacy population. Here 'N' signifies number of subjects analyzed who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    64
    61
    64
    15
    Units: Units on a scale
    arithmetic mean (standard error)
        CFB in SDAI Score Over Time up to Week 12
    -14.8 ( 1.628 )
    -13.9 ( 2.090 )
    -16.6 ( 1.954 )
    -18.9 ( 3.218 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs), and Serious AEs (SAEs)

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    End point title
    		 Number of Subjects With Adverse Events (AEs), and Serious AEs (SAEs)
    End point description
    An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event. Analysis was performed on all treated subjects.
    End point type
    Secondary
    End point timeframe
    Up to 30 days after treatment discontinuation
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Subjects
        AEs
    36
    39
    39
    19
        SAEs
    4
    2
    0
    0
    No statistical analyses for this end point

    Secondary: Trough Observed Plasma Concentration (Ctrough) of BMS-986142

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    End point title
    		 Trough Observed Plasma Concentration (Ctrough) of BMS-986142 [7]
    End point description
    Ctrough was defined as trough observed plasma concentration. Analysis was performed on pharmacokinetic population which included all subjects who received BMS-986142 and had any available concentration-time data.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, and 12
    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: This end point evaluated PK characteristic for Experimental Arms only.
    End point values
    		 BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    73
    73
    26
    Units: nanogram/mL
    geometric mean (geometric coefficient of variation)
        Week 4
    47.9 ( 119.0 )
    111.8 ( 101.7 )
    195.9 ( 91.9 )
        Week 8
    41.2 ( 95.3 )
    92.2 ( 124.5 )
    283.0 ( 133.3 )
        Week 12
    28.4 ( 123.0 )
    75.6 ( 155.4 )
    169.5 ( 83.2 )
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring system (RAMRIS) scores for Synovitis at Week 4 and 12

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    End point title
    		 Mean Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring system (RAMRIS) scores for Synovitis at Week 4 and 12
    End point description
    ynovitis is assessed in 3 wrist regions (A. the distal radioulnar joint; B. the radiocarpal joint; C. the intercarpal and carpometacarpophalangeal, CMC, joints) and in each MCP joint. For each wrist region, possible score ranges from 0–3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Week 4 and Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Scores on a scale
    arithmetic mean (standard error)
        Week 4 (n = 68,66,70,23)
    0.1 ( 0.226 )
    -0.2 ( 0.202 )
    0.1 ( 0.182 )
    0.1 ( 0.558 )
        Week 12 (n = 68,66,70,23)
    0.7 ( 0.467 )
    -0.0 ( 0.315 )
    -0.3 ( 0.263 )
    0.9 ( 1.163 )
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring system (RAMRIS) scores for Osteitis at Weeks 4 and 12

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    End point title
    		 Mean Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring system (RAMRIS) scores for Osteitis at Weeks 4 and 12
    End point description
    Osteitis was assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 to 3, indicating involvement of original articular bone. The total score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 23 (total number of anatomic locations) * 3 (maximum per joint)=69. Minimum score=0, indicating normal. Increasing score=greater severity. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Week 4 and Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Scores on a scale
    arithmetic mean (standard error)
        Week 4 (n = 64, 65, 69, 22)
    0.1 ( 0.223 )
    0.2 ( 0.262 )
    0.1 ( 0.148 )
    -0.1 ( 0.249 )
        Week 12 (n = 64, 65, 69, 22)
    0.4 ( 0.574 )
    0.5 ( 0.451 )
    0.0 ( 0.257 )
    0.2 ( 0.654 )
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring system (RAMRIS) scores for Bone Erosion at Weeks 4 and 12

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    End point title
    		 Mean Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring system (RAMRIS) scores for Bone Erosion at Weeks 4 and 12
    End point description
    Bone erosion assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage) according to erosion of the original articular bone (each unit=10% loss of articular bone). The total erosion score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 230. Increasing score=greater severity.A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Week 4 and Week 12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Scores on a scale
    arithmetic mean (standard error)
        Week 4 (n = 69, 67, 70, 23)
    0.1 ( 0.048 )
    0.1 ( 0.089 )
    -0.0 ( 0.036 )
    0.0 ( 0.030 )
        Week 12 (n = 69, 67, 70, 23)
    0.1 ( 0.048 )
    0.3 ( 0.248 )
    0.0 ( 0.046 )
    0.1 ( 0.072 )
    No statistical analyses for this end point

    Secondary: Mean Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring system (RAMRIS) scores for Cartilage Loss at Weeks 4 and 12

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    End point title
    		 Mean Change from Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring system (RAMRIS) scores for Cartilage Loss at Weeks 4 and 12
    End point description
    Cartilage loss was assessed by MRI. Scans of 25 joints were read and scored for each participant by assessors. Scores for each location ranged 0-4 on a 9-point scale, with 0= no cartilage loss and 4= complete cartilage loss. Total score was the sum of the 25 individual scores and ranged 0-100 with 0= no cartilage loss and 100= most severe cartilage loss. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Week 4 and week12
    End point values
    		 Placebo BMS 100mg BMS 200mg BMS 350mg
    Number of subjects analysed
    75
    73
    73
    26
    Units: Scores on a scale
    arithmetic mean (standard error)
        Week 4 (n = 69, 67, 70, 23)
    0.1 ( 0.105 )
    0.0 ( 0.064 )
    -0.0 ( 0.079 )
    0.4 ( 0.169 )
        Week 12 (n = 69, 67, 70, 23)
    0.0 ( 0.116 )
    0.3 ( 0.139 )
    0.0 ( 0.111 )
    0.5 ( 0.294 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events were collected from signature of the informed consent until 30 days after last treatment administration (Approximately 26 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.

    Reporting group title
    BMS 100 mg
    Reporting group description
    		 Oral dose of BMS-986142 100 milligram (mg) was administered daily for 12 weeks.

    Reporting group title
    BMS 200 mg
    Reporting group description
    		 Oral dose of BMS-986142 200 mg was administered daily for 12 weeks.

    Reporting group title
    BMS 350 mg
    Reporting group description
    		 Oral dose of BMS-986142 350 mg was administered daily for 12 weeks.

    Serious adverse events
    		 Placebo BMS 100 mg BMS 200 mg BMS 350 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 75 (5.33%)
    2 / 73 (2.74%)
    0 / 73 (0.00%)
    0 / 26 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Open globe injury
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 73 (1.37%)
    0 / 73 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo BMS 100 mg BMS 200 mg BMS 350 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 75 (14.67%)
    12 / 73 (16.44%)
    16 / 73 (21.92%)
    14 / 26 (53.85%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 75 (4.00%)
    0 / 73 (0.00%)
    1 / 73 (1.37%)
    5 / 26 (19.23%)
         occurrences all number
    4
    0
    1
    6
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 75 (2.67%)
    0 / 73 (0.00%)
    1 / 73 (1.37%)
    2 / 26 (7.69%)
         occurrences all number
    2
    0
    1
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
    4 / 26 (15.38%)
         occurrences all number
    0
    0
    0
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 75 (2.67%)
    2 / 73 (2.74%)
    4 / 73 (5.48%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    4
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 73 (1.37%)
    3 / 73 (4.11%)
    2 / 26 (7.69%)
         occurrences all number
    1
    1
    3
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 75 (2.67%)
    4 / 73 (5.48%)
    3 / 73 (4.11%)
    0 / 26 (0.00%)
         occurrences all number
    2
    4
    4
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 75 (1.33%)
    5 / 73 (6.85%)
    5 / 73 (6.85%)
    5 / 26 (19.23%)
         occurrences all number
    2
    5
    7
    5
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    3 / 75 (4.00%)
    1 / 73 (1.37%)
    3 / 73 (4.11%)
    6 / 26 (23.08%)
         occurrences all number
    3
    1
    4
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 May 2016
    Incorporate changes in response to health authorities’ comments and update information collected during course of study.
    04 Aug 2016
    Introduced a change in ratio of the subpopulation of patients with RA from predominantly tumor necrosis factor- inadequate responder(s) (TNF-IR) to predominantly MTX-IR.
    29 Oct 2017
    - This protocol was updated mainly to incorporate preliminary results of drug-drug interactions studies IM006-031 and IM006-032 as described in Dear Investigator Letter dated 17-Oct-2016. - Revisions were also made to provide further clarifications on study timelines, leflunomide washout, inclusion and exclusion criteria, PI expectations on x-ray and MRI results, Physicians Global Assessment of Disease Activity (PGA) and Joint Count Assessments, as well as to include administrative changes.

    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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