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    Clinical Trial Results:
    A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.

    Summary
    EudraCT number
    		 2019-000868-18
    Trial protocol
    		 GB   DE   PL   LT   ES   BE   CZ   HU   IT  
    Global end of trial date
    01 Feb 2022

    Results information
    Results version number
    		 v1
    This version publication date
    17 Feb 2023
    First version publication date
    17 Feb 2023
    Other versions
    		 v2 , v3

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    202018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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
    15 Mar 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare efficacy and safety of GSK3196165 (Otilimab) versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Oct 2019
    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: 104
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Czechia: 46
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Japan: 38
    Country: Number of subjects enrolled
    Lithuania: 6
    Country: Number of subjects enrolled
    Poland: 108
    Country: Number of subjects enrolled
    South Africa: 11
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 5
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    United States: 199
    Worldwide total number of subjects
    550
    EEA total number of subjects
    187
    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)
    419
    From 65 to 84 years
    131
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a multicenter study conducted across 14 countries. Participants were randomized to receive either GSK3196165 or Sarilumab or placebo. After week 12, the participants were switched to either GSK3196165 or Sarilumab.

    Pre-assignment
    Screening details
    		 Total of 550 participants were randomized and one participant from the randomized set withdrew from the study before receiving study intervention of GSK3196165 90 mg + csDMARD arm due to Protocol Deviation. Hence the participant was removed from intent-to-treat (ITT) and safety population (N=549).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK3196165 90 mg + csDMARD
    Arm description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK3196165
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 90 mg of GSK3196165 once every week

    Arm title
    		 GSK3196165 150 mg + csDMARD
    Arm description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK3196165
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 150 mg of GSK3196165 once every week

    Arm title
    		 Sarilumab 200 mg or placebo + csDMARD
    Arm description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sarilumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 200 mg of Sarilumab once every alternate week.

    Arm title
    		 Pooled Placebo
    Arm description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injectionuntil Week 12.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo once every week

    Number of subjects in period 1 [1]
    		GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Started
    156
    158
    156
    79
    Completed
    143
    144
    133
    74
    Not completed
    13
    14
    23
    5
         Physician decision
    2
    -
    -
    -
         Adverse event, non-fatal
    3
    2
    9
    -
         Informed Consent Withdrawn
    3
    6
    8
    2
         Protocol Deviation
    -
    -
    1
    -
         Investigator Site Closed
    -
    1
    1
    -
         Protocol-Specified Withdrawal Criterion Met
    1
    -
    2
    -
         Lost to follow-up
    1
    2
    1
    1
         Lack of efficacy
    3
    3
    1
    2
    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: One participant from the randomized set withdrew from the study before receiving study intervention of GSK3196165 90 mg + csDMARD arm due to Protocol Deviation. Hence the participant was removed from intent-to-treat (ITT) and safety population.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK3196165 90 mg + csDMARD
    Reporting group description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.

    Reporting group title
    GSK3196165 150 mg + csDMARD
    Reporting group description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.

    Reporting group title
    Sarilumab 200 mg or placebo + csDMARD
    Reporting group description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.

    Reporting group title
    Pooled Placebo
    Reporting group description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injectionuntil Week 12.

    Reporting group values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo Total
    Number of subjects
    		 156 158 156 79 549
    Age categorical
    Total of 550 participants were randomized and one participant from the randomized population withdrew from the study before receiving study intervention. Hence the participant was removed from intent-to-treat (ITT) and safety population (N=549).
    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)
    		 119 121 115 63 418
        From 65-84 years
    		 37 37 41 16 131
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.7 ± 10.59 56.0 ± 10.52 57.5 ± 10.69 55.5 ± 10.64 -
    Sex: Female, Male
    Units: Participants
        Female
    		 134 135 132 65 466
        Male
    		 22 23 24 14 83
    Race/Ethnicity, Customized
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    		 1 0 0 0 1
        ASIAN
    		 13 15 12 7 47
        BLACK OR AFRICAN AMERICAN
    		 5 8 6 4 23
        MISSING
    		 0 2 0 0 2
        MULTIPLE
    		 0 0 0 1 1
        WHITE
    		 137 133 138 67 475
    Age, Continuous
    Units: YEARS
        arithmetic mean (standard deviation)
    		 56.7 ± 10.59 56.0 ± 10.52 57.5 ± 10.69 55.5 ± 10.64 -

    End points

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    End points reporting groups
    Reporting group title
    GSK3196165 90 mg + csDMARD
    Reporting group description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.

    Reporting group title
    GSK3196165 150 mg + csDMARD
    Reporting group description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.

    Reporting group title
    Sarilumab 200 mg or placebo + csDMARD
    Reporting group description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.

    Reporting group title
    Pooled Placebo
    Reporting group description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injectionuntil Week 12.

    Subject analysis set title
    Placebo + csDMARD and GSK3196165 90 mg + csDMARD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.

    Subject analysis set title
    Placebo + csDMARD and GSK3196165 150 mg + csDMARD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.

    Subject analysis set title
    Placebo + csDMARD and Sarilumab 200 mg + csDMARD
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.

    Primary: Percentage of participants with 20% improvement in American College of Rheumatology criteria (ACR20) at Week 12 superiority comparison with placebo

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    End point title
    		 Percentage of participants with 20% improvement in American College of Rheumatology criteria (ACR20) at Week 12 superiority comparison with placebo
    End point description
    ACR20 is calculated as a 20% improvement from Baseline in both tender and swollen joint counts and a 20% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, pain visual analogue scale, (HAQ-DI) and an acute-phase reactant (hsCRP or ESR). For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Percentage of participants
        number (not applicable)
    44.8
    50.7
    57.5
    37.7
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from placebo in the proportion of participants with ACR20 response at Week 12
    Comparison groups
    Pooled Placebo v GSK3196165 90 mg + csDMARD
    Number of subjects included in analysis
    235
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2868
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.38
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 2.48
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The null hypothesis is that there is no difference between 150 mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 150 mg dose of GSK3196165 differs from placebo in the proportion of participants with ACR20 response at Week 12
    Comparison groups
    GSK3196165 150 mg + csDMARD v Pooled Placebo
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0596
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.75
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 3.15
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    The null hypothesis is that there is no difference between 200 mg dose of Sarilumab alternating with placebo every week and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 200 mg dose of Sarilumab alternating with placebo every week differs from placebo in the proportion of participants with ACR20 response at Week 12
    Comparison groups
    Sarilumab 200 mg or placebo + csDMARD v Pooled Placebo
    Number of subjects included in analysis
    235
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0049
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.34
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 4.23
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants with ACR20 response at Week 12
    Comparison groups
    GSK3196165 90 mg + csDMARD v Sarilumab 200 mg or placebo + csDMARD
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0293
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.59
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 0.95
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    The null hypothesis is that there is no difference between 150 mg dose of GSK3196165 and 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 150 mg dose of GSK3196165 differs from 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants with ACR20 response at Week 12
    Comparison groups
    GSK3196165 150 mg + csDMARD v Sarilumab 200 mg or placebo + csDMARD
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2308
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.75
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 1.2

    Secondary: Change from Baseline in HAQ-DI (verus Placebo) at Week 12

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    End point title
    		 Change from Baseline in HAQ-DI (verus Placebo) at Week 12
    End point description
    The HAQ-DI Score is calculated from 20-questions which assesses the degree of difficulty a participant has in accomplishing tasks in eight functional areas: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Score on scale
        least squares mean (standard error)
    -0.33 ± 0.044
    -0.41 ± 0.043
    -0.46 ± 0.044
    -0.23 ± 0.061
    No statistical analyses for this end point

    Secondary: Percentage of participants with Clinical disease activity index (CDAI) total score <=10 (CDAI Low disease activity [LDA]) at Week 12

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    End point title
    		 Percentage of participants with Clinical disease activity index (CDAI) total score <=10 (CDAI Low disease activity [LDA]) at Week 12
    End point description
    The CDAI total score is a composite score to determine disease severity using only clinical data. It is calculated by the simple sum of the 4 following parameters: Tender joint count 28 (TJC28), Swollen joint count 28 (SJC28), Patient's global assessment of arthritis and Physician's global assessment of arthritis both transformed to a 0-10 scale. Total score approximate range 0-76, higher total score indicating more severe disease. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Percentage of participants
        number (not applicable)
    20.7
    18.2
    28.1
    14.2
    No statistical analyses for this end point

    Secondary: Percentage of participants with CDAI total score <=10 (CDAI LDA) at Week 24

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    End point title
    		 Percentage of participants with CDAI total score <=10 (CDAI LDA) at Week 24 [1]
    End point description
    The CDAI total score is a composite score to determine disease severity using only clinical data. It is calculated by the simple sum of the 4 following parameters: TJC28, SJC28, Patient's global assessment of arthritis and Physician's global assessment of arthritis. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Week 24
    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: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Percentage of participants
        number (not applicable)
    31.2
    30.1
    42.6
    No statistical analyses for this end point

    Secondary: Change from Baseline in CDAI total score at Week 12

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    End point title
    		 Change from Baseline in CDAI total score at Week 12
    End point description
    The CDAI total score is a composite score to determine disease severity using only clinical data. It is calculated by the simple sum of the 4 following parameters: TJC28, SJC28, Patient's global assessment of arthritis and Physician's global assessment of arthritis. Total score approximate range 0-76, higher total score indicates more severe disease. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Score on scale
        least squares mean (standard error)
    -16.87 ± 1.03
    -17.23 ± 1.018
    -20.22 ± 1.027
    -14.86 ± 1.438
    No statistical analyses for this end point

    Secondary: Change from Baseline in CDAI total score at Week 24

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    End point title
    		 Change from Baseline in CDAI total score at Week 24 [2]
    End point description
    The CDAI total score is a composite score to determine disease severity using only clinical data. It is calculated by the simple sum of the 4 following parameters: TJC28, SJC28, Patient's global assessment of arthritis and Physician's global assessment of arthritis. Total score approximate range 0-76, higher total score indicates more severe disease. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    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: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Score on scale
        least squares mean (standard error)
    -20.93 ± 1.04
    -20.75 ± 1.022
    -23.22 ± 1.048
    No statistical analyses for this end point

    Secondary: Change from Baseline in Arthritis pain VAS at Week 12

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    End point title
    		 Change from Baseline in Arthritis pain VAS at Week 12
    End point description
    Participants assessment of the severity of their arthritis pain over the past week, using a 100 unit VAS, with anchors "0" (no pain) and "100" (most severe pain). For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Score on scale
        least squares mean (standard error)
    -19.35 ± 2.127
    -21.17 ± 2.088
    -25.93 ± 2.12
    -16.73 ± 2.939
    No statistical analyses for this end point

    Secondary: Change from Baseline in Arthritis pain VAS at Week 24

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    End point title
    		 Change from Baseline in Arthritis pain VAS at Week 24 [3]
    End point description
    Participants assessment of the severity of their arthritis pain over the past week, using a 100 unit VAS, with anchors "0" (no pain) and "100" (most severe pain). Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    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: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Score on scale
        least squares mean (standard error)
    -25.06 ± 2.153
    -24.31 ± 2.115
    -30.62 ± 2.141
    No statistical analyses for this end point

    Secondary: Percentage of participants with CDAI total score <=2.8 (CDAI Remission) at Week 12

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    End point title
    		 Percentage of participants with CDAI total score <=2.8 (CDAI Remission) at Week 12
    End point description
    The CDAI total score is a composite score to determine disease severity using only clinical data. It is calculated by the simple sum of the 4 following parameters: TJC28, SJC28, Patient's global assessment of arthritis and Physician's global assessment of arthritis. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Percentage of participants
        number (not applicable)
    2.2
    4.3
    8.7
    0.6
    No statistical analyses for this end point

    Secondary: Percentage of participants with CDAI total score <=2.8 (CDAI Remission) at Week 24

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    End point title
    		 Percentage of participants with CDAI total score <=2.8 (CDAI Remission) at Week 24 [4]
    End point description
    The CDAI total score is a composite score to determine disease severity using only clinical data. It is calculated by the simple sum of the 4 following parameters: TJC28, SJC28, Patient's global assessment of arthritis and Physician's global assessment of arthritis. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Week 24
    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: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Percentage of participants
        number (not applicable)
    7.9
    8.4
    8.3
    No statistical analyses for this end point

    Secondary: Percentage of participants with ACR20 at Week 24

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    End point title
    		 Percentage of participants with ACR20 at Week 24 [5]
    End point description
    ACR20 is calculated as a 20% improvement from Baseline in both tender and swollen joint counts and a 20% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, pain VAS, HAQ-DI and an acute-phase reactant (hsCRP or ESR). Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Week 24
    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: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Percentage of participants
        number (not applicable)
    58.1
    60.5
    65.1
    No statistical analyses for this end point

    Secondary: Percentage of participants with ACR50 at Week 12

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    End point title
    		 Percentage of participants with ACR50 at Week 12
    End point description
    ACR50 is calculated as a 50% improvement from Baseline in both tender and swollen joint counts and a 50% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, pain VAS, HAQ-DI and an acute-phase reactant (hsCRP or ESR). For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Percentage of participants
        number (not applicable)
    18.2
    22.5
    25.9
    11.5
    No statistical analyses for this end point

    Secondary: Percentage of participants with ACR50 at Week 24

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    End point title
    		 Percentage of participants with ACR50 at Week 24 [6]
    End point description
    ACR50 is calculated as a 50% improvement from Baseline in both tender and swollen joint counts and a 50% improvement in 3 of the following 5 measures: Patient global assessment of disease activity, physician global assessment of disease activity, pain VAS, HAQ-DI and an acute-phase reactant (hsCRP or ESR). Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Week 24
    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: This endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Percentage of participants
        number (not applicable)
    23.6
    30.1
    42.9
    No statistical analyses for this end point

    Secondary: Percentage of participants with ACR70 at Week 12

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    End point title
    		 Percentage of participants with ACR70 at Week 12
    End point description
    ACR70 is calculated as a 70% improvement from Baseline in both tender and swollen joint counts and a 70% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, pain VAS, HAQ-DI and an acute-phase reactant (hsCRP or ESR). For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Percentage of participants
        number (not applicable)
    5.9
    10.8
    13.3
    6.1
    No statistical analyses for this end point

    Secondary: Percentage of participants with ACR70 at Week 24

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    End point title
    		 Percentage of participants with ACR70 at Week 24 [7]
    End point description
    ACR70 is calculated as a 70% improvement from Baseline in both tender and swollen joint counts and a 70% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, pain VAS, HAQ-DI and an acute-phase reactant (hsCRP or ESR). Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Week 24
    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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Percentage of participants
        number (not applicable)
    12.3
    13.2
    22.7
    No statistical analyses for this end point

    Secondary: Percentage of participants with Disease Activity Score using 28 joint count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12

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    End point title
    		 Percentage of participants with Disease Activity Score using 28 joint count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12
    End point description
    The DAS28-CRP is a measure of RA disease activity calculated using the number of TJC28, SJC28, hsCRP (mg per liter [/L]) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Percentage of participants
        number (not applicable)
    17
    17
    40.1
    13.2
    No statistical analyses for this end point

    Secondary: Percentage of participants with (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 24

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    End point title
    		 Percentage of participants with (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 24 [8]
    End point description
    The DAS28-CRP is a measure of RA disease activity calculated using the number of TJC28, SJC28, hsCRP (mg per liter [/L]) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [8] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Percentage of participants
        number (not applicable)
    26.8
    24.8
    46.9
    No statistical analyses for this end point

    Secondary: Percentage of participants with DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12

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    End point title
    		 Percentage of participants with DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12
    End point description
    The DAS28-CRP is a measure of RA disease activity calculated using the number of TJC28, SJC28, hsCRP (mg per liter [/L]) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Percentage of participants
        number (not applicable)
    13.3
    8.5
    36.2
    1.9
    No statistical analyses for this end point

    Secondary: Percentage of participants with DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24

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    End point title
    		 Percentage of participants with DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 [9]
    End point description
    The DAS28-CRP is a measure of RA disease activity calculated using the number of TJC28, SJC28, hsCRP (mg per liter [/L]) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [9] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Percentage of participants
        number (not applicable)
    17.4
    17.2
    45.8
    No statistical analyses for this end point

    Secondary: Percentage of participants with DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12

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    End point title
    		 Percentage of participants with DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12
    End point description
    The DAS28-CRP is a measure of RA disease activity calculated using the number of TJC28, SJC28, hsCRP (mg per liter [/L]) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Percentage of participants
        number (not applicable)
    10.2
    7.2
    22.2
    1.8
    No statistical analyses for this end point

    Secondary: Percentage of participants with DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24

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    End point title
    		 Percentage of participants with DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 [10]
    End point description
    The DAS28-CRP is a measure of RA disease activity calculated using the number of TJC28, SJC28, hsCRP (mg per liter [/L]) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [10] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Percentage of participants
        number (not applicable)
    16.2
    13.9
    32.6
    No statistical analyses for this end point

    Secondary: Percentage of participants with DAS28-ESR <2.6 (DAS28-ESR Remission) at Week 12

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    End point title
    		 Percentage of participants with DAS28-ESR <2.6 (DAS28-ESR Remission) at Week 12
    End point description
    The DAS28-CRP is a measure of RA disease activity calculated using the number of TJC28, SJC28, hsCRP (mg per liter [/L]) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Percentage of participants
        number (not applicable)
    3.1
    5.7
    23
    0.7
    No statistical analyses for this end point

    Secondary: Percentage of participants with DAS28-ESR <2.6 (DAS28-ESR Remission) Week 24

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    End point title
    		 Percentage of participants with DAS28-ESR <2.6 (DAS28-ESR Remission) Week 24 [11]
    End point description
    The DAS28-CRP is a measure of RA disease activity calculated using the number of TJC28, SJC28, hsCRP (mg per liter [/L]) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [11] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Percentage of participants
        number (not applicable)
    10.8
    8.9
    29.8
    No statistical analyses for this end point

    Secondary: Percentage of participants with a good/moderate European League against Rheumatism (EULAR) response at Week 12

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    End point title
    		 Percentage of participants with a good/moderate European League against Rheumatism (EULAR) response at Week 12
    End point description
    EULAR response criteria defined as Good response = DAS28 change >1.2 with DAS28 <=3.2; Moderate response = DAS28 change >0.6 with DAS28 >3.2-5.1; Non-response = DAS28 change <=0.6 and absolute DAS28 >5.1. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Percentage of participants
        number (not applicable)
    66.3
    68.4
    84.1
    62.9
    No statistical analyses for this end point

    Secondary: Percentage of participants with a good/moderate EULAR response at Week 24

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    End point title
    		 Percentage of participants with a good/moderate EULAR response at Week 24 [12]
    End point description
    EULAR response criteria defined as Good response = DAS28 change >1.2 with DAS28 <=3.2; Moderate response = DAS28 change >0.6 with DAS28 >3.2-5.1; Non-response = DAS28 change <=0.6 and absolute DAS28 >5.1. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [12] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Percentage of participants
        number (not applicable)
    76.3
    71.3
    86.6
    No statistical analyses for this end point

    Secondary: Percentage of participants with ACR/EULAR remission at Week 12

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    End point title
    		 Percentage of participants with ACR/EULAR remission at Week 12
    End point description
    Percentage of participants achieving ACR/EULAR remission at Week 12 is summarized. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Percentage of participants
        number (not applicable)
    2
    4
    9
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with ACR/EULAR remission at Week 24

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    End point title
    		 Percentage of participants with ACR/EULAR remission at Week 24 [13]
    End point description
    Percentage of participants with ACR/EULAR remission at Week 24 is summarized. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [13] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Percentage of participants
        number (not applicable)
    6
    4
    5
    No statistical analyses for this end point

    Secondary: Change from Baseline in DAS28(CRP) and DAS28-ESR at Week 12

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    End point title
    		 Change from Baseline in DAS28(CRP) and DAS28-ESR at Week 12
    End point description
    DAS28 (CRP) and DAS28-ESR are measure of RA disease activity calculated using tender joint count and swollen joint count (28-joint count), hsCRP (mg/L)/ESR (mm/hour) and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, higher score indicating more disease activity. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Score on scale
    least squares mean (standard error)
        DAS28-CRP
    -1.34 ± 0.1
    -1.42 ± 0.098
    -2.15 ± 0.1
    -1.08 ± 0.139
        DAS28-ESR
    -1.41 ± 0.109
    -1.46 ± 0.106
    -2.57 ± 0.108
    -1.06 ± 0.152
    No statistical analyses for this end point

    Secondary: Change from Baseline in DAS28 (CRP) and DAS28-ESR at Week 24

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    End point title
    		 Change from Baseline in DAS28 (CRP) and DAS28-ESR at Week 24 [14]
    End point description
    DAS28 (CRP) and DAS28-ESR are measure of RA disease activity calculated using TJC28, SJC28, hsCRP (mg/L)/ESR (mm/hour) and PtGA transformed to a 0-10 scale. Total score approximate range 0-9.4, higher score indicating more disease activity. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [14] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Score on scale
    least squares mean (standard error)
        DAS28-CRP
    -1.67 ± 0.108
    -1.67 ± 0.106
    -2.38 ± 0.109
        DAS28-ESR
    -1.7 ± 0.121
    -1.68 ± 0.117
    -2.85 ± 0.121
    No statistical analyses for this end point

    Secondary: Change from Baseline in HAQ-DI at Week 24

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    End point title
    		 Change from Baseline in HAQ-DI at Week 24 [15]
    End point description
    HAQ-DI: 20-questions which assesses the degree of difficulty a participant has in accomplishing tasks in eight functional areas: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [15] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Score on scale
        least squares mean (standard error)
    -0.39 ± 0.05
    -0.45 ± 0.049
    -0.48 ± 0.05
    No statistical analyses for this end point

    Secondary: Change from Baseline in Functional assessment of chronic illness therapy (FACIT)-Fatigue at Week 12

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    End point title
    		 Change from Baseline in Functional assessment of chronic illness therapy (FACIT)-Fatigue at Week 12
    End point description
    FACIT-fatigue is a validated patient-reported measure developed originally to assess fatigue in individuals with cancer and has subsequently been used and validated in numerous chronic conditions, including RA. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Score on scale
        least squares mean (standard error)
    5.5 ± 0.735
    6.8 ± 0.724
    7.3 ± 0.749
    5.45 ± 1.023
    No statistical analyses for this end point

    Secondary: Change from Baseline in FACIT-Fatigue at Week 24

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    End point title
    		 Change from Baseline in FACIT-Fatigue at Week 24 [16]
    End point description
    FACIT-fatigue is a validated patient-reported measure developed originally to assess fatigue in individuals with cancer and has subsequently been used and validated in numerous chronic conditions, including RA. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [16] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Score on scale
        least squares mean (standard error)
    6.55 ± 0.795
    7.21 ± 0.777
    7.99 ± 0.806
    No statistical analyses for this end point

    Secondary: Change from Baseline in Short form (36) (SF-36) physical component scores at Week 12

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    End point title
    		 Change from Baseline in Short form (36) (SF-36) physical component scores at Week 12
    End point description
    SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Score on scale
        least squares mean (standard error)
    5.08 ± 0.619
    5.03 ± 0.61
    5.61 ± 0.627
    3.72 ± 0.866
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 physical component scores at Week 24

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    End point title
    		 Change from Baseline in SF-36 physical component scores at Week 24 [17]
    End point description
    SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [17] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Score on scale
        least squares mean (standard error)
    5.67 ± 0.707
    5.5 ± 0.694
    7.18 ± 0.71
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 mental component scores at Week 12

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    End point title
    		 Change from Baseline in SF-36 mental component scores at Week 12
    End point description
    SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Score on scale
        least squares mean (standard error)
    1.64 ± 0.731
    3.45 ± 0.72
    4.15 ± 0.744
    1.61 ± 1.024
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 mental component scores at Week 24

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    End point title
    		 Change from Baseline in SF-36 mental component scores at Week 24 [18]
    End point description
    SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [18] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Score on scale
        least squares mean (standard error)
    2.22 ± 0.772
    3.05 ± 0.756
    3.61 ± 0.78
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 domain scores at Week 12

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    End point title
    		 Change from Baseline in SF-36 domain scores at Week 12
    End point description
    SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: Percentage of participants
    arithmetic mean (standard deviation)
        Bodily Pain
    17 ± 21.45
    16.8 ± 22.2
    19.8 ± 23.27
    10.7 ± 21.38
        General Health
    6.3 ± 15.89
    6.7 ± 16.07
    6.7 ± 15.69
    4.2 ± 15.84
        Mental Health
    4.3 ± 19.3
    7.6 ± 16.9
    8.2 ± 18.55
    4.8 ± 16.31
        Physical Function
    9.69 ± 21.423
    14.22 ± 23.909
    13.15 ± 24.135
    6.55 ± 21.156
        Role Emotional
    5.77 ± 22.405
    9.4 ± 25.128
    10.93 ± 23.908
    3.87 ± 22.219
        Role Physical
    12.94 ± 22.371
    14.19 ± 25.155
    13.81 ± 23.488
    10.74 ± 19.456
        Social Function
    6.99 ± 23.107
    10.73 ± 27.51
    11.59 ± 24.383
    6.87 ± 27.774
        Vitality
    9.48 ± 18.03
    11.82 ± 19.94
    13 ± 19.895
    5.11 ± 18.61
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 domain scores at Week 24

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    End point title
    		 Change from Baseline in SF-36 domain scores at Week 24 [19]
    End point description
    SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [19] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Percentage of participants
    arithmetic mean (standard deviation)
        Bodily Pain
    20.7 ± 22.82
    18.5 ± 22.43
    23.9 ± 27.29
        General Health
    6.4 ± 15.25
    6.7 ± 16.3
    8.8 ± 17.3
        Mental Health
    6.1 ± 17.16
    8.4 ± 19.63
    10 ± 18.71
        Physical Function
    11.43 ± 23.714
    16.36 ± 25.64
    18.86 ± 24.472
        Role Emotional
    5.83 ± 23.522
    7.99 ± 28.03
    8.88 ± 26.589
        Role Physical
    13.97 ± 21.332
    15.22 ± 27.352
    17.37 ± 26.25
        Social Function
    9.46 ± 25.704
    10.37 ± 29.237
    12.04 ± 24.599
        Vitality
    11.29 ± 17.913
    13.22 ± 21.245
    16.31 ± 19.854
    No statistical analyses for this end point

    Secondary: Incidence of Adverse events (AEs), Serious adverse event (SAEs), Adverse events of special interest (AESI)

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    End point title
    		 Incidence of Adverse events (AEs), Serious adverse event (SAEs), Adverse events of special interest (AESI)
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Placebo was not administered beyond Week 12. The Pooled Placebo collected data during the timeframe Week 0 to Week 12; Subject Analysis Sets collected from Week 12 to Week 24 and the Reporting Groups collected from Week 0 to Week 24.
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo Placebo + csDMARD and GSK3196165 90 mg + csDMARD Placebo + csDMARD and GSK3196165 150 mg + csDMARD Placebo + csDMARD and Sarilumab 200 mg + csDMARD
    Number of subjects analysed
    156
    158
    156
    79
    24
    25
    26
    Units: Participants
        AE
    92
    99
    98
    37
    9
    10
    12
        SAE
    8
    1
    12
    2
    1
    3
    1
        AESI
    16
    15
    33
    0
    2
    3
    5
    No statistical analyses for this end point

    Secondary: Change from Baseline in neutrophil, lymphocyte, platelet count (Giga cells per liter) at Week 12

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    End point title
    		 Change from Baseline in neutrophil, lymphocyte, platelet count (Giga cells per liter) at Week 12
    End point description
    Blood samples was collected for the assessment of hematology parameters. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: 10^9/L (Giga cells per liter)
    arithmetic mean (standard deviation)
        Lymphocytes
    -0.039 ± 0.5089
    -0.01 ± 0.508
    -0.057 ± 0.4989
    0.009 ± 0.5354
        Neutrophils
    -0.255 ± 1.5469
    -0.412 ± 2.0477
    -1.843 ± 2.1359
    -0.113 ± 1.4395
        Platelets
    -10.9 ± 56.51
    -17.3 ± 60.17
    -76.5 ± 62.76
    -10.3 ± 62.82
    No statistical analyses for this end point

    Secondary: Change from Baseline in neutrophil, lymphocyte, platelet count (Giga cells per liter) at Week 24

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    End point title
    		 Change from Baseline in neutrophil, lymphocyte, platelet count (Giga cells per liter) at Week 24 [20]
    End point description
    Blood samples was collected for the assessment of hematology parameters. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [20] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: 10^9/L (Giga cells per liter)
    arithmetic mean (standard deviation)
        Lymphocytes
    -0.079 ± 0.5135
    0.012 ± 0.5939
    -0.108 ± 0.52
        Neutrophils
    -0.388 ± 1.692
    -0.422 ± 1.7963
    -1.99 ± 2.3395
        Platelets
    -9.3 ± 50.96
    -9 ± 64.92
    -79.2 ± 71.13
    No statistical analyses for this end point

    Secondary: Change from Baseline in white blood cell (WBC) count (Giga cells per liter) at Week 12

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    End point title
    		 Change from Baseline in white blood cell (WBC) count (Giga cells per liter) at Week 12
    End point description
    Blood samples was collected for the assessment of hematology parameters. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: 10^9/L (Giga cells per liter)
        arithmetic mean (standard deviation)
    -0.29 ± 1.753
    -0.42 ± 2.072
    -1.95 ± 2.325
    -0.09 ± 1.558
    No statistical analyses for this end point

    Secondary: Change from Baseline in WBC count (Giga cells per liter) at Week 24

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    End point title
    		 Change from Baseline in WBC count (Giga cells per liter) at Week 24 [21]
    End point description
    Blood samples was collected for the assessment of hematology parameters. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [21] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: 10^9/L (Giga cells per liter)
        arithmetic mean (standard deviation)
    -0.45 ± 1.851
    -0.43 ± 1.787
    -2.15 ± 2.51
    No statistical analyses for this end point

    Secondary: Change from Baseline in hemoglobin level (Grams per liter) Week 12

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    End point title
    		 Change from Baseline in hemoglobin level (Grams per liter) Week 12
    End point description
    Blood samples was collected for the assessment of hematology parameters. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: g/L (Grams per liter)
        arithmetic mean (standard deviation)
    -0.9 ± 8.06
    0.3 ± 8.54
    5.5 ± 9.19
    -2 ± 7.98
    No statistical analyses for this end point

    Secondary: Change from Baseline in hemoglobin level (Grams per liter) Week 24

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    End point title
    		 Change from Baseline in hemoglobin level (Grams per liter) Week 24 [22]
    End point description
    Blood samples was collected for the assessment of hematology parameters. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [22] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: g/L (Grams per liter)
        arithmetic mean (standard deviation)
    -1.9 ± 9.05
    -1 ± 8.63
    5.8 ± 11.07
    No statistical analyses for this end point

    Secondary: Change from Baseline in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP) gamma-glutamyl transferase(GGT) levels (International units per liter) at Week 12

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    End point title
    		 Change from Baseline in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP) gamma-glutamyl transferase(GGT) levels (International units per liter) at Week 12
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: IU/L (International units per liter)
    arithmetic mean (standard deviation)
        AP
    0.7 ± 14.42
    -3 ± 14.94
    -15.6 ± 20.63
    -1 ± 14.57
        ALT
    0.8 ± 16.22
    -0.7 ± 12.95
    8.1 ± 21.3
    -1 ± 10.8
        AST
    0.6 ± 10.29
    0.7 ± 8.52
    4.5 ± 11.43
    0.3 ± 9.82
        GGT
    -0.8 ± 14.24
    -2.6 ± 15.23
    0.6 ± 12.37
    -1.8 ± 11.46
    No statistical analyses for this end point

    Secondary: Change from Baseline in AST, ALT, AP, GGT levels (International units per liter) at Week 24

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    End point title
    		 Change from Baseline in AST, ALT, AP, GGT levels (International units per liter) at Week 24 [23]
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [23] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: IU/L (International units per liter)
    arithmetic mean (standard deviation)
        AP
    1.8 ± 16.48
    -1.7 ± 18.76
    -14.3 ± 19.23
        ALT
    1.6 ± 12.73
    1.9 ± 20.52
    6.2 ± 12.98
        AST
    1.7 ± 7.89
    2.1 ± 11.21
    3.0 ± 9.29
        GGT
    -0.3 ± 13.07
    -0.3 ± 25.67
    0.9 ± 15.73
    No statistical analyses for this end point

    Secondary: Change from Baseline in albumin level (Grams per liter) at Week 12

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    End point title
    		 Change from Baseline in albumin level (Grams per liter) at Week 12
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: g/L (Grams per liter)
        arithmetic mean (standard deviation)
    0 ± 2.5
    0.3 ± 2.38
    1.6 ± 2.64
    -0.4 ± 2.9
    No statistical analyses for this end point

    Secondary: Change from Baseline in albumin level (Grams per liter) at Week 24

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    End point title
    		 Change from Baseline in albumin level (Grams per liter) at Week 24 [24]
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [24] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: g/L (Grams per liter)
        arithmetic mean (standard deviation)
    0.2 ± 2.55
    0.2 ± 2.50
    2.0 ± 3.16
    No statistical analyses for this end point

    Secondary: Change from Baseline in total bilirubin (Micromoles per liter) at Week 12

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    End point title
    		 Change from Baseline in total bilirubin (Micromoles per liter) at Week 12
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    156
    158
    156
    79
    Units: umol/L (Micromoles per liter)
        arithmetic mean (standard deviation)
    0.1 ± 2.35
    0.4 ± 3.07
    2.3 ± 4.5
    0.3 ± 2.64
    No statistical analyses for this end point

    Secondary: Change from Baseline in total bilirubin (Micromoles per liter) at Week 24

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    End point title
    		 Change from Baseline in total bilirubin (Micromoles per liter) at Week 24 [25]
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [25] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: umol/L (Micromoles per liter)
        arithmetic mean (standard deviation)
    0.1 ± 2.06
    0.2 ± 2.70
    2.5 ± 4.11
    No statistical analyses for this end point

    Secondary: Change from Baseline in total cholesterol (Millimoles per liter) at Week 12

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    End point title
    		 Change from Baseline in total cholesterol (Millimoles per liter) at Week 12
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    0 [26]
    0 [27]
    0 [28]
    0 [29]
    Units: mmol/L (Millimoles per liter)
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [26] - Data was not collected as there is no corresponding time point in schedule of activity of Protocol.
    [27] - Data was not collected as there is no corresponding time point in schedule of activity of Protocol.
    [28] - Data was not collected as there is no corresponding time point in schedule of activity of Protocol.
    [29] - Data was not collected as there is no corresponding time point in schedule of activity of Protocol.
    No statistical analyses for this end point

    Secondary: Change from Baseline in total cholesterol (Millimoles per liter) at Week 24

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    End point title
    		 Change from Baseline in total cholesterol (Millimoles per liter) at Week 24 [30]
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [30] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: mmol/L (Millimoles per liter)
        arithmetic mean (standard deviation)
    0.053 ± 1.0158
    0.061 ± 0.7881
    0.445 ± 0.8863
    No statistical analyses for this end point

    Secondary: Change from Baseline in fasting lipid profile: LDL cholesterol, HDL cholesterol (Millimoles per liter) at Week 12

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    End point title
    		 Change from Baseline in fasting lipid profile: LDL cholesterol, HDL cholesterol (Millimoles per liter) at Week 12
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    0 [31]
    0 [32]
    0 [33]
    0 [34]
    Units: mmol/L (Millimoles per liter)
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [31] - Data was not collected as there is no corresponding time point in schedule of activity of Protocol.
    [32] - Data was not collected as there is no corresponding time point in schedule of activity of Protocol.
    [33] - Data was not collected as there is no corresponding time point in schedule of activity of Protocol.
    [34] - Data was not collected as there is no corresponding time point in schedule of activity of Protocol.
    No statistical analyses for this end point

    Secondary: Change from Baseline in fasting lipid profile: LDL cholesterol, HDL cholesterol (Millimoles per liter) at Week 24

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    End point title
    		 Change from Baseline in fasting lipid profile: LDL cholesterol, HDL cholesterol (Millimoles per liter) at Week 24 [35]
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [35] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: mmol/L (Millimoles per liter)
    arithmetic mean (standard deviation)
        HDL Cholesterol, Direct
    0.044 ± 0.2523
    0.051 ± 0.2931
    0.063 ± 0.2784
        LDL Cholesterol
    -0.026 ± 0.8577
    0.021 ± 0.6769
    0.334 ± 0.7472
    No statistical analyses for this end point

    Secondary: Change from Baseline in fasting lipid profile triglycerides (Millimoles per liter) at Week 12

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    End point title
    		 Change from Baseline in fasting lipid profile triglycerides (Millimoles per liter) at Week 12
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    0 [36]
    0 [37]
    0 [38]
    0 [39]
    Units: mmol/L (Millimoles per liter)
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [36] - Data was not collected as there is no corresponding time point in schedule of activity of Protocol.
    [37] - Data was not collected as there is no corresponding time point in schedule of activity of Protocol.
    [38] - Data was not collected as there is no corresponding time point in schedule of activity of Protocol.
    [39] - Data was not collected as there is no corresponding time point in schedule of activity of Protocol.
    No statistical analyses for this end point

    Secondary: Change from Baseline in fasting lipid profile triglycerides (Millimoles per liter) at Week 24

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    End point title
    		 Change from Baseline in fasting lipid profile triglycerides (Millimoles per liter) at Week 24 [40]
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [40] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: mmol/L (Millimoles per liter)
        arithmetic mean (standard deviation)
    0.075 ± 0.5799
    -0.038 ± 0.5519
    0.103 ± 0.7552
    No statistical analyses for this end point

    Secondary: Number of participants with National Cancer Institute (NCI)-Common terminology criteria for adverse events (CTCAE) >=Grade 3 hematological/clinical chemistry abnormalities

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    End point title
    		 Number of participants with National Cancer Institute (NCI)-Common terminology criteria for adverse events (CTCAE) >=Grade 3 hematological/clinical chemistry abnormalities [41]
    End point description
    Number of participants who reported NCI-CTCAE Grade 3 or higher for hematological and clinical chemistry abnormalities were summarized. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Up to Week 34
    Notes
    [41] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    156
    158
    156
    Units: Participants
        Alanine aminotransferase increased, Total, Grade 3
    1
    2
    1
        Alanine aminotransferase increased, Total, Grade 4
    0
    0
    0
        Aspartate aminotransferase increased,Total,Grade 3
    1
    1
    0
        Aspartate aminotransferase increased,Total,Grade 4
    0
    0
    0
        Blood bilirubin increased, Total, Grade 3
    0
    0
    1
        Blood bilirubin increased, Total, Grade 4
    0
    0
    0
        Lymphocyte count decreased, Total, Grade 3
    6
    1
    2
        Lymphocyte count decreased, Total, Grade 4
    0
    0
    1
        Lymphocyte count increased, Total, Grade 3
    0
    0
    0
        Lymphocyte count increased, Total, Grade 4
    0
    0
    0
        Neutrophil count decreased, Total, Grade 3
    2
    1
    10
        Neutrophil count decreased, Total, Grade 4
    1
    1
    4
        Platelet count decreased, Total, Grade 3
    0
    0
    0
        Platelet count decreased, Total, Grade 4
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Concentrations of Granulocyte-macrophage colony stimulating factor (GM-CSF) autoantibody

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    End point title
    		 Concentrations of Granulocyte-macrophage colony stimulating factor (GM-CSF) autoantibody [42]
    End point description
    Blood samples were collected for markers which may influence rheumatoid arthritis. Concentrations of GM-CSF autoantibodies was determined. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    At baseline
    Notes
    [42] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Placebo + csDMARD and GSK3196165 90 mg + csDMARD Placebo + csDMARD and GSK3196165 150 mg + csDMARD Placebo + csDMARD and Sarilumab 200 mg + csDMARD
    Number of subjects analysed
    156
    158
    156
    26
    26
    27
    Units: ug/L (microgram per liter)
        arithmetic mean (standard deviation)
    334.008 ± 823.7538
    417.378 ± 1632.7755
    250.015 ± 671.9296
    237.1 ± 357.4074
    330.527 ± 496.9961
    142.446 ± 169.6796
    No statistical analyses for this end point

    Secondary: Number of participants with anti-GSK3196165 antibodies

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    End point title
    		 Number of participants with anti-GSK3196165 antibodies [43]
    End point description
    Blood samples were collected for anti-GSK3196165 antibodies detection assay using tiered testing schema: screening, confirmation and titration steps was used for immunogenicity analysis. Placebo was not administered beyond Week 12.
    End point type
    Secondary
    End point timeframe
    Up to Week 34
    Notes
    [43] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Placebo + csDMARD and GSK3196165 90 mg + csDMARD Placebo + csDMARD and GSK3196165 150 mg + csDMARD Placebo + csDMARD and Sarilumab 200 mg + csDMARD
    Number of subjects analysed
    156
    158
    156
    26
    26
    27
    Units: Participants
    4
    2
    0
    1
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline 4-beta-hydroxyl cholesterol, cholesterol at (Millimoles per liter) Week 12

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    End point title
    		 Change from Baseline 4-beta-hydroxyl cholesterol, cholesterol at (Millimoles per liter) Week 12
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. For the purpose of all analyses up to week 12, the placebo-sequence arms were pooled into a single placebo arm. All participants received the same (placebo) treatment during the study period (up to week 12) in the pooled placebo arm.
    End point type
    Other pre-specified
    End point timeframe
    Baseline and Week 12
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD Pooled Placebo
    Number of subjects analysed
    139
    141
    134
    71
    Units: mmol/L (Millimoles per liter)
    arithmetic mean (standard deviation)
        4-Beta-Hydroxycholesterol
    0.9897 ± 0.81483
    1.0156 ± 0.57323
    1.1148 ± 0.56873
    1.0913 ± 1.03027
        Cholesterol
    58.5438 ± 13.25606
    59.1757 ± 14.83734
    64.3791 ± 15.12089
    58.6880 ± 14.62446
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline 4-beta-hydroxyl cholesterol, cholesterol at (Millimoles per liter) Week 24

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    End point title
    		 Change from Baseline 4-beta-hydroxyl cholesterol, cholesterol at (Millimoles per liter) Week 24 [44]
    End point description
    Blood samples was collected for the assessment of clinical chemistry parameters. Placebo was not administered beyond Week 12.
    End point type
    Other pre-specified
    End point timeframe
    Baseline and Week 24
    Notes
    [44] - 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 endpoint is only reporting on a subset of the arms that are contained in the Baseline period.
    End point values
    		 GSK3196165 90 mg + csDMARD GSK3196165 150 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD
    Number of subjects analysed
    136
    139
    123
    Units: mmol/L (Millimoles per liter)
    arithmetic mean (standard deviation)
        4-Beta-Hydroxycholesterol
    0.9766 ± 0.45665
    1.0064 ± 0.58945
    1.1925 ± 0.57339
        Cholesterol
    59.1937 ± 14.12055
    58.9174 ± 15.00108
    65.2270 ± 14.70946
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs and SAEs were collected from start of study intervention. The Pooled Placebo collected data during the timeframe Week 0 to Week 12; Subject Analysis Sets collected from Week 12 to Week 24 and the Reporting Groups collected from Week 0 to Week 24.
    Adverse event reporting additional description
    The analysis was performed on Safety Set that include randomized participants who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    GSK3196165 90 mg + csDMARD
    Reporting group description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.

    Reporting group title
    Sarilumab 200 mg or placebo + csDMARD
    Reporting group description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.

    Reporting group title
    GSK3196165 150 mg + csDMARD
    Reporting group description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.

    Reporting group title
    Pooled Placebo
    Reporting group description
    		 Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12.

    Reporting group title
    Placebo + csDMARD and GSK3196165 150 mg + csDMARD
    Reporting group description
    		 Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection.

    Reporting group title
    Placebo + csDMARD and GSK3196165 90 mg + csDMARD
    Reporting group description
    		 Participants received Placebo + csDMARD until Week 12 later switched to GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection.

    Reporting group title
    Placebo + csDMARD and Sarilumab 200 mg + csDMARD
    Reporting group description
    		 Participants received Placebo + csDMARD until Week 12 later switched to Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind.

    Serious adverse events
    		 GSK3196165 90 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD GSK3196165 150 mg + csDMARD Pooled Placebo Placebo + csDMARD and GSK3196165 150 mg + csDMARD Placebo + csDMARD and GSK3196165 90 mg + csDMARD Placebo + csDMARD and Sarilumab 200 mg + csDMARD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 156 (5.13%)
    12 / 156 (7.69%)
    1 / 158 (0.63%)
    2 / 79 (2.53%)
    3 / 25 (12.00%)
    1 / 24 (4.17%)
    1 / 26 (3.85%)
         number of deaths (all causes)
    1
    1
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 156 (0.64%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 156 (0.64%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 156 (0.64%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural hypotension
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    0 / 0
    Congenital, familial and genetic disorders
    Gilbert's syndrome
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 156 (0.64%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Vascular disorders
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 156 (0.64%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 156 (0.00%)
    2 / 156 (1.28%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    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
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Optic neuritis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 156 (0.00%)
    1 / 158 (0.63%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 156 (0.64%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Cerebellar hemorrhage
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 156 (0.64%)
    2 / 156 (1.28%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    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
    0 / 0
    General disorders and administration site conditions
    Drowning
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 156 (0.64%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Gastrointestinal disorders
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 156 (0.64%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    1 / 79 (1.27%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    1 / 79 (1.27%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 156 (0.64%)
    2 / 156 (1.28%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    0 / 0
    Osteomyelitis bacterial
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK3196165 90 mg + csDMARD Sarilumab 200 mg or placebo + csDMARD GSK3196165 150 mg + csDMARD Pooled Placebo Placebo + csDMARD and GSK3196165 150 mg + csDMARD Placebo + csDMARD and GSK3196165 90 mg + csDMARD Placebo + csDMARD and Sarilumab 200 mg + csDMARD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 156 (16.03%)
    41 / 156 (26.28%)
    32 / 158 (20.25%)
    5 / 79 (6.33%)
    4 / 25 (16.00%)
    1 / 24 (4.17%)
    6 / 26 (23.08%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 156 (1.28%)
    10 / 156 (6.41%)
    6 / 158 (3.80%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    11
    6
    0
    0
    0
    0
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    9 / 156 (5.77%)
    17 / 156 (10.90%)
    10 / 158 (6.33%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    17
    35
    11
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    2 / 156 (1.28%)
    11 / 156 (7.05%)
    1 / 158 (0.63%)
    0 / 79 (0.00%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    2
    12
    1
    0
    1
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 156 (3.21%)
    1 / 156 (0.64%)
    10 / 158 (6.33%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    6
    1
    10
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    5 / 79 (6.33%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    0
    5
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    8 / 156 (5.13%)
    6 / 156 (3.85%)
    8 / 158 (5.06%)
    0 / 79 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    10
    6
    9
    0
    0
    0
    0
    Latent tuberculosis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    COVID-19
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 156 (0.00%)
    0 / 158 (0.00%)
    0 / 79 (0.00%)
    2 / 25 (8.00%)
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 May 2019
    Correction of contraceptive requirements for Women of Child Bearing Potential (WOCBP) and additional clarifications.
    21 Jan 2020
    To introduce new medical device safety reporting wording, required in advance of roll out of pre-filled syringes to this study. Other minor corrections and clarifications added throughout the protocol

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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