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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
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

202018

ISRCTN number

US NCT number

WHO universal trial number (UTN)

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

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

15 Mar 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

01 Feb 2022

Was the trial ended prematurely?

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

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Lithuania: 6

Country: Number of subjects enrolled

Poland: 108

Country: Number of subjects enrolled

Argentina: 104

Country: Number of subjects enrolled

Canada: 2

Country: Number of subjects enrolled

Japan: 38

Country: Number of subjects enrolled

Korea, Democratic People's Republic of: 5

Country: Number of subjects enrolled

South Africa: 11

Country: Number of subjects enrolled

United States: 199

Country: Number of subjects enrolled

Czechia: 46

Country: Number of subjects enrolled

Germany: 12

Country: Number of subjects enrolled

Spain: 8

Country: Number of subjects enrolled

Belgium: 1

Country: Number of subjects enrolled

Hungary: 6

Country: Number of subjects enrolled

United Kingdom: 4

Worldwide total number of subjects

550

EEA total number of subjects

187

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

419

From 65 to 84 years

131

85 years and over

Subject disposition

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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.

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 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Assessor

Are arms mutually exclusive

Yes

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

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

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.

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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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

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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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

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 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 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 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 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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

Top of page

End point title

Change from Baseline in SF-36 physical component scores at Week 24 ^[17]

End point description

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

Top of page

End point title

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

End point description

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

Top of page

End point title

Change from Baseline in SF-36 mental component scores at Week 24 ^[18]

End point description

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

Top of page

End point title

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

End point description

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

Top of page

End point title

Change from Baseline in SF-36 domain scores at Week 24 ^[19]

End point description

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

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

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

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

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

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

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

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

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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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 name

MedDRA

Dictionary version

25.0

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

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

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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Were there any global substantial amendments to the protocol? Yes

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

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Secondary: Percentage of participants with ACR20 at Week 24

Secondary: Percentage of participants with ACR20 at Week 24

Secondary: Percentage of participants with ACR50 at Week 12

Secondary: Percentage of participants with ACR50 at Week 12

Secondary: Percentage of participants with ACR50 at Week 24

Secondary: Percentage of participants with ACR50 at Week 24

Secondary: Percentage of participants with ACR70 at Week 12

Secondary: Percentage of participants with ACR70 at Week 12

Secondary: Percentage of participants with ACR70 at Week 24

Secondary: Percentage of participants with ACR70 at Week 24

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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