Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors

ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Blood samples was collected for the assessment of change from baseline in laboratory parameter albumin level. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received.

Blood samples was collected for the assessment of change from baseline in laboratory parameter albumin level.

Time frame: Baseline (Week 12) and Week 24

Population: The analysis was performed on Safety set that includes all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in laboratory parameter albumin level.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on Safety set that includes all randomized participants who received study intervention from Day 01 to Week 24.

For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at 0 (no pain) and 100 (most severe pain). A negative change from baseline indicates an improvement.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at 0 (no pain) and 100 (most severe pain). A negative change from baseline indicates an improvement.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at 0 (no pain) and 100 (most severe pain). A negative change from baseline indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Blood samples was collected for the assessment of change from baseline in laboratory parameters including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP) gamma-glutamyl transferase (GGT) levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment and for whom data available for specific parameters. This population was based on the treatment the participants actually received.

Blood samples was collected for the assessment of change from baseline in laboratory parameters including AST, ALT, AP, GGT levels.

Time frame: Baseline (Week 12) and Week 24

Population: The analysis was performed on Safety set that includes all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in laboratory parameters including AST, ALT, AP, GGT levels.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on Safety Set that includes all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28),Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. A negative CDAI total score change from baseline indicates an improvement in disease activity. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR in mm/hr (mm/hour) and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR in mm/hr (mm/hour) and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR in mm/hr (mm/hour) and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

Blood samples was collected for the assessment of change from baseline in fasting lipid profile including LDL cholesterol, HDL cholesterol levels.

Time frame: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in fasting lipid profile including LDL cholesterol, HDL cholesterol levels.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in fasting lipid profile including LDL cholesterol, HDL cholesterol levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: Blood samples were collected at indicated time points as per schedule of assessment in the protocol. The Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for the lipid panel, there is no corresponding time point in the schedule of assessment. Consequently, the only objective that can be assessed for the lipid panel is Week 4 and not at Week 12.

Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: Blood samples were collected at indicated time points as per schedule of assessment in the protocol. The Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for the lipid panel, there is no corresponding time point in the schedule of assessment. Consequently, the only objective that can be assessed for the lipid panel is Week 4 and not at Week 12.

Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels.

Time frame: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24.

The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the difficulty of a participant in eight domains of daily activities: Dressing & grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Common daily activities. HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0=least difficulty to 3=extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the difficulty of a participant in eight domains of daily activities: Dressing & grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Common daily activities. HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0=least difficulty to 3=extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the difficulty of a participant in eight domains of daily living activities: Dressing & grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Common daily activities. Overall HAQ-DI score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Blood samples was collected for the assessment of change from baseline in hematology parameter hemoglobin level. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received.

Blood samples was collected for the assessment of change from baseline in in hematology parameter hemoglobin level.

Time frame: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in in hematology parameter hemoglobin level.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24.

Blood samples was collected for the assessment of change from baseline in hematology parameters including neutrophil, lymphocyte, platelet count. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment and for whom data available for specific parameters. This population was based on the treatment the participants actually received.

Blood samples was collected for the assessment of change from baseline in hematology parameters including neutrophil, lymphocyte, platelet count.

Time frame: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in hematology parameters including neutrophil, lymphocyte, platelet count.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are scaled between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention and for whom data available for specific parameters. This population was based on the treatment the participants were randomized into.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are scaled between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are scaled between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The MCS is an aggregated score derived from 4 domains (social functioning, vitality, mental health, and role-emotional domains) representing overall mental health. T-score scale was used for MCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall mental health. Quality Metrics software was used for scoring for SF-36.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The MCS is an aggregated score derived from 4 domains (social functioning, vitality, mental health, and role-emotional domains) representing overall mental health. T-score scale was used for MCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall mental health. Quality Metrics software was used for scoring for SF-36.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The MCS is an aggregated score derived from 4 domains (social functioning, vitality, mental health, and role-emotional domains) representing overall mental health. T-score scale was used for MCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall mental health. Quality Metrics software was used for scoring for SF-36. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The PCS is an aggregate score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. T-score scale was used for PCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall physical heath. Quality Metrics software was used for scoring for SF-36.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The PCS is an aggregate score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. T-score scale was used for PCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall physical heath. Quality Metrics software was used for scoring for SF-36.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The PCS is an aggregate score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. T-score scale was used for PCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall physical heath. Quality Metrics software was used for scoring for SF-36. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Blood samples was collected for the assessment of change from baseline in laboratory parameter total bilirubin level. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participant was randomized to.

Blood samples was collected for the assessment of change from baseline in laboratory parameter bilirubin level.

Time frame: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in laboratory parameter bilirubin level.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24.

Blood samples was collected for the assessment of change from baseline in lipid profile of total cholesterol levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: Blood samples were collected at indicated time points as per schedule of assessment in the protocol. The Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for the lipid panel, there is no corresponding time point in the schedule of assessment. Consequently, the only objective that can be assessed for the lipid panel is Week 4 and not at Week 12.

Blood samples was collected for the assessment of change from baseline in lipid profile of total cholesterol levels.

Time frame: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in lipid profile of total cholesterol levels.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24.

Blood samples was collected for the assessment of change from baseline in hematology parameter WBC count.

Time frame: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in hematology parameter WBC count.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24.

Blood samples was collected for the assessment of change from baseline in hematology parameter WBC count. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received.

Blood samples were collected for markers which may influence rheumatoid arthritis. Concentrations of GM-CSF autoantibodies was determined.

Time frame: At baseline

Population: The analysis was performed on the safety set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received.

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.

Time frame: Up to Week 24

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Pooled Placebo collected data till Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected data from Week 12 to 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected data till Week 24

Blood samples were collected for anti-GSK3196165 antibodies detection assay using tiered testing schema: screening, confirmation and titration steps was used for immunogenicity analysis.

Time frame: Up to Week 24

Population: The analysis was performed on the safety set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received.

Number of participants who reported NCI-CTCAE Grade 3 or higher for hematological and clinical chemistry abnormalities were summarized.

Time frame: Up to Week 24

Population: The analysis was performed on the randomized participants who received at least one dose of study treatment and for whom data available for specific parameters. Pooled Placebo collected data till Week 12. Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Sarilumab 200mg or placebo+csDMARD collected data from Week 12 to 24. GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Sarilumab 200mg or placebo+csDMARD collected data till Week 24.

ACR50 is calculated as a 50% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 50% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

ACR70 is calculated as a 70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

ACR20 is calculated as a 20% improvement from Baseline in TJC68 and SJC66 and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP).

Time frame: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

ACR20 is calculated as a 20% improvement from Baseline in TJC68 and SJC66 and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP).

Time frame: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

ACR50 is calculated as a 50% improvement from Baseline in TJC68 and SJC66 and a 50% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP).

Time frame: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

ACR50 is calculated as a 50% improvement from Baseline in TJC68 and SJC66 and a 50% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP).

Time frame: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

ACR70 is calculated as a 70% improvement from Baseline in TJC68 and SJC66 and a 70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP).

Time frame: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

ACR70 is calculated as a 70% improvement from Baseline in TJC68 and SJC66 and a 70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP).

Time frame: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) ≤ 1, Swollen Joint Count 66 (SJC66) ≤ 1, high sensitivity C-reactive Protein (hsCRP) ≤ 1mg/dl and patient's global assessment of disease activity (PtGA) ≤ 10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) ≤ 1, Swollen Joint Count 66 (SJC66) ≤ 1, high sensitivity C-reactive Protein (CRP) ≤ 1mg/dl and patient's global assessment of disease activity (PtGA) ≤ 10.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) ≤ 1, Swollen Joint Count 66 (SJC66) ≤ 1, high sensitivity C-reactive Protein (CRP) ≤ 1mg/dl and patient's global assessment of disease activity (PtGA) ≤ 10.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

DAS28-CRP and DAS28-ESR scores categorised using EULAR response criteria. Response based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to baseline (Good response = DAS28 change \>1.2 with current DAS28 ≤3.2; Moderate response = DAS28 change \>0.6 with current DAS28 \>3.2-5.1; Non-response = DAS28 change ≤0.6 and current DAS28 \>5.1).

Time frame: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

DAS28-CRP and DAS28-ESR scores categorised using EULAR response criteria. Response based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to baseline (Good response = DAS28 change \>1.2 with current DAS28 ≤3.2; Moderate response = DAS28 change \>0.6 with current DAS28 \>3.2-5.1; Non-response = DAS28 change ≤0.6 and current DAS28 \>5.1).

Time frame: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

DAS28-CRP and DAS28-ESR scores categorized using EULAR response criteria. Response based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to baseline (Good response = DAS28 change \>1.2 with current DAS28 ≤3.2; Moderate response = DAS28 change \>0.6 with current DAS28 \>3.2-5.1; Non-response = DAS28 change ≤0.6 and current DAS28 \>5.1). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28),Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. LDA is achieved when CDAI total score \<=10.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28),Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. LDA is achieved when CDAI total score \<=10.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28),Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP \<2.6. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-CRP arthritis is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP \<2.6. A negative change from baseline in DAS28-CRP indicates an improvement.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-CRP arthritis is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP \<2.6. A negative change from baseline in DAS28-CRP indicates an improvement.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP\<=3.2 . A negative change from baseline in DAS28-CRP indicates an improvement.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP\<=3.2 . A negative change from baseline in DAS28-CRP indicates an improvement.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR\<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR\<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR\<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement.

Time frame: Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data.

The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP\<=3.2. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Week 12

Population: The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data.

Blood samples was collected for the assessment of change from baseline in lipid profile parameter including 4-beta-hydroxycholesterol, cholesterol levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Time frame: Baseline (Day 01) and Week 12

Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment and for whom data available for specific parameters. This population was based on the treatment the participants actually received.

Blood samples was collected for the assessment of change from baseline in lipid profile parameter including 4-beta-hydroxycholesterol, cholesterol levels.

Time frame: Baseline (Week 12) and Week 24

Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters.

Blood samples was collected for the assessment of change from baseline in lipid profile parameter including 4-beta-hydroxycholesterol, cholesterol levels.

Time frame: Baseline (Day 01) and Week 24

Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters.