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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03970837




Registration number
NCT03970837
Ethics application status
Date submitted
16/05/2019
Date registered
3/06/2019

Titles & IDs
Public title
Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)
Scientific title
A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs
Secondary ID [1] 0 0
201791
Universal Trial Number (UTN)
Trial acronym
contRAst 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GSK3196165 (Otilimab)
Treatment: Drugs - Tofacitinib
Treatment: Drugs - Placebo

Experimental: GSK3196165 90mg + csDMARD (Global Cohort) - Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).

Experimental: GSK3196165 150mg + csDMARD (Global Cohort) - Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.

Active comparator: Tofacitinib 5mg + csDMARD (Global Cohort) - Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks.

Placebo comparator: Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort) - Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

Placebo comparator: Placebo +csDMARD and GSK3196165 150mg +csDMARD (Global Cohort) - Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

Placebo comparator: Placebo +csDMARD and Tofacitinib 5mg +csDMARD (Global Cohort) - Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.

Experimental: GSK3196165 90mg + csDMARD (Asia Cohort) - Participants in Asia Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.

Experimental: GSK3196165 150mg + csDMARD (Asia Cohort) - Participants in Asia Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.

Active comparator: Tofacitinib 5mg + csDMARD (Asia Cohort) - Participants in Asia Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks.

Placebo comparator: Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort) - Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

Placebo comparator: Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort) - Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

Placebo comparator: Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort) - Participants in Asia Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.


Treatment: Other: GSK3196165 (Otilimab)
GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.

Treatment: Drugs: Tofacitinib
Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally.

Treatment: Drugs: Placebo
Placebo matching GSK3196165 and Tofacitinib was administered.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo (Global Cohort)
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 (Asia Cohort)
Timepoint [2] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Less Than or Equal to (<=)10 [CDAI Low Disease Activity (LDA)] at Week 12 (Global Cohort)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Global Cohort)
Timepoint [2] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving 20% Improvement in ACR20 at Week 24: Non-inferiority Comparison With Tofacitinib (Global Cohort)
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [4] 0 0
Week 24 and Week 52
Secondary outcome [5] 0 0
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [5] 0 0
Week 24 and Week 52
Secondary outcome [6] 0 0
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12 (Global Cohort)
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [7] 0 0
Week 24 and Week 52
Secondary outcome [8] 0 0
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [8] 0 0
Week 24 and Week 52
Secondary outcome [9] 0 0
Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Global Cohort)
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [10] 0 0
Week 24 and Week 52
Secondary outcome [11] 0 0
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [11] 0 0
Week 24 and Week 52
Secondary outcome [12] 0 0
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12 (Global Cohort)
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
Percentage of Participants Achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 (Global Cohort)
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [14] 0 0
Week 24 and Week 52
Secondary outcome [15] 0 0
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [15] 0 0
Week 24 and Week 52
Secondary outcome [16] 0 0
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [16] 0 0
Week 24 and Week 52
Secondary outcome [17] 0 0
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [17] 0 0
Week 24 and Week 52
Secondary outcome [18] 0 0
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 (Global Cohort)
Timepoint [18] 0 0
Week 12
Secondary outcome [19] 0 0
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12 (Global Cohort)
Timepoint [19] 0 0
Week 12
Secondary outcome [20] 0 0
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [20] 0 0
Week 24 and Week 52
Secondary outcome [21] 0 0
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [21] 0 0
Week 24 and Week 52
Secondary outcome [22] 0 0
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [22] 0 0
Week 24 and Week 52
Secondary outcome [23] 0 0
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [23] 0 0
Week 24 and Week 52
Secondary outcome [24] 0 0
Percentage of Participants Achieving a Good/Moderate (European League Against Rheumatism) EULAR Response at Week 12 (Global Cohort)
Timepoint [24] 0 0
Week 12
Secondary outcome [25] 0 0
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [25] 0 0
Week 24 and Week 52
Secondary outcome [26] 0 0
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [26] 0 0
Week 24 and Week 52
Secondary outcome [27] 0 0
Number of Participants Achieving ACR/EULAR Remission at Week 12 (Global Cohort)
Timepoint [27] 0 0
Week 12
Secondary outcome [28] 0 0
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [28] 0 0
Week 24 and Week 52
Secondary outcome [29] 0 0
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [29] 0 0
Week 24 and Week 52
Secondary outcome [30] 0 0
Percentage of Participants Achieving no Radiographic Progression Van Der Heijde Modified Total Sharp Scores (mTSS) <= 0.5) at Week 12 (Global Cohort)
Timepoint [30] 0 0
Week 12
Secondary outcome [31] 0 0
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [31] 0 0
Week 24 and Week 52
Secondary outcome [32] 0 0
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [32] 0 0
Week 24 and Week 52
Secondary outcome [33] 0 0
Change From Baseline in CDAI Total Score at Week 12 (Global Cohort)
Timepoint [33] 0 0
Baseline (Day 1) and week 12
Secondary outcome [34] 0 0
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [34] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [35] 0 0
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [35] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [36] 0 0
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 12 (Global Cohort)
Timepoint [36] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [37] 0 0
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [37] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [38] 0 0
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [38] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [39] 0 0
Change From Baseline in Van Der Heijde mTSS at Week 12 (Global Cohort)
Timepoint [39] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [40] 0 0
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [40] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [41] 0 0
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [41] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [42] 0 0
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [42] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [43] 0 0
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [43] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [44] 0 0
Change From Baseline in Arthritis Pain VAS at Week 12 (Global Cohort)
Timepoint [44] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [45] 0 0
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [45] 0 0
Baseline (Day 1) and Week 24 and Week 52
Secondary outcome [46] 0 0
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [46] 0 0
Baseline (Day 1) and Week 24 and Week 52
Secondary outcome [47] 0 0
Change From Baseline in Short Form (SF)-36 Physical Component Scores at Week 12 (Global Cohort)
Timepoint [47] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [48] 0 0
Change From Baseline in SF-36 Mental Component Scores at Week 12 (Global Cohort)
Timepoint [48] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [49] 0 0
Change From Baseline in SF-36 Domain Scores at Week 12 (Global Cohort)
Timepoint [49] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [50] 0 0
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [50] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [51] 0 0
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [51] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [52] 0 0
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [52] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [53] 0 0
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [53] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [54] 0 0
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [54] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [55] 0 0
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [55] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [56] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12 (Global Cohort)
Timepoint [56] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [57] 0 0
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [57] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [58] 0 0
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [58] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [59] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Global Cohort)
Timepoint [59] 0 0
Up to Week 59
Secondary outcome [60] 0 0
Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Global Cohort)
Timepoint [60] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [61] 0 0
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [61] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [62] 0 0
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 (Global Cohort)
Timepoint [62] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [63] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 12 (Global Cohort)
Timepoint [63] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [64] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [64] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [65] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [65] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [66] 0 0
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Global Cohort)
Timepoint [66] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [67] 0 0
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [67] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [68] 0 0
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [68] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [69] 0 0
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 12 (Global Cohort)
Timepoint [69] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [70] 0 0
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [70] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [71] 0 0
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [71] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [72] 0 0
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 12 (Global Cohort)
Timepoint [72] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [73] 0 0
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [73] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [74] 0 0
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [74] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [75] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 12 (Global Cohort)
Timepoint [75] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [76] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [76] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [77] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Placebo Switched Arms (Global Cohort)
Timepoint [77] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [78] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [78] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [79] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [79] 0 0
Baseline (Week 4) and Week 52
Secondary outcome [80] 0 0
Change From Baseline in Lipid Profile Parameter of Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol at Week 12 (Global Cohort)
Timepoint [80] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [81] 0 0
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [81] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [82] 0 0
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Placebo Switched Arms (Global Cohort)
Timepoint [82] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [83] 0 0
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [83] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [84] 0 0
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [84] 0 0
Baseline (Week 4) and Week 52
Secondary outcome [85] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 12 (Global Cohort)
Timepoint [85] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [86] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [86] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [87] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Placebo Switched Arms (Global Cohort)
Timepoint [87] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [88] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Timepoint [88] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [89] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Placebo Switched Arms (Global Cohort)
Timepoint [89] 0 0
Baseline (Week 4) and Week 52
Secondary outcome [90] 0 0
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Timepoint [90] 0 0
Up to Week 59
Secondary outcome [91] 0 0
Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody (Global Cohort)
Timepoint [91] 0 0
At baseline
Secondary outcome [92] 0 0
Number of Participants With Anti-GSK3196165 Antibodies (Global Cohort)
Timepoint [92] 0 0
Up to Week 52
Secondary outcome [93] 0 0
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Less Than or Equal to (<=)10 [CDAI Low Disease Activity (LDA)] at Week 12 (Asia Cohort)
Timepoint [93] 0 0
Week 12
Secondary outcome [94] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Asia Cohort)
Timepoint [94] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [95] 0 0
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [95] 0 0
Week 24 and Week 52
Secondary outcome [96] 0 0
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [96] 0 0
Week 24 and Week 52
Secondary outcome [97] 0 0
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12 (Asia Cohort)
Timepoint [97] 0 0
Week 12
Secondary outcome [98] 0 0
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [98] 0 0
Week 24 and Week 52
Secondary outcome [99] 0 0
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [99] 0 0
Week 24 and Week 52
Secondary outcome [100] 0 0
Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Asia Cohort)
Timepoint [100] 0 0
Week 12
Secondary outcome [101] 0 0
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [101] 0 0
Week 24 and Week 52
Secondary outcome [102] 0 0
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [102] 0 0
Week 24 and Week 52
Secondary outcome [103] 0 0
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12 (Asia Cohort)
Timepoint [103] 0 0
Week 12
Secondary outcome [104] 0 0
Percentage of Participants Achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 (Asia Cohort)
Timepoint [104] 0 0
Week 12
Secondary outcome [105] 0 0
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [105] 0 0
Week 24 and Week 52
Secondary outcome [106] 0 0
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [106] 0 0
Week 24 and Week 52
Secondary outcome [107] 0 0
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [107] 0 0
Week 24 and Week 52
Secondary outcome [108] 0 0
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [108] 0 0
Week 24 and Week 52
Secondary outcome [109] 0 0
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 (Asia Cohort)
Timepoint [109] 0 0
Week 12
Secondary outcome [110] 0 0
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12 (Asia Cohort)
Timepoint [110] 0 0
Week 12
Secondary outcome [111] 0 0
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [111] 0 0
Week 24 and Week 52
Secondary outcome [112] 0 0
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [112] 0 0
Week 24 and Week 52
Secondary outcome [113] 0 0
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [113] 0 0
Week 24 and Week 52
Secondary outcome [114] 0 0
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [114] 0 0
Week 24 and Week 52
Secondary outcome [115] 0 0
Percentage of Participants Achieving a Good/Moderate European League Against Rheumatism (EULAR) Response at Week 12(Asia Cohort)
Timepoint [115] 0 0
Week 12
Secondary outcome [116] 0 0
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [116] 0 0
Week 24 and Week 52
Secondary outcome [117] 0 0
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [117] 0 0
Week 24 and Week 52
Secondary outcome [118] 0 0
Number of Participants Achieving ACR/EULAR Remission at Week 12 (Asia Cohort)
Timepoint [118] 0 0
Week 12
Secondary outcome [119] 0 0
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [119] 0 0
Week 24 and Week 52
Secondary outcome [120] 0 0
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [120] 0 0
Week 24 and Week 52
Secondary outcome [121] 0 0
Percentage of Participants Achieving no Radiographic Progression Van Der Heijde Modified Total Sharp Scores (mTSS) <= 0.5) at Week 12 (Asia Cohort)
Timepoint [121] 0 0
Week 12
Secondary outcome [122] 0 0
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [122] 0 0
Week 24 and Week 52
Secondary outcome [123] 0 0
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [123] 0 0
Week 24 and Week 52
Secondary outcome [124] 0 0
Change From Baseline in CDAI Total Score at Week 12 (Asia Cohort)
Timepoint [124] 0 0
Baseline (Day 1) and week 12
Secondary outcome [125] 0 0
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [125] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [126] 0 0
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [126] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [127] 0 0
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 12 (Asia Cohort)
Timepoint [127] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [128] 0 0
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [128] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [129] 0 0
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [129] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [130] 0 0
Change From Baseline in Van Der Heijde mTSS at Week 12 (Asia Cohort)
Timepoint [130] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [131] 0 0
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [131] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [132] 0 0
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [132] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [133] 0 0
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [133] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [134] 0 0
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [134] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [135] 0 0
Change From Baseline in Arthritis Pain VAS at Week 12 (Asia Cohort)
Timepoint [135] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [136] 0 0
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [136] 0 0
Baseline (Day 1) and Week 24 and Week 52
Secondary outcome [137] 0 0
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [137] 0 0
Baseline (Day 1) and Week 24 and Week 52
Secondary outcome [138] 0 0
Change From Baseline in Short Form (SF)-36 Physical Component Scores at Week 12 (Asia Cohort)
Timepoint [138] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [139] 0 0
Change From Baseline in SF-36 Mental Component Scores at Week 12 (Asia Cohort)
Timepoint [139] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [140] 0 0
Change From Baseline in SF-36 Domain Scores at Week 12 (Asia Cohort)
Timepoint [140] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [141] 0 0
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [141] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [142] 0 0
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [142] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [143] 0 0
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [143] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [144] 0 0
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [144] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [145] 0 0
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [145] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [146] 0 0
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [146] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [147] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12 (Asia Cohort)
Timepoint [147] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [148] 0 0
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [148] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [149] 0 0
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [149] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [150] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Asia Cohort)
Timepoint [150] 0 0
Up to Week 59
Secondary outcome [151] 0 0
Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Asia Cohort)
Timepoint [151] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [152] 0 0
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [152] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [153] 0 0
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [153] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [154] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 12 (Asia Cohort)
Timepoint [154] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [155] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [155] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [156] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [156] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [157] 0 0
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Asia Cohort)
Timepoint [157] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [158] 0 0
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [158] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [159] 0 0
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [159] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [160] 0 0
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 12 (Asia Cohort)
Timepoint [160] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [161] 0 0
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [161] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [162] 0 0
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [162] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [163] 0 0
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 12 (Asia Cohort)
Timepoint [163] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [164] 0 0
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [164] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [165] 0 0
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [165] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [166] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 12 (Asia Cohort)
Timepoint [166] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [167] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [167] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [168] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Placebo Switched Arms (Asia Cohort)
Timepoint [168] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [169] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [169] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [170] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [170] 0 0
Baseline (Week 4) and Week 52
Secondary outcome [171] 0 0
Change From Baseline in Lipid Profile Parameter of Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol at Week 12 (Asia Cohort)
Timepoint [171] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [172] 0 0
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [172] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [173] 0 0
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Placebo Switched Arms (Asia Cohort)
Timepoint [173] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [174] 0 0
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [174] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [175] 0 0
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [175] 0 0
Baseline (Week 4) and Week 52
Secondary outcome [176] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 12 (Asia Cohort)
Timepoint [176] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [177] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [177] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [178] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Placebo Switched Arms (Asia Cohort)
Timepoint [178] 0 0
Baseline (Week 12) and Week 24
Secondary outcome [179] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Timepoint [179] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [180] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Placebo Switched Arms (Asia Cohort)
Timepoint [180] 0 0
Baseline (Week 4) and Week 52
Secondary outcome [181] 0 0
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Asia Cohort)
Timepoint [181] 0 0
Up to Week 59
Secondary outcome [182] 0 0
Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody (Asia Cohort)
Timepoint [182] 0 0
At baseline
Secondary outcome [183] 0 0
Number of Participants With Anti-GSK3196165 Antibodies (Asia Cohort)
Timepoint [183] 0 0
Up to Week 59
Secondary outcome [184] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Global Cohort)
Timepoint [184] 0 0
Week 12 to Week 59
Secondary outcome [185] 0 0
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Global Cohort)
Timepoint [185] 0 0
Week 12 to Week 59
Secondary outcome [186] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Asia Cohort)
Timepoint [186] 0 0
Week 12 to Week 59
Secondary outcome [187] 0 0
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Asia Cohort)
Timepoint [187] 0 0
Week 12 to Week 59

Eligibility
Key inclusion criteria
Key inclusion criteria

* >=18 years of age
* Has had RA for >=6 months and was not diagnosed before 16 years of age
* Has active disease, as defined by having both*

* >=6/68 tender/painful joint count (TJC), and
* >=6/66 swollen joint count (SJC)
* Has at least 1 bone erosion present on hand/wrist or foot radiographs
* Has had an inadequate response to one or two of the csDMARDs:

* methotrexate (MTX) 15-25 mg/week** oral or injected
* hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day
* sulfasalazine up to 3000 mg/day
* leflunomide up to 20 mg/day***
* bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement)
* iguratimod up to 50 mg/day

* If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.

* A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.

* Concomitant use of leflunomide and methotrexate is not allowed, for safety reasons.

Key exclusion criteria

* History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjögren's syndrome secondary to RA, that may confound the evaluation of the effect of the study intervention.
* Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
* Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/01/2023
Sample size
Target
Accrual to date
Final
1764
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [2] 0 0
GSK Investigational Site - Gold Coast
Recruitment hospital [3] 0 0
GSK Investigational Site - Woodville
Recruitment hospital [4] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [5] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [6] 0 0
GSK Investigational Site - Heidelberg West
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4222 - Gold Coast
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3081 - Heidelberg West
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New Mexico
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
North Dakota
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Córdova
Country [27] 0 0
Argentina
State/province [27] 0 0
Tucumán
Country [28] 0 0
Argentina
State/province [28] 0 0
Ciudad Autonoma Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Ciudad Autónoma de Buenos Aires
Country [30] 0 0
Argentina
State/province [30] 0 0
Cordoba
Country [31] 0 0
Argentina
State/province [31] 0 0
San Juan
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Blagoevgrad
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Pleven
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Plovdiv
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Ruse
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Sevlievo
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Sofia
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Stara Zagora
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Vidin
Country [40] 0 0
China
State/province [40] 0 0
Anhui
Country [41] 0 0
China
State/province [41] 0 0
Guangxi
Country [42] 0 0
China
State/province [42] 0 0
Hebei
Country [43] 0 0
China
State/province [43] 0 0
Hubei
Country [44] 0 0
China
State/province [44] 0 0
Hunan
Country [45] 0 0
China
State/province [45] 0 0
Inner Mongolia
Country [46] 0 0
China
State/province [46] 0 0
Jiangsu
Country [47] 0 0
China
State/province [47] 0 0
Jiangxi
Country [48] 0 0
China
State/province [48] 0 0
Jilin
Country [49] 0 0
China
State/province [49] 0 0
Liaoning
Country [50] 0 0
China
State/province [50] 0 0
Zhejiang
Country [51] 0 0
China
State/province [51] 0 0
Beijing
Country [52] 0 0
China
State/province [52] 0 0
Changchun
Country [53] 0 0
China
State/province [53] 0 0
Changzhou
Country [54] 0 0
China
State/province [54] 0 0
Chengdu
Country [55] 0 0
China
State/province [55] 0 0
Guangzhou
Country [56] 0 0
China
State/province [56] 0 0
Hangzhou
Country [57] 0 0
China
State/province [57] 0 0
Nanjing
Country [58] 0 0
China
State/province [58] 0 0
Shanghai
Country [59] 0 0
China
State/province [59] 0 0
Tianjin
Country [60] 0 0
China
State/province [60] 0 0
Xian
Country [61] 0 0
China
State/province [61] 0 0
Yangzhou
Country [62] 0 0
China
State/province [62] 0 0
Yanji
Country [63] 0 0
Colombia
State/province [63] 0 0
Barranquilla
Country [64] 0 0
Colombia
State/province [64] 0 0
Bogota
Country [65] 0 0
Colombia
State/province [65] 0 0
Bucaramanga
Country [66] 0 0
Colombia
State/province [66] 0 0
Medellin
Country [67] 0 0
Estonia
State/province [67] 0 0
Parnu
Country [68] 0 0
Estonia
State/province [68] 0 0
Tallinn
Country [69] 0 0
Estonia
State/province [69] 0 0
Tartu
Country [70] 0 0
France
State/province [70] 0 0
Cahors
Country [71] 0 0
Germany
State/province [71] 0 0
Sachsen
Country [72] 0 0
Germany
State/province [72] 0 0
Schleswig-Holstein
Country [73] 0 0
Germany
State/province [73] 0 0
Berlin
Country [74] 0 0
Germany
State/province [74] 0 0
Hamburg
Country [75] 0 0
Germany
State/province [75] 0 0
Magdeburg
Country [76] 0 0
Hungary
State/province [76] 0 0
Budapest
Country [77] 0 0
Hungary
State/province [77] 0 0
Szekesfehervar
Country [78] 0 0
Hungary
State/province [78] 0 0
Szentes
Country [79] 0 0
Japan
State/province [79] 0 0
Aichi
Country [80] 0 0
Japan
State/province [80] 0 0
Chiba
Country [81] 0 0
Japan
State/province [81] 0 0
Fukuoka
Country [82] 0 0
Japan
State/province [82] 0 0
Hiroshima
Country [83] 0 0
Japan
State/province [83] 0 0
Hokkaido
Country [84] 0 0
Japan
State/province [84] 0 0
Hyogo
Country [85] 0 0
Japan
State/province [85] 0 0
Ibaraki
Country [86] 0 0
Japan
State/province [86] 0 0
Kagawa
Country [87] 0 0
Japan
State/province [87] 0 0
Kagoshima
Country [88] 0 0
Japan
State/province [88] 0 0
Kanagawa
Country [89] 0 0
Japan
State/province [89] 0 0
Kochi
Country [90] 0 0
Japan
State/province [90] 0 0
Kumamoto
Country [91] 0 0
Japan
State/province [91] 0 0
Miyagi
Country [92] 0 0
Japan
State/province [92] 0 0
Nagano
Country [93] 0 0
Japan
State/province [93] 0 0
Nagasaki
Country [94] 0 0
Japan
State/province [94] 0 0
Niigata
Country [95] 0 0
Japan
State/province [95] 0 0
Okayama
Country [96] 0 0
Japan
State/province [96] 0 0
Saga
Country [97] 0 0
Japan
State/province [97] 0 0
Saitama
Country [98] 0 0
Japan
State/province [98] 0 0
Shizuoka
Country [99] 0 0
Japan
State/province [99] 0 0
Tokyo
Country [100] 0 0
Japan
State/province [100] 0 0
Tottori
Country [101] 0 0
Japan
State/province [101] 0 0
Wakayama
Country [102] 0 0
Japan
State/province [102] 0 0
Yamaguchi
Country [103] 0 0
Korea, Republic of
State/province [103] 0 0
Anyang-Si, Gyeonggi-do
Country [104] 0 0
Korea, Republic of
State/province [104] 0 0
Cheonan-si
Country [105] 0 0
Korea, Republic of
State/province [105] 0 0
Daegu-si
Country [106] 0 0
Korea, Republic of
State/province [106] 0 0
Daegu
Country [107] 0 0
Korea, Republic of
State/province [107] 0 0
Gwangju
Country [108] 0 0
Korea, Republic of
State/province [108] 0 0
Incheon
Country [109] 0 0
Korea, Republic of
State/province [109] 0 0
Seongnam-si
Country [110] 0 0
Korea, Republic of
State/province [110] 0 0
Seoul
Country [111] 0 0
Korea, Republic of
State/province [111] 0 0
Suwon
Country [112] 0 0
Mexico
State/province [112] 0 0
Durango
Country [113] 0 0
Mexico
State/province [113] 0 0
Jalisco
Country [114] 0 0
Mexico
State/province [114] 0 0
Yucatán
Country [115] 0 0
Mexico
State/province [115] 0 0
San Luis Potosí
Country [116] 0 0
Poland
State/province [116] 0 0
Bialystok
Country [117] 0 0
Poland
State/province [117] 0 0
Bydgoszcz
Country [118] 0 0
Poland
State/province [118] 0 0
Czestochowa
Country [119] 0 0
Poland
State/province [119] 0 0
Elblag
Country [120] 0 0
Poland
State/province [120] 0 0
Gdansk
Country [121] 0 0
Poland
State/province [121] 0 0
Gdynia
Country [122] 0 0
Poland
State/province [122] 0 0
Grodzisk Mazowiecki
Country [123] 0 0
Poland
State/province [123] 0 0
Katowice
Country [124] 0 0
Poland
State/province [124] 0 0
Krakow
Country [125] 0 0
Poland
State/province [125] 0 0
Lodz
Country [126] 0 0
Poland
State/province [126] 0 0
Lublin
Country [127] 0 0
Poland
State/province [127] 0 0
Nowy Targ
Country [128] 0 0
Poland
State/province [128] 0 0
Olsztyn
Country [129] 0 0
Poland
State/province [129] 0 0
Poznan
Country [130] 0 0
Poland
State/province [130] 0 0
Siedlce
Country [131] 0 0
Poland
State/province [131] 0 0
Sochaczew
Country [132] 0 0
Poland
State/province [132] 0 0
Warszawa
Country [133] 0 0
Poland
State/province [133] 0 0
Wroclaw
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Ekaterinburg
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Kemerovo
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Korolev
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Krasnoyarsk
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Moscow
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Novosibirsk
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Omsk
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Saint-Petersburg
Country [142] 0 0
Russian Federation
State/province [142] 0 0
Tomsk
Country [143] 0 0
Russian Federation
State/province [143] 0 0
Ulyanovsk
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Yaroslavl
Country [145] 0 0
Spain
State/province [145] 0 0
Barcelona
Country [146] 0 0
Spain
State/province [146] 0 0
Santander
Country [147] 0 0
Spain
State/province [147] 0 0
Sevilla
Country [148] 0 0
Thailand
State/province [148] 0 0
Bangkok
Country [149] 0 0
Thailand
State/province [149] 0 0
Muang
Country [150] 0 0
Thailand
State/province [150] 0 0
Rajathevee
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Essex
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Middlesex
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Warwickshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03970837