Clinical trial NCT03970837: 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)
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
GSK3196165
Otilimab
Tofacitinib
Placebo
DMARDs
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2019-06-03
Enrollment: 1764
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of six intervention arms in ratio of 6:6:3:1:1:1
Primary purpose: TREATMENT

Brief summary: This study \[contRAst 2 (201791: NCT03970837)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study \[contRAst X (209564: NCT04333147)\]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.


Eligibility 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).

Primary outcomes:
measure: Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo (Global Cohort)
timeFrame: Week 12
measure: Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 (Asia Cohort)
timeFrame: Week 12
Secondary outcomes:
measure: 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)
timeFrame: Week 12
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: Percentage of Participants Achieving 20% Improvement in ACR20 at Week 24: Non-inferiority Comparison With Tofacitinib (Global Cohort)
timeFrame: Week 24
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12 (Global Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Global Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Week 24 and Week 52
measure: 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)
timeFrame: Week 12
measure: Percentage of Participants Achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 (Global Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 (Global Cohort)
timeFrame: Week 12
measure: Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12 (Global Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving a Good/Moderate (European League Against Rheumatism) EULAR Response at Week 12 (Global Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Week 24 and Week 52
measure: Number of Participants Achieving ACR/EULAR Remission at Week 12 (Global Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving no Radiographic Progression Van Der Heijde Modified Total Sharp Scores (mTSS) <= 0.5) at Week 12 (Global Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Week 24 and Week 52
measure: Change From Baseline in CDAI Total Score at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in DAS28-CRP/DAS28-ESR at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Van Der Heijde mTSS at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Arthritis Pain VAS at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1) and Week 24 and Week 52
measure: Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Day 1) and Week 24 and Week 52
measure: Change From Baseline in Short Form (SF)-36 Physical Component Scores at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in SF-36 Mental Component Scores at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in SF-36 Domain Scores at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Global Cohort)
timeFrame: Up to Week 59
measure: 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)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 (Global Cohort)
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Hematology Parameter of Hemoglobin at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: 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)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Week 12) and Week 24
measure: 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)
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Week 4) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Week 12) and Week 24
measure: 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)
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Week 4) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 12 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Week 12) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Placebo Switched Arms (Global Cohort)
timeFrame: Baseline (Week 4) and Week 52
measure: Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
timeFrame: Up to Week 59
measure: Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody (Global Cohort)
timeFrame: At baseline
measure: Number of Participants With Anti-GSK3196165 Antibodies (Global Cohort)
timeFrame: Up to Week 52
measure: 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)
timeFrame: Week 12
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12 (Asia Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Asia Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Week 24 and Week 52
measure: 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)
timeFrame: Week 12
measure: Percentage of Participants Achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 (Asia Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 (Asia Cohort)
timeFrame: Week 12
measure: Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12 (Asia Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving a Good/Moderate European League Against Rheumatism (EULAR) Response at Week 12(Asia Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Week 24 and Week 52
measure: Number of Participants Achieving ACR/EULAR Remission at Week 12 (Asia Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving no Radiographic Progression Van Der Heijde Modified Total Sharp Scores (mTSS) <= 0.5) at Week 12 (Asia Cohort)
timeFrame: Week 12
measure: 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)
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Week 24 and Week 52
measure: Change From Baseline in CDAI Total Score at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in DAS28-CRP and DAS28-ESR at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Van Der Heijde mTSS at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Arthritis Pain VAS at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1) and Week 24 and Week 52
measure: Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 24 and Week 52
measure: Change From Baseline in Short Form (SF)-36 Physical Component Scores at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in SF-36 Mental Component Scores at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in SF-36 Domain Scores at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Asia Cohort)
timeFrame: Up to Week 59
measure: 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)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: 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)
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Hematology Parameter of Hemoglobin at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: 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)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Week 12) and Week 24
measure: 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)
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Week 4) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: 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)
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Week 12) and Week 24
measure: 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)
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Week 4) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 12 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Week 12) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Placebo Switched Arms (Asia Cohort)
timeFrame: Baseline (Week 4) and Week 52
measure: Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Asia Cohort)
timeFrame: Up to Week 59
measure: Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody (Asia Cohort)
timeFrame: At baseline
measure: Number of Participants With Anti-GSK3196165 Antibodies (Asia Cohort)
timeFrame: Up to Week 59
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Global Cohort)
timeFrame: Week 12 to Week 59
measure: 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)
timeFrame: Week 12 to Week 59
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Asia Cohort)
timeFrame: Week 12 to Week 59
measure: 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)
timeFrame: Week 12 to Week 59
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: GSK Investigational Site
state: Arizona
city: Glendale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Poway
country: United States
facility: GSK Investigational Site
state: California
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: Roseville
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Tustin
country: United States
facility: GSK Investigational Site
state: California
city: Van Nuys
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Fort Collins
country: United States
facility: GSK Investigational Site
state: Colorado
city: Aventura
country: United States
facility: GSK Investigational Site
state: Florida
city: Boca Raton
country: United States
facility: GSK Investigational Site
state: Florida
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Hialeah
country: United States
facility: GSK Investigational Site
state: Florida
city: Margate
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: GSK Investigational Site
state: Florida
city: Palmetto Bay
country: United States
facility: GSK Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: GSK Investigational Site
state: Florida
city: Tamarac
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Idaho Falls
country: United States
facility: GSK Investigational Site
state: Idaho
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Bowling Green
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lake Charles
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Monroe
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Hagerstown
country: United States
facility: GSK Investigational Site
state: Maryland
city: Worcester
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Grand Blanc
country: United States
facility: GSK Investigational Site
state: Michigan
city: Lansing
country: United States
facility: GSK Investigational Site
state: Michigan
city: Novi
country: United States
facility: GSK Investigational Site
state: Michigan
city: Freehold
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Brooklyn
country: United States
facility: GSK Investigational Site
state: New York
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Minot
country: United States
facility: GSK Investigational Site
state: North Dakota
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Yukon
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Duncansville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Wyomissing
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Summerville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Amarillo
country: United States
facility: GSK Investigational Site
state: Texas
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Colleyville
country: United States
facility: GSK Investigational Site
state: Texas
city: Corpus Christi
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Lubbock
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Tomball
country: United States
facility: GSK Investigational Site
state: Texas
city: Glendale
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: GSK Investigational Site
state: Córdova
city: San Miguel de Tucuman
country: Argentina
facility: GSK Investigational Site
state: Tucumán
city: San Miguel de Tucumán
country: Argentina
facility: GSK Investigational Site
state: Tucumán
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Cordoba
country: Argentina
facility: GSK Investigational Site
city: San Juan
country: Argentina
facility: GSK Investigational Site
city: Westmead
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Gold Coast
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Woodville
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Hobart
country: Australia
facility: GSK Investigational Site
state: Tasmania
city: Box Hill
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Heidelberg West
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Blagoevgrad
country: Bulgaria
facility: GSK Investigational Site
city: Pleven
country: Bulgaria
facility: GSK Investigational Site
city: Plovdiv
country: Bulgaria
facility: GSK Investigational Site
city: Ruse
country: Bulgaria
facility: GSK Investigational Site
city: Ruse
country: Bulgaria
facility: GSK Investigational Site
city: Sevlievo
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Stara Zagora
country: Bulgaria
facility: GSK Investigational Site
city: Vidin
country: Bulgaria
facility: GSK Investigational Site
city: Bengbu
country: China
facility: GSK Investigational Site
state: Anhui
city: Guilin
country: China
facility: GSK Investigational Site
state: Guangxi
city: Shijiazhuang
country: China
facility: GSK Investigational Site
state: Hebei
city: Wuhan
country: China
facility: GSK Investigational Site
state: Hubei
city: Changsha
country: China
facility: GSK Investigational Site
state: Hunan
city: ZhuZhou
country: China
facility: GSK Investigational Site
state: Hunan
city: Baotou
country: China
facility: GSK Investigational Site
state: Inner Mongolia
city: Tongliao
country: China
facility: GSK Investigational Site
state: Inner Mongolia
city: Nanjing
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Taizhou
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Xuzhou
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Yancheng
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Jiujiang
country: China
facility: GSK Investigational Site
state: Jiangxi
city: Nanchang,
country: China
facility: GSK Investigational Site
state: Jiangxi
city: Changchun
country: China
facility: GSK Investigational Site
state: Jilin
city: Jinzhou
country: China
facility: GSK Investigational Site
state: Liaoning
city: Huzhou
country: China
facility: GSK Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Changchun
country: China
facility: GSK Investigational Site
city: Changzhou
country: China
facility: GSK Investigational Site
city: Chengdu
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Hangzhou
country: China
facility: GSK Investigational Site
city: Nanjing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Tianjin
country: China
facility: GSK Investigational Site
city: Xian
country: China
facility: GSK Investigational Site
city: Yangzhou
country: China
facility: GSK Investigational Site
city: Yanji
country: China
facility: GSK Investigational Site
city: Barranquilla
country: Colombia
facility: GSK Investigational Site
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Bucaramanga
country: Colombia
facility: GSK Investigational Site
city: Medellin
country: Colombia
facility: GSK Investigational Site
city: Parnu
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Cahors
country: France
facility: GSK Investigational Site
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Rendsburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Magdeburg
country: Germany
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Szekesfehervar
country: Hungary
facility: GSK Investigational Site
city: Szentes
country: Hungary
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Hiroshima
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hyogo
country: Japan
facility: GSK Investigational Site
city: Hyogo
country: Japan
facility: GSK Investigational Site
city: Ibaraki
country: Japan
facility: GSK Investigational Site
city: Kagawa
country: Japan
facility: GSK Investigational Site
city: Kagoshima
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kochi
country: Japan
facility: GSK Investigational Site
city: Kochi
country: Japan
facility: GSK Investigational Site
city: Kumamoto
country: Japan
facility: GSK Investigational Site
city: Miyagi
country: Japan
facility: GSK Investigational Site
city: Miyagi
country: Japan
facility: GSK Investigational Site
city: Nagano
country: Japan
facility: GSK Investigational Site
city: Nagasaki
country: Japan
facility: GSK Investigational Site
city: Nagasaki
country: Japan
facility: GSK Investigational Site
city: Nagasaki
country: Japan
facility: GSK Investigational Site
city: Niigata
country: Japan
facility: GSK Investigational Site
city: Niigata
country: Japan
facility: GSK Investigational Site
city: Okayama
country: Japan
facility: GSK Investigational Site
city: Okayama
country: Japan
facility: GSK Investigational Site
city: Okayama
country: Japan
facility: GSK Investigational Site
city: Saga
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Shizuoka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tottori
country: Japan
facility: GSK Investigational Site
city: Wakayama
country: Japan
facility: GSK Investigational Site
city: Yamaguchi
country: Japan
facility: GSK Investigational Site
city: Anyang-Si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Cheonan-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Gwangju
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Seongnam-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon
country: Korea, Republic of
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
state: Durango
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Merida
country: Mexico
facility: GSK Investigational Site
state: Yucatán
city: San Luis Potosí
country: Mexico
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Czestochowa
country: Poland
facility: GSK Investigational Site
city: Elblag
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gdynia
country: Poland
facility: GSK Investigational Site
city: Grodzisk Mazowiecki
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Nowy Targ
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Siedlce
country: Poland
facility: GSK Investigational Site
city: Sochaczew
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Korolev
country: Russian Federation
facility: GSK Investigational Site
city: Krasnoyarsk
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Omsk
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Ulyanovsk
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Muang
country: Thailand
facility: GSK Investigational Site
city: Rajathevee
country: Thailand
facility: GSK Investigational Site
city: Romford
country: United Kingdom
facility: GSK Investigational Site
state: Essex
city: Northwood
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Kenilworth
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: