Clinical trial NCT04134728: Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors
Official title: A 24-week, Phase 3, Multicentre, Randomised, Double-blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Sarilumab, in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological DMARDs and/or Janus Kinase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: bDMARD
GSK3196165
Rheumatoid Arthritis
Sarilumab
Otilimab
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2019-10-22
Enrollment: 550
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 6:6:6:1:1:1
Primary purpose: TREATMENT

Brief summary: This study (contRAst 3 \[202018: NCT04134728\]) is a Phase 3, randomized, multicenter, double-blind study to assess the safety and efficacy of GSK3196165 in combination with conventional (cs) DMARD\[s\]) or the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to biologic (b) DMARD\[s\]) and/or JAK inhibitors. The study will consist of a screening phase of up to 6 weeks followed by 24 week treatment phase in which participants will be randomized in ratio of 6:6:6:1:1:1 to GSK3196165 150 milligrams (mg) subcutaneously (SC) weekly,GSK3196165 90 mg SC weekly, sarilumab 200 mg SC every other week or placebo (three arms) respectively, all in combination with background csDMARD(s). At Week 12, participants in the three placebo arms will switch from placebo to active intervention (either GSK3196165 150 mg SC weekly, GSK3196165 90 mg SC weekly, or sarilumab 200 mg SC every other week). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165, may be included in the long-term extension study (contRAst X \[209564: NCT04333147\]). Any participant who does not transition into study 209564 will undergo a safety follow-up visit at Week 34 (corresponding to 12 weeks after the last potential dose of sarilumab, at Week 22).


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 joints (tender joint count \[TJC\]), and
  * \>=6/66 swollen joints (swollen joint count \[SJC\])
* Has had an inadequate response despite currently taking at least one and at the most two concomitant csDMARDs for at least 12 weeks, from the following:

  * Methotrexate (MTX)
  * Hydroxychloroquine or chloroquine
  * Sulfasalazine
  * Leflunomide
  * Bucillamine
  * Iguratimod
  * Tacrolimus
* Has had inadequate response to at least one bDMARD at an approved dose and/or at least one JAK inhibitors at an approved dose. In both cases this may be with or without combination with a csDMARD.

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

Key exclusion criteria:

* 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.
* Has known infection with human immunodeficiency virus (HIV) or current acute or chronic hepatitis B and/or hepatitis C.

Primary outcomes:
measure: Percentage of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) (Versus Placebo) at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) Total Score <=10 (CDAI Low Disease Activity [LDA]) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With CDAI Total Score <=10 (CDAI LDA) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Week 24
measure: Percentage of Participants With CDAI Total Score <=10 (CDAI LDA) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Week 24
measure: Change From Baseline in CDAI Total Score at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in CDAI Total Score at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in CDAI Total Score at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Arthritis Pain Visual Analogue Scale (VAS) at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in Arthritis Pain VAS at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Arthritis Pain VAS at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Day 01) and Week 24
measure: Percentage of Participants With CDAI Total Score <=2.8 (CDAI Remission) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With CDAI Total Score <=2.8 (CDAI Remission) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Week 24
measure: Percentage of Participants With CDAI Total Score <=2.8 (CDAI Remission) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Week 24
measure: Percentage of Participants With ACR20 at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Week 24
measure: Percentage of Participants With ACR20 at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Week 24
measure: Percentage of Participants With 50% Improvement in American College of Rheumatology Criteria (ACR50) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With ACR50 at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Week 24
measure: Percentage of Participants With ACR50 at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Week 24
measure: Percentage of Participants With 70% Improvement in American College of Rheumatology Criteria (ACR70) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With ACR70 at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Week 24
measure: Percentage of Participants With ACR70 at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Week 24
measure: Percentage of Participants With Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Week 24
measure: Percentage of Participants With DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Week 24
measure: Percentage of Participants With DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Week 24
measure: Percentage of Participants With DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Week 24
measure: Percentage of Participants With DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Week 24
measure: Percentage of Participants With DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Week 24
measure: Percentage of Participants With DAS28-ESR <2.6 (DAS28-ESR Remission) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With DAS28-ESR <2.6 (DAS28-ESR Remission) Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Week 24
measure: Percentage of Participants With DAS28-ESR <2.6 (DAS28-ESR Remission) Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Week 24
measure: Percentage of Participants With a Good/Moderate European League Against Rheumatism (EULAR) Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With a Good/Moderate EULAR Response at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Week 24
measure: Percentage of Participants With a Good/Moderate EULAR Response at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Week 24
measure: Percentage of Participants With ACR/EULAR Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants With ACR/EULAR Remission at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Week 24
measure: Percentage of Participants With ACR/EULAR Remission at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Week 24
measure: Change From Baseline in DAS28-CRP and DAS28-ESR at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in HAQ-DI at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in HAQ-DI at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in FACIT-Fatigue at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in FACIT-Fatigue at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Subject-completed Medical Outcomes Study Short-Form 36 (SF-36) Physical Component Scores (PCS) at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in SF-36 PCS at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in SF-36 PCS at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in SF-36 Mental Component Scores (MCS) at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in SF-36 MCS at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in SF-36 MCS at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in SF-36 Domain Scores at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in SF-36 Domain Scores at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in SF-36 Domain Scores at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Day 01) and Week 24
measure: Incidence of Adverse Events (AEs), Serious Adverse Event (SAEs), Adverse Events of Special Interest (AESI)
timeFrame: Up to Week 24
measure: Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Week 12) and Week 24
measure: Change From Baseline in White Blood Cell (WBC) Count (Giga Cells Per Liter) at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in WBC Count (Giga Cells Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in WBC Count (Giga Cells Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Week 12) and Week 24
measure: Change From Baseline in Hemoglobin Level (Grams Per Liter) Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in Hemoglobin Level (Grams Per Liter) Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Hemoglobin Level (Grams Per Liter) Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Week 12) and Week 24
measure: Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP) Gamma-glutamyl Transferase(GGT) Levels (International Units Per Liter) at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Week 12) and Week 24
measure: Change From Baseline in Albumin Level (Grams Per Liter) at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in Albumin Level (Grams Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Albumin Level (Grams Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Week 12) and Week 24
measure: Change From Baseline in Total Bilirubin (Micromoles Per Liter) at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in Total Bilirubin (Micromoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Total Bilirubin (Micromoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Week 12) and Week 24
measure: Change From Baseline in Total Cholesterol (Millimoles Per Liter) at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in Total Cholesterol (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Total Cholesterol (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Week 12) and Week 24
measure: Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol (Millimoles Per Liter) at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in Fasting Lipid Profile: LDL Cholesterol, HDL Cholesterol (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Fasting Lipid Profile: LDL Cholesterol, HDL Cholesterol (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Week 12) and Week 24
measure: Change From Baseline in Fasting Lipid Profile Triglycerides (Millimoles Per Liter) at Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline in Fasting Lipid Profile Triglycerides (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Fasting Lipid Profile Triglycerides (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Week 12) and Week 24
measure: Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Up to Week 24
measure: Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody
timeFrame: At baseline
measure: Number of Participants With Anti-GSK3196165 Antibodies
timeFrame: Up to Week 24
Other outcomes:
measure: Change From Baseline 4-beta-hydroxy Cholesterol, Cholesterol at (Millimoles Per Liter) Week 12
timeFrame: Baseline (Day 01) and Week 12
measure: Change From Baseline 4-beta-hydroxy Cholesterol, Cholesterol at (Millimoles Per Liter) Week 24 for Treatment Arms That Started Study Intervention From Day 1
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline 4-beta-hydroxy Cholesterol, Cholesterol at (Millimoles Per Liter) Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12
timeFrame: Baseline (Week 12) and Week 24
Locations:
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Sun City
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Covina
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Tujunga
country: United States
facility: GSK Investigational Site
state: California
city: Upland
country: United States
facility: GSK Investigational Site
state: California
city: Whittier
country: United States
facility: GSK Investigational Site
state: California
city: Brandon
country: United States
facility: GSK Investigational Site
state: Florida
city: DeBary
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami Lakes
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: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Newnan
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Skokie
country: United States
facility: GSK Investigational Site
state: Illinois
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Lebanon
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: Minot
country: United States
facility: GSK Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Baytown
country: United States
facility: GSK Investigational Site
state: Texas
city: College Station
country: United States
facility: GSK Investigational Site
state: Texas
city: Colleyville
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: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Marcos
country: United States
facility: GSK Investigational Site
state: Texas
city: The Woodlands
country: United States
facility: GSK Investigational Site
state: Texas
city: Tomball
country: United States
facility: GSK Investigational Site
state: Texas
city: Waco
country: United States
facility: GSK Investigational Site
state: Texas
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: Ciudad Autonoma Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: La Palta
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: San Isidro
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: San Nicolas
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: San Juan
country: Argentina
facility: GSK Investigational Site
city: Mons
country: Belgium
facility: GSK Investigational Site
city: Barrie
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Trois-Rivieres
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Brno
country: Czechia
facility: GSK Investigational Site
city: Brno
country: Czechia
facility: GSK Investigational Site
city: Ostrava
country: Czechia
facility: GSK Investigational Site
city: Praha 11
country: Czechia
facility: GSK Investigational Site
city: Praha 2
country: Czechia
facility: GSK Investigational Site
city: Praha 5
country: Czechia
facility: GSK Investigational Site
city: Uherske Hradiste
country: Czechia
facility: GSK Investigational Site
city: Zlin
country: Czechia
facility: GSK Investigational Site
city: Rendsburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
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: Szekesfehervar
country: Hungary
facility: GSK Investigational Site
city: Veszprem
country: Hungary
facility: GSK Investigational Site
city: Verona
country: Italy
facility: GSK Investigational Site
state: Veneto
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: Fukuoka
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: Kagoshima
country: Japan
facility: GSK Investigational Site
city: Kanagawa
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: Nagasaki
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Incheon
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: Klaipeda
country: Lithuania
facility: GSK Investigational Site
city: Siauliai
country: Lithuania
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gdynia
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Kraków
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Sochaczew
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wrocław
country: Poland
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: GSK Investigational Site
state: KwaZulu- Natal
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Kempton Park
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Stellenbosch
country: South Africa
facility: GSK Investigational Site
city: A Coruña
country: Spain
facility: GSK Investigational Site
city: Elche
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
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
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: