Clinical trial NCT04333147: Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
Official title: A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid arthritis
GSK3196165
Otilimab
Long-term safety
Long-term efficacy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2020-04-03
Enrollment: 2916
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who received GSK3196165 in their qualifying study will continue in this study on the same dose. Participants who received a comparator (tofacitinib or sarilumab) in their qualifying study will be centrally randomized using interactive response technology (IRT) in a ratio of 1:1 to either GSK3196165 90 mg or 150 mg.
Primary purpose: TREATMENT

Brief summary: RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X \[209564: NCT04333147\]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) \[csDMARD(s)\] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study


Eligibility criteria: Inclusion Criteria:

* Participants with rheumatoid arthritis who are aged \>=18 years at the time of signing informed consent, who have completed one of the qualifying GSK3196165 clinical studies and who, in the opinion of the investigator, may benefit from treatment with GSK3196165.
* Body weight \>=40 kilograms (kg).
* Male or female participants are eligible to participate as long as they meet the contraceptive eligibility criteria and agree to abide by the contraceptive requirements.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* For participants on methotrexate (MTX): must be willing to continue treatment with oral folic acid (at least 5 mg/week) or equivalent while receiving MTX (mandatory co-medication for MTX treatment).

Exclusion Criteria:

* Had study intervention permanently discontinued at any time during a qualifying study except any participant with a new diagnosis of latent Mycobacterium tuberculosis (TB) at the end of study assessment in a qualifying study and currently undertaking or willing to complete at least 4 weeks of anti-TB treatment off study treatment, per world health organization (WHO) or national guidelines prior to re-commencing therapy and complete the remainder of anti-TB treatment while on study.
* Evidence of latent TB (as documented by a positive QuantiFERON-TB Gold plus test or T-SPOT.TB test, no findings on medical history or clinical examination consistent with active TB, and a normal chest radiograph) except for participants that

  * Are currently undertaking or willing to complete at least 4 weeks of anti-TB therapy off study treatment, as per WHO or national guidelines prior to re- commencing study treatment and agree to complete the remainder of anti-TB treatment while in the study or
  * Had documented evidence of satisfactory anti-TB treatment as per WHO or national guidelines following review by a physician specializing in TB on entry to a qualifying study.
* Current or previous active TB regardless of treatment.
* Were temporarily discontinued from study intervention at the time of the final study visit of a qualifying study and, in the opinion of the investigator, participation in the extension study poses an unacceptable risk for the participant's participation.
* A new cancer or malignancy except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured by the investigator.
* Have developed any lymphoproliferative disorder during a qualifying study, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, or signs and symptoms suggestive of current lymphatic disease.
* Have significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the participant's participation.
* Participants who are expected to be non-compliant with restrictions on medications and vaccinations prior to the study, during the study or during the 8-week safety follow-up of the study.
* Participants who are currently participating in any interventional clinical study other than a qualifying GSK3196165 clinical study.
* Abnormal chest radiograph within the last 12 weeks judged by the investigator as clinically-significant.
* Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
* History of sensitivity to any of the study treatments, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
timeFrame: Up to approximately 145 Weeks
measure: Change From Baseline in Hematology Parameter of Platelet Count at Week 24
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Hematology Parameter of Platelet Count at Week 48
timeFrame: Baseline (Day 01) and Week 48
measure: Change From Baseline in Hematology Parameter of Platelet Count at Week 96
timeFrame: Baseline (Day 01) and Week 96
measure: Change From Baseline in Hematology Parameter of Platelet Count at Week 144
timeFrame: Baseline (Day 01) and Week 144
measure: Change From Baseline in Hematology Parameter of Hemoglobin at Week 24
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Hematology Parameter of Hemoglobin at Week 48
timeFrame: Baseline (Day 01) and Week 48
measure: Change From Baseline in Hematology Parameter of Hemoglobin at Week 96
timeFrame: Baseline (Day 01) and Week 96
measure: Change From Baseline in Hematology Parameter of Hemoglobin at Week 144
timeFrame: Baseline (Day 01) and Week 144
measure: Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48
timeFrame: Baseline (Day 01) and Week 48
measure: Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96
timeFrame: Baseline (Day 01) and Week 96
measure: Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144
timeFrame: Baseline (Day 01) and Week 144
measure: Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48
timeFrame: Baseline (Day 01) and Week 48
measure: Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96
timeFrame: Baseline (Day 01) and Week 96
measure: Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144
timeFrame: Baseline (Day 01) and Week 144
measure: Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48
timeFrame: Baseline (Day 01) and Week 48
measure: Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96
timeFrame: Baseline (Day 01) and Week 96
measure: Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144
timeFrame: Baseline (Day 01) and Week 144
measure: Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities
timeFrame: Up to approximately 145 Weeks
measure: Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24
timeFrame: Baseline (Day 01) and Week 24
measure: Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48
timeFrame: Baseline (Day 01) and Week 48
measure: Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96
timeFrame: Baseline (Day 01) and Week 96
measure: Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144
timeFrame: Baseline (Day 01) and Week 144
Secondary outcomes:
measure: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144
timeFrame: Week 24, 48, 96 and 144
measure: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144
timeFrame: Week 24, 48, 96 and 144
measure: Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144
timeFrame: Week 24, 48, 96 and 144
measure: Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132
timeFrame: Week 24, 48, 96 and 132
measure: Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144
timeFrame: Week 24, 48, 96 and 144
measure: Absolute Values for Clinical Disease Activity Index (CDAI) Total Score
timeFrame: Week 24, 48, 96 and 144
measure: Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP)
timeFrame: Week 24, 48, 96 and 144
measure: Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)
timeFrame: Week 24, 48, 96 and 132
measure: Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS)
timeFrame: Week 24 and 48
measure: Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Week 24, 48, 96 and 144
measure: Absolute Values for Arthritis Pain Visual Analogue Scale (VAS)
timeFrame: Week 24, 48, 96 and 144
measure: Absolute Values Short Form (SF)-36 Mental Component Scores (MCS)
timeFrame: Week 24, 48, 96 and 144
measure: Absolute Values SF-36 Domain Scores
timeFrame: Week 24, 48, 96 and 144
measure: Absolute Values SF-36 Physical Component Scores (PCS)
timeFrame: Week 24, 48, 96 and 144
measure: Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
timeFrame: Week 24, 48, 96 and 144
measure: Number of Participants With Anti-GSK3196165 Antibodies
timeFrame: Week 120
Other outcomes:
Locations:
city: Anniston
country: United States
facility: GSK Investigational Site
state: Alabama
city: Flagstaff
country: United States
facility: GSK Investigational Site
state: Arizona
city: Gilbert
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: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
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: Poway
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Upland
country: United States
facility: GSK Investigational Site
state: California
city: Van Nuys
country: United States
facility: GSK Investigational Site
state: California
city: Whittier
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: Brandon
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: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami Lakes
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
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facility: GSK Investigational Site
state: Florida
city: New Port Richey
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state: Florida
city: Orlando
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facility: GSK Investigational Site
state: Florida
city: Palmetto Bay
country: United States
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state: Florida
city: Tamarac
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state: Florida
city: Tampa
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state: Florida
city: Tampa
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state: Florida
city: Atlanta
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state: Georgia
city: Marietta
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facility: GSK Investigational Site
state: Georgia
city: Idaho Falls
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state: Idaho
city: Skokie
country: United States
facility: GSK Investigational Site
state: Illinois
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
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facility: GSK Investigational Site
state: Kentucky
city: Lake Charles
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state: Louisiana
city: Monroe
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facility: GSK Investigational Site
state: Louisiana
city: Wheaton
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facility: GSK Investigational Site
state: Maryland
city: Grand Blanc
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facility: GSK Investigational Site
state: Michigan
city: Lansing
country: United States
facility: GSK Investigational Site
state: Michigan
city: Novi
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facility: GSK Investigational Site
state: Michigan
city: Saint Louis
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state: Missouri
city: Lincoln
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state: Nebraska
city: Lebanon
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state: New Hampshire
city: Freehold
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state: New Jersey
city: Brooklyn
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state: New York
city: Fayetteville
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state: North Carolina
city: Greensboro
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state: North Carolina
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state: North Dakota
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state: Ohio
city: Vandalia
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Oklahoma City
country: United States
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state: Oklahoma
city: Oklahoma City
country: United States
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state: Oklahoma
city: Yukon
country: United States
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state: Oklahoma
city: Greenville
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state: South Carolina
city: Summerville
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state: South Carolina
city: Amarillo
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state: Texas
city: Austin
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state: Texas
city: Austin
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facility: GSK Investigational Site
state: Texas
city: Baytown
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facility: GSK Investigational Site
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city: Colleyville
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city: Dallas
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state: Texas
city: Houston
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facility: GSK Investigational Site
state: Texas
city: Houston
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facility: GSK Investigational Site
state: Texas
city: Houston
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facility: GSK Investigational Site
state: Texas
city: Houston
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facility: GSK Investigational Site
state: Texas
city: Lubbock
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state: Texas
city: Plano
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facility: GSK Investigational Site
state: Texas
city: The Woodlands
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facility: GSK Investigational Site
state: Texas
city: Tomball
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state: Texas
city: Waco
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: 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: Ciudad Autonoma de 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: Quilmes
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: Cordoba
country: Argentina
facility: GSK Investigational Site
state: Córdova
city: Rosario
country: Argentina
facility: GSK Investigational Site
state: Santa Fe
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: Buenos Aires
country: Argentina
facility: GSK Investigational Site
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: Nueva Cordoba
country: Argentina
facility: GSK Investigational Site
city: Salta
country: Argentina
facility: GSK Investigational Site
city: San Juan
country: Argentina
facility: GSK Investigational Site
city: Gold Coast
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Woodville
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Mons
country: Belgium
facility: GSK Investigational Site
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: 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: Vidin
country: Bulgaria
facility: GSK Investigational Site
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Trois-Rivieres
country: Canada
facility: GSK Investigational Site
state: Quebec
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: Taizhou
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Xuzhou
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Nanchang,
country: China
facility: GSK Investigational Site
state: Jiangxi
city: Pingxiang
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: Chengdu
country: China
facility: GSK Investigational Site
state: Sichuan
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: 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: Yangzhou
country: China
facility: GSK Investigational Site
city: Yanji
country: China
facility: GSK Investigational Site
city: Barranquilla
country: Colombia
facility: GSK Investigational Site
city: Barranquilla
country: Colombia
facility: GSK Investigational Site
city: Bogotá
country: Colombia
facility: GSK Investigational Site
city: Bucaramanga
country: Colombia
facility: GSK Investigational Site
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 10
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 4 Nusle
country: Czechia
facility: GSK Investigational Site
city: Praha 4
country: Czechia
facility: GSK Investigational Site
city: Praha 5
country: Czechia
facility: GSK Investigational Site
city: Uherske Hradiste
country: Czechia
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city: Zlin
country: Czechia
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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: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
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: Baja
country: Hungary
facility: GSK Investigational Site
city: Balatonfured
country: Hungary
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: Székesfehérvár
country: Hungary
facility: GSK Investigational Site
city: Veszprem
country: Hungary
facility: GSK Investigational Site
city: Ahmedabad
country: India
facility: GSK Investigational Site
city: Ahmedabad
country: India
facility: GSK Investigational Site
city: Belagavi
country: India
facility: GSK Investigational Site
city: Hubli
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Kolkata
country: India
facility: GSK Investigational Site
city: Nagpur
country: India
facility: GSK Investigational Site
city: Nagpur
country: India
facility: GSK Investigational Site
city: New Delhi
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Surat
country: India
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: 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: 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: 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: Saitama
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: Wakayama
country: Japan
facility: GSK Investigational Site
city: Yamaguchi
country: Japan
facility: GSK Investigational Site
city: Anyang-Si
country: Korea, Republic of
facility: GSK Investigational Site
city: Cheonan-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: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Adazi
country: Latvia
facility: GSK Investigational Site
city: Liepaja
country: Latvia
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Klaipeda
country: Lithuania
facility: GSK Investigational Site
city: Siauliai
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Klang
country: Malaysia
facility: GSK Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: GSK Investigational Site
city: Seremban, Negeri Sembilan
country: Malaysia
facility: GSK Investigational Site
city: Sibu
country: Malaysia
facility: GSK Investigational Site
city: Mexicali
country: Mexico
facility: GSK Investigational Site
state: Baja California Sur
city: Mexico City
country: Mexico
facility: GSK Investigational Site
state: Durango
city: Leon
country: Mexico
facility: GSK Investigational Site
state: Guanajuato
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Merida
country: Mexico
facility: GSK Investigational Site
state: Yucatán
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: San Luis Potosí
country: Mexico
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
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: 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: Kraków
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: Lublin
country: Poland
facility: GSK Investigational Site
city: Nowa Sol
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: 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: Staszow
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Warsaw
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: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wrocław
country: Poland
facility: GSK Investigational Site
city: Zamosc
country: Poland
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
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: 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: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: Smolensk
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Tver
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: Belgrade
country: Serbia
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: Bellville
country: South Africa
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
city: Johannesburg
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: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Stellenbosch
country: South Africa
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Cordoba
country: Spain
facility: GSK Investigational Site
city: 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. La Coruña.
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Rajathevee
country: Thailand
facility: GSK Investigational Site
city: Cherkasy
country: Ukraine
facility: GSK Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Lutsk
country: Ukraine
facility: GSK Investigational Site
city: Lutsk
country: Ukraine
facility: GSK Investigational Site
city: Odessa
country: Ukraine
facility: GSK Investigational Site
city: Poltava
country: Ukraine
facility: GSK Investigational Site
city: Vinnytsia
country: Ukraine
facility: GSK Investigational Site
city: Vinnytsia
country: Ukraine
facility: GSK Investigational Site
city: Vinnytsia
country: Ukraine
facility: GSK Investigational Site
city: Vinnytsia
country: Ukraine
facility: GSK Investigational Site
city: Vinnytsya
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhzia
country: Ukraine
facility: GSK Investigational Site
city: Zhytomyr
country: Ukraine
facility: GSK Investigational Site
city: Orpington
country: United Kingdom
facility: GSK Investigational Site
state: Kent
city: Northwood
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Coventry
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: