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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04333147




Registration number
NCT04333147
Ethics application status
Date submitted
27/03/2020
Date registered
3/04/2020

Titles & IDs
Public title
Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
Scientific title
A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis
Secondary ID [1] 0 0
209564
Universal Trial Number (UTN)
Trial acronym
contRAst X
Linked study record

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

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

Experimental: Otilimab 90 mg - Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.

Experimental: Otilimab 150 mg - Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.


Treatment: Other: Otilimab (GSK3196165)
GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

Treatment: Drugs: csDMARD(s)
Stable dose of csDMARD(s) as standard of care (SoC).
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Timepoint [1] 0 0
Up to approximately 145 Weeks
Primary outcome [2] 0 0
Change From Baseline in Hematology Parameter of Platelet Count at Week 24
Timepoint [2] 0 0
Baseline (Day 01) and Week 24
Primary outcome [3] 0 0
Change From Baseline in Hematology Parameter of Platelet Count at Week 48
Timepoint [3] 0 0
Baseline (Day 01) and Week 48
Primary outcome [4] 0 0
Change From Baseline in Hematology Parameter of Platelet Count at Week 96
Timepoint [4] 0 0
Baseline (Day 01) and Week 96
Primary outcome [5] 0 0
Change From Baseline in Hematology Parameter of Platelet Count at Week 144
Timepoint [5] 0 0
Baseline (Day 01) and Week 144
Primary outcome [6] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24
Timepoint [6] 0 0
Baseline (Day 01) and Week 24
Primary outcome [7] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 48
Timepoint [7] 0 0
Baseline (Day 01) and Week 48
Primary outcome [8] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 96
Timepoint [8] 0 0
Baseline (Day 01) and Week 96
Primary outcome [9] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 144
Timepoint [9] 0 0
Baseline (Day 01) and Week 144
Primary outcome [10] 0 0
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24
Timepoint [10] 0 0
Baseline (Day 01) and Week 24
Primary outcome [11] 0 0
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48
Timepoint [11] 0 0
Baseline (Day 01) and Week 48
Primary outcome [12] 0 0
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96
Timepoint [12] 0 0
Baseline (Day 01) and Week 96
Primary outcome [13] 0 0
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144
Timepoint [13] 0 0
Baseline (Day 01) and Week 144
Primary outcome [14] 0 0
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
Timepoint [14] 0 0
Baseline (Day 01) and Week 24
Primary outcome [15] 0 0
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
Timepoint [15] 0 0
Baseline (Day 01) and Week 48
Primary outcome [16] 0 0
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
Timepoint [16] 0 0
Baseline (Day 01) and Week 96
Primary outcome [17] 0 0
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
Timepoint [17] 0 0
Baseline (Day 01) and Week 144
Primary outcome [18] 0 0
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24
Timepoint [18] 0 0
Baseline (Day 01) and Week 24
Primary outcome [19] 0 0
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48
Timepoint [19] 0 0
Baseline (Day 01) and Week 48
Primary outcome [20] 0 0
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96
Timepoint [20] 0 0
Baseline (Day 01) and Week 96
Primary outcome [21] 0 0
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144
Timepoint [21] 0 0
Baseline (Day 01) and Week 144
Primary outcome [22] 0 0
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities
Timepoint [22] 0 0
Up to approximately 145 Weeks
Primary outcome [23] 0 0
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24
Timepoint [23] 0 0
Baseline (Day 01) and Week 24
Primary outcome [24] 0 0
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48
Timepoint [24] 0 0
Baseline (Day 01) and Week 48
Primary outcome [25] 0 0
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96
Timepoint [25] 0 0
Baseline (Day 01) and Week 96
Primary outcome [26] 0 0
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144
Timepoint [26] 0 0
Baseline (Day 01) and Week 144
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 24, 48, 96 and 144
Secondary outcome [2] 0 0
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144
Timepoint [2] 0 0
Week 24, 48, 96 and 144
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Week 24, 48, 96 and 144
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Week 24, 48, 96 and 132
Secondary outcome [5] 0 0
Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144
Timepoint [5] 0 0
Week 24, 48, 96 and 144
Secondary outcome [6] 0 0
Absolute Values for Clinical Disease Activity Index (CDAI) Total Score
Timepoint [6] 0 0
Week 24, 48, 96 and 144
Secondary outcome [7] 0 0
Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP)
Timepoint [7] 0 0
Week 24, 48, 96 and 144
Secondary outcome [8] 0 0
Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)
Timepoint [8] 0 0
Week 24, 48, 96 and 132
Secondary outcome [9] 0 0
Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS)
Timepoint [9] 0 0
Week 24 and 48
Secondary outcome [10] 0 0
Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI)
Timepoint [10] 0 0
Week 24, 48, 96 and 144
Secondary outcome [11] 0 0
Absolute Values for Arthritis Pain Visual Analogue Scale (VAS)
Timepoint [11] 0 0
Week 24, 48, 96 and 144
Secondary outcome [12] 0 0
Absolute Values Short Form (SF)-36 Mental Component Scores (MCS)
Timepoint [12] 0 0
Week 24, 48, 96 and 144
Secondary outcome [13] 0 0
Absolute Values SF-36 Domain Scores
Timepoint [13] 0 0
Week 24, 48, 96 and 144
Secondary outcome [14] 0 0
Absolute Values SF-36 Physical Component Scores (PCS)
Timepoint [14] 0 0
Week 24, 48, 96 and 144
Secondary outcome [15] 0 0
Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Timepoint [15] 0 0
Week 24, 48, 96 and 144
Secondary outcome [16] 0 0
Number of Participants With Anti-GSK3196165 Antibodies
Timepoint [16] 0 0
Week 120

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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


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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/02/2023
Sample size
Target
Accrual to date
Final
2916
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Gold Coast
Recruitment hospital [2] 0 0
GSK Investigational Site - Woodville
Recruitment postcode(s) [1] 0 0
4222 - Gold Coast
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
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Indiana
Country [10] 0 0
United States of America
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Kansas
Country [11] 0 0
United States of America
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Kentucky
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United States of America
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Louisiana
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Maryland
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Michigan
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Missouri
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Nebraska
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United States of America
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New Hampshire
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United States of America
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New Jersey
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United States of America
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New York
Country [20] 0 0
United States of America
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North Carolina
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North Dakota
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United States of America
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Ohio
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Oklahoma
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South Carolina
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Texas
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Wisconsin
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Argentina
State/province [27] 0 0
Buenos Aires
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Argentina
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Córdova
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Argentina
State/province [29] 0 0
Santa Fe
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Argentina
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Tucumán
Country [31] 0 0
Argentina
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Ciudad Autonoma Buenos Aires
Country [32] 0 0
Argentina
State/province [32] 0 0
Ciudad Autónoma de Buenos Aires
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Argentina
State/province [33] 0 0
Cordoba
Country [34] 0 0
Argentina
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Nueva Cordoba
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Argentina
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Salta
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Argentina
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San Juan
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Belgium
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Mons
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Bulgaria
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Blagoevgrad
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sevlievo
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Bulgaria
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Sofia
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Bulgaria
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Vidin
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Canada
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Ontario
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Canada
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Quebec
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China
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Anhui
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Guangxi
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China
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Inner Mongolia
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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Liaoning
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China
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Sichuan
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China
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Zhejiang
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China
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Beijing
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China
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Guangzhou
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China
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Hangzhou
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China
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Nanjing
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Shanghai
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China
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Tianjin
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China
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Yangzhou
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China
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Yanji
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Colombia
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Barranquilla
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Colombia
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Bogotá
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Colombia
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Bucaramanga
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Czechia
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Brno
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Czechia
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Ostrava
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Czechia
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Praha 10
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Praha 11
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Czechia
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Praha 2
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Czechia
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Praha 4 Nusle
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Praha 4
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Czechia
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Praha 5
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Czechia
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Uherske Hradiste
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Czechia
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Zlin
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Estonia
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Parnu
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Estonia
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Tallinn
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Estonia
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Tartu
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Hamburg
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Germany
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Magdeburg
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Hungary
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Baja
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Hungary
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Balatonfured
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Hungary
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Budapest
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Hungary
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Szekesfehervar
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Hungary
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Szentes
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Hungary
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Székesfehérvár
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Hungary
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Veszprem
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India
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Ahmedabad
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India
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Belagavi
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India
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Hubli
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India
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Hyderabad
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India
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Jaipur
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India
State/province [99] 0 0
Kolkata
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India
State/province [100] 0 0
Nagpur
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India
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New Delhi
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India
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Pune
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India
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Surat
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ibaraki
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Japan
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Kagawa
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Japan
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Kagoshima
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Japan
State/province [113] 0 0
Kanagawa
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Japan
State/province [114] 0 0
Kochi
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Japan
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Kumamoto
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Japan
State/province [116] 0 0
Miyagi
Country [117] 0 0
Japan
State/province [117] 0 0
Nagano
Country [118] 0 0
Japan
State/province [118] 0 0
Nagasaki
Country [119] 0 0
Japan
State/province [119] 0 0
Niigata
Country [120] 0 0
Japan
State/province [120] 0 0
Okayama
Country [121] 0 0
Japan
State/province [121] 0 0
Saitama
Country [122] 0 0
Japan
State/province [122] 0 0
Tokyo
Country [123] 0 0
Japan
State/province [123] 0 0
Wakayama
Country [124] 0 0
Japan
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Yamaguchi
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Korea, Republic of
State/province [125] 0 0
Anyang-Si
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Cheonan-si
Country [127] 0 0
Korea, Republic of
State/province [127] 0 0
Daegu
Country [128] 0 0
Korea, Republic of
State/province [128] 0 0
Gwangju
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Korea, Republic of
State/province [129] 0 0
Incheon
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Korea, Republic of
State/province [130] 0 0
Seongnam-si
Country [131] 0 0
Korea, Republic of
State/province [131] 0 0
Seoul
Country [132] 0 0
Korea, Republic of
State/province [132] 0 0
Suwon-si, Gyeonggi-do
Country [133] 0 0
Latvia
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Adazi
Country [134] 0 0
Latvia
State/province [134] 0 0
Liepaja
Country [135] 0 0
Lithuania
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Kaunas
Country [136] 0 0
Lithuania
State/province [136] 0 0
Klaipeda
Country [137] 0 0
Lithuania
State/province [137] 0 0
Siauliai
Country [138] 0 0
Lithuania
State/province [138] 0 0
Vilnius
Country [139] 0 0
Malaysia
State/province [139] 0 0
Klang
Country [140] 0 0
Malaysia
State/province [140] 0 0
Kuala Lumpur
Country [141] 0 0
Malaysia
State/province [141] 0 0
Seremban, Negeri Sembilan
Country [142] 0 0
Malaysia
State/province [142] 0 0
Sibu
Country [143] 0 0
Mexico
State/province [143] 0 0
Baja California Sur
Country [144] 0 0
Mexico
State/province [144] 0 0
Durango
Country [145] 0 0
Mexico
State/province [145] 0 0
Guanajuato
Country [146] 0 0
Mexico
State/province [146] 0 0
Jalisco
Country [147] 0 0
Mexico
State/province [147] 0 0
Yucatán
Country [148] 0 0
Mexico
State/province [148] 0 0
Mexico
Country [149] 0 0
Mexico
State/province [149] 0 0
San Luis Potosí
Country [150] 0 0
Poland
State/province [150] 0 0
Bialystok
Country [151] 0 0
Poland
State/province [151] 0 0
Bydgoszcz
Country [152] 0 0
Poland
State/province [152] 0 0
Czestochowa
Country [153] 0 0
Poland
State/province [153] 0 0
Elblag
Country [154] 0 0
Poland
State/province [154] 0 0
Gdansk
Country [155] 0 0
Poland
State/province [155] 0 0
Gdynia
Country [156] 0 0
Poland
State/province [156] 0 0
Grodzisk Mazowiecki
Country [157] 0 0
Poland
State/province [157] 0 0
Katowice
Country [158] 0 0
Poland
State/province [158] 0 0
Krakow
Country [159] 0 0
Poland
State/province [159] 0 0
Kraków
Country [160] 0 0
Poland
State/province [160] 0 0
Lodz
Country [161] 0 0
Poland
State/province [161] 0 0
Lublin
Country [162] 0 0
Poland
State/province [162] 0 0
Nowa Sol
Country [163] 0 0
Poland
State/province [163] 0 0
Olsztyn
Country [164] 0 0
Poland
State/province [164] 0 0
Poznan
Country [165] 0 0
Poland
State/province [165] 0 0
Siedlce
Country [166] 0 0
Poland
State/province [166] 0 0
Sochaczew
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Poland
State/province [167] 0 0
Staszow
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Poland
State/province [168] 0 0
Torun
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Poland
State/province [169] 0 0
Warsaw
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Poland
State/province [170] 0 0
Warszawa
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Poland
State/province [171] 0 0
Wroclaw
Country [172] 0 0
Poland
State/province [172] 0 0
Zamosc
Country [173] 0 0
Russian Federation
State/province [173] 0 0
Ekaterinburg
Country [174] 0 0
Russian Federation
State/province [174] 0 0
Kemerovo
Country [175] 0 0
Russian Federation
State/province [175] 0 0
Korolev
Country [176] 0 0
Russian Federation
State/province [176] 0 0
Krasnoyarsk
Country [177] 0 0
Russian Federation
State/province [177] 0 0
Moscow
Country [178] 0 0
Russian Federation
State/province [178] 0 0
Novosibirsk
Country [179] 0 0
Russian Federation
State/province [179] 0 0
Omsk
Country [180] 0 0
Russian Federation
State/province [180] 0 0
Saint Petersburg
Country [181] 0 0
Russian Federation
State/province [181] 0 0
Saint-Petersburg
Country [182] 0 0
Russian Federation
State/province [182] 0 0
Saratov
Country [183] 0 0
Russian Federation
State/province [183] 0 0
Smolensk
Country [184] 0 0
Russian Federation
State/province [184] 0 0
Tomsk
Country [185] 0 0
Russian Federation
State/province [185] 0 0
Tver
Country [186] 0 0
Russian Federation
State/province [186] 0 0
Ulyanovsk
Country [187] 0 0
Russian Federation
State/province [187] 0 0
Yaroslavl
Country [188] 0 0
Serbia
State/province [188] 0 0
Belgrade
Country [189] 0 0
South Africa
State/province [189] 0 0
Gauteng
Country [190] 0 0
South Africa
State/province [190] 0 0
KwaZulu- Natal
Country [191] 0 0
South Africa
State/province [191] 0 0
Bellville
Country [192] 0 0
South Africa
State/province [192] 0 0
Bloemfontein
Country [193] 0 0
South Africa
State/province [193] 0 0
Cape Town
Country [194] 0 0
South Africa
State/province [194] 0 0
Johannesburg
Country [195] 0 0
South Africa
State/province [195] 0 0
Kempton Park
Country [196] 0 0
South Africa
State/province [196] 0 0
Pretoria
Country [197] 0 0
South Africa
State/province [197] 0 0
Somerset West
Country [198] 0 0
South Africa
State/province [198] 0 0
Stellenbosch
Country [199] 0 0
Spain
State/province [199] 0 0
Barcelona
Country [200] 0 0
Spain
State/province [200] 0 0
Cordoba
Country [201] 0 0
Spain
State/province [201] 0 0
Coruña
Country [202] 0 0
Spain
State/province [202] 0 0
Elche
Country [203] 0 0
Spain
State/province [203] 0 0
Santander
Country [204] 0 0
Spain
State/province [204] 0 0
Santiago De Compostela. La Coruña.
Country [205] 0 0
Spain
State/province [205] 0 0
Sevilla
Country [206] 0 0
Spain
State/province [206] 0 0
Valencia
Country [207] 0 0
Thailand
State/province [207] 0 0
Bangkok
Country [208] 0 0
Thailand
State/province [208] 0 0
Rajathevee
Country [209] 0 0
Ukraine
State/province [209] 0 0
Cherkasy
Country [210] 0 0
Ukraine
State/province [210] 0 0
Ivano-Frankivsk
Country [211] 0 0
Ukraine
State/province [211] 0 0
Kharkiv
Country [212] 0 0
Ukraine
State/province [212] 0 0
Kyiv
Country [213] 0 0
Ukraine
State/province [213] 0 0
Lutsk
Country [214] 0 0
Ukraine
State/province [214] 0 0
Odessa
Country [215] 0 0
Ukraine
State/province [215] 0 0
Poltava
Country [216] 0 0
Ukraine
State/province [216] 0 0
Vinnytsia
Country [217] 0 0
Ukraine
State/province [217] 0 0
Vinnytsya
Country [218] 0 0
Ukraine
State/province [218] 0 0
Zaporizhzhia
Country [219] 0 0
Ukraine
State/province [219] 0 0
Zaporizhzia
Country [220] 0 0
Ukraine
State/province [220] 0 0
Zhytomyr
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Kent
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Middlesex
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Coventry

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

Ethics approval
Ethics application status

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

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

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

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


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04333147