Last updated: 08/29/2024 09:04:16

Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic (cs)/biologic (b) disease modifying anti-rheumatic drugs (DMARDs)contRAst 2

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GSK study ID
201791
See study documents
Clinicaltrials.gov ID
NCT03970837
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs
Trial description: This study [contRAst 2 (201791: NCT03970837)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator’s judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study [contRAst X (209564: NCT04333147)]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Percentage (%) of participants with 20% improvement in American College of Rheumatology criteria (ACR20) at Week 12 superiority comparison with placebo (Global Cohort)

Timeframe: Week 12

Percentage (%) of participants with 20% improvement in American College of Rheumatology criteria (ACR20) at Week 12 (Asia Cohort)

Timeframe: Week 12

Secondary outcomes:

Percentage of participants achieving Clinical disease activity index (CDAI) total score less than or equal to (<=)10 [CDAI Low disease activity (LDA)] at Week 12 (Global Cohort)

Timeframe: Week 12

Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Percentage of participants achieving 20% improvement in ACR20 at Week 24: non-inferiority comparison with tofacitinib (Global Cohort)

Timeframe: Week 24

Percentage of participants achieving CDAI total score <=10 (CDAI LDA) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving CDAI total score <=10 (CDAI LDA) at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 12 (Global Cohort)

Timeframe: Week 12

Percentage of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving 50%/70% improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Global Cohort)

Timeframe: Week 12

Percentage of participants achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for placebo switched arms (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving Disease Activity Score using 28 joint count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12 (Global Cohort)

Timeframe: Week 12

Percentage of participants achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 (Global Cohort)

Timeframe: Week 12

Percentage of participants achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 (Global Cohort)

Timeframe: Week 12

Percentage of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12 (Global Cohort)

Timeframe: Week 12

Percentage of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving a good/moderate (European league against rheumatism) EULAR response at Week 12 (Global Cohort)

Timeframe: Week 12

Percentage of participants achieving a good/moderate EULAR response at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving a good/moderate EULAR response at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Week 24 and Week 52

Number of participants achieving ACR/EULAR remission at Week 12 (Global Cohort)

Timeframe: Week 12

Number of participants achieving ACR/EULAR remission at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Week 24 and Week 52

Number of participants achieving ACR/EULAR remission at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving no radiographic progression Van der Heijde modified total sharp scores (mTSS) <= 0.5) at Week 12 (Global Cohort)

Timeframe: Week 12

Percentage of participants achieving no radiographic progression (mTSS <= 0.5) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving no radiographic progression (mTSS <= 0.5) at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Week 24 and Week 52

Change from Baseline in CDAI total score at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and week 12

Change from Baseline in CDAI total score at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in CDAI total score at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in DAS28-CRP/DAS28-ESR at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in Van der Heijde mTSS at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in Van der Heijde mTSS at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in Van der Heijde mTSS at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in HAQ-DI at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 24

Change from Baseline in HAQ-DI at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Day 1) and Week 52

Change from Baseline in Arthritis pain VAS at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in Arthritis pain VAS at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 24 and Week 52

Change from Baseline in Arthritis pain VAS at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Day 1) and Week 24 and Week 52

Change from Baseline in Short form (SF)-36 physical component scores at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in SF-36 mental component scores at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in SF-36 domain scores at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in SF-36 physical component scores at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in SF-36 mental component scores at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in SF-36 domain scores at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in SF-36 physical component scores at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in SF-36 mental component scores at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in SF-36 domain scores at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in Functional assessment of chronic illness therapy (FACIT)-Fatigue at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in FACIT-Fatigue at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in FACIT-Fatigue at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) (Global Cohort)

Timeframe: Up to Week 59

Change from Baseline in hematology parameter of white blood cell (WBC) count, platelet count, neutrophils, lymphocytes at Week 12 (Giga cells per liter) (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in hematology parameter of WBC count, platelet count, neutrophils, lymphocytes at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in hematology parameter of WBC count, platelet count, neutrophils, lymphocytes at Week 24 and Week 52 (Global Cohort)

Timeframe: Baseline (Week 12), Week 24 and Week 52

Change from Baseline in hematology parameter of hemoglobin at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in hematology parameter of hemoglobin at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in hematology parameter of hemoglobin at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Week 12), Week 24 and Week 52

Change from Baseline in clinical chemistry parameter of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), Gamma-Glutamyl transpeptidase (GGT) at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in clinical chemistry parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in clinical chemistry parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Week 12), Week 24 and Week 52

Change from Baseline in clinical chemistry parameter of total bilirubin at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in clinical chemistry parameter of total bilirubin at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in clinical chemistry parameter of total bilirubin at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Week 12), Week 24 and Week 52

Change from Baseline in clinical chemistry parameter of albumin at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in clinical chemistry parameter of albumin at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in clinical chemistry parameter of albumin at Week 24 and Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Week 12), Week 24 and Week 52

Change from Baseline in lipid profile parameter of total cholesterol at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in lipid profile parameter of total cholesterol at Week 24 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 24

Change from Baseline in lipid profile parameter of total cholesterol at Week 24 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Week 12) and Week 24

Change from Baseline in lipid profile parameter of total cholesterol at Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 52

Change from Baseline in lipid profile parameter of total cholesterol at Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Week 4) and Week 52

Change from Baseline in lipid profile parameter of low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in lipid profile parameter of LDL cholesterol, HDL cholesterol at Week 24 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 24

Change from Baseline in lipid profile parameter of LDL cholesterol, HDL cholesterol at Week 24 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Week 12) and Week 24

Change from Baseline in lipid profile parameter of LDL cholesterol, HDL cholesterol at Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 52

Change from Baseline in lipid profile parameter of LDL cholesterol, HDL cholesterol at Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Week 4) and Week 52

Change from Baseline in lipid profile parameter of triglycerides at Week 12 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in lipid profile parameter of triglycerides at Week 24 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 24

Change from Baseline in lipid profile parameter of triglycerides at Week 24 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Week 12) and Week 24

Change from Baseline in lipid profile parameter of triglycerides at Week 52 for treatment arms who started study intervention from Day 1 (Global Cohort)

Timeframe: Baseline (Day 1) and Week 52

Change from Baseline in lipid profile parameter of triglycerides at Week 52 for placebo switched arms (Global Cohort)

Timeframe: Baseline (Week 4) and Week 52

Number of participants with National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE)>=Grade 3 hematological/clinical chemistry abnormalities (Global Cohort)

Timeframe: Up to Week 59

Concentrations of Granulocyte-macrophage colony stimulating factor (GM-CSF) autoantibody (Global Cohort)

Timeframe: At baseline

Number of participants with anti-GSK3196165 antibodies (Global Cohort)

Timeframe: Up to Week 52

Percentage of participants achieving Clinical disease activity index (CDAI) total score less than or equal to (<=)10 [CDAI Low disease activity (LDA)] at Week 12 (Asia Cohort)

Timeframe: Week 12

Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Percentage of participants achieving CDAI total score <=10 (CDAI LDA) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving CDAI total score <=10 (CDAI LDA) at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 12 (Asia Cohort)

Timeframe: Week 12

Percentage of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving 50%/70% improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Asia Cohort)

Timeframe: Week 12

Percentage of participants achieving ACR20/50/70 at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving ACR20/50/70 at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving Disease Activity Score using 28 joint count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12 (Asia Cohort)

Timeframe: Week 12

Percentage of participants achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 (Asia Cohort)

Timeframe: Week 12

Percentage of participants achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 (Asia Cohort)

Timeframe: Week 12

Percentage of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12 (Asia Cohort)

Timeframe: Week 12

Percentage of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving a good/moderate European league against rheumatism (EULAR) response at Week 12(Asia Cohort)

Timeframe: Week 12

Percentage of participants achieving a good/moderate EULAR response at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving a good/moderate EULAR response at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Week 24 and Week 52

Number of participants achieving ACR/EULAR remission at Week 12 (Asia Cohort)

Timeframe: Week 12

Number of participants achieving ACR/EULAR remission at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Week 24 and Week 52

Number of participants achieving ACR/EULAR remission at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving no radiographic progression Van der Heijde modified total sharp scores (mTSS) <= 0.5) at Week 12 (Asia Cohort)

Timeframe: Week 12

Percentage of participants achieving no radiographic progression (mTSS <= 0.5) at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Week 24 and Week 52

Percentage of participants achieving no radiographic progression (mTSS <= 0.5) at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Week 24 and Week 52

Change from Baseline in CDAI total score at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and week 12

Change from Baseline in CDAI total score at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in CDAI total score at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in DAS28-CRP and DAS28-ESR at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in DAS28-CRP and DAS28-ESR at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in Van der Heijde mTSS at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in Van der Heijde mTSS at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in Van der Heijde mTSS at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in HAQ-DI at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 24

Change from Baseline in HAQ-DI at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 52

Change from Baseline in Arthritis pain VAS at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in Arthritis pain VAS at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 24 and Week 52

Change from Baseline in Arthritis pain VAS at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 24 and Week 52

Change from Baseline in Short form (SF)-36 physical component scores at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in SF-36 mental component scores at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in SF-36 domain scores at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in SF-36 physical component scores at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in SF-36 mental component scores at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in SF-36 domain scores at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in SF-36 physical component scores at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in SF-36 mental component scores at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in SF-36 domain scores at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in Functional assessment of chronic illness therapy (FACIT)-Fatigue at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in FACIT-Fatigue at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in FACIT-Fatigue at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) (Asia Cohort)

Timeframe: Up to Week 59

Change from Baseline in hematology parameter of white blood cell (WBC) count, platelet count, neutrophils, lymphocytes at Week 12 (Giga cells per liter) (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in hematology parameter of WBC count, platelet count, neutrophils, lymphocytes at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in hematology parameter of WBC count, platelet count, neutrophils, lymphocytes at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Week 12), Week 24 and Week 52

Change from Baseline in hematology parameter of hemoglobin at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in hematology parameter of hemoglobin at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in hematology parameter of hemoglobin at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Week 12), Week 24 and Week 52

Change from Baseline in clinical chemistry parameter of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), Gamma-Glutamyl transpeptidase (GGT) at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in clinical chemistry parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in clinical chemistry parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Week 12), Week 24 and Week 52

Change from Baseline in clinical chemistry parameter of total bilirubin at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in clinical chemistry parameter of total bilirubin at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in clinical chemistry parameter of total bilirubin at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Week 12), Week 24 and Week 52

Change from Baseline in clinical chemistry parameter of albumin at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in clinical chemistry parameter of albumin at Week 24 and Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1), Week 24 and Week 52

Change from Baseline in clinical chemistry parameter of albumin at Week 24 and Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Week 12), Week 24 and Week 52

Change from Baseline in lipid profile parameter of total cholesterol at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in lipid profile parameter of total cholesterol at Week 24 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 24

Change from Baseline in lipid profile parameter of total cholesterol at Week 24 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Week 12) and Week 24

Change from Baseline in lipid profile parameter of total cholesterol at Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 52

Change from Baseline in lipid profile parameter of total cholesterol at Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Week 4) and Week 52

Change from Baseline in lipid profile parameter of low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in lipid profile parameter of LDL cholesterol, HDL cholesterol at Week 24 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 24

Change from Baseline in lipid profile parameter of LDL cholesterol, HDL cholesterol at Week 24 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Week 12) and Week 24

Change from Baseline in lipid profile parameter of LDL cholesterol, HDL cholesterol at Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 52

Change from Baseline in lipid profile parameter of LDL cholesterol, HDL cholesterol at Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Week 4) and Week 52

Change from Baseline in lipid profile parameter of triglycerides at Week 12 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline in lipid profile parameter of triglycerides at Week 24 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 24

Change from Baseline in lipid profile parameter of triglycerides at Week 24 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Week 12) and Week 24

Change from Baseline in lipid profile parameter of triglycerides at Week 52 for treatment arms who started study intervention from Day 1 (Asia Cohort)

Timeframe: Baseline (Day 1) and Week 52

Change from Baseline in lipid profile parameter of triglycerides at Week 52 for placebo switched arms (Asia Cohort)

Timeframe: Baseline (Week 4) and Week 52

Number of participants with National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE)>=Grade 3 hematological/clinical chemistry abnormalities (Asia Cohort)

Timeframe: Up to Week 59

Concentrations of Granulocyte-macrophage colony stimulating factor (GM-CSF) autoantibody (Asia Cohort)

Timeframe: At baseline

Number of participants with anti-GSK3196165 antibodies (Asia Cohort)

Timeframe: Up to Week 59

Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) for placebo switched arms (Global Cohort)

Timeframe: Week 12 to Week 59

Number of participants with National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE)>=Grade 3 hematological/clinical chemistry abnormalities for placebo switched arms (Global Cohort)

Timeframe: Week 12 to Week 59

Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) for placebo switched arms (Asia Cohort)

Timeframe: Week 12 to Week 59

Number of participants with National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE)>=Grade 3 hematological/clinical chemistry abnormalities for placebo switched arms (Asia Cohort)

Timeframe: Week 12 to Week 59

Interventions:
Biological/vaccine: GSK3196165 (Otilimab)
Drug: Tofacitinib
Drug: Placebo
Enrollment:
1764
Observational study model:
Not applicable
Primary completion date:
2021-29-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Arthritis, Rheumatoid
Product
Not applicable
Collaborators
IQVIA
Study date(s)
May 2021 to August 2022
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Key inclusion criteria
  • >=18 years of age
Inclusion and exclusion criteria
Inclusion criteria:

    Key inclusion criteria

    • >=18 years of age
    • Has had RA for >=6 months and was not diagnosed before 16 years of age
    • Has active disease, as defined by having both* − >=6/68 tender/painful joint count (TJC), and − >=6/66 swollen joint count (SJC)
    • Has at least 1 bone erosion present on hand/wrist or foot radiographs
    • Has had an inadequate response to one or two of the csDMARDs: o methotrexate (MTX) 15–25 mg/week** oral or injected o hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day o sulfasalazine up to 3000 mg/day o leflunomide up to 20 mg/day*** o bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement) o iguratimod up to 50 mg/day * If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC. ** A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement. *** Concomitant use of leflunomide and methotrexate is not allowed, for safety reasons. Key exclusion criteria
    • History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjögren’s syndrome secondary to RA, that may confound the evaluation of the effect of the study intervention.
    • Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
    • Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved).

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Grand Blanc, United States, 48439
Status
Study Complete
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Location
GSK Investigational Site
Houston, United States, 77065
Status
Study Complete
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Location
GSK Investigational Site
Duncansville, United States, 16635
Status
Study Complete
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Location
GSK Investigational Site
Hagerstown, United States, 21740
Status
Study Complete
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Location
GSK Investigational Site
Barranquilla, Colombia, 80020
Status
Will Be Recruiting
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Location
GSK Investigational Site
Bucaramanga, Colombia, 680003
Status
Will Be Recruiting
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Location
GSK Investigational Site
Medellin, Colombia, 50015
Status
Will Be Recruiting
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Location
GSK Investigational Site
Bogota, Colombia, 110221
Status
Will Be Recruiting
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Location
GSK Investigational Site
Daytona Beach, United States, 32117
Status
Study Complete
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Location
GSK Investigational Site
Lansing, United States, 48910
Status
Study Complete
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Location
GSK Investigational Site
Monroe, United States, 71203
Status
Study Complete
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Location
GSK Investigational Site
Myrtle Beach, United States, 29572
Status
Study Complete
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Location
GSK Investigational Site
New Port Richey, United States, 34652
Status
Study Complete
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Location
GSK Investigational Site
San Antonio, United States, 78229
Status
Study Complete
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Location
GSK Investigational Site
Summerville, United States, 29486
Status
Study Complete
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Location
GSK Investigational Site
Wichita, United States, 67207
Status
Study Complete
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Location
GSK Investigational Site
Worcester, United States, 1605
Status
Study Complete
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Location
GSK Investigational Site
Bowling Green, United States, 42101
Status
Study Complete
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Location
GSK Investigational Site
Fort Collins, United States, 80528
Status
Study Complete
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Location
GSK Investigational Site
Freehold, United States, 7728
Status
Study Complete
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Location
GSK Investigational Site
Clearwater, United States, 33765
Status
Study Complete
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Location
GSK Investigational Site
Yukon, United States, 73099
Status
Study Complete
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Location
GSK Investigational Site
Tamarac, United States, 33321
Status
Study Complete
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Location
GSK Investigational Site
Albuquerque, United States, 87102
Status
Study Complete
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Location
GSK Investigational Site
Aventura, United States, 33180
Status
Study Complete
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Location
GSK Investigational Site
Corpus Christi, United States, 78404
Status
Study Complete
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Location
GSK Investigational Site
Dallas, United States, 75231
Status
Study Complete
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Location
GSK Investigational Site
El Cajon, United States, 92108
Status
Study Complete
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Location
GSK Investigational Site
Gainesville, United States, 32607
Status
Study Complete
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Location
GSK Investigational Site
Greensboro, United States, 27408
Status
Study Complete
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Location
GSK Investigational Site
Miami Lakes, United States, 33016
Status
Study Complete
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Location
GSK Investigational Site
Knoxville, United States, 37909-1907
Status
Study Complete
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Location
GSK Investigational Site
Lake Charles, United States, 70601
Status
Study Complete
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Location
GSK Investigational Site
Novi, United States, 48375
Status
Study Complete
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Location
GSK Investigational Site
Poway, United States, 92064
Status
Study Complete
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Location
GSK Investigational Site
Riverside, United States, 92506
Status
Study Complete
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Location
GSK Investigational Site
Roseville, United States, 95661
Status
Study Complete
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Location
GSK Investigational Site
Tampa, United States, 33606
Status
Study Complete
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Location
GSK Investigational Site
Van Nuys, United States, 91405
Status
Study Complete
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Location
GSK Investigational Site
Flagstaff, United States, 86001
Status
Study Complete
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Location
GSK Investigational Site
Parnu, Estonia, 80010
Status
Study Complete
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Location
GSK Investigational Site
Pleven, Bulgaria, 5800
Status
Study Complete
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Location
GSK Investigational Site
Sofia, Bulgaria, 1606
Status
Study Complete
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Location
GSK Investigational Site
Tallinn, Estonia, 10117
Status
Study Complete
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Location
GSK Investigational Site
Tartu, Estonia, 50406
Status
Study Complete
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Location
GSK Investigational Site
Vidin, Bulgaria, 3700
Status
Study Complete
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Location
GSK Investigational Site
Glendale, United States, 85210
Status
Study Complete
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Location
GSK Investigational Site
Glendale, United States, 85306
Status
Study Complete
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Location
GSK Investigational Site
Hyogo, Japan, 675-1392
Status
Study Complete
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Location
GSK Investigational Site
Hyogo, Japan, 673-1462
Status
Study Complete
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Location
GSK Investigational Site
Nagasaki, Japan, 857-1195
Status
Study Complete
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Location
GSK Investigational Site
Aichi, Japan, 455-8530
Status
Study Complete
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Location
GSK Investigational Site
Bialystok, Poland, 15-879
Status
Study Complete
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Location
GSK Investigational Site
Daegu, South Korea, 41944
Status
Study Complete
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Location
GSK Investigational Site
Elblag, Poland, 82-300
Status
Study Complete
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Location
GSK Investigational Site
Fukuoka, Japan, 820-8505
Status
Study Complete
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Location
GSK Investigational Site
Gdynia, Poland, 81-537
Status
Study Complete
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Location
GSK Investigational Site
Hokkaido, Japan, 053-8567
Status
Study Complete
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Location
GSK Investigational Site
Hokkaido, Japan, 063-0811
Status
Study Complete
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Location
GSK Investigational Site
Kochi, Japan, 780-8522
Status
Study Complete
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Location
GSK Investigational Site
Pittsburgh, United States, 15224
Status
Study Complete
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Location
GSK Investigational Site
Quilmes, Argentina, B1878GEG
Status
Study Complete
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Location
GSK Investigational Site
Ruse, Bulgaria, 7002
Status
Study Complete
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Location
GSK Investigational Site
Tucuman, Argentina, T4000BRD
Status
Study Complete
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Location
GSK Investigational Site
Seongnam-si Gyeonggi-do, South Korea, 13620
Status
Study Complete
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Location
GSK Investigational Site
Seoul, South Korea, 3080
Status
Study Complete
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Location
GSK Investigational Site
Sevlievo, Bulgaria, 5400
Status
Study Complete
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Location
GSK Investigational Site
Siedlce, Poland, 08-110
Status
Study Complete
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Location
GSK Investigational Site
Suwon Kyunggi-do, South Korea, 16499
Status
Study Complete
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Location
GSK Investigational Site
Tallinn, Estonia, 13419
Status
Study Complete
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Location
GSK Investigational Site
Tucson, United States, 85724
Status
Study Complete
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Location
GSK Investigational Site
Warszawa, Poland, 01-192
Status
Study Complete
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Location
GSK Investigational Site
Wroclaw, Poland, 50-088
Status
Study Complete
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Location
GSK Investigational Site
Ciudad AutOnoma de Buenos Aire, Argentina, C1015ABO
Status
Study Complete
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Location
GSK Investigational Site
Miami, United States, 33134
Status
Study Complete
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Location
GSK Investigational Site
San Miguel de Tucuman, Argentina, T4000AXL
Status
Study Complete
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Location
GSK Investigational Site
Sofia, Bulgaria, 1431
Status
Study Complete
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Location
GSK Investigational Site
St Petersburg, United States, 33705
Status
Study Complete
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Location
GSK Investigational Site
Barcelona, Spain, 08003
Status
Study Complete
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Location
GSK Investigational Site
Barcelona, Spain, 08035
Status
Study Complete
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Location
GSK Investigational Site
Torun, Poland, 85-065
Status
Study Complete
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Location
GSK Investigational Site
Chiba, Japan, 260-8712
Status
Study Complete
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Location
GSK Investigational Site
Cordoba, Argentina, 5000
Status
Study Complete
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Location
GSK Investigational Site
Gdansk, Poland, 80-382
Status
Study Complete
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Location
GSK Investigational Site
Hokkaido, Japan, 060-0001
Status
Study Complete
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Location
GSK Investigational Site
Ibaraki, Japan, 312-0057
Status
Study Complete
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Location
GSK Investigational Site
Kanagawa, Japan, 252-0392
Status
Study Complete
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Location
GSK Investigational Site
Kenilworth, United Kingdom, CV8 1JD
Status
Study Complete
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Location
GSK Investigational Site
Kochi, Japan, 781-0112
Status
Study Complete
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Location
GSK Investigational Site
Krakow, Poland, 30510
Status
Study Complete
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Location
GSK Investigational Site
Moscow, Russia, 111539
Status
Study Complete
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Location
GSK Investigational Site
Nagano, Japan, 380-8582
Status
Study Complete
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Location
GSK Investigational Site
Nagasaki, Japan, 852-8501
Status
Study Complete
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Location
GSK Investigational Site
Northwood, United Kingdom, HA6 2RN
Status
Study Complete
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Location
GSK Investigational Site
Nowy Targ, Poland, 34-400
Status
Study Complete
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Location
GSK Investigational Site
Okayama, Japan, 700-8557
Status
Study Complete
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Location
GSK Investigational Site
Okayama, Japan, 700-8607
Status
Study Complete
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Location
GSK Investigational Site
Romford, United Kingdom, RM1 3PJ
Status
Study Complete
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Location
GSK Investigational Site
Sofia, Bulgaria, 1000
Status
Study Complete
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Location
GSK Investigational Site
Tallinn, Estonia, 10128
Status
Study Complete
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Location
GSK Investigational Site
Tartu, Estonia, 50106
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 153-8515
Status
Study Complete
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Location
GSK Investigational Site
Yaroslavl, Russia, 150007
Status
Study Complete
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Location
GSK Investigational Site
Yaroslavl, Russia, 150062
Status
Study Complete
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Location
GSK Investigational Site
Ekaterinburg, Russia, 620102
Status
Study Complete
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Location
GSK Investigational Site
Fukuoka, Japan, 807-8555
Status
Study Complete
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Location
GSK Investigational Site
Fukuoka, Japan, 814-0180
Status
Study Complete
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Location
GSK Investigational Site
Gold Coast, Australia, 4222
Status
Study Complete
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Location
GSK Investigational Site
Gwangju, South Korea, 61469
Status
Study Complete
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Location
GSK Investigational Site
Hokkaido, Japan, 085-0032
Status
Study Complete
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Location
GSK Investigational Site
Kanagawa, Japan, 231-8682
Status
Study Complete
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Location
GSK Investigational Site
Kemerovo, Russia, 650066
Status
Study Complete
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Location
GSK Investigational Site
Kumamoto, Japan, 862-0976
Status
Study Complete
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Location
GSK Investigational Site
Omsk, Russia, 644024
Status
Study Complete
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Location
GSK Investigational Site
Saga, Japan, 843-0393
Status
Study Complete
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Location
GSK Investigational Site
Saint-Petersburg, Russia, 190068
Status
Study Complete
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Location
GSK Investigational Site
Shizuoka, Japan, 430-8558
Status
Study Complete
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Location
GSK Investigational Site
Szentes, Hungary, 6600
Status
Study Complete
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Location
GSK Investigational Site
Wakayama, Japan, 649-2211
Status
Study Complete
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Location
GSK Investigational Site
Kyungki-do, South Korea, 14068
Status
Study Complete
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Location
GSK Investigational Site
Incheon, South Korea, 400-711
Status
Study Complete
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Location
GSK Investigational Site
Krasnoyarsk, Russia, 660123
Status
Study Complete
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Location
GSK Investigational Site
Magdeburg, Germany, 39120
Status
Study Complete
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Location
GSK Investigational Site
Rendsburg, Germany, 24768
Status
Study Complete
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Location
GSK Investigational Site
Fukuoka, Japan, 804-0025
Status
Study Complete
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Location
GSK Investigational Site
Hokkaido, Japan, 060-8648
Status
Study Complete
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Location
GSK Investigational Site
Kanagawa, Japan, 232-0024
Status
Study Complete
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Location
GSK Investigational Site
Nagasaki, Japan, 850-0832
Status
Study Complete
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Location
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
Status
Study Complete
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Location
GSK Investigational Site
Lublin, Poland, 20-582
Status
Study Complete
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Location
GSK Investigational Site
Olsztyn, Poland, 10-117
Status
Study Complete
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Location
GSK Investigational Site
Kanagawa, Japan, 222-0036
Status
Study Complete
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Location
GSK Investigational Site
Okayama, Japan, 700-0013
Status
Study Complete
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Location
GSK Investigational Site
Berlin, Germany, 10117
Status
Study Complete
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Location
GSK Investigational Site
Chengdu, China, 610041
Status
Study Complete
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Location
GSK Investigational Site
Heidelberg, Australia, 3081
Status
Study Complete
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Location
GSK Investigational Site
Marietta, United States, 30060
Status
Study Complete
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Location
GSK Investigational Site
Merida, Mexico, 97070
Status
Study Complete
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Location
GSK Investigational Site
Mexico DF, Mexico, 06700
Status
Study Complete
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Location
GSK Investigational Site
Palmetto Bay, United States, 33157
Status
Study Complete
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Location
GSK Investigational Site
Plovdiv, Bulgaria, 4000
Status
Study Complete
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Location
GSK Investigational Site
Rajathevee, Thailand, 10400
Status
Study Complete
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Location
GSK Investigational Site
San Luis PotosI, Mexico, 78213
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 113-8431
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 198-0042
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 204-8585
Status
Study Complete
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Location
GSK Investigational Site
Bengbu, China, 233004
Status
Study Complete
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Location
GSK Investigational Site
Changchun, China, 130012
Status
Study Complete
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Location
GSK Investigational Site
Changsha, China, 410013
Status
Study Complete
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Location
GSK Investigational Site
Changzhou, China, 213003
Status
Study Complete
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Location
GSK Investigational Site
Dresden, Germany, 01307
Status
Study Complete
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Location
GSK Investigational Site
Evansville, United States, 47715
Status
Study Complete
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Location
GSK Investigational Site
Hangzhou, China, 310005
Status
Study Complete
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Location
GSK Investigational Site
Moscow, Russia, 129110
Status
Study Complete
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Location
GSK Investigational Site
San Juan, Argentina, 5400
Status
Study Complete
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Location
GSK Investigational Site
Santander, Spain, 39008
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 113-8519
Status
Study Complete
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Location
GSK Investigational Site
Westmead, Australia, 2145
Status
Study Complete
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Location
GSK Investigational Site
Guadalajara, Mexico, 44650
Status
Study Complete
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Location
GSK Investigational Site
Khon Kaen, Thailand, 40002
Status
Study Complete
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Location
GSK Investigational Site
Beijing, China, 100144
Status
Study Complete
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Location
GSK Investigational Site
Guangzhou, China, 510080
Status
Study Complete
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Location
GSK Investigational Site
Guilin, China, 541001
Status
Study Complete
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Location
GSK Investigational Site
Jinzhou, China, 121000
Status
Study Complete
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Location
GSK Investigational Site
Jiujiang, China, 332000
Status
Study Complete
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Location
GSK Investigational Site
Shanghai, China, 200040
Status
Study Complete
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Location
GSK Investigational Site
Shijiazhuang, China, 050051
Status
Study Complete
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Location
GSK Investigational Site
Stara Zagora, Bulgaria, 6000
Status
Study Complete
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Location
GSK Investigational Site
Hohhot, China, 10050
Status
Study Complete
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Location
GSK Investigational Site
Xian, China, 710061
Status
Study Complete
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Location
GSK Investigational Site
Xuzhou, China, 221009
Status
Study Complete
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Location
GSK Investigational Site
Yangzhou, China, 225000
Status
Study Complete
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Location
GSK Investigational Site
Bangkok, Thailand, 10400
Status
Study Complete
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Location
GSK Investigational Site
Beijing, China, 100032
Status
Study Complete
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Location
GSK Investigational Site
Guangzhou, China, 510630
Status
Study Complete
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Location
GSK Investigational Site
Nanjing, China, 210009
Status
Study Complete
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Location
GSK Investigational Site
Novosibirsk, Russia, 630099
Status
Study Complete
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Location
GSK Investigational Site
Saitama, Japan, 359-1111
Status
Study Complete
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Location
GSK Investigational Site
Taizhou, China, 225300
Status
Study Complete
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Location
GSK Investigational Site
Yancheng, China, 224001
Status
Study Complete
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Location
GSK Investigational Site
Grodzisk Mazowiecki, Poland, 05-825
Status
Study Complete
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Location
GSK Investigational Site
Margate, United States, 33063
Status
Study Complete
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Location
GSK Investigational Site
Miyagi, Japan, 980-8574
Status
Study Complete
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Location
GSK Investigational Site
Miyagi, Japan, 983-8512
Status
Study Complete
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Location
GSK Investigational Site
Tianjin, China, 300052
Status
Study Complete
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Location
GSK Investigational Site
Aichi, Japan, 457-8511
Status
Study Complete
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Location
GSK Investigational Site
Aichi, Japan, 466-8560
Status
Study Complete
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Location
GSK Investigational Site
Amarillo, United States, 79124
Status
Study Complete
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Location
GSK Investigational Site
Austin, United States, 78745
Status
Study Complete
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Location
GSK Investigational Site
Baotou, China, 014010
Status
Study Complete
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Location
GSK Investigational Site
Blagoevgrad, Bulgaria, 2700
Status
Study Complete
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Location
GSK Investigational Site
Boca Raton, United States, 33486
Status
Study Complete
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Location
GSK Investigational Site
Box Hill, Australia, 3128
Status
Study Complete
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Location
GSK Investigational Site
Brooklyn, United States, 11201
Status
Study Complete
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Location
GSK Investigational Site
Budapest, Hungary, 1023
Status
Study Complete
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Location
GSK Investigational Site
Cahors, France, 46000
Status
Study Complete
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Location
GSK Investigational Site
Changchun, China, 130021
Status
Study Complete
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Location
GSK Investigational Site
Cheonan-si, South Korea, 330-721
Status
Study Complete
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Location
GSK Investigational Site
Chiba, Japan, 284-0003
Status
Study Complete
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Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1128AAF
Status
Study Complete
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Location
GSK Investigational Site
Colleyville, United States, 76034
Status
Study Complete
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Location
GSK Investigational Site
Columbia, United States, 29204
Status
Study Complete
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Location
GSK Investigational Site
Cordoba, Argentina, X5003DCE
Status
Study Complete
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Location
GSK Investigational Site
Czestochowa, Poland, 42202
Status
Study Complete
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Location
GSK Investigational Site
Denver, United States, 80230
Status
Study Complete
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Location
GSK Investigational Site
Phoenix, United States, 85306
Status
Study Complete
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Location
GSK Investigational Site
Glendale, United States, 53217
Status
Study Complete
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Location
GSK Investigational Site
Hamburg, Germany, 20095
Status
Study Complete
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Location
GSK Investigational Site
Hiroshima, Japan, 734-8551
Status
Study Complete
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Location
GSK Investigational Site
Hobart, Australia, 7000
Status
Study Complete
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Location
GSK Investigational Site
Hokkaido, Japan, 060-8604
Status
Study Complete
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Location
GSK Investigational Site
Houston, United States, 77034
Status
Study Complete
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Location
GSK Investigational Site
Houston, United States, 77084
Status
Study Complete
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Location
GSK Investigational Site
Huzhou, China, 313000
Status
Study Complete
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Location
GSK Investigational Site
Idaho Falls, United States, 83404
Status
Study Complete
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Location
GSK Investigational Site
Kagawa, Japan, 761-0793
Status
Study Complete
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Location
GSK Investigational Site
Kagoshima, Japan, 891-0133
Status
Study Complete
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Location
GSK Investigational Site
Kanagawa, Japan, 236-0004
Status
Study Complete
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Location
GSK Investigational Site
Kanagawa, Japan, 245-8575
Status
Study Complete
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Location
GSK Investigational Site
Katowice, Poland, 40-040
Status
Study Complete
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Location
GSK Investigational Site
Katowice, Poland, 40-282
Status
Study Complete
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Location
GSK Investigational Site
Kemerovo, Russia, 650070
Status
Study Complete
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Location
GSK Investigational Site
Korolev Moscow region, Russia, 141060
Status
Study Complete
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Location
GSK Investigational Site
Krakow, Poland, 30-033
Status
Study Complete
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Location
GSK Investigational Site
Lodz, Poland, 90-127
Status
Study Complete
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Location
GSK Investigational Site
Lodz, Poland, 90-644
Status
Study Complete
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Location
GSK Investigational Site
Lubbock, United States, 79410
Status
Study Complete
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Location
GSK Investigational Site
Miami, United States, 33155
Status
Study Complete
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Location
GSK Investigational Site
Minot, United States, 58701
Status
Study Complete
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Location
GSK Investigational Site
Moscow, Russia, 115404
Status
Study Complete
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Location
GSK Investigational Site
St Petersburg, Russia, 115522
Status
Study Complete
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Location
GSK Investigational Site
Nanchang, China, 330006
Status
Study Complete
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Location
GSK Investigational Site
Nanjing, China, 210008
Status
Study Complete
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Location
GSK Investigational Site
Niigata, Japan, 940-2085
Status
Study Complete
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Location
GSK Investigational Site
Niigata, Japan, 957-0054
Status
Study Complete
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Location
GSK Investigational Site
Novosibirsk, Russia, 630091
Status
Study Complete
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Location
GSK Investigational Site
Oklahoma City, United States, 73103
Status
Study Complete
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Location
GSK Investigational Site
Poznan, Poland, 60-702
Status
Study Complete
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Location
GSK Investigational Site
Poznan, Poland, 61-113
Status
Study Complete
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Location
GSK Investigational Site
Ruse, Bulgaria, 7000
Status
Study Complete
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Location
GSK Investigational Site
Sevilla, Spain, 41009
Status
Study Complete
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Location
GSK Investigational Site
Sochaczew, Poland, 96-500
Status
Study Complete
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Location
GSK Investigational Site
Szekesfehervar, Hungary, 8000
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 104-8560
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 142-0054
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 142-8666
Status
Study Complete
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Location
GSK Investigational Site
Tomball, United States, 77375
Status
Study Complete
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Location
GSK Investigational Site
Tomsk, Russia, 634050
Status
Study Complete
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Location
GSK Investigational Site
Tottori, Japan, 683-8504
Status
Study Complete
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Location
GSK Investigational Site
Tustin, United States, 92780
Status
Study Complete
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Location
GSK Investigational Site
Ulyanovsk, Russia, 432063
Status
Study Complete
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Location
GSK Investigational Site
Warszawa, Poland, 02-793
Status
Study Complete
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Location
GSK Investigational Site
Woodville, Australia, 5011
Status
Study Complete
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Location
GSK Investigational Site
Wroclaw, Poland, 52-416
Status
Study Complete
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Location
GSK Investigational Site
Wuhan, China, 430030
Status
Study Complete
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Location
GSK Investigational Site
Wyomissing, United States, 19610
Status
Study Complete
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Location
GSK Investigational Site
Yamaguchi, Japan, 750-8520
Status
Study Complete
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Location
GSK Investigational Site
Yanji, China, 133000
Status
Study Complete
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Location
GSK Investigational Site
Yaroslavl, Russia, 150030
Status
Study Complete
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Location
GSK Investigational Site
ZhuZhou, China, 412007
Status
Study Complete
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Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2021-29-10
Actual study completion date
2022-02-08

Plain language summaries

Summary of results in plain language
Available language(s): English, Bulgarian, Estonian, French, German, Hungarian, Japanese, Korean, Polish, Russian, Chinese (Simplified)
Download document(s)

To view plain language summaries on trialsummaries.com click here.

Additional information about the trial

Participate in clinical trial
Additional information
209564 contRAst X NCT04333147
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Access to clinical trial data by researchers
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