Back to results

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)

Primary Purpose

Arthritis, Rheumatoid

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

GSK3196165 (Otilimab)

Tofacitinib

Placebo to GSK3196165 (Otilimab)

Placebo to Tofacitinib

csDMARDs

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid Arthritis, GSK3196165, Otilimab, Tofacitinib, Placebo, DMARDs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key inclusion criteria

>=18 years of age
Has had RA for >=6 months and was not diagnosed before 16 years of age
Has active disease, as defined by having both*
- >=6/68 tender/painful joint count (TJC), and
- >=6/66 swollen joint count (SJC)
Has at least 1 bone erosion present on hand/wrist or foot radiographs
Has had an inadequate response to one or two of the csDMARDs:
- methotrexate (MTX) 15-25 mg/week** oral or injected
- hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day
- sulfasalazine up to 3000 mg/day
- leflunomide up to 20 mg/day***
- bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement)
- iguratimod up to 50 mg/day
  - If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.
    - A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.
      - Concomitant use of leflunomide and methotrexate is not allowed, for safety reasons.

Key exclusion criteria

History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjögren's syndrome secondary to RA, that may confound the evaluation of the effect of the study intervention.
Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved).

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

GSK3196165 90 mg

GSK3196165 150 mg

Tofacitinib 5 mg

Placebo sequence 1

Placebo sequence 2

Placebo sequence 3

Arm Description

Entire treatment period (52 Weeks): GSK3196165 90 mg SC injection once weekly + placebo cap twice daily. Participants will also receive a stable dose of csDMARD(s) as standard of care (SoC).

Entire treatment period (52 Weeks): GSK3196165 150 mg SC injection once weekly + placebo cap twice daily. Participants will also receive a stable dose of csDMARD(s) as SoC.

Entire treatment period (52 Weeks): Tofacitinib 5 mg cap twice daily + placebo SC injection once weekly. Participants will also receive a stable dose of csDMARD(s) as SoC.

From Week 0-11: Placebo SC injection once weekly + placebo cap twice daily. From Week 12 onwards: GSK3196165 90 mg SC injection once weekly + placebo cap twice daily. Participants will also receive a stable dose of csDMARD(s) as SoC.

From Week 0-11: Placebo SC injection once weekly + placebo cap twice daily. From Week 12 onwards: GSK3196165 150 mg SC injection once weekly + placebo cap twice daily. Participants will also receive a stable dose of csDMARD(s) as SoC.

From Week 0-11: Placebo SC injection once weekly + placebo cap twice daily. From Week 12 onwards: Tofacitinib 5 mg cap twice daily + placebo SC injection once weekly. Participants will also receive a stable dose of csDMARD(s) as SoC.

Outcomes

Primary Outcome Measures

Proportion of participants achieving 20% improvement in American College of Rheumatology Criteria (ACR20) at Week 12: superiority comparison with placebo

ACR20 is calculated as a 20% improvement from Baseline in both tender and swollen joint counts and a 20% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, pain visual analogue scale (VAS), health assessment questionnaire-disability index (HAQ-DI) and an acute-phase reactant (high sensitivity C-reactive protein [hsCRP] or erythrocyte sedimentation rate [ESR]). For comparison of GSK3196165 with placebo, the placebo sequences are combined into a single reporting group for Week 12 analysis.

Secondary Outcome Measures

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

CDAI: Clinical Disease Activity Index for rheumatoid arthritis determines a composite score to determine disease severity using only clinical data. It is calculated by the simple sum of the 4 following parameters: Tender joint count (28), Swollen joint count (28), Patient's global assessment of arthritis and Physician's global assessment of arthritis both transformed to a 0-10 scale. Total score approximate range 0-76, higher score indicating more severe disease. Proportion of participants achieving CDAI total score <=10 at Week 12 will be summarized.

Change from Baseline in HAQ-DI at Week 12 (Scores on a scale)

HAQ-DI: 20-questions which assesses the degree of difficulty a participant has in accomplishing tasks in eight functional areas: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.

Proportion of participants achieving ACR20 at Week 12: non-inferiority comparison with tofacitinib

ACR20 is calculated as a 20% improvement from Baseline in both tender and swollen joint counts and a 20% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, pain VAS, HAQ-DI and an acute-phase reactant hsCRP or ESR. Proportion of participants achieving ACR20 at Week 12 will be summarized.

Proportion of participants achieving CDAI total score <=10 (CDAI LDA) at Week 24

CDAI: a composite score to determine disease severity using only clinical data: Tender joint count (28), Swollen joint count (28), Patient's global assessment of arthritis and Physician's global assessment of arthritis. Proportion of participants achieving CDAI total score <=10 at Week 24 will be summarized.

Proportion of participants achieving CDAI total score <=10 (CDAI LDA) at Week 52

Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 12

Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 24

Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 52

Proportion of participants achieving ACR20/50/70 at Week 12

ACR20/50/70 is calculated as a 20%/50%/70% improvement from Baseline in both tender and swollen joint counts and a 20%/50%/70% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, pain VAS, HAQ-DI and an acute-phase reactant (hsCRP or ESR). Proportion of participants achieving ACR20/50/70 at Week 12 will be summarized.

Proportion of participants achieving ACR20/50/70 at Week 24

Proportion of participants achieving ACR20/50/70 at Week 52

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

DAS28-CRP is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), hsCRP (mg/liter [L]) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28-CRP <=3.2 at Week 12 will be summarized.

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

DAS28-ESR is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), ESR (millimeters[mm]/hour) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28 ESR <=3.2 at Week 12 will be summarized.

Proportion of participants achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24

DAS28-CRP is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), hsCRP (mg/L) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28-CRP <=3.2 at Week 24 will be summarized.

Proportion of participants achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24

DAS28-ESR is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), ESR (millimeter [mm]/hour) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28 ESR <=3.2 at Week 24 will be summarized.

Proportion of participants achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 52

Proportion of participants achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 52

DAS28-ESR is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), ESR (mm/hour) and patient's global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28 ESR <=3.2 at Week 52 will be summarized.

Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12

Proportion of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12

Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24

Proportion of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24

Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 52

Proportion of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 52

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

Proportion of participants achieving a good/moderate EULAR response at Week 12 will be summarized.

Proportion of participants achieving a good/moderate EULAR response at Week 24

Proportion of participants achieving a good/moderate EULAR response at Week 24 will be summarized.

Proportion of participants achieving a good/moderate EULAR response at Week 52

Proportion of participants achieving a good/moderate EULAR response at Week 52 will be summarized.

Proportion of participants achieving ACR/EULAR remission at Week 12

Proportion of participants achieving ACR/EULAR remission at Week 12 will be summarized.

Proportion of participants achieving ACR/EULAR remission at Week 24

Proportion of participants achieving ACR/EULAR remission at Week 24 will be summarized.

Proportion of participants achieving ACR/EULAR remission at Week 52

Proportion of participants achieving ACR/EULAR remission at Week 52 will be summarized.

Proportion of participants achieving no radiographic progression at Week 12

Van der Heijde modified total sharp scores (mTSS) is a scoring method which utilized for scoring radiographs of hands and feet in rheumatoid arthritis. No radiographic progression defined as a change from Baseline in van der Heijde mTSS score of <=0.5. Proportion of participants achieving no radiographic progression at Week 12 will be summarized.

Proportion of participants achieving no radiographic progression at Week 24

Van der Heijde mTSS is a scoring method which utilized for scoring radiographs of hands and feet in rheumatoid arthritis. No radiographic progression defined as a change from Baseline in van der Heijde modified total sharp score (mTSS) score of <=0.5. Proportion of participants achieving no radiographic progression at Week 24 will be summarized.

Proportion of participants achieving no radiographic progression at Week 52

Change from Baseline in CDAI total score at Week 12 (Scores on a scale)

CDAI: Clinical Disease Activity Index for rheumatoid arthritis determines disease severity using only clinical data. It is calculated by the simple sum of the 4 following parameters: Tender joint count (28), Swollen joint count (28), Patient's global assessment of arthritis and Physician's global assessment of arthritis both transformed to a 0-10 scale. Total score approximate range 0-76, higher score indicating more severe disease.

Change from Baseline in CDAI total score at Week 24 (Scores on a scale)

Change from Baseline in CDAI total score at Week 52 (Scores on a scale)

Change from Baseline in DAS28-CRP/DAS28-ESR at Week 12 (Scores on a scale)

DAS28-CRP and DAS28-ESR are measures of RA disease activity calculated using tender joint count and swollen joint count (28 joint count), hsCRP (mg/L) / ESR (mm/hour) and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, higher score indicating more severe disease.

Change from Baseline in DAS28-CRP/DAS28-ESR at Week 24 (Scores on a scale)

Change from Baseline in DAS28-CRP/DAS28-ESR at Week 52 (Scores on a scale)

Change from Baseline in Van der Heijde mTSS at Week 12 (Scores on a scale)

Van der Heijde mTSS is a scoring method which utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes, in each hand, 16 areas of erosions, and 15 areas for joint space narrowing, and in each foot, 6 areas for erosions and 6 areas joint space narrowing.

Change from Baseline in Van der Heijde mTSS at Week 24 (Scores on a scale)

Change from Baseline in Van der Heijde mTSS at Week 52 (Scores on a scale)

Change from Baseline in HAQ-DI at Week 24 (Scores on a scale)

Change from Baseline in HAQ-DI at Week 52 (Scores on a scale)

Change from Baseline in Arthritis pain at Week 12 (Scores on a scale)

Participants' assessment of the severity of their arthritis pain over the past week, using a 100 unit VAS, with anchors "0" (no pain) and "100" (most severe pain).

Change from Baseline in Arthritis pain VAS at Week 24 (Scores on a scale)

Participants' assessment of the severity of their arthritis pain over the past week, using a 100 unit VAS, with anchors "0" (no pain) and "100" (most severe pain).

Change from Baseline in Arthritis pain VAS at Week 52 (Scores on a scale)

Participants' assessment of the severity of their arthritis pain over the past week, using a 100 unit VAS, with anchors "0" (no pain) and "100" (most severe pain).

Change from Baseline in Short form (SF)-36 physical component scores at Week 12 (Scores on a scale)

SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

Change from Baseline in SF-36 mental component scores at Week 12 (Scores on a scale)

Change from Baseline in SF-36 domain scores at Week 12 (Scores on a scale)

Change from Baseline in SF-36 physical component scores at Week 24 (Scores on a scale)

Change from Baseline in SF-36 mental component scores at Week 24 (Scores on a scale)

Change from Baseline in SF-36 domain scores at Week 24 (Scores on a scale)

Change from Baseline in SF-36 physical component scores at Week 52 (Scores on a scale)

Change from Baseline in SF-36 mental component scores at Week 52 (Scores on a scale)

Change from Baseline in SF-36 domain scores at Week 52 (Scores on a scale)

Change from Baseline in Functional assessment of chronic illness therapy (FACIT)-Fatigue at Week 12 (Scores on a scale)

FACIT-fatigue is a validated participant-reported measure developed originally to assess fatigue in individuals with cancer and has subsequently been used and validated in numerous chronic conditions, including RA.

Change from Baseline in FACIT-Fatigue at Week 24 (Scores on a scale)

Change from Baseline in FACIT-Fatigue at Week 52 (Scores on a scale)

Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs will be included.

Change from Baseline in white blood cell (WBC) count at Week 12 (Giga cells per liter)

Blood samples will be collected for the assessment of WBC count.

Change from Baseline in WBC count at Week 24 (Giga cells per liter)

Blood samples will be collected for the assessment of WBC count.

Change from Baseline in WBC count at Week 52 (Giga cells per liter)

Blood samples will be collected for the assessment of WBC count.

Change from Baseline in hematology parameter of platelet count, neutrophils, lymphocytes at Week 12 (Giga cells per liter)

Blood samples will be collected for the assessment of hematology parameters.

Change from Baseline in hematology parameter of platelet count, neutrophils, lymphocytes at Week 24 (Giga cells per liter)

Blood samples will be collected for the assessment of hematology parameters.

Change from Baseline in hematology parameter of platelet count, neutrophils, lymphocytes at Week 52 (Giga cells per liter)

Blood samples will be collected for the assessment of hematology parameters.

Change from Baseline in hematology parameter of hemoglobin at Week 12 (Grams per liter)

Blood samples will be collected for the assessment of hematology parameters.

Change from Baseline in hematology parameter of hemoglobin at Week 24 (Grams per liter)

Blood samples will be collected for the assessment of hematology parameters.

Change from Baseline in hematology parameter of hemoglobin at Week 52 (Grams per liter)

Blood samples will be collected for the assessment of hematology parameters.

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

Blood samples will be collected for the assessment of clinical chemistry parameters.

Change from Baseline in clinical chemistry parameter of AST, ALT, AP, GGT at Week 24 (International units per liter)

Blood samples will be collected for the assessment of clinical chemistry parameters.

Change from Baseline in clinical chemistry parameter of AST, ALT, AP, GGT at Week 52 (International units per liter)

Blood samples will be collected for the assessment of clinical chemistry parameters.

Change from Baseline in clinical chemistry parameter of total bilirubin at Week 12 (Micromoles per liter)

Blood samples will be collected for the assessment of clinical chemistry parameters.

Change from Baseline in clinical chemistry parameter of total bilirubin at Week 24 (Micromoles per liter)

Blood samples will be collected for the assessment of clinical chemistry parameters.

Change from Baseline in clinical chemistry parameter of total bilirubin at Week 52 (Micromoles per liter)

Blood samples will be collected for the assessment of clinical chemistry parameters.

Change from Baseline in clinical chemistry parameter of albumin at Week 12 (Grams per liter)

Blood samples will be collected for the assessment of clinical chemistry parameters.

Change from Baseline in clinical chemistry parameter of albumin at Week 24 (Grams per liter)

Blood samples will be collected for the assessment of clinical chemistry parameters.

Change from Baseline in clinical chemistry parameter of albumin at Week 52 (Grams per liter)

Blood samples will be collected for the assessment of clinical chemistry parameters.

Change from Baseline in lipid profile parameter of total cholesterol at Week 4 (Millimoles per liter)

Blood samples will be collected for the assessment of lipid profile parameters.

Change from Baseline in lipid profile parameter of total cholesterol at Week 16 (Millimoles per liter)

Blood samples will be collected for the assessment of lipid profile parameters.

Change from Baseline in lipid profile parameter of total cholesterol at Week 52 (Millimoles per liter)

Blood samples will be collected for the assessment of lipid profile parameters.

Change from Baseline in lipid profile parameter of low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol at Week 4 (Millimoles per liter)

Blood samples will be collected for the assessment of lipid profile parameters.

Change from Baseline in lipid profile parameter of LDL cholesterol, high-density lipoprotein-cholesterol at Week 16 (Millimoles per liter)

Blood samples will be collected for the assessment of lipid profile parameters.

Change from Baseline in lipid profile parameter of LDL cholesterol, high-density lipoprotein-cholesterol at Week 52 (Millimoles per liter)

Blood samples will be collected for the assessment of lipid profile parameters.

Change from Baseline in lipid profile parameter of triglycerides at Week 4 (Millimoles per liter)

Blood samples will be collected for the assessment of lipid profile parameters.

Change from Baseline in lipid profile parameter of triglycerides at Week 16 (Millimoles per liter)

Blood samples will be collected for the assessment of lipid profile parameters.

Change from Baseline in lipid profile parameter of triglycerides at Week 52 (Millimoles per liter)

Blood samples will be collected for the assessment of lipid profile parameters.

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

Proportion of participants with NCI-CTCAE >=Grade 3 hematological/clinical chemistry abnormalities will be summarized.

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

Concentrations of GM-CSF autoantibodies will be determined

Number of participants with anti-GSK3196165 antibodies

Presence of anti-GSK3196165 antibodies will be determined.

Full Information

NCT ID

NCT03970837

First Posted

May 16, 2019

Last Updated

August 23, 2023

Sponsor

GlaxoSmithKline

Collaborators

Iqvia Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03970837

Brief Title

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)

Acronym

contRAst 2

Official Title

A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Why Stopped

Only Asia cohort is early terminated.Limited efficacy demonstrated in the contRAst program does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has decided not to progress with regulatory submissions.

Study Start Date

June 5, 2019 (Actual)

Primary Completion Date

October 29, 2021 (Actual)

Study Completion Date

January 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

Collaborators

Iqvia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis, GSK3196165, Otilimab, Tofacitinib, Placebo, DMARDs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Participants will be randomized to one of six intervention arms in ratio of 6:6:3:1:1:1

Masking

ParticipantInvestigator

Masking Description

Double blinded

Allocation

Randomized

Enrollment

1764 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK3196165 90 mg

Arm Type

Experimental

Arm Description

Entire treatment period (52 Weeks): GSK3196165 90 mg SC injection once weekly + placebo cap twice daily. Participants will also receive a stable dose of csDMARD(s) as standard of care (SoC).

Arm Title

GSK3196165 150 mg

Arm Type

Experimental

Arm Description

Entire treatment period (52 Weeks): GSK3196165 150 mg SC injection once weekly + placebo cap twice daily. Participants will also receive a stable dose of csDMARD(s) as SoC.

Arm Title

Tofacitinib 5 mg

Arm Type

Active Comparator

Arm Description

Entire treatment period (52 Weeks): Tofacitinib 5 mg cap twice daily + placebo SC injection once weekly. Participants will also receive a stable dose of csDMARD(s) as SoC.

Arm Title

Placebo sequence 1

Arm Type

Placebo Comparator

Arm Description

Arm Title

Placebo sequence 2

Arm Type

Placebo Comparator

Arm Description

Arm Title

Placebo sequence 3

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

GSK3196165 (Otilimab)

Intervention Description

GSK3196165 solution in vial/pre-filled syringe (PFS) to be administered SC.

Intervention Type

Drug

Intervention Name(s)

Tofacitinib

Intervention Description

Tofacitinib cap (over encapsulated 5mg tablet) to be administered orally.

Intervention Type

Drug

Intervention Name(s)

Placebo to GSK3196165 (Otilimab)

Intervention Description

Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/pre-filled syringe (PFS) to be administered SC.

Intervention Type

Drug

Intervention Name(s)

Placebo to Tofacitinib

Intervention Description

Placebo cap (containing lactose) to be administered orally.

Intervention Type

Drug

Intervention Name(s)

csDMARDs

Intervention Description

Stable dose of csDMARD(s) as SoC.

Primary Outcome Measure Information:

Title

Proportion of participants achieving 20% improvement in American College of Rheumatology Criteria (ACR20) at Week 12: superiority comparison with placebo

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Week 12

Title

Change from Baseline in HAQ-DI at Week 12 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 12

Title

Proportion of participants achieving ACR20 at Week 12: non-inferiority comparison with tofacitinib

Description

ACR20 is calculated as a 20% improvement from Baseline in both tender and swollen joint counts and a 20% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, pain VAS, HAQ-DI and an acute-phase reactant hsCRP or ESR. Proportion of participants achieving ACR20 at Week 12 will be summarized.

Time Frame

Week 12

Title

Proportion of participants achieving CDAI total score <=10 (CDAI LDA) at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants achieving CDAI total score <=10 (CDAI LDA) at Week 52

Description

Time Frame

Week 52

Title

Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 12

Description

Time Frame

Week 12

Title

Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 52

Description

Time Frame

Week 52

Title

Proportion of participants achieving ACR20/50/70 at Week 12

Description

Time Frame

Week 12

Title

Proportion of participants achieving ACR20/50/70 at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants achieving ACR20/50/70 at Week 52

Description

Time Frame

Week 52

Title

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

Description

Time Frame

Week 12

Title

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

Description

Time Frame

Week 12

Title

Proportion of participants achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 52

Description

Time Frame

Week 52

Title

Proportion of participants achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 52

Description

Time Frame

Week 52

Title

Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12

Description

Time Frame

Week 12

Title

Proportion of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12

Description

Time Frame

Week 12

Title

Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 52

Description

Time Frame

Week 52

Title

Proportion of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 52

Description

Time Frame

Week 52

Title

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

Description

Proportion of participants achieving a good/moderate EULAR response at Week 12 will be summarized.

Time Frame

Week 12

Title

Proportion of participants achieving a good/moderate EULAR response at Week 24

Description

Proportion of participants achieving a good/moderate EULAR response at Week 24 will be summarized.

Time Frame

Week 24

Title

Proportion of participants achieving a good/moderate EULAR response at Week 52

Description

Proportion of participants achieving a good/moderate EULAR response at Week 52 will be summarized.

Time Frame

Week 52

Title

Proportion of participants achieving ACR/EULAR remission at Week 12

Description

Proportion of participants achieving ACR/EULAR remission at Week 12 will be summarized.

Time Frame

Week 12

Title

Proportion of participants achieving ACR/EULAR remission at Week 24

Description

Proportion of participants achieving ACR/EULAR remission at Week 24 will be summarized.

Time Frame

Week 24

Title

Proportion of participants achieving ACR/EULAR remission at Week 52

Description

Proportion of participants achieving ACR/EULAR remission at Week 52 will be summarized.

Time Frame

Week 52

Title

Proportion of participants achieving no radiographic progression at Week 12

Description

Time Frame

Week 12

Title

Proportion of participants achieving no radiographic progression at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants achieving no radiographic progression at Week 52

Description

Time Frame

Week 52

Title

Change from Baseline in CDAI total score at Week 12 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in CDAI total score at Week 24 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in CDAI total score at Week 52 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in DAS28-CRP/DAS28-ESR at Week 12 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in DAS28-CRP/DAS28-ESR at Week 24 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in DAS28-CRP/DAS28-ESR at Week 52 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in Van der Heijde mTSS at Week 12 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in Van der Heijde mTSS at Week 24 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in Van der Heijde mTSS at Week 52 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in HAQ-DI at Week 24 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in HAQ-DI at Week 52 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in Arthritis pain at Week 12 (Scores on a scale)

Description

Participants' assessment of the severity of their arthritis pain over the past week, using a 100 unit VAS, with anchors "0" (no pain) and "100" (most severe pain).

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in Arthritis pain VAS at Week 24 (Scores on a scale)

Description

Participants' assessment of the severity of their arthritis pain over the past week, using a 100 unit VAS, with anchors "0" (no pain) and "100" (most severe pain).

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in Arthritis pain VAS at Week 52 (Scores on a scale)

Description

Participants' assessment of the severity of their arthritis pain over the past week, using a 100 unit VAS, with anchors "0" (no pain) and "100" (most severe pain).

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in Short form (SF)-36 physical component scores at Week 12 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in SF-36 mental component scores at Week 12 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in SF-36 domain scores at Week 12 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in SF-36 physical component scores at Week 24 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in SF-36 mental component scores at Week 24 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in SF-36 domain scores at Week 24 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in SF-36 physical component scores at Week 52 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in SF-36 mental component scores at Week 52 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in SF-36 domain scores at Week 52 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in Functional assessment of chronic illness therapy (FACIT)-Fatigue at Week 12 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in FACIT-Fatigue at Week 24 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in FACIT-Fatigue at Week 52 (Scores on a scale)

Description

Time Frame

Baseline (Day 1) and Week 52

Title

Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI)

Description

Time Frame

Up to Week 59

Title

Change from Baseline in white blood cell (WBC) count at Week 12 (Giga cells per liter)

Description

Blood samples will be collected for the assessment of WBC count.

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in WBC count at Week 24 (Giga cells per liter)

Description

Blood samples will be collected for the assessment of WBC count.

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in WBC count at Week 52 (Giga cells per liter)

Description

Blood samples will be collected for the assessment of WBC count.

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in hematology parameter of platelet count, neutrophils, lymphocytes at Week 12 (Giga cells per liter)

Description

Blood samples will be collected for the assessment of hematology parameters.

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in hematology parameter of platelet count, neutrophils, lymphocytes at Week 24 (Giga cells per liter)

Description

Blood samples will be collected for the assessment of hematology parameters.

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in hematology parameter of platelet count, neutrophils, lymphocytes at Week 52 (Giga cells per liter)

Description

Blood samples will be collected for the assessment of hematology parameters.

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in hematology parameter of hemoglobin at Week 12 (Grams per liter)

Description

Blood samples will be collected for the assessment of hematology parameters.

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in hematology parameter of hemoglobin at Week 24 (Grams per liter)

Description

Blood samples will be collected for the assessment of hematology parameters.

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in hematology parameter of hemoglobin at Week 52 (Grams per liter)

Description

Blood samples will be collected for the assessment of hematology parameters.

Time Frame

Baseline (Day 1) and Week 52

Title

Description

Blood samples will be collected for the assessment of clinical chemistry parameters.

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in clinical chemistry parameter of AST, ALT, AP, GGT at Week 24 (International units per liter)

Description

Blood samples will be collected for the assessment of clinical chemistry parameters.

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in clinical chemistry parameter of AST, ALT, AP, GGT at Week 52 (International units per liter)

Description

Blood samples will be collected for the assessment of clinical chemistry parameters.

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in clinical chemistry parameter of total bilirubin at Week 12 (Micromoles per liter)

Description

Blood samples will be collected for the assessment of clinical chemistry parameters.

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in clinical chemistry parameter of total bilirubin at Week 24 (Micromoles per liter)

Description

Blood samples will be collected for the assessment of clinical chemistry parameters.

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in clinical chemistry parameter of total bilirubin at Week 52 (Micromoles per liter)

Description

Blood samples will be collected for the assessment of clinical chemistry parameters.

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in clinical chemistry parameter of albumin at Week 12 (Grams per liter)

Description

Blood samples will be collected for the assessment of clinical chemistry parameters.

Time Frame

Baseline (Day 1) and Week 12

Title

Change from Baseline in clinical chemistry parameter of albumin at Week 24 (Grams per liter)

Description

Blood samples will be collected for the assessment of clinical chemistry parameters.

Time Frame

Baseline (Day 1) and Week 24

Title

Change from Baseline in clinical chemistry parameter of albumin at Week 52 (Grams per liter)

Description

Blood samples will be collected for the assessment of clinical chemistry parameters.

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in lipid profile parameter of total cholesterol at Week 4 (Millimoles per liter)

Description

Blood samples will be collected for the assessment of lipid profile parameters.

Time Frame

Baseline (Day 1) and Week 4

Title

Change from Baseline in lipid profile parameter of total cholesterol at Week 16 (Millimoles per liter)

Description

Blood samples will be collected for the assessment of lipid profile parameters.

Time Frame

Baseline (Day 1) and Week 16

Title

Change from Baseline in lipid profile parameter of total cholesterol at Week 52 (Millimoles per liter)

Description

Blood samples will be collected for the assessment of lipid profile parameters.

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in lipid profile parameter of low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol at Week 4 (Millimoles per liter)

Description

Blood samples will be collected for the assessment of lipid profile parameters.

Time Frame

Baseline (Day 1) and Week 4

Title

Change from Baseline in lipid profile parameter of LDL cholesterol, high-density lipoprotein-cholesterol at Week 16 (Millimoles per liter)

Description

Blood samples will be collected for the assessment of lipid profile parameters.

Time Frame

Baseline (Day 1) and Week 16

Title

Change from Baseline in lipid profile parameter of LDL cholesterol, high-density lipoprotein-cholesterol at Week 52 (Millimoles per liter)

Description

Blood samples will be collected for the assessment of lipid profile parameters.

Time Frame

Baseline (Day 1) and Week 52

Title

Change from Baseline in lipid profile parameter of triglycerides at Week 4 (Millimoles per liter)

Description

Blood samples will be collected for the assessment of lipid profile parameters.

Time Frame

Baseline (Day 1) and Week 4

Title

Change from Baseline in lipid profile parameter of triglycerides at Week 16 (Millimoles per liter)

Description

Blood samples will be collected for the assessment of lipid profile parameters.

Time Frame

Baseline (Day 1) and Week 16

Title

Change from Baseline in lipid profile parameter of triglycerides at Week 52 (Millimoles per liter)

Description

Blood samples will be collected for the assessment of lipid profile parameters.

Time Frame

Baseline (Day 1) and Week 52

Title

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

Description

Proportion of participants with NCI-CTCAE >=Grade 3 hematological/clinical chemistry abnormalities will be summarized.

Time Frame

Up to Week 59

Title

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

Description

Concentrations of GM-CSF autoantibodies will be determined

Time Frame

Up to Week 59

Title

Number of participants with anti-GSK3196165 antibodies

Description

Presence of anti-GSK3196165 antibodies will be determined.

Time Frame

Up to Week 59

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Flagstaff

State/Province

Arizona

ZIP/Postal Code

86001

Country

United States

Facility Name

GSK Investigational Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

GSK Investigational Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

GSK Investigational Site

City

Poway

State/Province

California

ZIP/Postal Code

92064

Country

United States

Facility Name

GSK Investigational Site

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

GSK Investigational Site

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

GSK Investigational Site

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

GSK Investigational Site

City

Van Nuys

State/Province

California

ZIP/Postal Code

91405

Country

United States

Facility Name

GSK Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

GSK Investigational Site

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

GSK Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

GSK Investigational Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

GSK Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

GSK Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

GSK Investigational Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

GSK Investigational Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

GSK Investigational Site

City

Margate

State/Province

Florida

ZIP/Postal Code

33063

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

GSK Investigational Site

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

GSK Investigational Site

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

GSK Investigational Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

GSK Investigational Site

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

GSK Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

GSK Investigational Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

GSK Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47715

Country

United States

Facility Name

GSK Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

GSK Investigational Site

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

GSK Investigational Site

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

GSK Investigational Site

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

GSK Investigational Site

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

GSK Investigational Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

GSK Investigational Site

City

Grand Blanc

State/Province

Michigan

ZIP/Postal Code

48439

Country

United States

Facility Name

GSK Investigational Site

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

GSK Investigational Site

City

Novi

State/Province

Michigan

ZIP/Postal Code

48375

Country

United States

Facility Name

GSK Investigational Site

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

GSK Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

GSK Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

GSK Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

GSK Investigational Site

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58701

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

GSK Investigational Site

City

Yukon

State/Province

Oklahoma

ZIP/Postal Code

73099

Country

United States

Facility Name

GSK Investigational Site

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

GSK Investigational Site

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

GSK Investigational Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

GSK Investigational Site

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

Country

United States

Facility Name

GSK Investigational Site

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29486

Country

United States

Facility Name

GSK Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909-1907

Country

United States

Facility Name

GSK Investigational Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79124

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

GSK Investigational Site

City

Colleyville

State/Province

Texas

ZIP/Postal Code

76034

Country

United States

Facility Name

GSK Investigational Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78404

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77065

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77084

Country

United States

Facility Name

GSK Investigational Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

GSK Investigational Site

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

GSK Investigational Site

City

Glendale

State/Province

Wisconsin

ZIP/Postal Code

53217

Country

United States

Facility Name

GSK Investigational Site

City

Ciudad Autonoma Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1114ABH

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1430EGF

Country

Argentina

Facility Name

GSK Investigational Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878GEG

Country

Argentina

Facility Name

GSK Investigational Site

City

Cordoba

State/Province

Córdova

ZIP/Postal Code

X5003DCE

Country

Argentina

Facility Name

GSK Investigational Site

City

San Miguel de Tucuman

State/Province

Tucumán

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

GSK Investigational Site

City

San Miguel de Tucumán

State/Province

Tucumán

ZIP/Postal Code

T4000BRD

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autónoma de Buenos Aires

ZIP/Postal Code

C1128AAF

Country

Argentina

Facility Name

GSK Investigational Site

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

GSK Investigational Site

City

San Juan

ZIP/Postal Code

5400

Country

Argentina

Facility Name

GSK Investigational Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

GSK Investigational Site

City

Gold Coast

State/Province

Queensland

ZIP/Postal Code

4222

Country

Australia

Facility Name

GSK Investigational Site

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

GSK Investigational Site

City

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

GSK Investigational Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

GSK Investigational Site

City

Heidelberg West

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

GSK Investigational Site

City

Blagoevgrad

ZIP/Postal Code

2700

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sevlievo

ZIP/Postal Code

5400

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Vidin

ZIP/Postal Code

3700

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Bengbu

State/Province

Anhui

ZIP/Postal Code

233004

Country

China

Facility Name

GSK Investigational Site

City

Guilin

State/Province

Guangxi

ZIP/Postal Code

541001

Country

China

Facility Name

GSK Investigational Site

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050051

Country

China

Facility Name

GSK Investigational Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Facility Name

GSK Investigational Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

Facility Name

GSK Investigational Site

City

ZhuZhou

State/Province

Hunan

ZIP/Postal Code

412007

Country

China

Facility Name

GSK Investigational Site

City

Baotou

State/Province

Inner Mongolia

ZIP/Postal Code

014010

Country

China

Facility Name

GSK Investigational Site

City

Tongliao

State/Province

Inner Mongolia

ZIP/Postal Code

10050

Country

China

Facility Name

GSK Investigational Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

Facility Name

GSK Investigational Site

City

Taizhou

State/Province

Jiangsu

ZIP/Postal Code

225300

Country

China

Facility Name

GSK Investigational Site

City

Xuzhou

State/Province

Jiangsu

ZIP/Postal Code

221009

Country

China

Facility Name

GSK Investigational Site

City

Yancheng

State/Province

Jiangsu

ZIP/Postal Code

224001

Country

China

Facility Name

GSK Investigational Site

City

Jiujiang

State/Province

Jiangxi

ZIP/Postal Code

332000

Country

China

Facility Name

GSK Investigational Site

City

Nanchang,

State/Province

Jiangxi

ZIP/Postal Code

330006

Country

China

Facility Name

GSK Investigational Site

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Facility Name

GSK Investigational Site

City

Jinzhou

State/Province

Liaoning

ZIP/Postal Code

121000

Country

China

Facility Name

GSK Investigational Site

City

Huzhou

State/Province

Zhejiang

ZIP/Postal Code

313000

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100144

Country

China

Facility Name

GSK Investigational Site

City

Changchun

ZIP/Postal Code

130012

Country

China

Facility Name

GSK Investigational Site

City

Changzhou

ZIP/Postal Code

213003

Country

China

Facility Name

GSK Investigational Site

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

GSK Investigational Site

City

Guangzhou

ZIP/Postal Code

510080

Country

China

Facility Name

GSK Investigational Site

City

Guangzhou

ZIP/Postal Code

510630

Country

China

Facility Name

GSK Investigational Site

City

Hangzhou

ZIP/Postal Code

310005

Country

China

Facility Name

GSK Investigational Site

City

Nanjing

ZIP/Postal Code

210008

Country

China

Facility Name

GSK Investigational Site

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

GSK Investigational Site

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

GSK Investigational Site

City

Xian

ZIP/Postal Code

710061

Country

China

Facility Name

GSK Investigational Site

City

Yangzhou

ZIP/Postal Code

225000

Country

China

Facility Name

GSK Investigational Site

City

Yanji

ZIP/Postal Code

133000

Country

China

Facility Name

GSK Investigational Site

City

Barranquilla

ZIP/Postal Code

80020

Country

Colombia

Facility Name

GSK Investigational Site

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

GSK Investigational Site

City

Bucaramanga

ZIP/Postal Code

680003

Country

Colombia

Facility Name

GSK Investigational Site

City

Medellin

ZIP/Postal Code

50015

Country

Colombia

Facility Name

GSK Investigational Site

City

Parnu

ZIP/Postal Code

80010

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

10117

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

10128

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

50106

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

50406

Country

Estonia

Facility Name

GSK Investigational Site

City

Cahors

ZIP/Postal Code

46000

Country

France

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

GSK Investigational Site

City

Rendsburg

State/Province

Schleswig-Holstein

ZIP/Postal Code

24768

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20095

Country

Germany

Facility Name

GSK Investigational Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

GSK Investigational Site

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

GSK Investigational Site

City

Szentes

ZIP/Postal Code

6600

Country

Hungary

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

455-8530

Country

Japan

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

457-8511

Country

Japan

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

GSK Investigational Site

City

Chiba

ZIP/Postal Code

260-8712

Country

Japan

Facility Name

GSK Investigational Site

City

Chiba

ZIP/Postal Code

284-0003

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

804-0025

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

807-8555

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

820-8505

Country

Japan

Facility Name

GSK Investigational Site

City

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

053-8567

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

060-0001

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

060-8604

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

063-0811

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

085-0032

Country

Japan

Facility Name

GSK Investigational Site

City

Hyogo

ZIP/Postal Code

673-1462

Country

Japan

Facility Name

GSK Investigational Site

City

Hyogo

ZIP/Postal Code

675-1392

Country

Japan

Facility Name

GSK Investigational Site

City

Ibaraki

ZIP/Postal Code

312-0057

Country

Japan

Facility Name

GSK Investigational Site

City

Kagawa

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

GSK Investigational Site

City

Kagoshima

ZIP/Postal Code

891-0133

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

222-0036

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

231-8682

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

232-0024

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

236-0004

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

245-8575

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

252-0392

Country

Japan

Facility Name

GSK Investigational Site

City

Kochi

ZIP/Postal Code

780-8522

Country

Japan

Facility Name

GSK Investigational Site

City

Kochi

ZIP/Postal Code

781-0112

Country

Japan

Facility Name

GSK Investigational Site

City

Kumamoto

ZIP/Postal Code

862-0976

Country

Japan

Facility Name

GSK Investigational Site

City

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

GSK Investigational Site

City

Miyagi

ZIP/Postal Code

983-8512

Country

Japan

Facility Name

GSK Investigational Site

City

Nagano

ZIP/Postal Code

380-8582

Country

Japan

Facility Name

GSK Investigational Site

City

Nagasaki

ZIP/Postal Code

850-0832

Country

Japan

Facility Name

GSK Investigational Site

City

Nagasaki

ZIP/Postal Code

852-8501

Country

Japan

Facility Name

GSK Investigational Site

City

Nagasaki

ZIP/Postal Code

857-1195

Country

Japan

Facility Name

GSK Investigational Site

City

Niigata

ZIP/Postal Code

940-2085

Country

Japan

Facility Name

GSK Investigational Site

City

Niigata

ZIP/Postal Code

957-0054

Country

Japan

Facility Name

GSK Investigational Site

City

Okayama

ZIP/Postal Code

700-0013

Country

Japan

Facility Name

GSK Investigational Site

City

Okayama

ZIP/Postal Code

700-8557

Country

Japan

Facility Name

GSK Investigational Site

City

Okayama

ZIP/Postal Code

700-8607

Country

Japan

Facility Name

GSK Investigational Site

City

Saga

ZIP/Postal Code

843-0393

Country

Japan

Facility Name

GSK Investigational Site

City

Saitama

ZIP/Postal Code

359-1111

Country

Japan

Facility Name

GSK Investigational Site

City

Shizuoka

ZIP/Postal Code

430-8558

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

104-8560

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

113-8519

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

142-0054

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

153-8515

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

198-0042

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

204-8585

Country

Japan

Facility Name

GSK Investigational Site

City

Tottori

ZIP/Postal Code

683-8504

Country

Japan

Facility Name

GSK Investigational Site

City

Wakayama

ZIP/Postal Code

649-2211

Country

Japan

Facility Name

GSK Investigational Site

City

Yamaguchi

ZIP/Postal Code

750-8520

Country

Japan

Facility Name

GSK Investigational Site

City

Anyang-Si, Gyeonggi-do

ZIP/Postal Code

14068

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Cheonan-si

ZIP/Postal Code

330-721

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Daegu-si

ZIP/Postal Code

42601

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Daegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

134-727

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

3080

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Suwon

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Mexico City

State/Province

Durango

ZIP/Postal Code

06700

Country

Mexico

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44650

Country

Mexico

Facility Name

GSK Investigational Site

City

Merida

State/Province

Yucatán

ZIP/Postal Code

97070

Country

Mexico

Facility Name

GSK Investigational Site

City

San Luis Potosí

ZIP/Postal Code

78213

Country

Mexico

Facility Name

GSK Investigational Site

City

Bialystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

GSK Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-065

Country

Poland

Facility Name

GSK Investigational Site

City

Czestochowa

ZIP/Postal Code

42202

Country

Poland

Facility Name

GSK Investigational Site

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

GSK Investigational Site

City

Gdansk

ZIP/Postal Code

80-382

Country

Poland

Facility Name

GSK Investigational Site

City

Gdynia

ZIP/Postal Code

81-537

Country

Poland

Facility Name

GSK Investigational Site

City

Grodzisk Mazowiecki

ZIP/Postal Code

05-825

Country

Poland

Facility Name

GSK Investigational Site

City

Katowice

ZIP/Postal Code

40-040

Country

Poland

Facility Name

GSK Investigational Site

City

Katowice

ZIP/Postal Code

40-282

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

30-033

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

30510

Country

Poland

Facility Name

GSK Investigational Site

City

Lodz

ZIP/Postal Code

90-127

Country

Poland

Facility Name

GSK Investigational Site

City

Lodz

ZIP/Postal Code

90-644

Country

Poland

Facility Name

GSK Investigational Site

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

GSK Investigational Site

City

Nowy Targ

ZIP/Postal Code

34-400

Country

Poland

Facility Name

GSK Investigational Site

City

Olsztyn

ZIP/Postal Code

10-117

Country

Poland

Facility Name

GSK Investigational Site

City

Poznan

ZIP/Postal Code

60-702

Country

Poland

Facility Name

GSK Investigational Site

City

Poznan

ZIP/Postal Code

61-113

Country

Poland

Facility Name

GSK Investigational Site

City

Siedlce

ZIP/Postal Code

08-110

Country

Poland

Facility Name

GSK Investigational Site

City

Sochaczew

ZIP/Postal Code

96-500

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

02-793

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

52-416

Country

Poland

Facility Name

GSK Investigational Site

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Kemerovo

ZIP/Postal Code

650070

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Korolev

ZIP/Postal Code

141060

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Krasnoyarsk

ZIP/Postal Code

660123

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

111539

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

115404

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Omsk

ZIP/Postal Code

644024

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Ulyanovsk

ZIP/Postal Code

432063

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Yaroslavl

ZIP/Postal Code

150007

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Yaroslavl

ZIP/Postal Code

150030

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

GSK Investigational Site

City

Muang

ZIP/Postal Code

40002

Country

Thailand

Facility Name

GSK Investigational Site

City

Rajathevee

ZIP/Postal Code

10400

Country

Thailand

Facility Name

GSK Investigational Site

City

Romford

State/Province

Essex

ZIP/Postal Code

RM1 3PJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Northwood

State/Province

Middlesex

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Kenilworth

State/Province

Warwickshire

ZIP/Postal Code

CV8 1JD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

IPD Sharing URL

http://clinicalstudydatarequest.com

Links:

URL

https://clinicaltrials.gov/ct2/show/NCT04333147?term=209564&draw=2&rank=1

Description

209564 contRAst X NCT04333147

Learn more about this trial

We'll reach out to this number within 24 hrs

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)

Arthritis, Rheumatoid

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial