COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03970837




Registration number
NCT03970837
Ethics application status
Date submitted
16/05/2019
Date registered
3/06/2019
Date last updated
22/10/2020

Titles & IDs
Public 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)
Scientific 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
Secondary ID [1] 0 0
201791
Universal Trial Number (UTN)
Trial acronym
contRAst 2
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - GSK3196165
Treatment: Drugs - Tofacitinib
Treatment: Drugs - Placebo to GSK3196165
Treatment: Drugs - Placebo to Tofacitinib
Treatment: Drugs - csDMARDs

Experimental: GSK3196165 90 mg - 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).

Experimental: GSK3196165 150 mg - 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.

Active Comparator: Tofacitinib 5 mg - 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.

Placebo Comparator: Placebo sequence 1 - 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.

Placebo Comparator: Placebo sequence 2 - 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.

Placebo Comparator: Placebo sequence 3 - 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.


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

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

Treatment: Drugs: Placebo to GSK3196165
Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/pre-filled syringe (PFS) to be administered SC.

Treatment: Drugs: Placebo to Tofacitinib
Placebo cap (containing lactose) to be administered orally.

Treatment: Drugs: csDMARDs
Stable dose of csDMARD(s) as SoC.

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Proportion of participants achieving CDAI total score <=10 (CDAI LDA) at Week 52 - 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 52 will be summarized.
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 12 - 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 <=2.8 at Week 12 will be summarized.
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) 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 <=2.8 at Week 24 will be summarized.
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 52 - 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 <=2.8 at Week 52 will be summarized.
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Proportion of participants achieving ACR20/50/70 at Week 24 - 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 24 will be summarized.
Timepoint [10] 0 0
Week 24
Secondary outcome [11] 0 0
Proportion of participants achieving ACR20/50/70 at Week 52 - 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 52 will be summarized.
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
Week 24
Secondary outcome [15] 0 0
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.
Timepoint [15] 0 0
Week 24
Secondary outcome [16] 0 0
Proportion of participants achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 52 - 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 52 will be summarized.
Timepoint [16] 0 0
Week 52
Secondary outcome [17] 0 0
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.
Timepoint [17] 0 0
Week 52
Secondary outcome [18] 0 0
Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) 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/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 <2.6 at Week 12 will be summarized.
Timepoint [18] 0 0
Week 12
Secondary outcome [19] 0 0
Proportion of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) 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 (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 <2.6 at Week 12 will be summarized.
Timepoint [19] 0 0
Week 12
Secondary outcome [20] 0 0
Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) 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 <2.6 at Week 24 will be summarized.
Timepoint [20] 0 0
Week 24
Secondary outcome [21] 0 0
Proportion of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) 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 (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 <2.6 at Week 24 will be summarized.
Timepoint [21] 0 0
Week 24
Secondary outcome [22] 0 0
Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 52 - 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 <2.6 at Week 52 will be summarized.
Timepoint [22] 0 0
Week 52
Secondary outcome [23] 0 0
Proportion of participants achieving DAS28 ESR <2.6 (DAS28-ESR Remission) 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 <2.6 at Week 52 will be summarized.
Timepoint [23] 0 0
Week 52
Secondary outcome [24] 0 0
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.
Timepoint [24] 0 0
Week 12
Secondary outcome [25] 0 0
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.
Timepoint [25] 0 0
Week 24
Secondary outcome [26] 0 0
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.
Timepoint [26] 0 0
Week 52
Secondary outcome [27] 0 0
Proportion of participants achieving ACR/EULAR remission at Week 12 - Proportion of participants achieving ACR/EULAR remission at Week 12 will be summarized.
Timepoint [27] 0 0
Week 12
Secondary outcome [28] 0 0
Proportion of participants achieving ACR/EULAR remission at Week 24 - Proportion of participants achieving ACR/EULAR remission at Week 24 will be summarized.
Timepoint [28] 0 0
Week 24
Secondary outcome [29] 0 0
Proportion of participants achieving ACR/EULAR remission at Week 52 - Proportion of participants achieving ACR/EULAR remission at Week 52 will be summarized.
Timepoint [29] 0 0
Week 52
Secondary outcome [30] 0 0
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.
Timepoint [30] 0 0
Week 12
Secondary outcome [31] 0 0
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.
Timepoint [31] 0 0
Week 24
Secondary outcome [32] 0 0
Proportion of participants achieving no radiographic progression at Week 52 - 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 52 will be summarized.
Timepoint [32] 0 0
Week 52
Secondary outcome [33] 0 0
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.
Timepoint [33] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [34] 0 0
Change from Baseline in CDAI total score at Week 24 (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
Timepoint [34] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [35] 0 0
Change from Baseline in CDAI total score at Week 52 (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
Timepoint [35] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [36] 0 0
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.
Timepoint [36] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [37] 0 0
Change from Baseline in DAS28-CRP/DAS28-ESR at Week 24 (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.
Timepoint [37] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [38] 0 0
Change from Baseline in DAS28-CRP/DAS28-ESR at Week 52 (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.
Timepoint [38] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [39] 0 0
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.
Timepoint [39] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [40] 0 0
Change from Baseline in Van der Heijde mTSS at Week 24 (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.
Timepoint [40] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [41] 0 0
Change from Baseline in Van der Heijde mTSS at Week 52 (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.
Timepoint [41] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [42] 0 0
Change from Baseline in HAQ-DI at Week 24 (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.
Timepoint [42] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [43] 0 0
Change from Baseline in HAQ-DI at Week 52 (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.
Timepoint [43] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [44] 0 0
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).
Timepoint [44] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [45] 0 0
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).
Timepoint [45] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [46] 0 0
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).
Timepoint [46] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [47] 0 0
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.
Timepoint [47] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [48] 0 0
Change from Baseline in SF-36 mental 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.
Timepoint [48] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [49] 0 0
Change from Baseline in SF-36 domain 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.
Timepoint [49] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [50] 0 0
Change from Baseline in SF-36 physical component scores at Week 24 (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.
Timepoint [50] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [51] 0 0
Change from Baseline in SF-36 mental component scores at Week 24 (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.
Timepoint [51] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [52] 0 0
Change from Baseline in SF-36 domain scores at Week 24 (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.
Timepoint [52] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [53] 0 0
Change from Baseline in SF-36 physical component scores at Week 52 (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.
Timepoint [53] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [54] 0 0
Change from Baseline in SF-36 mental component scores at Week 52 (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.
Timepoint [54] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [55] 0 0
Change from Baseline in SF-36 domain scores at Week 52 (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.
Timepoint [55] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [56] 0 0
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.
Timepoint [56] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [57] 0 0
Change from Baseline in FACIT-Fatigue at Week 24 (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.
Timepoint [57] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [58] 0 0
Change from Baseline in FACIT-Fatigue at Week 52 (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.
Timepoint [58] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [59] 0 0
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.
Timepoint [59] 0 0
Up to Week 59
Secondary outcome [60] 0 0
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.
Timepoint [60] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [61] 0 0
Change from Baseline in WBC count at Week 24 (Giga cells per liter) - Blood samples will be collected for the assessment of WBC count.
Timepoint [61] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [62] 0 0
Change from Baseline in WBC count at Week 52 (Giga cells per liter) - Blood samples will be collected for the assessment of WBC count.
Timepoint [62] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [63] 0 0
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.
Timepoint [63] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [64] 0 0
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.
Timepoint [64] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [65] 0 0
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.
Timepoint [65] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [66] 0 0
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.
Timepoint [66] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [67] 0 0
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.
Timepoint [67] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [68] 0 0
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.
Timepoint [68] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [69] 0 0
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.
Timepoint [69] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [70] 0 0
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.
Timepoint [70] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [71] 0 0
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.
Timepoint [71] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [72] 0 0
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.
Timepoint [72] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [73] 0 0
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.
Timepoint [73] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [74] 0 0
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.
Timepoint [74] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [75] 0 0
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.
Timepoint [75] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [76] 0 0
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.
Timepoint [76] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [77] 0 0
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.
Timepoint [77] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [78] 0 0
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.
Timepoint [78] 0 0
Baseline (Day 1) and Week 4
Secondary outcome [79] 0 0
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.
Timepoint [79] 0 0
Baseline (Day 1) and Week 16
Secondary outcome [80] 0 0
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.
Timepoint [80] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [81] 0 0
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.
Timepoint [81] 0 0
Baseline (Day 1) and Week 4
Secondary outcome [82] 0 0
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.
Timepoint [82] 0 0
Baseline (Day 1) and Week 16
Secondary outcome [83] 0 0
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.
Timepoint [83] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [84] 0 0
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.
Timepoint [84] 0 0
Baseline (Day 1) and Week 4
Secondary outcome [85] 0 0
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.
Timepoint [85] 0 0
Baseline (Day 1) and Week 16
Secondary outcome [86] 0 0
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.
Timepoint [86] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [87] 0 0
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.
Timepoint [87] 0 0
Up to Week 59
Secondary outcome [88] 0 0
Concentrations of Granulocyte-macrophage colony stimulating factor (GM-CSF) autoantibody - Concentrations of GM-CSF autoantibodies will be determined
Timepoint [88] 0 0
Up to Week 59
Secondary outcome [89] 0 0
Number of participants with anti-GSK3196165 antibodies - Presence of anti-GSK3196165 antibodies will be determined.
Timepoint [89] 0 0
Up to Week 59

Eligibility
Key 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:

- 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).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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


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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS
Recruitment hospital [1] 0 0
GSK Investigational Site - Broadmeadow
Recruitment hospital [2] 0 0
GSK Investigational Site - Gold Coast
Recruitment hospital [3] 0 0
GSK Investigational Site - Maroochydore
Recruitment hospital [4] 0 0
GSK Investigational Site - Hobart
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
4222 - Gold Coast
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
North Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
United States of America
State/province [28] 0 0
West Virginia
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
Argentina
State/province [30] 0 0
Buenos Aires
Country [31] 0 0
Argentina
State/province [31] 0 0
Córdova
Country [32] 0 0
Argentina
State/province [32] 0 0
Tucumán
Country [33] 0 0
Argentina
State/province [33] 0 0
Ciudad Autonoma Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Cordoba
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Blagoevgrad
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Pleven
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Plovdiv
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Ruse
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Sevlievo
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Sofia
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Vidin
Country [42] 0 0
Colombia
State/province [42] 0 0
Barranquilla
Country [43] 0 0
Colombia
State/province [43] 0 0
Bogota
Country [44] 0 0
Colombia
State/province [44] 0 0
Bucaramanga
Country [45] 0 0
Colombia
State/province [45] 0 0
Medellin
Country [46] 0 0
Estonia
State/province [46] 0 0
Parnu
Country [47] 0 0
Estonia
State/province [47] 0 0
Tallinn
Country [48] 0 0
Estonia
State/province [48] 0 0
Tartu
Country [49] 0 0
France
State/province [49] 0 0
Cahors
Country [50] 0 0
France
State/province [50] 0 0
Le Kremlin-Bicêtre
Country [51] 0 0
France
State/province [51] 0 0
Nantes
Country [52] 0 0
France
State/province [52] 0 0
Paris cedex 10
Country [53] 0 0
France
State/province [53] 0 0
Paris cedex 14
Country [54] 0 0
France
State/province [54] 0 0
Saint-Etienne
Country [55] 0 0
Germany
State/province [55] 0 0
Nordrhein-Westfalen
Country [56] 0 0
Germany
State/province [56] 0 0
Schleswig-Holstein
Country [57] 0 0
Germany
State/province [57] 0 0
Bad Doberan
Country [58] 0 0
Germany
State/province [58] 0 0
Hamburg
Country [59] 0 0
Germany
State/province [59] 0 0
Magdeburg
Country [60] 0 0
Hungary
State/province [60] 0 0
Budapest
Country [61] 0 0
Hungary
State/province [61] 0 0
Szekesfehervar
Country [62] 0 0
Hungary
State/province [62] 0 0
Szentes
Country [63] 0 0
Japan
State/province [63] 0 0
Aichi
Country [64] 0 0
Japan
State/province [64] 0 0
Chiba
Country [65] 0 0
Japan
State/province [65] 0 0
Fukuoka
Country [66] 0 0
Japan
State/province [66] 0 0
Hokkaido
Country [67] 0 0
Japan
State/province [67] 0 0
Hyogo
Country [68] 0 0
Japan
State/province [68] 0 0
Ibaraki
Country [69] 0 0
Japan
State/province [69] 0 0
Kagoshima
Country [70] 0 0
Japan
State/province [70] 0 0
Kanagawa
Country [71] 0 0
Japan
State/province [71] 0 0
Kochi
Country [72] 0 0
Japan
State/province [72] 0 0
Kumamoto
Country [73] 0 0
Japan
State/province [73] 0 0
Nagano
Country [74] 0 0
Japan
State/province [74] 0 0
Nagasaki
Country [75] 0 0
Japan
State/province [75] 0 0
Niigata
Country [76] 0 0
Japan
State/province [76] 0 0
Okayama
Country [77] 0 0
Japan
State/province [77] 0 0
Saga
Country [78] 0 0
Japan
State/province [78] 0 0
Shizuoka
Country [79] 0 0
Japan
State/province [79] 0 0
Tokyo
Country [80] 0 0
Japan
State/province [80] 0 0
Wakayama
Country [81] 0 0
Japan
State/province [81] 0 0
Yamaguchi
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Anyang-Si, Gyeonggi-do
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Daegu
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Daejeon
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Gwangju
Country [86] 0 0
Korea, Republic of
State/province [86] 0 0
Incheon
Country [87] 0 0
Korea, Republic of
State/province [87] 0 0
Jeonju-si, Jeollabuk-do
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Seongnam-si
Country [89] 0 0
Korea, Republic of
State/province [89] 0 0
Seoul
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Suwon-si, Gyeonggi-do
Country [91] 0 0
Poland
State/province [91] 0 0
Bialystok
Country [92] 0 0
Poland
State/province [92] 0 0
Bydgoszcz
Country [93] 0 0
Poland
State/province [93] 0 0
Czestochowa
Country [94] 0 0
Poland
State/province [94] 0 0
Elblag
Country [95] 0 0
Poland
State/province [95] 0 0
Gdansk
Country [96] 0 0
Poland
State/province [96] 0 0
Gdynia
Country [97] 0 0
Poland
State/province [97] 0 0
Katowice
Country [98] 0 0
Poland
State/province [98] 0 0
Krakow
Country [99] 0 0
Poland
State/province [99] 0 0
Kraków
Country [100] 0 0
Poland
State/province [100] 0 0
Lodz
Country [101] 0 0
Poland
State/province [101] 0 0
Lublin
Country [102] 0 0
Poland
State/province [102] 0 0
Nowy Targ
Country [103] 0 0
Poland
State/province [103] 0 0
Olsztyn
Country [104] 0 0
Poland
State/province [104] 0 0
Poznan
Country [105] 0 0
Poland
State/province [105] 0 0
Siedlce
Country [106] 0 0
Poland
State/province [106] 0 0
Sochaczew
Country [107] 0 0
Poland
State/province [107] 0 0
Warszawa
Country [108] 0 0
Poland
State/province [108] 0 0
Wroclaw
Country [109] 0 0
Russian Federation
State/province [109] 0 0
Ekaterinburg
Country [110] 0 0
Russian Federation
State/province [110] 0 0
Kemerovo
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Korolev
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Krasnoyarsk
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Moscow
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Novosibirsk
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Omsk
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Saint-Petersburg
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Tomsk
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Ulyanovsk
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Yaroslavl
Country [120] 0 0
Spain
State/province [120] 0 0
Barcelona
Country [121] 0 0
Spain
State/province [121] 0 0
Madrid
Country [122] 0 0
Spain
State/province [122] 0 0
Salamanca
Country [123] 0 0
Spain
State/province [123] 0 0
Sevilla
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Essex
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Middlesex
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Warwickshire
Country [127] 0 0
United Kingdom
State/province [127] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03970837
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03970837