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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03980483




Registration number
NCT03980483
Ethics application status
Date submitted
15/05/2019
Date registered
10/06/2019
Date last updated
25/10/2023

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 Methotrexate
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 Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Secondary ID [1] 0 0
201790
Universal Trial Number (UTN)
Trial acronym
contRAst 1
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 (Otilimab)
Treatment: Drugs - Tofacitinib 5 mg
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo

Experimental: GSK3196165 90mg + MTX - Participants received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with methotrexate (MTX).

Experimental: GSK3196165 150mg + MTX - Participants received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with MTX.

Active Comparator: Tofacitinib 5mg + MTX - Participants received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with MTX plus placebo injection weekly to maintain the blind for 52 weeks.

Placebo Comparator: Placebo + MTX and GSK3196165 90mg + MTX - Participants received Placebo weekly SC injection in combination with MTX for 12 weeks. At Week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with MTX until Week 52.

Placebo Comparator: Placebo + MTX and GSK3196165 150mg + MTX - Participants received Placebo weekly SC injection in combination with MTX for 12 weeks. At Week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with MTX until Week 52.

Placebo Comparator: Placebo + MTX and Tofacitinib 5mg + MTX - Participants received Placebo capsule weekly in combination with MTX for 12 weeks. At Week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with MTX plus placebo injection to maintain the blind for 52 weeks.


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

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

Treatment: Drugs: Placebo
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
Placebo cap (containing lactose) to be administered orally.
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
Percentage of Participants Achieving 20 Percentage (%) Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Less Than or Equal to (<=)10 [CDAI Low Disease Activity (LDA)] at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Timepoint [2] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving 20% Improvement in ACR20 at Week 24 (Non-Inferiority Versus Tofacitinib)
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria (ACR50/70) at Week 24 and ACR 20/50/70 at and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [4] 0 0
Week 24 and Week 52
Secondary outcome [5] 0 0
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [5] 0 0
Week 24 and Week 52
Secondary outcome [6] 0 0
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [6] 0 0
Week 24 and Week 52
Secondary outcome [7] 0 0
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [7] 0 0
Week 24 and Week 52
Secondary outcome [8] 0 0
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [9] 0 0
Week 24 and Week 52
Secondary outcome [10] 0 0
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [10] 0 0
Week 24 and Week 52
Secondary outcome [11] 0 0
Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria (ACR50/70) at Week 12
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
Percentage of Participants Achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [14] 0 0
Week 24 and Week 52
Secondary outcome [15] 0 0
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [15] 0 0
Week 24 and Week 52
Secondary outcome [16] 0 0
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [16] 0 0
Week 24 and Week 52
Secondary outcome [17] 0 0
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [17] 0 0
Week 24 and Week 52
Secondary outcome [18] 0 0
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12
Timepoint [18] 0 0
Week 12
Secondary outcome [19] 0 0
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12
Timepoint [19] 0 0
Week 12
Secondary outcome [20] 0 0
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [20] 0 0
Week 24 and Week 52
Secondary outcome [21] 0 0
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [21] 0 0
Week 24 and Week 52
Secondary outcome [22] 0 0
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [22] 0 0
Week 24 and Week 52
Secondary outcome [23] 0 0
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [23] 0 0
Week 24 and Week 52
Secondary outcome [24] 0 0
Percentage of Participants Achieving a Good/Moderate (European League Against Rheumatism) EULAR Response at Week 12
Timepoint [24] 0 0
Week 12
Secondary outcome [25] 0 0
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [25] 0 0
Week 24 and Week 52
Secondary outcome [26] 0 0
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [26] 0 0
Week 24 and Week 52
Secondary outcome [27] 0 0
Number of Participants Achieving ACR/EULAR Remission at Week 12
Timepoint [27] 0 0
Week 12
Secondary outcome [28] 0 0
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [28] 0 0
Week 24 and Week 52
Secondary outcome [29] 0 0
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [29] 0 0
Week 24 and Week 52
Secondary outcome [30] 0 0
Percentage of Participants Achieving no Radiographic Progression (Van Der Heijde Modified Total Sharp Scores (mTSS <= 0.5) at Week 12
Timepoint [30] 0 0
Week 12
Secondary outcome [31] 0 0
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [31] 0 0
Week 24 and Week 52
Secondary outcome [32] 0 0
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [32] 0 0
Week 24 and Week 52
Secondary outcome [33] 0 0
Change From Baseline in CDAI Total Score at Week 12
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 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [34] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [35] 0 0
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [35] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [36] 0 0
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 12
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 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [37] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [38] 0 0
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [38] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [39] 0 0
Change From Baseline in Van Der Heijde mTSS at Week 12
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 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [40] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [41] 0 0
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [41] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [42] 0 0
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [42] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [43] 0 0
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [43] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [44] 0 0
Change From Baseline in Arthritis Pain VAS at Week 12
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 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [45] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [46] 0 0
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [46] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [47] 0 0
Change From Baseline in Short Form (SF)-36 Physical Component Scores (PCS) at Week 12
Timepoint [47] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [48] 0 0
Change From Baseline in SF-36 Mental Component Scores (MCS) at Week 12
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
Timepoint [49] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [50] 0 0
Change From Baseline in SF-36 PCS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [50] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [51] 0 0
Change From Baseline in SF-36 MCS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [51] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [52] 0 0
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [52] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [53] 0 0
Change From Baseline in SF-36 PCS at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [53] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [54] 0 0
Change From Baseline in SF-36 MCS at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [54] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [55] 0 0
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [55] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [56] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12
Timepoint [56] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [57] 0 0
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [57] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [58] 0 0
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [58] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [59] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Timepoint [59] 0 0
Up to Week 59
Secondary outcome [60] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms
Timepoint [60] 0 0
Up to Week 59
Secondary outcome [61] 0 0
Change From Baseline in White Blood Cell (WBC) Count at Week 12
Timepoint [61] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [62] 0 0
Change From Baseline in WBC Count at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [62] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [63] 0 0
Change From Baseline in WBC Count at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [63] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [64] 0 0
Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes at Week 12
Timepoint [64] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [65] 0 0
Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [65] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [66] 0 0
Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [66] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [67] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 12
Timepoint [67] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [68] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [68] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [69] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [69] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [70] 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
Timepoint [70] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [71] 0 0
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [71] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [72] 0 0
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [72] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [73] 0 0
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 12
Timepoint [73] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [74] 0 0
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [74] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [75] 0 0
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [75] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [76] 0 0
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 12
Timepoint [76] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [77] 0 0
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [77] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [78] 0 0
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms
Timepoint [78] 0 0
Baseline (Week 12), Week 24 and Week 52
Secondary outcome [79] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 12
Timepoint [79] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [80] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [80] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [81] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Placebo Switched Arms
Timepoint [81] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [82] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [82] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [83] 0 0
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Placebo Switched Arms
Timepoint [83] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [84] 0 0
Change From Baseline in Lipid Profile Parameter of Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein-cholesterol at Week 12
Timepoint [84] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [85] 0 0
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, High-density Lipoprotein-cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [85] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [86] 0 0
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, High-density Lipoprotein-cholesterol at Week 24 for Placebo Switched Arms
Timepoint [86] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [87] 0 0
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, High-density Lipoprotein-cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [87] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [88] 0 0
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, High-density Lipoprotein-cholesterol at Week 52 for Placebo Switched Arms
Timepoint [88] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [89] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 12
Timepoint [89] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [90] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [90] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [91] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Placebo Switched Arms
Timepoint [91] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [92] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Treatment Arms Who Started Study Intervention From Day 1
Timepoint [92] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [93] 0 0
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Placebo Switched Arms
Timepoint [93] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [94] 0 0
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities
Timepoint [94] 0 0
Up to Week 59
Secondary outcome [95] 0 0
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms
Timepoint [95] 0 0
Up to Week 59
Secondary outcome [96] 0 0
Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody
Timepoint [96] 0 0
At baseline
Secondary outcome [97] 0 0
Number of Participants With Anti-GSK3196165 Antibodies
Timepoint [97] 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 MTX, despite currently taking MTX 15-25 mg/week**
oral or injected

- 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.

Key exclusion criteria

- 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)

- Has received prior treatment with a biologic Disease-modifying antirheumatic drug
(DMARD) which has been discontinued due to an inadequate response.
Minimum age
18 Years
Maximum age
No limit
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/08/2022
Sample size
Target
Accrual to date
Final
1537
Recruitment in Australia
Recruitment state(s)
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
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
North Dakota
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Córdova
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa Fe
Country [18] 0 0
Argentina
State/province [18] 0 0
Ciudad Autónoma de Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Salta
Country [20] 0 0
Argentina
State/province [20] 0 0
San Juan
Country [21] 0 0
Argentina
State/province [21] 0 0
Santiago Del Estero
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
China
State/province [24] 0 0
Anhui
Country [25] 0 0
China
State/province [25] 0 0
Jiangxi
Country [26] 0 0
China
State/province [26] 0 0
Jilin
Country [27] 0 0
China
State/province [27] 0 0
Sichuan
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
Czechia
State/province [29] 0 0
Brno
Country [30] 0 0
Czechia
State/province [30] 0 0
Ostrava
Country [31] 0 0
Czechia
State/province [31] 0 0
Praha 10
Country [32] 0 0
Czechia
State/province [32] 0 0
Praha 2
Country [33] 0 0
Czechia
State/province [33] 0 0
Praha 4 Nusle
Country [34] 0 0
Czechia
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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 1 (201790: NCT03980483)] is a phase 3, randomized, multicenter, double
blind study to assess the safety and efficacy of GSK3196165, in combination with methotrexate
(MTX), for the treatment of adult participants with moderate to severe active rheumatoid
arthritis (RA) who have had an inadequate response to MTX. 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 MTX. 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/ct2/show/NCT03980483
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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