Clinical trial NCT03980483: 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
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 Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid arthritis
GSK3196165
Otilimab
Tofacitinib
Methotrexate
Placebo
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2019-06-10
Enrollment: 1537
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of six intervention arms in ratio of 6:6:3:1:1:1.
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: Percentage of Participants Achieving 20 Percentage (%) Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo
timeFrame: Week 12
Secondary outcomes:
measure: 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
timeFrame: Week 12
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Percentage of Participants Achieving 20% Improvement in ACR20 at Week 24 (Non-Inferiority Versus Tofacitinib)
timeFrame: Week 24
measure: 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
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Week 24 and Week 52
measure: 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
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria (ACR50/70) at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Week 12
measure: Percentage of Participants Achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Week 24 and Week 52
measure: 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
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Week 24 and Week 52
measure: 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
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving a Good/Moderate (European League Against Rheumatism) EULAR Response at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Week 24 and Week 52
measure: Number of Participants Achieving ACR/EULAR Remission at Week 12
timeFrame: Week 12
measure: Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Week 24 and Week 52
measure: Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving no Radiographic Progression (Van Der Heijde Modified Total Sharp Scores (mTSS <= 0.5) at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Week 24 and Week 52
measure: Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Week 24 and Week 52
measure: Change From Baseline in CDAI Total Score at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in DAS28-CRP/DAS28-ESR at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Van Der Heijde mTSS at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Arthritis Pain VAS at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Short Form (SF)-36 Physical Component Scores (PCS) at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in SF-36 Mental Component Scores (MCS) at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in SF-36 Domain Scores at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in SF-36 PCS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in SF-36 MCS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in SF-36 PCS at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in SF-36 MCS at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
timeFrame: Up to Week 59
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms
timeFrame: Up to Week 59
measure: Change From Baseline in White Blood Cell (WBC) Count at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in WBC Count at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in WBC Count at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: 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
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Hematology Parameter of Hemoglobin at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: 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
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: 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
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: 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
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms
timeFrame: Baseline (Week 12), Week 24 and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Placebo Switched Arms
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Placebo Switched Arms
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein-cholesterol at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: 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
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, High-density Lipoprotein-cholesterol at Week 24 for Placebo Switched Arms
timeFrame: Baseline (Day 1) and Week 24
measure: 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
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, High-density Lipoprotein-cholesterol at Week 52 for Placebo Switched Arms
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Placebo Switched Arms
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Treatment Arms Who Started Study Intervention From Day 1
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Placebo Switched Arms
timeFrame: Baseline (Day 1) and Week 52
measure: Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities
timeFrame: Up to Week 59
measure: 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
timeFrame: Up to Week 59
measure: Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody
timeFrame: At baseline
measure: Number of Participants With Anti-GSK3196165 Antibodies
timeFrame: Up to Week 59
Other outcomes:
Locations:
city: Bengbu
country: China
facility: GSK Investigational Site
state: Anhui
city: Pingxiang
country: China
facility: GSK Investigational Site
state: Jiangxi
city: Changchun
country: China
facility: GSK Investigational Site
state: Jilin
city: Chengdu
country: China
facility: GSK Investigational Site
state: Sichuan
city: Shanghai
country: China
facility: GSK Investigational Site
city: Baja
country: Hungary
facility: GSK Investigational Site
city: Balatonfured
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Kistarcsa
country: Hungary
facility: GSK Investigational Site
city: Szekesfehervar
country: Hungary
facility: GSK Investigational Site
city: Szentes
country: Hungary
facility: GSK Investigational Site
city: Székesfehérvár
country: Hungary
facility: GSK Investigational Site
city: Veszprem
country: Hungary
facility: GSK Investigational Site
city: Ahmedabad
country: India
facility: GSK Investigational Site
city: Ahmedabad
country: India
facility: GSK Investigational Site
city: Ahmedabad
country: India
facility: GSK Investigational Site
city: Ahmedabad
country: India
facility: GSK Investigational Site
city: Banglore
country: India
facility: GSK Investigational Site
city: Belagavi
country: India
facility: GSK Investigational Site
city: Hubli
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Kolkata
country: India
facility: GSK Investigational Site
city: Nagpur
country: India
facility: GSK Investigational Site
city: Nagpur
country: India
facility: GSK Investigational Site
city: Nashik
country: India
facility: GSK Investigational Site
city: Nashik
country: India
facility: GSK Investigational Site
city: New Delhi
country: India
facility: GSK Investigational Site
city: Pimpri-Chinchwad
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Rajkot
country: India
facility: GSK Investigational Site
city: Surat
country: India
facility: GSK Investigational Site
city: Vadodara
country: India
facility: GSK Investigational Site
city: Verona
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Klang
country: Malaysia
facility: GSK Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: GSK Investigational Site
city: Seremban, Negeri Sembilan
country: Malaysia
facility: GSK Investigational Site
city: Sibu
country: Malaysia
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Czestochowa
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gdynia
country: Poland
facility: GSK Investigational Site
city: Gdynia
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Kraków
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Nowa Sol
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Sochaczew
country: Poland
facility: GSK Investigational Site
city: Staszow
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Warsaw
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wrocław
country: Poland
facility: GSK Investigational Site
city: Zamosc
country: Poland
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Belgrade
country: Serbia
facility: GSK Investigational Site
city: A Coruña
country: Spain
facility: GSK Investigational Site
city: Cordoba
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Romford
country: United Kingdom
facility: GSK Investigational Site
state: Essex
city: Northwood
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Kenilworth
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Fleischmann RM, van der Heijde D, Strand V, Atsumi T, McInnes IB, Takeuchi T, Taylor PC, Bracher M, Brooks D, Davies J, Goode C, Gupta A, Mukherjee S, O'Shea C, Saurigny D, Schifano LA, Shelton C, Smith JE, Wang M, Wang R, Watts S, Weinblatt ME. Anti-GM-CSF otilimab versus tofacitinib or placebo in patients with active rheumatoid arthritis and an inadequate response to conventional or biologic DMARDs: two phase 3 randomised trials (contRAst 1 and contRAst 2). Ann Rheum Dis. 2023 Dec;82(12):1516-1526. doi: 10.1136/ard-2023-224482. Epub 2023 Sep 12.