跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT03970837
NCT03970837终止3 期

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

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 1,764 人开始时间: 2019年6月5日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施

试验速览

阶段
3 期
状态
终止
入组人数
1,764
试验地点
1
主要终点
Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo (Global Cohort)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Double blinded

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

GSK3196165 90mg + csDMARD (Global Cohort)

Experimental

Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).

干预措施: GSK3196165 (Otilimab) (Biological)

GSK3196165 150mg + csDMARD (Global Cohort)

Experimental

Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.

干预措施: GSK3196165 (Otilimab) (Biological)

Tofacitinib 5mg + csDMARD (Global Cohort)

Active Comparator

Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks.

干预措施: Tofacitinib (Drug)

Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort)

Placebo Comparator

Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

干预措施: GSK3196165 (Otilimab) (Biological)

Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort)

Placebo Comparator

Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

干预措施: Placebo (Drug)

Placebo +csDMARD and GSK3196165 150mg +csDMARD (Global Cohort)

Placebo Comparator

Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

干预措施: GSK3196165 (Otilimab) (Biological)

Placebo +csDMARD and GSK3196165 150mg +csDMARD (Global Cohort)

Placebo Comparator

Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

干预措施: Placebo (Drug)

Placebo +csDMARD and Tofacitinib 5mg +csDMARD (Global Cohort)

Placebo Comparator

Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.

干预措施: Tofacitinib (Drug)

Placebo +csDMARD and Tofacitinib 5mg +csDMARD (Global Cohort)

Placebo Comparator

Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.

干预措施: Placebo (Drug)

GSK3196165 90mg + csDMARD (Asia Cohort)

Experimental

Participants in Asia Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.

干预措施: GSK3196165 (Otilimab) (Biological)

GSK3196165 150mg + csDMARD (Asia Cohort)

Experimental

Participants in Asia Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.

干预措施: GSK3196165 (Otilimab) (Biological)

Tofacitinib 5mg + csDMARD (Asia Cohort)

Active Comparator

Participants in Asia Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks.

干预措施: Tofacitinib (Drug)

Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort)

Placebo Comparator

Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

干预措施: GSK3196165 (Otilimab) (Biological)

Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort)

Placebo Comparator

Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

干预措施: Placebo (Drug)

Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort)

Placebo Comparator

Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

干预措施: GSK3196165 (Otilimab) (Biological)

Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort)

Placebo Comparator

Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

干预措施: Placebo (Drug)

Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort)

Placebo Comparator

Participants in Asia Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.

干预措施: Tofacitinib (Drug)

Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort)

Placebo Comparator

Participants in Asia Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.

干预措施: Placebo (Drug)

结局指标

主要结局

Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo (Global Cohort)

时间窗: Week 12

ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) \[visual analogue scale (VAS) with values from 0=best to 100=worst\], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant \[high sensitivity C-reactive Protein milligram per liter (mg/L) (hsCRP)\]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.

Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 (Asia Cohort)

时间窗: Week 12

ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) \[visual analogue scale (VAS) with values from 0=best to 100=worst\], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant \[high sensitivity C-reactive Protein milligram per liter (mg/L) (hsCRP)\]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.

次要结局

  • Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Less Than or Equal to (<=)10 [CDAI Low Disease Activity (LDA)] at Week 12 (Global Cohort)(Week 12)
  • Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving 20% Improvement in ACR20 at Week 24: Non-inferiority Comparison With Tofacitinib (Global Cohort)(Week 24)
  • Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12 (Global Cohort)(Week 12)
  • Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Global Cohort)(Week 12)
  • Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12 (Global Cohort)(Week 12)
  • Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 (Global Cohort)(Week 12)
  • Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12 (Global Cohort)(Week 12)
  • Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Placebo Switched Arms (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 (Global Cohort)(Week 12)
  • Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Week 24 and Week 52)
  • Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Week 24 and Week 52)
  • Change From Baseline in CDAI Total Score at Week 12 (Global Cohort)(Baseline (Day 1) and week 12)
  • Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Week 24 and Week 52)
  • Change From Baseline in DAS28-CRP/DAS28-ESR at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in SF-36 Domain Scores at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Week 24 and Week 52)
  • Number of Participants Achieving ACR/EULAR Remission at Week 12 (Global Cohort)(Week 12)
  • Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Week 24 and Week 52)
  • Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Arthritis Pain VAS at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in SF-36 Mental Component Scores at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving a Good/Moderate (European League Against Rheumatism) EULAR Response at Week 12 (Global Cohort)(Week 12)
  • Percentage of Participants Achieving no Radiographic Progression Van Der Heijde Modified Total Sharp Scores (mTSS) <= 0.5) at Week 12 (Global Cohort)(Week 12)
  • Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Week 24 and Week 52)
  • Change From Baseline in Van Der Heijde mTSS at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1) and Week 24)
  • Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Day 1) and Week 24 and Week 52)
  • Change From Baseline in Short Form (SF)-36 Physical Component Scores at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Day 1) and Week 52)
  • Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1) and Week 24 and Week 52)
  • Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Global Cohort)(Up to Week 59)
  • Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 (Global Cohort)(Baseline (Week 12), Week 24 and Week 52)
  • Change From Baseline in Hematology Parameter of Hemoglobin at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Week 12), Week 24 and Week 52)
  • Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Week 12), Week 24 and Week 52)
  • Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Week 12), Week 24 and Week 52)
  • Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1) and Week 24)
  • Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1) and Week 24)
  • Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Less Than or Equal to (<=)10 [CDAI Low Disease Activity (LDA)] at Week 12 (Asia Cohort)(Week 12)
  • Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1) and Week 52)
  • Change From Baseline in Lipid Profile Parameter of Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1) and Week 24)
  • Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1) and Week 52)
  • Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Week 4) and Week 52)
  • Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Placebo Switched Arms (Global Cohort)(Baseline (Week 12) and Week 24)
  • Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)(Baseline (Day 1) and Week 52)
  • Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Week 4) and Week 52)
  • Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Week 12), Week 24 and Week 52)
  • Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Placebo Switched Arms (Global Cohort)(Baseline (Week 12) and Week 24)
  • Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Placebo Switched Arms (Global Cohort)(Baseline (Week 4) and Week 52)
  • Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Placebo Switched Arms (Global Cohort)(Baseline (Week 12) and Week 24)
  • Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 12 (Global Cohort)(Baseline (Day 1) and Week 12)
  • Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody (Global Cohort)(At baseline)
  • Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Week 24 and Week 52)
  • Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)(Up to Week 59)
  • Number of Participants With Anti-GSK3196165 Antibodies (Global Cohort)(Up to Week 52)
  • Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 (Asia Cohort)(Week 12)
  • Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12 (Asia Cohort)(Week 12)
  • Percentage of Participants Achieving a Good/Moderate European League Against Rheumatism (EULAR) Response at Week 12(Asia Cohort)(Week 12)
  • Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12 (Asia Cohort)(Week 12)
  • Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Asia Cohort)(Week 12)
  • Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12 (Asia Cohort)(Week 12)
  • Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 (Asia Cohort)(Week 12)
  • Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving no Radiographic Progression Van Der Heijde Modified Total Sharp Scores (mTSS) <= 0.5) at Week 12 (Asia Cohort)(Week 12)
  • Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Week 24 and Week 52)
  • Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Week 24 and Week 52)
  • Change From Baseline in CDAI Total Score at Week 12 (Asia Cohort)(Baseline (Day 1) and week 12)
  • Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Week 24 and Week 52)
  • Number of Participants Achieving ACR/EULAR Remission at Week 12 (Asia Cohort)(Week 12)
  • Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Week 24 and Week 52)
  • Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Week 24 and Week 52)
  • Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1) and Week 24)
  • Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1) and Week 24 and Week 52)
  • Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Day 1) and Week 52)
  • Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Day 1) and Week 24 and Week 52)
  • Change From Baseline in Short Form (SF)-36 Physical Component Scores at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in SF-36 Mental Component Scores at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in DAS28-CRP and DAS28-ESR at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Van Der Heijde mTSS at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in SF-36 Domain Scores at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Arthritis Pain VAS at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Asia Cohort)(Up to Week 59)
  • Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Week 12), Week 24 and Week 52)
  • Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Week 12), Week 24 and Week 52)
  • Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1) and Week 52)
  • Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1), Week 24 and Week 52)
  • Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1) and Week 24)
  • Change From Baseline in Lipid Profile Parameter of Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Placebo Switched Arms (Asia Cohort)(Baseline (Week 12) and Week 24)
  • Change From Baseline in Hematology Parameter of Hemoglobin at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Week 12), Week 24 and Week 52)
  • Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Week 12), Week 24 and Week 52)
  • Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Week 12), Week 24 and Week 52)
  • Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 12 (Asia Cohort)(Baseline (Day 1) and Week 12)
  • Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 24 for Placebo Switched Arms (Asia Cohort)(Baseline (Week 12) and Week 24)
  • Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Week 4) and Week 52)
  • Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1) and Week 52)
  • Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Week 4) and Week 52)
  • Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1) and Week 24)
  • Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1) and Week 24)
  • Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 24 for Placebo Switched Arms (Asia Cohort)(Baseline (Week 12) and Week 24)
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Global Cohort)(Week 12 to Week 59)
  • Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Global Cohort)(Week 12 to Week 59)
  • Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Asia Cohort)(Week 12 to Week 59)
  • Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)(Baseline (Day 1) and Week 52)
  • Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Placebo Switched Arms (Asia Cohort)(Baseline (Week 4) and Week 52)
  • Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Asia Cohort)(Up to Week 59)
  • Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody (Asia Cohort)(At baseline)
  • Number of Participants With Anti-GSK3196165 Antibodies (Asia Cohort)(Up to Week 59)
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Asia Cohort)(Week 12 to Week 59)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

已完成
3 期
Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateArthritis, Rheumatoid
NCT03980483GlaxoSmithKline1,537
已完成
3 期
Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) InhibitorsArthritis, Rheumatoid
NCT04134728GlaxoSmithKline550
进行中（未招募）
3 期
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistaminesChronic Inducible Urticaria
NCT05976243Novartis Pharmaceuticals362
终止
2 期
The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell TransplantAcute-graft-versus-host Disease
NCT03805789CSL Behring222
已完成
2 期
The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)Attention-Deficit/Hyperactivity Disorder
NCT00928148Shire86