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临床试验/NCT01332994
NCT01332994已完成3 期

Efficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI)

Hoffmann-La Roche0 个研究点目标入组 519 人开始时间: 2011年3月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
519
主要终点
Percentage of Participants Achieving Remission at Week 16 According to DAS28
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记录与标识符相似试验

研究概览

简要总结

This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12 weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study treatment is 32 weeks.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • •Adult patients >/=18 years of age
  • •Body weight < /=130kg
  • •Active rheumatoid arthritis of at least 6 months duration, diagnosed according to the American College of Rheumatology (ACR) criteria of 1987
  • •Disease Activity Score (DAS28) of >3.2
  • •Inadequate clinical response to a stable dose of traditional Disease-Modifying Anti-Rheumatic Drugs (DMARD)
  • •Have received permitted DMARDs, one or more; current DMARD therapy must have been at stable dose for at least 4 weeks prior to baseline

排除标准

  • •Prior treatment with TNF-inhibitors or other biologic DMARD
  • •Major surgery (including joint surgery) within eight weeks prior to baseline or planned major surgery within the study duration
  • •Functional class IV (American College of Rheumatology classification)
  • •Rheumatic autoimmune disease other than rheumatoid arthritis
  • •History of or current inflammatory joint disease other than rheumatoid arthritis

研究组 & 干预措施

1

Experimental

干预措施: tocilizumab [RoActemra/Actemra] (Drug)

2

Experimental

干预措施: rituximab [MabThera/Rituxan] (Drug)

2

Experimental

干预措施: tocilizumab [RoActemra/Actemra] (Drug)

结局指标

主要结局

Percentage of Participants Achieving Remission at Week 16 According to DAS28

时间窗: Week 16

The DAS28 was calculated as \[0.28 times (x) the square root of number of swollen joints\] plus (+) \[0.56 x the square root of number of tender joints\] + \[0.7 x the natural log of erythrocyte sedimentation rate (ESR)\] + \[0.014 x Visual Analog Scale (VAS) patient global assessment of disease activity\]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score \<2.6 at the assessment visit.

次要结局

  • Percentage of Participants Achieving Remission According to DAS28 at Weeks 4, 8, and 12(Weeks 4, 8, and 12)
  • Percentage of Participants Achieving Remission According to DAS28 at Weeks 16, 20, 24, and 28 Among Participants Treated With 8 Courses of Tocilizumab(Weeks 16, 20, 24, and 28)
  • Percentage of Participants Achieving Remission According to DAS28 at Week 32 Among Participants Treated With 8 Courses of Tocilizumab(Week 32)
  • Percentage of Participants Achieving Remission According to DAS28 at Week 32 Among Nonresponding Participants Treated With Rituximab(Week 32)
  • Percentage of Participants Achieving Low Disease Activity Score (LDAS) According to DAS28(Week 16)
  • Percentage of Participants Achieving LDAS According to DAS28 Among Among Nonresponding Participants Treated With Rituximab(Week 32)
  • Percentage of Participants Achieving a Clinically Relevant Reduction From Baseline in DAS28 at Week 16(Baseline and Week 16)
  • DAS28 Scores During and After Treatment(Baseline and Weeks 4, 8, 12, 16)
  • DAS28 Scores During and After Treatment Among Participants Treated With 8 Courses of Tocilizumab(Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, and 32)
  • DAS28 Scores During and After Treatment Among Nonresponding Participants Treated With Rituximab(Baseline and Weeks 4, 8, 12, 16, 24, and 32)
  • DAS28 Scores During Safety Follow-Up Among Nonresponding Participants Treated With Rituximab(Weeks 40, 48, 56, and 66)
  • Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Weeks 4, 8, 12 and 16(Baseline and Weeks 4, 8, 12, and 16)
  • Percentage of Participants Achieving a Response According to EULAR Criteria at Week 32 Compared to Week 16 Among Nonresponding Participants Treated With Rituximab(Weeks 16 and 32)
  • Percentage of Participants Achieving a Clinically Relevant Reduction From Baseline in DAS28 at Weeks 4, 8, and 12(Baseline and Weeks 4, 8, and 12)
  • Percentage of Participants Achieving a Clinically Relevant Reduction in DAS28 From Week 16 to Week 32 Among Nonresponding Participants Treated With Rituximab(Weeks 16 and 32)
  • Percentage of Participants Achieving a Response According to EULAR Criteria at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab(Baseline and Weeks 20, 24, 28, and 32)
  • Percentage of Participants Achieving a Response According to American College of Rheumatology (ACR) Criteria at Weeks 4, 8, 12, and 16(Baseline and Weeks 4, 8, 12, and 16)
  • Change in Hemoglobin From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab(Weeks 16 and 32)
  • Change in CRP From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab(Weeks 16 and 32)
  • Change in ESR From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab(Weeks 16 and 32)
  • Change From Baseline in Hemoglobin at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab(Baseline and Weeks 20, 24, 28, and 32)
  • Change From Baseline in CRP at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab(Baseline and Weeks 20, 24, 28, and 32)
  • Percentage of Participants Achieving a Response According to ACR Criteria at Week 32 Compared to Week 16 Among Nonresponding Participants Treated With Rituximab(Weeks 16 and 32)
  • Percentage of Participants Achieving a Response According to ACR Criteria at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab(Baseline and Weeks 20, 24, 28, and 32)
  • Change From Baseline in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Scores at Weeks 4, 8, 12, and 16(Baseline and Weeks 4, 8, 12, and 16)
  • Change From Week 16 to 32 in CDAI and SDAI Scores Among Nonresponding Participants Treated With Rituximab(Weeks 16 and 32)
  • Change From Baseline in CDAI and SDAI Scores at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab(Baseline and Weeks 20, 24, 28, and 32)
  • Change From Baseline in Hemoglobin at Weeks 4, 8, 12, and 16(Baseline and Weeks 4, 8, 12, and 16)
  • Change From Baseline in ESR at Weeks 4, 8, 12, and 16(Baseline and Weeks 4, 8, 12, and 16)
  • Change From Baseline in CRP at Weeks 4, 8, 12, and 16(Baseline and Weeks 4, 8, 12, and 16)
  • Change From Baseline in ESR at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab(Baseline and Weeks 20, 24, 28, and 32)
  • Percentage of Participants Withdrawing From the Study for Insufficient Therapeutic Response(Baseline to Week 16)
  • Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Participants With Early Remission(Baseline)
  • Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Participants Treated With 8 Courses of Tocilizumab(Baseline)
  • Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Nonresponding Participants Treated With Rituximab(Baseline)
  • Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Week 16 Among Participants With Early Remission(Baseline and Week 16)
  • Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Weeks 16, 24, and 32 Among Participants Treated With 8 Courses of Tocilizumab(Baseline and Weeks 16, 24, and 32)
  • Quality of Life as Assessed Using HAQ-DI(Baseline and Week 16)
  • Change From Baseline in Quality of Life as Assessed Using HAQ-DI at Week 16(Baseline and Week 16)
  • Change From Week 16 to 32 in Quality of Life as Assessed Using HAQ-DI Among Participants Treated With 8 Courses of Tocilizumab(Weeks 16 and 32)
  • Change From Week 16 to 32 in Quality of Life as Assessed Using HAQ-DI Among Nonresponding Participants Treated With Rituximab(Weeks 16 and 32)
  • Percentage of Participants Achieving a Response According to HAQ-DI Criteria(Baseline and Week 16)
  • Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Weeks 16, 32, 40, 48, and 66 Among Nonresponding Participants Treated With Rituximab(Baseline and Weeks 16, 32, 40, 48, and 66)
  • Mean Number of Work Days Missed Per Week(Baseline and Week 16)
  • Quality of Life as Assessed Using Short Form 36 (SF-36)(Baseline and Week 16)
  • Change From Baseline in Quality of Life as Assessed Using SF-36 at Week 16(Baseline and Week 16)
  • Change From Week 16 to 32 in Quality of Life as Assessed Using SF-36 Scores Among Participants Treated With 8 Courses of Tocilizumab(Weeks 16 and 32)
  • Change From Week 16 to 32 in Quality of Life as Assessed Using SF-36 Scores Among Nonresponding Participants Treated With Rituximab(Weeks 16 and 32)
  • Quality of Life as Assessed Using Functional Assessment of Chronic Illness Therapy (FACIT)(Baseline and Week 16)
  • Change From Baseline in Quality of Life as Assessed Using FACIT at Week 16(Baseline and Week 16)
  • Change From Week 16 to 32 in Quality of Life as Assessed Using FACIT Among Participants Treated With 8 Courses of Tocilizumab(Weeks 16 and 32)
  • Change From Week 16 to 32 in Quality of Life as Assessed Using FACIT Among Nonresponding Participants Treated With Rituximab(Weeks 16 and 32)

研究者

申办方类型
Industry
责任方
Sponsor

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