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临床试验/NCT02552940
NCT02552940已完成不适用

A PROSPECTIVE, NON-INTERVENTIONAL STUDY TO EVALUATE THE CLINICAL EFFECTIVENESS, THE CONSISTENCY OF EVALUATION SCORES, QUALITY OF LIFE, SAFETY AND TOLERABILITY OF TOCILIZUMAB SUBCUTANEOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN DAILY CLINICAL PRACTICE

Hoffmann-La Roche22 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2015年10月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
22
主要终点
Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)

研究概览

简要总结

This observational trial will evaluate the effectiveness, the consistency of evaluation scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in participants with RA in daily clinical practice.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Participants naive to TCZ or who have received TCZ SC treatment within 8 weeks prior to the enrolment visit can be included
  • Participants in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria

排除标准

  • Participants who have received TCZ >8 weeks prior to the enrolment visit
  • Participants who have previously received TCZ SC
  • Participants who have received treatment with any investigational agent within 4 weeks before starting treatment with TCZ SC

研究组 & 干预措施

Rheumatoid Arthritis participants treated with Tocilizumab SC

Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.

干预措施: Tocilizumab (Drug)

结局指标

主要结局

Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)

时间窗: Up to Week 24

次要结局

  • Percentage of participants to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)(Up to Week 24)
  • Time to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)(Up to Week 24)
  • Time to achieve a major and minor improvement in CDAl (>=13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)(Up to Week 24)
  • Percentage of participants to achieve low disease activity (LDA) using DAS28 (less than or equal to [<=] 3.2), CDAl (<=10.0) and SDAI (<=11 .0)(Up to Week 24)
  • Change from baseline in total tender joint count (TJC)(Up to Week 24)
  • Physician Global Assessment of disease activity VAS score(Up to Week 24)
  • Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)(Up to Week 24)
  • Time to achieve low disease activity (LDA) using DAS28 (<= 3.2), CDAl (<=10.0) and SDAI (<=11 .0)(Up to week 24)
  • Time to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)(Up to Week 24)
  • Correlation Coefficient Between CDAI and simplified disease activity index (SDAI) and Between SDAI and DAS28-ESR(Up to Week 24)
  • Change from baseline in total swollen joint count (SJC)(Up to Week 24)
  • Percentage of participants having TJC <=1(Up to Week 24)
  • Patient Global Assessment of disease activity visual analogue scale (VAS) score(Up to Week 24)
  • Percentage of participants having CRP <=1mg/dl(Up to Week 24)
  • Health Assessment Questionnaire Disability Index (HAQ-DI)(Up to Week 24)
  • EQ-5D-5L Health Questionnaire (EuroQoL)(Up to Week 24)
  • Morisky Medication-Taking Adherence Scale (MMAS)(Up to Week 24)
  • Percentage of participants using TCZ in monotherapy(At baseline)
  • Percentage of participants presenting a high inflammation (DAS28-ESR >5.1)(At baseline)
  • Percentage of participants to achieve a major and minor improvement in CDAl (more than or equal to [>=]13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)(Up to Week 24)
  • Percentage of participants having SJC <=1(Up to Week 24)
  • Percentage of participants using TCZ in combination with disease-modifying antirheumatic drug's (DMARD's)(At baseline)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (22)

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