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临床试验/NCT01921478
NCT01921478已完成不适用

Retrospective, Multi-center, Observational Study of Daily Practice Patterns and Outcomes of the Management of Rheumatoid Arthritis Patients Without Documented Erosions Treated With RoACTEMRA in Belgium

Hoffmann-La Roche0 个研究点目标入组 77 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
主要终点
Joint erosion assessment in clinical practice

研究概览

简要总结

This retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Adult patients, >=18 years of age
  • Diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a DAS28 >=5.1
  • Inadequate responder to at least 2 non-biological DMARDs
  • Absence of documented erosions at start of RoActemra/Actemra treatment
  • Received RoActemra/Actemra treatment for at least 6 months
  • Availability of data from at least the RoActemra/Actemra treatment initiation visit and the 6 months visit

排除标准

  • Contraindications for treatment with RoActemra/Actemra

结局指标

主要结局

Joint erosion assessment in clinical practice

时间窗: 6 months

次要结局

  • Evolution of the pattern of joint erosion(6 months)
  • Disease Activity Score 28(6 months)
  • Patient's global assessment of disease activity (Visual Analogue Scale)(6 months)
  • C-reactive protein assessment(6 months)
  • Swollen joint counts(6 months)
  • Tender joint counts(6 months)
  • Erythrocyte Sedimentation Rate(6 months)

研究者

申办方类型
Industry
责任方
Sponsor

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