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临床试验/NL-OMON36162
NL-OMON36162撤回4 期

Effects of Tocilizumab (RoACTEMRA) on biomarkers in synovial tissue of patients with rheumatoid arthritis - Mode of Action Tocilizumab

Academisch Medisch Centrum0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • males/females suffering form RA according to the ACR/EULAR 2010 classification criteria
  • active disease das 28 * 3.2 despite adequate MTX treatment
  • ARA functional classes I, II and III
  • * 18 and * 70 years of age
  • stable MTX treatment (5 - 30 mg/week) for at least 28 days
  • inflamed knee, ankle or wrist joint

排除标准

  • Breastfeeding;
  • Subjects who are impaired, incapacitated, or incapable of completing study related assessments;
  • Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematosus);
  • Subjects who have previously received treatment with tocilizumab;
  • Current use of oral corticosteroids (if exceeding a prednisone equivalent of 10 mg daily) or DMARDs other than MTX; intra-articular injections of corticosteroids 28 days or less before inclusion.
  • Current use of TNF blocking agents, such as etanercept, adalimumab, infliximab, golimumab or certlizumab. Washout periods are depending on pharmacokinetic profile of the various agents
  • Rituximab en abatacept washout
  • Subjects with active vasculitis of a major organ system with the exception of rheumatoid nodules.

研究者

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