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临床试验/NL-OMON47003
NL-OMON47003已完成不适用

Synovial Tissue characteristics in Rheumatoid Arthritis patients TreAted with their FIrst Tnf-inhibitor - STRATAFIT

niversitair Medisch Centrum Utrecht0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50

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

  • * Age * 18 years
  • * Fulfilling 2010 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for RA (Appendix A).
  • * DAS28 * 3.2
  • * At least one clinically active wrist or knee or MCP joint
  • * Start with aTNFi (all currently approved TNFi are allowed* infliximab (3 mg/kg at week 0, 2, 6 and 14), etanercept, adalimumab, golimumab, certolizumab pegol) within 4 weeks from the baseline study visit.
  • * Having insufficient response to treatment with * 2 conventional DMARDs.
  • * Current treatment with either methotrexate (*10 mg/week), sulfasalazine (*2000 mg/day), hydroxychloroquine (*200 mg/day), and/or leflunomide (*10 mg/day).
  • * Naïve to previous biological treatment regimens, including other TNFi, rituximab, abatacept, tocilizumab (and biosimilar equivalents).

排除标准

  • * Treatment with systemic glucocorticoids at a dose above 10 mg/day of prednisone or equivalent within 4 weeks of enrolment.
  • * Treatment with intra-articular glucocorticoids in a knee or wrist or MCP joint within 3 months of enrolment.
  • * Any rheumatic disease other than RA (except secondary Sjogren*s syndrome)

研究者

发起方
niversitair Medisch Centrum Utrecht

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