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临床试验/EUCTR2018-004605-57-NL
EUCTR2018-004605-57-NL进行中(未招募)1 期

Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients: a randomised, multicenter, non-inferiority trial (TODORA) - Use of TOcilizumab Drug levels to Optimize treatment in RA (TODORA)

Reade0 个研究点目标入组 98 人开始时间: 2019年7月24日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
98

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • -Rheumatoid arthritis according to the ACR 1987 or 2010 criteria;
  • -Current use of subcutaneous tocilizumab 162 mg weekly, for at least the last 6 months;
  • -The treating rheumatologist is convinced of the benefit of tocilizumab continuation;
  • -No changes in the treatment with glucocorticoids and DMARDs such as methotrexate in the past three months;
  • -Written informed consent.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 85
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 13

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • -A scheduled surgery in the next 12 months or other pre-planned reasons for treatment discontinuation.

研究者

发起方
Reade

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