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.
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