EUCTR2019-001754-25-NL进行中（未招募）1 期
sing adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority trail - ADalimumab Dose Optimization in Rheumatoid Arthritis-switch (ADDORA-switch)
Reade0 个研究点目标入组 84 人开始时间: 2019年11月25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
- 84
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
- 性别
- All
入选标准
- •rheumatoid arthritis patient, according to ACR 1987/2010 criteria;
- •failed treatment with adalimumab (defined as DAS28-CRP >2,9)
- •who has agreed to participate (written informed consent);
- •age 18 years or older.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •scheduled surgery during the follow-up of the study or other pre-planned reasons for treatment discontinuation
- •life expectancy shorter than follow-up period of the study;
- •no possibility to safely receive an TNFi or a non TNFi
- •Treatment with all non-TNFi options (abatacept, rituximab, sarilumab and tocilizumab) prior to adalimumab
研究者
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