NL-OMON52747招募中不适用
sing adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): a blinded randomized superiority trail - ADDORA-switch
Reade0 个研究点目标入组 84 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
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Rheumatoid arthritis patient, according to ACR 1987/2010 criteria;
- •Failed treatment with adalimumab (defined as DAS28-CRP >2,9) and not treated
- •with a subsequent biological DMARD (bDMARD) or target synthetic DMARD (tsDMARD)
- •Who has agreed to participate (written informed consent);
- •Age 18 years or older.
- •Received adalimumab for at least 10 weeks in standard dosing (40mg
- •subcutaneously every other week, either in monotherapy or combined with
- •methotrexate or leflunomide)
- •Stop adalimumab due to inefficacy, either alone or combined with side effects
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 TNF-inhibitor or a non-TNF-inhibitor '
- •Treatment with another TNF inhibitor prior to adalimumab
- •Treatment with all non-TNFi options (abatacept, rituximab, sarilumab,
- •tocilizumab, baricitinib, filgotinib, upadacitinib or tofacitinib) prior to
研究者
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