EUCTR2019-000505-72-NL进行中（未招募）1 期
Pragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT)
Transparency in Healthcare0 个研究点目标入组 200 人开始时间: 2019年2月18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
- 200
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
- •Clinical diagnosis of RA
- •Active disease (DAS28> 3.2 )
- •Former treatment according to T2T principles, at the discretion of the attending rheumatologist, i.e. past treatment decisions informed by disease activity measurements
- •Previous use of at least one csDMARD
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •Disease duration >5 years
- •Previous treatment with any biological DMARD or tsDMARD
- •Contraindication for either TNFi or baricitinib
- •Latent or active tuberculosis
- •Active or recurrent infections
- •3x upper limit of normal ALAT
- •GFR < 30 ml/min.
- •Failure to provide written informed consent
- •Refusal to use effective contraceptive during the study period
研究者
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