EUCTR2006-005386-19-BE进行中（未招募）1 期
Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •Diagnosis of RA (according to ACR criteria)
- •Active RA defined by a DAS28-CRP score > 5.1 or >3.2 with a swollen joint count = 8
- •Presence of knee arthralgia or synovitis
- •Failure to at least one TNF blocker (Remicade, Enbrel, Humira)
- •Stable therapy with MTX, corticosteroïds or NSAIDs
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous Rituximab treatment
- •Exclusion for general safety (history of severe allergic reaction, sepsis, malignancy within 5 years, pregnancy, severe heart failure)
- •Excluded Concomitant Medications :
- •Concurrent treatment with other DMARDs than MTX or any anti-TNF and biological therapies. Enbrel, Remicade and Humira should be respectively stopped 4, 8 and 8 weeks before inclusion.
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