EUCTR2010-018331-18-GB进行中（未招募）不适用
A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Adult (= 18 years) patients with moderate to severe active RA of = 6 months duration
- •DAS28 = 3.2 at screening and baseline
- •Patients must have discontinued biologic DMARDs prior to receiving tocilizumab (patient must have discontinued etanercept for = 2 weeks, infliximab or adalimumab for = 8 weeks, anakinra for = 1 week, rituximab > 24 weeks [or B-cell count has returned to levels prior to treatment and patient meets requirement for active disease])
- •If continuing non-biologic DMARDs, the dose must be stable for 8 weeks
- •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
- •Major surgery (including joint surgery) within 8 weeks prior to screening or not recovered from prior surgery
- •History of or current inflammatory joint disease or rheumatic autoimmune disease other than RA
- •Active current infection or history of recurrent bacterial, viral, fungal, or mycobacterial infection
- •Pregnant women or nursing (breast feeding) mothers
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