EUCTR2010-018375-22-LT进行中（未招募）不适用
A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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
- 性别
- All
入选标准
- •Adult patients >= 18 years
- •Rheumatoid arthritis of >= 6 months duration
- •Swollen joint count (SJC) = 4 (66 joint count), and tender joint count (TJC) = 4 (68 joint count) both at screening and baseline visits
- •At screening, CRP =10 mg/L (= 1 mg/dL) and/or ESR = 28 mm/h
- •Have to be on at least one permitted DMARD, which has been at a stable dose for at least 8 weeks prior to baseline
- •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 1043
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 219
排除标准
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomisation
- •Prior history of or current inflammatory joint disease other than RA
- •Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples are CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20.
- •Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
- •Active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds).
研究者
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