NCT01214733已完成3 期
An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Safety (incidence of adverse events)
研究概览
简要总结
This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid arthritis. Patients who successfully completed studies WA17823 and WA18696 in South Africa are eligible to participate in this study. Patients will be allowed DMARDs according to the treatment they received in the previous studies. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 104 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/=18 years of age
- •Moderate to severe rheumatoid arthritis of more than 6 months duration upon entering the study
- •Patients successfully completed studies WA17823 and WA18696 in South Africa
- •Body weight <150 kg
排除标准
- •Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug in studies WA17823 and WA18696
- •Previous treatment with any cell depleting therapies
- •Treatment with intravenous gamma globulin, plasmapheresis or Prosorba(TM) column since the last administration of study drug in studies WA17823 and WA18696
研究组 & 干预措施
1
Experimental
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Safety (incidence of adverse events)
时间窗: 104 weeks
Safety (laboratory assessments e.g. hematology)
时间窗: 104 weeks
次要结局
- Efficacy: Change in Disease Activity Score (DAS28)(104 weeks)
研究者
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