An Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
研究概览
简要总结
This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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;
- •inadequate response to current non-biologic DMARDs
排除标准
- •rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
- •previous treatment with other biologics.
研究组 & 干预措施
1
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
时间窗: Baseline up to Week 24
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.
次要结局
- Disease Activity Score (DAS28)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response(Weeks 4, 8, 12, 16, 20, and 24)
- C-Reactive Protein (CRP) Level(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Erythrocyte Sedimentation Rate (ESR)(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Neutrophil Count(Baseline, Weeks 4, 8, and 12)
- Percentage of Participants Who Discontinued the Study(Up to Week 24)
- Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal(Up to Week 24)
- Percentage of Participants With Lipid Level Elevations(Week 24)