Phase II Multi-centre, Randomized, Parallel Group, Pilot Trial to Compare the Incidence of Tocilizumab Related Infusion Reactions in Moderate to Severe RA Patients When Infusion is Made Over 1 Hour Against 31 Minutes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 主要终点
- Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion
研究概览
简要总结
This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using 2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion time for the first administration, followed by a 31 minute infusion time for subsequent administrations (unless drug-related infusion reactions occur).The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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;
- •active moderate or severe rheumatoid arthritis;
- •active disease for >6 months;
- •inadequate response to a stable dose of non-biologic DMARDs or antiTNFs.
排除标准
- •rheumatic autoimmune disease other than rheumatoid arthritis;
- •prior history of, or current inflammatory joint disease other than rheumatoid arthritis;
- •major surgery (including joint surgery) within 8 weeks prior to screening, or planned major surgery within 6 months following enrollment.
研究组 & 干预措施
1
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
2
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion
时间窗: Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24
An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion.
次要结局
- Percentage of Participants Achieving a DAS28 Score <3.2 by Visit(Weeks 4, 8, 12, 16, 20 and Final Visit)
- Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response)(Weeks 4, 8, 12, 16, 20 and Final Visit)
- Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response)(Weeks 4, 8, 12, 16, 20 and Final Visit)
- Percentage of Participants Discontinuing Tocilizumab for Any Reason(Weeks 4, 8, 12, 16, 20 and Final Visit)
- Percentage of Participants Achieving a DAS28 Score <2.6 (Remission)(Weeks 4, 8, 12, 16, 20 and Final Visit)
- Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response)(Weeks 4, 8, 12, 16, 20 and Final Visit)
- Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE)(Weeks 4, 8, 12, 16, 20 and Final Visit)
- Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit(Weeks 4, 8, 12, 16, 20 and Final Visit)
- DAS28 Score by Visit(Weeks 4, 8, 12, 16, 20, and Final Visit)
- Erythrocyte Sedimentation Rate(Baseline, Weeks 2, 4, 8, 12,16, 20, and 24)
- C-Reactive Protein (CRP) Levels(Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit)
- HAQ-DI Score by Visit(Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24)
- Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response)(Weeks 4, 8, 12, 16, 20 and Final Visit)
- Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI(Weeks 4, 8, 12, 16, 20 and Final Visit)