An Open Label Study to Evaluate the Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24
研究概览
简要总结
This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.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
- 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;
- •rheumatoid arthritis diagnosed >8 weeks and <4 years prior to baseline;
- •naive to, or not responding well to, methotrexate;
- •swollen joint count >=8 (66 joint count) and tender joint count>=8 (68 joint count) at screening and baseline.
排除标准
- •rheumatic autoimmune disease other than rheumatoid arthritis;
- •patients with functional class IV rheumatoid arthritis;
- •history of, or current, inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder.
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 Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24
时间窗: Week 24
ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale \[VAS\]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.
次要结局
- Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) at Week 24(Week 24)
- Percentage of Participants With Low Disease Activity at Week 24 Assessed Using DAS28-ESR(Week 24)
- Time to Onset of ACR20/50/70 Response(Weeks 4, 8, 12, 16, 20, and 24)
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline and Week 24(Baseline and Week 24)
- Percentage of Participants With Disease Remission at Week 24 Assessed Using DAS28-ESR(Week 24)
- Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) at Week 24(Week 24)
- Disease Activity Score Based on 28 Joint Count - Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline and Week 24(Baseline and Week 24)
- HAQ Disability Index (HAQ-DI) Score at Baseline and Week 24(Baseline and Week 24)