Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the 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 DMARD and/or Anti- TNF Therapy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 95
- 主要终点
- Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events
研究概览
简要总结
This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
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 (DAS28 >3.2) of 6 months duration
- •inadequate clinical response to non-biologic DMARDs or anti-TNF
- •bodyweight </=150 kg
排除标准
- •rheumatic autoimmune disease or inflammatory joint disease other than RA
- •major surgery within 8 weeks prior to screening or planned major surgery within 6 months following screening
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 Reporting Any Adverse Event - Overall Summary of Events
时间窗: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Percentage of participants with a serious adverse event (SAE), who died, with an adverse event (AE), or study drug related AE during the study.
次要结局
- Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
- Time to DAS28 Response by DAS28 Category(Weeks 4, 8, 12, 16, 20, and 24)
- Erythrocyte Sedimentation Rate(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units(Weeks 4, 8, 12, 16, 20, and 24)
- C-Reactive Protein (CRP) Values by Study Visit(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With Improvement in Physical Function by HAQ-DI Category(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- HAQ-DI Score by Visit(Baseline and Weeks 4, 8, 12, 16, 20, and 24)