A Randomized, Double Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With DMARD Therapy, in Patients With Active Rheumatoid Arthritis and Inadequate Response to Current DMARD Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 9
- 主要终点
- Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24
研究概览
简要总结
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-70 years of age;
- •rheumatoid arthritis for >= 6 months;
- •receiving permitted DMARDs, at a stable dose, for >= 8 weeks prior to baseline;
- •current inadequate clinical response to DMARDs.
排除标准
- •major surgery, including joint surgery, within 8 weeks before entering study, or planned major surgery within 6 months following randomization;
- •rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
- •unsuccessful treatment with an anti-TNF agent;
- •previous treatment with tocilizumab.
研究组 & 干预措施
1
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24
时间窗: Week 24
To achieve an ACR20 response required at least a 20% improvement, compared with baseline, in both (tender joints count)TJC and (swollen joints count) SJC, as well as in 3 out of 5 additional ACR core set variables: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain, health assessment questionnaire disease index (HAQ-DI) and C-reactive protein (CRP). CRP was used primarily for the calculation of the ACR response; if missing, Erythrocyte Sedimentation Rate (ESR) was substituted. ITT sensitivity analysis was carried out using an alternative imputation method (last observation carried forward \[LOCF\]).
次要结局
- Change in Participant's Global Assessment of Pain From Baseline to Week 24(Baseline and Week 24)
- Number of Participants Who Received Escape Therapy(24 Weeks)
- Change in Tender and Swollen Joint Counts From Baseline to Week 24(Baseline and Week 24)
- Change in C-Reactive Protein From Baseline to Week 24(Baseline and Week 24)
- Change in ESR From Baseline to Week 24(Baseline and Week 24)
- Mean Rheumatoid Factor at Baseline and Week 24(Baseline and 24 Weeks)
- Change in Health Assessment Questionnaire - Disease Index (HAQ-DI) From Baseline to Week 24(Baseline and 24 Weeks)
- Percentage of Participants With ACR50 and ACR70 Responses at Week 24(Week 24)
- Change in Physician's Global Assessment of Disease Activity From Baseline to Week 24(Baseline and Week 24)
- Percentage of Participants With Low Disease Activity and in Clinical Remission(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Change in Hemoglobin From Baseline to Week 24(Baseline and 24 Weeks)
- Change in Participant's Global Assessment of Disease Activity From Baseline to Week 24(Baseline and Week 24)
- Percentage of Participants With ACR20 Response by First Week of Onset(Weeks 2, 4, 8, 12, 16, 20, and 24)
- Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score(Baseline and Week 24)
- Time to First Low Disease Activity(Weeks 2, 4, 8, 12, 16, 20, and 24)
- Time to First Remission(Weeks 2, 4, 8, 12, 16, 20, and 24)