A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 619
- 主要终点
- Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24
研究概览
简要总结
This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 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 —（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 rheumatoid arthritis of >6 months duration
- •Received permitted DMARDs each at a stable dose for at least 7 weeks prior to baseline
排除标准
- •Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
- •Major surgery within 8 weeks prior to screening or planned within 6 months following randomization
- •Unsuccessful treatment with a biologic agent, including an anti-TNF agent
- •Previous treatment with tocilizumab
研究组 & 干预措施
Tocilizumab 8 mg/kg + DMARDs
干预措施: Tocilizumab (Drug)
Tocilizumab 8 mg/kg + DMARDs
干预措施: Permitted DMARDs (Drug)
Placebo + DMARDs
干预措施: Placebo (Drug)
Placebo + DMARDs
干预措施: Permitted DMARDs (Drug)
结局指标
主要结局
Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24
时间窗: Baseline to Week 24
Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein or, if missing, erythrocyte sedimentation rate.
次要结局
- Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Weeks 4, 8, 12, 16, 20, and 24(Baseline to Weeks 4, 8, 12, 16, 20, 24)
- Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 4, 8, 12, 16, 20, and 24(Baseline to Weeks 4, 8, 12, 16, 20, 24)
- Percentage of Patients With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 4, 8, 12, 16, 20, and 24(Baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Mean Change From Baseline in the Routine Assessment Patient Index Data (RAPID) Score at Weeks 4, 8, 12, 16, 20, and 24(Baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Mean Change From Baseline in 12-Item Short Form Health Survey v2 (SF-12) Scores at Weeks 4, 8, 12, 16, 20, and 24(Baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 4, 8, 12, 16, 20, and 24(Baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Mean Change From Baseline in the Medical Outcomes Study (MOS) Sleep Scale Score at Weeks 4, 8, 12, 16, 20, and 24(Baseline to Weeks 4, 8, 12, 16, 20, and 24)
- Mean Change From Baseline in Individual Components of the Routine Assessment Patient Index Data (RAPID) at Each Day During the First 7 Days of Treatment(Baseline through Day 7)
- Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Day 7(Baseline to Day 7)
- Mean Change From Baseline in C-reactive Protein (CRP) at Days 3 and 7(Baseline to Days 3 and 7)