A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 326
- 主要终点
- Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)
研究概览
简要总结
This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.
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.
- •Rheumatoid arthritis of > 6 months duration.
- •Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.
- •All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.
- •Weight ≤ 150 kg.
排除标准
- •Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline.
- •History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
- •Treatment with a biologic agent at any time prior to baseline.
- •Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.
- •Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.
研究组 & 干预措施
Tocilizumab 8 mg/kg
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
干预措施: Tocilizumab (Drug)
Tocilizumab 8 mg/kg
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
干预措施: Placebo to adalimumab (Drug)
Adalimumab 40 mg
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
干预措施: Adalimumab (Drug)
Adalimumab 40 mg
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
干预措施: Placebo to tocilizumab (Drug)
结局指标
主要结局
Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)
时间窗: Baseline to Week 24
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \[symptom-free and no arthritis symptoms\], right end = maximum disease activity \[maximum arthritis disease activity\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and \> 2 years) and region (US and non-US).
次要结局
- Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24(Week 24)
- Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24(Week 24)
- Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24(Baseline to Week 24)
- Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24(Baseline to Week 24)
- Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24(Baseline to Week 24)