A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 主要终点
- Percentage of Participants Achieving Disease Remission at Month 12 Assessed Using the Disease Activity Score Based on 28-Joint Count (DAS28)
研究概览
简要总结
This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.
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
- 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, over the age of 18 years
- •Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2 years duration
- •DAS28 >3.2
- •Swollen joint count (SJC) >/=6 (66 joint count), and tender joint count (TJC) >/=6 (68 joint count)
- •Patients who have received DMARDs (including methotrexate) for 3-7 months
排除标准
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
- •Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens syndrome or nodulosis with RA is permitted)
- •Functional class III or IV as defined by ACR Classification of Functional Status in Rheumatoid Arthritis
- •Prior history of or current inflammatory joint disease other than RA
研究组 & 干预措施
1
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
2
干预措施: DMARD (Drug)
结局指标
主要结局
Percentage of Participants Achieving Disease Remission at Month 12 Assessed Using the Disease Activity Score Based on 28-Joint Count (DAS28)
时间窗: Month 12
The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts (SJC and TJC), acute phase response, and general health status. For this study Erythrocyte sedimentation Rate (ESR) was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula: DAS28 equals (=) 0.56 times (×) square root of √(TJC) plus (+) 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant's global assessment of disease activity (100-mm Visual Analog Scale \[VAS\]). DAS28 less than/equal to (≤) 2.6 defined remission.
次要结局
- Number of Hours Absent From Work(Baseline and 6 and 12 months)
- Percentage of Participants Achieving Disease Remission at Month 6 Assessed Using DAS28(Month 6)
- Percentage of Participants Achieving Responses According to American College of Rheumatology (ACR) Criteria(Months 6 and 12)
- Percentage of Participants Achieving Remission at Months 6 and 12 Assessed Using Clinical Activity Disease Index (CDAI)(Months 6 and 12)
- Change From Baseline to Months 6 and 12 in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT F) Scores(Baseline and Months 6 and 12)
- Change From Baseline to Months 6 and 12 in European Quality of Life-5D (EQ-5D) Score(Baseline and Months 6 and 12)
- Change From Baseline to Months 6 and 12 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score(Baseline and Months 6 and 12)