"Effectiveness After Four and Twentyfour Weeks and Safety of Tocilizumab in Patients With Active RA"
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 286
- 主要终点
- Percentage of Participants With Low Disease Activity Score at Week 24
研究概览
简要总结
This single arm study will assess the effectiveness of tocilizumab in combination with traditional DMARDs with regard to the clinical improvement in disease activity (achievement of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have had an inadequate response to current traditional DMARD and/or anti-TNF therapy. Patients will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing DMARDs at the stable pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular treatment period and a further 6 infusions during an optional extension phase. The anticipated time on study treatment is 6 to 12 months, and the target sample size is <500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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;
- •rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria;
- •DAS28 of >3.2;
- •At screening either ESR >=28 mm/h or CRP >=1 mg/dL;
- •Having received permitted DMARDs, 1 or more; current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.
排除标准
- •major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening;
- •functional class IV as identified by the ACR classification of functional status in RA;
- •rheumatoid autoimmune disease other than RA;
- •prior history of or current inflammatory joint disease other than RA.
研究组 & 干预措施
Tocilizumab
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Percentage of Participants With Low Disease Activity Score at Week 24
时间窗: Week 24
Low Disease Activity Score (LDAS) is defined as Disease Activity score less than or equal to (≤ ) 3.2. Disease activity score 28 (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and global health assessment (participant rated global assessment of disease activity using 100-mm Visual analog scale \[VAS\]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
次要结局
- Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24(Week 24)
- Change From Baseline in Short Form-36 (SF-36) Score at Week 24(Week 24)
- Participant's Global Assessment of Pain as Assessed by Patient Take Home Form (PTHF)(Baseline and Weeks 1, 2, and 4)
- Duration of Morning Stiffness as Assessed Using PTHF(Baseline, Weeks 1, 2, and 4)
- Percentage of Participants With an American College of Rheumatology 20%, 50%, or 70% (ACR20/ACR50/ACR70) Response(Weeks 1, 2, 4, 8, 12, 16, 20 and 24)
- Change From Baseline in Swollen and Tender Joint Counts at Week 24(Week 24)
- Absolute Changes in DAS28 From Baseline(Weeks 1, 2, 4, 8, 12, 16, 20 and 24)
- Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category(Week 24)
- Percentage of Participants With a DAS28 Response at Weeks 4 and 24(Weeks 4 and 24)
- Change From Baseline in the Levels of C-Reactive Protein at Week 24(Week 24)
- Change From Baseline in Participant's Global Assessment of Pain (VAS) at Week 24(Week 24)
- Change From Baseline in Participant and Physician Assessment of Global Disease Activity (VAS) at Week 24(Week 24)
- Change From Baseline in Clinical Disease Activity Index (CDAI) Score(Weeks 1, 2, 4, 8, 12, 16, 20 and 24)
- Change From Baseline in HAQ-DI at Week 24(Week 24)
- Participant Assessment of Fatigue/Tiredness as Assessed Using PTHF(Baseline and Weeks 1, 2 and 4)
- Treatment Satisfaction Questionnaire for Medication (TSQM) Score(Week 24)
- Changes in Hemoglobin(Baseline, Weeks 1, 2, 4 and 24)
- Changes in C-Reactive Protein(Baseline, Weeks 1, 2 ,4 and 24)
- Changes in Erythrocyte Sedimentation Rate (ESR)(Baseline, Weeks 1, 2, 4 and 24)
- Percentage of Participants Withdrawing From Study Treatment Because of Insufficient Therapeutic Response(Weeks 1, 2, 4, 8, 12, 16, 20 and 24)