Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 28
- 主要终点
- Health Assessment Questionnaire (HAQ) Score
研究概览
简要总结
This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •moderate to severe active rheumatoid arthritis of >/=6 months duration
- •inadequate clinical response to current non-biologic DMARDs
- •current DMARDs must be at stable dose for 8 weeks prior to study entry
- •oral corticosteroids (</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for >/=4 weeks prior to screening
排除标准
- •rheumatic autoimmune disease other than RA
- •history of or current inflammatory joint disease other than RA
- •previous treatment with any biologic DMARD
- •functional class IV as defined by the ACR classification
- •intra-articular or parenteral corticosteroids within 6 weeks prior to screening
研究组 & 干预措施
1
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
1
干预措施: DMARDs (disease-modifying antirheumatic drugs) (Drug)
结局指标
主要结局
Health Assessment Questionnaire (HAQ) Score
时间窗: Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study.
Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment
时间窗: Weeks 4, 8, 12, 16, 20, and 24
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Change in HAQ Score at Week 24
时间窗: Baseline and Week 24
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
次要结局
- Pain Score as Assessed by Visual Analogue Scale (VAS)(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Change in EQ-5D Score at Week 24 From Baseline(Baseline and Week 24)
- General Health Score as Assessed by EQ-5D VAS(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Change in General Health Assessed by VAS(Baseline and Week 24)
- Disease Activity Score Based on 28-Joint Count (DAS28)(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Change in DAS28 Score From Baseline to Week 24(Baseline and Week 24)
- Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment(Weeks 0, 4, 8, 12, 16, 20, and 24)
- European Quality of Life - 5 Dimensions (EQ-5D) Score(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28(Weeks 4, 8, 12, 16, 20, and 24)
- C-Reactive Protein(Weeks 4, 8, 12, 16, 20, and 24)
- Erythrocyte Sedimentation Rate(Weeks 4, 8, 12, 16, 20, and 24)