NCT01667458已完成不适用
F-ACT Trial: Observational Study on Fatigue and Its Evolution During Treatment With Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis in Daily Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 主要终点
- Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16
研究概览
简要总结
This observational study will evaluate the presence and evolution of fatigue on treatment with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to at least two DMARDs (one of them methotrexate) or to anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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, defined as DAS28 >/= 3.7
- •Inadequate clinical response to current treatment with >/= 2 non-biologic DMARDs, 1 of them being methotrexate optimally administered for >/= 3 months, or inadequate clinical response to anti-TNF therapy
- •Eligible for RoActemra/Actemra treatment in daily clinical practice
- •Absence of evolutive tuberculosis (TB)
排除标准
- •Hypersensitivity to tocilizumab or any of the excipients
- •Active, severe infections
- •Pregnant or lactating women
- •Participation in any other interventional study
- •Patients with major depression
结局指标
主要结局
Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16
时间窗: 16 months
次要结局
- Disease Activity Score DAS28(16 months)
- Pain: Visual Analogue Scale VAS Pain(16 months)
- Anemia: Haemoglobin levels(16 months)
- Quality of sleep: VAS(16 months)
- Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue(16 months)
- Functional disability: Health Assessment Questionnaire HAQ(16 months)
- Depression: Beck Depression Inventory (BDI) questionnaire(16 months)
研究者
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