NCT01338545已完成不适用
A Multi-centre Observational Study to Describe Usage and Dosification Patterns of RoActemra (Tocilizumab) Treatment in Rheumatoid Arthritis (RA) Patients in the Routine Clinical Practice. ACT-LIFE Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons
研究概览
简要总结
This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from each patients for 12 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 rheumatoid arthritis (RA) of at least 6 months duration
- •Non-responder or intolerant to at least one DMARD or TNF inhibitor treatment
- •Initiated on treatment with RoActemra according to Summary of Product Characteristics (SPC) indications
排除标准
- •History of autoimmune disease or of any joint inflammatory disease other than RA
- •Pregnant or lactating women
- •Patients who have started RoActemra treatment in a clinical trial or for compassionate use
- •Treatment with any investigational drug in the previous 4 weeks (or at least 5 times the half-life of the drug)
结局指标
主要结局
Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons
时间窗: 12 months
次要结局
- Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors(12 months)
- Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI)(12 months)
- Response rate according to EULAR (European League Against Rheumatism) criteria(12 months)
- Safety: Incidence of adverse events(12 months)
- Quality of life (Visual Analogue Scales, Health Assessment Questionnaire)(12 months)
- Effect on DMARD tolerance/dosage in combination therapy(12 months)
- Dosages used in clinical practice(12 months)
研究者
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