NCT01663506已完成不适用
A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation
研究概览
简要总结
This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the local label will be followed 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 according to the revised (1987) ACR criteria
- •Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 week prior to the enrolment visit
排除标准
- •Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
- •Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
- •Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- •History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
结局指标
主要结局
Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation
时间窗: 6 Months
次要结局
- Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation(Month 12)
- Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity(Up to Month 12)
- Number of Participants With Comorbidities at Baseline(Baseline)
- Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)(Baseline)
- Number of Participants With Prior Exposure of Biologics(Baseline)
- Disease Activity Score Based on 28-joints Count (DAS28)(Baseline, Month 3, 6, and 12)
- Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28(Month 3, 6, and 12)
- Physician Global Assessment (PGA) of Disease Activity(Baseline, Month 6, and 12)
- Patient Global Assessment (PtGA) of Disease Activity Score(Baseline, Month 6, and 12)
- Health Assessment Questionnaire-Disability Index (HAQ-DI) Score(Baseline, Month 6, and 12)
- Visual Analog Scale (VAS)-Pain(Baseline, Month 6, and 12)
- Visual Analog Fatigue Scale (VAFS)(Baseline, Month 6, and 12)
- Visual Analog Scale-Morning Stiffness (VAS-MS)(Baseline, Month 6, and 12)
- Erythrocyte Sedimentation Rate (ESR)(Baseline, Month 6, and 12)
- C-Reactive Protein (CRP)(Baseline, Month 6, and 12)
- Number of Swollen and Tender Joints Based on 66 and 68 Joints(Baseline, Month 6, and 12)
- Number of Swollen and Tender Joints Based on 28 Joints(Baseline, Month 6, and 12)
- Simplified Disease Activity Index (SDAI) Score(Baseline, Month 6, and 12)
- Clinical Disease Activity Index (CDAI) Score(Baseline, Month 6, and 12)
- Number of Participants Who Received Tocilizumab as Monotherapy(Baseline, Study end (at Month 12 or at time of study discontinuation))
- Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)(Baseline, Study end (at Month 12 or at time of study discontinuation))
- Number of Participants Receiving Oral Corticosteroids(Baseline, Month 3, 6, and 12)
- Number of Participants With Disease Activity Status Based on DAS28 Score(Baseline, Month 3, 6, and 12)
- Number of Participants With Disease Activity Status Based on SDAI Score(Baseline, Month 3, 6, and 12)
- Number of Participants With Disease Activity Status Based on CDAI Score(Baseline, Month 3, 6, and 12)
研究者
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