NCT01194401Unknown不适用
A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Long-term Effectiveness and Safety of Tocilizumab in Patients With Active Rheumatoid Arthritis in Daily Practice
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 3,404
- 主要终点
- Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6
研究概览
简要总结
This prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. Data will be collected from patients initiated on RoActemra/Actemra treatment according to label by decision of the treating physician. Anticipated time for data collection from each patient will be 2 years.
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
- •Active moderate to severe rheumatoid arthritis
- •Inadequate response or intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists
- •Prescription of RoActemra/Actemra according to label
排除标准
- 未提供
结局指标
主要结局
Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6
时间窗: 5 years
次要结局
- Safety: Incidence of adverse events(5 years)
- Factors related to response (C-reactive protein, rheumatoid factor, inadequate response to DMARDs or anti-TNF, duration of illness)(5 years)
- Time to DAS28 remission(5 years)
- Proportion of patients with good or moderate response according to EULAR criteria(5 years)
- Time to good or moderate response according to EULAR criteria(5 years)
- Dose-modifications and discontinuations of RoActemra/Actemra(5 years)
- Efficacy of other possible RA therapies in case of inadequate response to RoActemra/Actemra (DAS28, EULAR criteria)(5 years)
- Safety of other possible RA therapies in case of inadequate response to RoActemra/Actemra (adverse events)(5 years)
研究者
相似试验
已完成
不适用
A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in ChinaPsoriasisNCT04894890Novartis Pharmaceuticals1,002
已完成
不适用
PRospectIve ObseRvatIonal mulTicenter Study of Patients With Arterial hYpertension and CKD in the Population of RussiaArterial Hypertension, Chronic Kidney DiseaseNCT06372431AstraZeneca9,914
招募中
不适用
Registry Study in MSI/dMMR Solid TumorsDMMR CancerMSI-HSolid TumorNCT06004713Peking University Cancer Hospital & Institute190
终止
不适用
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in VietnamHepatitis B, ChronicNCT01886300Hoffmann-La Roche16
已完成
不适用
Long Term Study of Fingolimod in MS Patients From the FTY Clinical ProgramMultiple SclerosisNCT01281657Novartis64