NCT02251860已完成不适用
A Prospective, Non-Interventional Study in Germany to Evaluate the Long-Term Effectiveness and Tolerability of Subcutaneously Administered RoActemra® (Tocilizumab; TCZ) in Patients With Rheumatoid Arthritis in Daily Clinical Practice (as Recommended in Label)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,454
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Clinical Remission Defined by Disease Activity Score based on 28 Joints-Erythrocyte Sedimentation Rate (DAS28-ESR) in Participants with Previous Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) Treatment
研究概览
简要总结
ARATA is a prospective, non-interventional, multicenter, observational study in Germany to evaluate the long-term effectiveness and tolerability of subcutaneously administered tocilizumab in participants with rheumatoid arthritis in daily clinical practice. Participants will be followed over an observation period of up to 2 years after the initial injection.
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
- •Participants who have not yet been treated with tocilizumab
- •Participants who have received the first injection with tocilizumab maximum 1 month before inclusion in the study and the necessary baseline data and disease characteristics are present
排除标准
- •Participants who at the time of the study inclusion are participating in a different interventional study on rheumatoid arthritis
结局指标
主要结局
Percentage of Participants with Clinical Remission Defined by Disease Activity Score based on 28 Joints-Erythrocyte Sedimentation Rate (DAS28-ESR) in Participants with Previous Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) Treatment
时间窗: Up to Week 104
Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants
时间窗: Up to Week 104
次要结局
- Health Assessment Questionnaire-Disability Index (HAQ-DI) Score(Up to Week 104)
- Response to Follow-up Treatment in Case of Switch from Tocilizumab(Up to Week 104)
- Percentage of Participants with Adverse Events During Follow-up Treatment(Up to Week 104)
- Percentage of Participants with Dose Reduction for Concomitant GCs(Up to Week 104)
- Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA)(Up to Week 104)
- Percentage of Participants with Concomitant Treatment with Methotrexate (MTX)(Up to Week 104)
- Percentage of Participants with Clinical Remission Defined by Clinical Disease Activity Index (CDAI)(Up to Week 104)
- Change from Baseline in Mean CDAI Score(Baseline up to Week 104)
- Mean Dose Used for Concomitant GCs(Up to Week 104)
- Percentage of Participants by Type of Physical Exercise(Up to Week 104)
- Percentage of Participants with Continuation of Tocilizumab(Up to Week 104)
- Mean Retention Time of Tocilizumab(Up to Week 104)
- Percentage of Participants with Low Disease Activity Defined by DAS28-ESR(Up to Week 104)
- Percentage of Participants with Low Disease Activity Defined by CDAI(Up to Week 104)
- Percentage of Participants with Critical Difference Related to DAS28 (Dcrit)-Response(At Month 3 and Month 6)
- Treatment Satisfaction Visual Analogue Scale (VAS)(Up to Week 104)
- Percentage of Participants by Frequency of Physical Exercise(Up to Week 104)
- Sleep Disturbance-VAS(Up to Week 104)
- Beck Depression Inventory (BDI) Questionnaire(Up to Week 104)
- Change from Baseline in Mean DAS28-ESR Score(Baseline up to Week 104)
- Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment(From Baseline up to tocilizumab treatment discontinuation (Up to Week 104))
- Percentage of Participants with Concomitant Treatment with Glucocorticoids (GCs)(Up to Week 104)
- Treatment User-Friendliness VAS(Up to Week 104)
- Percentage of Participants with Treatment Adherence(Up to Week 104)
- Hannover Functional Ability Questionnaire (FFbH) Score(Up to Week 104)
- Percentage of Participants by Duration of Physical Exercise(Up to Week 104)
- Fatigue-VAS(Up to Week 104)
- State-Trait Anxiety Inventory (STAI) Questionnaire(Up to Week 104)
研究者
研究点 (1)
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