Rheumatoid Arthritis Patients Treated With Tocilizumab in Real Clinical Practice: Effectiveness and Safety (TRUST Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 322
- 主要终点
- Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment
研究概览
简要总结
This observational study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis. Data will be collected from patients for the 12 months following the first infusion of RoActemra/Actemra.
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
- •Rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria
- •Initiated on RoActemra/Actemra treatment according to the Summary of Product Characteristics not more than 6 months before opening of study center
排除标准
- •Current serious infection
- •Hypersensitivity to the active component or any of the excipients
- •Pregnant women
结局指标
主要结局
Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment
时间窗: Up to 12 months
Low disease activity is defined as a disease activity score based on 28 joint count (DAS28) score lesser or equal to (\</=) 3.2. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. Erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) measurement, 4. Participant's judgement on his own overall health status expressed by a visual analogue scale (VAS). The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. Percentage of participants with low disease activity was reported.
Percentage of Participants Achieving Disease Remission After 6 Months of Treatment
时间窗: Up to 12 months
Disease remission is defined as a DAS28 score \< 2.6. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. Percentage of participants with disease remission was reported.
次要结局
- Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab(Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12)
- Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab(Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12)
- Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab(Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12)
- Number of Participants With Concomitant Medications(Up to 12 months)
- Percentage of Participants Discontinuing Treatment With Tocilizumab(Up to 12 months)
- Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand.(Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12)
- Number of Participants With Any Adverse Events and Serious Adverse Events(Up to 12 months)
- Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion(Up to 12 months)
- Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand.(Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12)
- Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand(Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12)
- Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand.(Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12)
- Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents(Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12)
- Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents(Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12)
- Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents(Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12)