A 1 Year Observational Study of the Use of Etanercept in Routine German Clinical Practice to Treat Rheumatoid Arthritis Patients: a Health Economic, Safety and Effectiveness Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 4,945
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26
研究概览
简要总结
The diagnosis, evaluation and treatment of rheumatoid arthritis (RA) continue to undergo rapid change. Randomized controlled trials such as the TEMPO study have demonstrated the efficacy and safety of the combination of etanercept and methotrexate. Importantly, the TEMPO study showed that patients treated with etanercept and methotrexate could reach the newer therapeutic goals of low disease activity and remission, and that the physicians, patients, and payers are no longer prepared to accept the goal of "Reduction of symptoms". RCT are important and powerful tools in assessing efficacy and safety but have their limitations in terms of generalisability. In order to assess health economics, clinical effectiveness and safety of etanercept, they need to be measured by performing observational studies of unselected patients. This study aims to provide a holistic assessment of patients receiving etanercept in a real world setting. This will include centers that would not normally take part in RCT. The study will assess treatment with etanercept with descriptive statistics of the following parameters: Health economic, Safety, Effectiveness. In addition, there was a previous study of similar design, but of only 3 months duration (101354), which will allow comparison with historical data. Since previous study, there have been a number of significant changes: Introduction of a new formulation for etanercept (Enbrel® 50mg · once weekly), Definition of early RA has been modified to short disease duration (from 3 months to 1 year).
详细描述
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
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
- •Clinical diagnosis of rheumatoid arthritis
排除标准
- •Sepsis or risk for sepsis,
- •Acute infection,
- •Hypersensitivity against Etanercept
研究组 & 干预措施
Patients with Rheumatoid Arthritis
干预措施: etanercept (Drug)
结局指标
主要结局
Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26
时间窗: Week 26
Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of \>= 83%.
Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52
时间窗: Week 52
Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores \* 100%) / (2 \* number of answered questions), ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of \>= 83%.
次要结局
- Duration of Working Disability(Baseline, Week 26, Week 52)
- Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)(Baseline, Week 26, Week 52)
- Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)(Baseline, Week 26, Week 52)
- Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)(Baseline, Week 26, Week 52)
- Healthcare Resource Utilization(Baseline, Week 26, Week 52)
- Duration of Healthcare Resources Utilization(Baseline, Week 26, Week 52)
- C-Reactive Protein (CRP)(Baseline, Week 2, 6, 12, 26, 38, 52)
- Fatigue Visual Analog Scale (VAS)(Baseline, Week 26, 52)
- Disease Activity Score Based on 28-Joints Count (DAS28)(Baseline, Week 2, 6, 12, 26, 38, 52)
- Swollen Joints Count (SJC)(Baseline, Week 2, 6, 12, 26, 38, 52)
- Tender Joints Count (TJC)(Baseline, Week 2, 6, 12, 26, 38, 52)
- Erythrocyte Sedimentation Rate (ESR)(Baseline, Week 2, 6, 12, 26, 38, 52)
- Percentage of Participants With Remission Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)(Week 2, 6, 12, 26, 38, 52)
- Percentage of Participants With Response Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)(Week 2, 6, 12, 26, 38, 52)
- Duration of Morning Stiffness(Baseline, Week 2, 6, 12, 26, 38, 52)
- Patient Global Assessment of Arthritis Pain(Baseline, Week 2, 6, 12, 26, 38, 52)
- Physician Global Assessment of Disease Activity(Baseline, Week 2, 6, 12, 26, 38, 52)
- Patient Global Assessment of Disease Activity(Baseline, Week 2, 6, 12, 26, 38, 52)