A Multicenter Non-interventional Study To Observe The Safety And Efficacy Of Etanercept (Enbrel (Registered)) In Patients With Moderately Active Rheumatoid Arthritis In Every Day Clinical Practice In Austria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 111
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24
研究概览
简要总结
This is a prospective non-interventional observational study to evaluate the treatment of moderately active RA patients in every day clinical practice in Austria. Patients will be observed over 52 weeks. The primary endpoint will be percentage of patients who reach CDAI remission after 24 weeks.
详细描述
Non-interventional observational study, national, multicenter prospective non-interventional study (NIS) as defined by the Austrian Drug Law § 2a Section 3 N/A
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •The patient is eligible to receive Etanercept treatment according to the Austrian SmPC.
- •The decision to treat the patient with Etanercept has been made independently by the physician and is clearly separated from the decision to include the patient in the study. The treatment decision was made in advance and is not dependent on the protocol.
- •The patient was informed about the study and gave his/her consent and signed an Independent Ethics Committee (IEC) submitted written Informed Consent form on use of the data.
- •The patient has moderately active RA, defined as a disease activity of CDAI >10 and ≤22 and/or DAS28 (CRP)>3.2 and ≤ 5.1
排除标准
- •Any contraindication according to the Austrian SmPC, which includes:
- •A hypersensitivity to any component of Etanercept, active tuberculosis or any other serious infection.
- •Patient has previously participated in this study.
结局指标
主要结局
Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24
时间窗: Week 24
CDAI is a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (\<=) 2.8 indicates disease remission, greater than (\>) 2.8 to 10 = low disease activity, greater than (\>) 10 to 22 = moderate disease activity, and \>22 = high disease activity. Percentage of participants with CDAI remission (score \<=2.8) at Week 24 were reported.
次要结局
- Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52(Week 12 and Week 52)
- Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52(Baseline, Week 12, Week 24, Week 52)