Observational Study Of The Use Of Enbrel (Registered) (Etanercept) In Routine Clinical Practice To Treat Ankylosing Spondylitis (as) Patients: An Effectiveness, Safety, And Health Economic Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,715
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Partial Remission at Week 26
研究概览
简要总结
This study aims to provide a holistic assessment of patients receiving etanercept in a real-world setting.
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
- •Diagnosis of ankylosing spondylitis (AS)
排除标准
- •Hypersensitivity to etanercept
- •Active infection including chronic or localised infection
- •Sepsis or risk of sepsis
研究组 & 干预措施
Patients with Ankylosing Spondylitis
干预措施: Etanercept (Drug)
结局指标
主要结局
Percentage of Participants Achieving Partial Remission at Week 26
时间窗: Week 26
Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.
Percentage of Participants Achieving Partial Remission at Week 52
时间窗: Week 52
Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.
次要结局
- Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)(Baseline up to Week 52)
- Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity(Baseline up to Week 52)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52(Baseline, Week 52)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52(Baseline, Week 52)
- Change From Baseline in Occiput-to-Wall Distance at Week 52(Baseline, Week 52)
- Change From Baseline in Lateral Lumbar Flexion at Week 52(Baseline, Week 52)
- Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52(Baseline, Week 52)
- Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)(Baseline, Week 26, 52)
- Healthcare Resource Utilization(Baseline, Week 26, 52)
- Duration of Healthcare Resources Utilization(Baseline, Week 26, 52)
- Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis(Baseline up to Week 52)
- Percentage of Participants With Discontinuation of Treatment Due to Adverse Events(Baseline up to Week 52)
- Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52(Baseline, Week 52)
- Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52(Baseline, Week 52)
- Change From Baseline in Duration of Morning Stiffness at Week 52(Baseline, Week 52)
- Percentage of Participants With Significant Reduction of Morning Stiffness(Week 2, 6, 12, 26, 38, 52)
- Percentage of Participants With Presence of Peripheral Arthritis(Baseline, Week 2, 6, 12, 26, 38, 52)
- Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52(Baseline, Week 52)
- Percentage of Participants With Presence of Enthesitis(Baseline, Week 2, 6, 12, 26, 38, 52)
- Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52(Baseline, Week 52)
- Change From Baseline in C-Reactive Protein (CRP) at Week 52(Baseline, Week 52)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52(Baseline, Week 52)
- Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response(Week 12, 26, 38, 52)
- Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response(Week 12, 26, 38, 52)
- Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)(Baseline, Week 26, 52)
- Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS)(Baseline, Week 26, 52)