An Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing Spondylitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 主要终点
- Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment
研究概览
简要总结
The primary purpose of this study is to evaluate the health care resource utilization and work status of patients with ankylosing spondylitis undergoing treatment with etanercept by comparing study evaluations with the baseline evaluations in the ASCEND (0881A3-402)(NCT00247962) study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Etanercept (ETN)
Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
干预措施: Enbrel (etanercept) (Drug)
结局指标
主要结局
Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment
时间窗: 96 weeks
Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).
Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment
时间窗: 96 weeks
Patients were asked whether or not they had taken sick leave during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).
次要结局
- Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment(48 weeks)
- Change in Patient Global Assessment of Disease Activity From Baseline to Week 38(Baseline and 38 weeks)
- Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38(Baseline and 38 weeks)
- Number of Sick Days Per Patient During the 48 Weeks of Treatment(48 weeks)
- Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38(Baseline and 38 weeks)
- Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment(48 weeks)
- Number of Patients With Sick Leave During 48 Weeks Treatment(48 weeks)
- Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38(Baseline and 38 weeks)
- Change From Baseline Haywood Quality of Life Score From Baseline to Week 38(Baseline and 38 weeks)
- Change in Total Back Pain Score From Baseline to Week 38(Baseline and 38 weeks)
- Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38(Baseline and 38 weeks)
- Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38(Baseline and 38 weeks)