Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 89
- 主要终点
- Percentage of Participants Achieving BASDAI 40 Response at Week 24
研究概览
简要总结
This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.
详细描述
The study population will be described using standard descriptive statistics for demographic, clinical, medical, characteristics, as well as for standard health-related quality of life and functional disability questionnaires .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines
- •Patients treated as an outpatient
排除标准
- •Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®.
- •Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localised infections.
- •Patients with sepsis or risk of sepsis should not be treated.
研究组 & 干预措施
Treatment Group Enbrel
干预措施: Enbrel (Drug)
结局指标
主要结局
Percentage of Participants Achieving BASDAI 40 Response at Week 24
时间窗: Week 24
BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.
次要结局
- Change From Baseline in BASDAI at Week 12 and 24(Baseline, Week 12 and Week 24)
- Change From Baseline in the BASFI at Weeks 12 and 24(Baseline, Week 12 and Week 24)
- Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24(Week 12 and Week 24)
- Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24(Week 12 and Week 24)
- Mean Duration of Morning Stiffness(Week 12 and Week 24)
- Change From Baseline in ASQoL at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Percentage of Participants Without Enthesitis(Week 12 and Week 24)
- Percentage of Participants Without Peripheral Arthritis(Week 12 and Week 24)
- Mean Occiput-to-wall Distance at Week 12 and Week 24(Week 12 and Week 24)
- Spine Agility Function by Schober Test(Week 12 and Week 24)
- Spine Agility Function by Ott Test(Week 12 and Week 24)