Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Ankylosing Spondylitis (AS) With Etanercept
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 763
- 试验地点
- 1
- 主要终点
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12
研究概览
简要总结
This study is to evaluate available data in Iraqi patients with ankylosing spondylitis on Enbrel treatment with regards to the impact of early treatment using data from the Baghdad Teaching Hospital registry
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Diagnosed AS patients.
- •18 years old
- •Did not receive previous biological treatment for any reason
排除标准
- •Patients previously or currently treated with other biological therapies.
- •Use of etanercept for less than 1 year duration.
研究组 & 干预措施
Patients with ankylosing spondylitis
Iraqi patients diagnosed with ankylosing spondylitis that received Etanercept as treatment for disease
干预措施: Etanercept (Drug)
结局指标
主要结局
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12
时间窗: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]
BASFI is a set of 10 questions to determine degree of functional limitation in participants with AS. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI total score was calculated as mean of scores from 10 questions. BASFI total score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in less than or equal to (\<=) 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and greater than (\>) 10 years after diagnosis with AS.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12
时间窗: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]
BASDAI is a set of 6 questions to determine disease activity in participant with AS. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ \[Q5 + Q6/2\])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in \<= 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and \>10 years after diagnosis with AS.
次要结局
未报告次要终点