Assial - Anti Tnf Treatment In Ankylosing Spondylitis: An Observational Cohort Study In Italy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 152
- 试验地点
- 17
- 主要终点
- Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18
研究概览
简要总结
Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.
详细描述
retrospective and prospective 150
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •retrospective:12 months at least first anti-TNF therapy prospective: at maximum 6 months observation AS patients with axial involvement
排除标准
- •patients in other AS studies involved
结局指标
主要结局
Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18
时间窗: Baseline up to Month 18
First line anti-TNF treatment included adalimumab, etanercept, golimumab and infliximab. In this outcome, percentage of participants who were taking any one of the first line anti-TNF treatment at baseline and maintained the same up to Month 18 without any change in prescription, were reported.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18
时间窗: Baseline, Month 18
BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. Utilizing a numerical rating scale (NRS) of 0-10 (0 = no problem to 10 = worst problem) participants answered 6 questions measuring symptoms of AS (spinal pain, fatigue, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+\[Q5+Q6/2\]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.
Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity
时间窗: Month 12, 18
Low disease activity was defined as a BASDAI score of less than or equal to (\<=) 2. BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. In this outcome, percentage of participants with unchanged first line anti-TNF drug (nor dose neither frequency, but drug only) in the state of low disease activity, during the specified time points were reported.
次要结局
- Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18(Month 18)
- C Reactive Protein Level at Baseline(Baseline)
- Erythrocyte Sedimentation Rate at Baseline(Baseline)
