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临床试验/NCT01856569
NCT01856569已完成不适用

Assial - Anti Tnf Treatment In Ankylosing Spondylitis: An Observational Cohort Study In Italy

Pfizer17 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2013年7月最近更新:
适应症

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

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)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (17)

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