跳至主要内容
临床试验/NCT01327638
NCT01327638已完成不适用

Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis Patients

Organon and Co0 个研究点目标入组 21,108 人开始时间: 2011年2月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
21,108
主要终点
Number of patients with Characteristics of inflammatory SPA/AS

研究概览

简要总结

The study is intended to provide additional post-marketing safety data regarding the use of etoricoxib for the indication of ankylosing spondylitis.

详细描述

The specific project objectives are to:

  1. Describe the characteristics of Swedish patients with inflammatory SpA/AS ; 2) Describe the use of etoricoxib and other cyclooxygenase-2 (COX-2 inhibitors)/non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) in Swedish patients with SpA/AS; and 3) Estimate and compare the rates of clinical outcomes of special interest (gastrointestinal, renovascular, cardiovascular and cerebrovascular) with use of etoricoxib and other COX-2 inhibitors/nsNSAIDs in Swedish patients with SpA/AS. Comparisons of clinical outcomes among the drugs of interest will be made by descriptive comparison of the point estimates for the incidence rates and their associated 95% confidence intervals (CIs), using both clinical and epidemiological judgment and in light of the limitations of this observational study. No formal statistical significance testing will be performed for purposes of such comparisons.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant attended an out-patient clinic 2001-
  • Participant is registered with an International Classification of diseases (ICD, Version 10)-code corresponding to SpA/AS and AS.

排除标准

  • Not applicable.

研究组 & 干预措施

Patients with SpA/AS and etoricoxib treatment

干预措施: etoricoxib (Drug)

Patients with SpA/AS and other COX-2 inhibitor treatment

干预措施: Other COX-2 inhibitor (Drug)

Patients with SpA/AS and nsNSAIDs treatment

干预措施: nsNSAIDs (Drug)

结局指标

主要结局

Number of patients with Characteristics of inflammatory SPA/AS

时间窗: Over a 12 year period (2001-2013)

Number of patients who used etoricoxib

时间窗: Up to 7 1/2 years (Q3 2005 - 2013)

Number of patients who used other COX-2 inhibitors

时间窗: Up to 7 1/2 years (Q3 2005 - 2013)

Number of patients who used nsNSAIDs

时间窗: Up to 7 1/2 years (Q3 2005 - 2013)

Number of clinical outcomes of special interest

时间窗: Up to 7 1/2 years (Q3 2005 - 2013)

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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