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临床试验/NCT03190603
NCT03190603已完成4 期

Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis Results From MRI Finding

Armed Forces Capital Hospital, Republic of Korea1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Spondyloarthritis Research Consortium of Canada (SPARCC) MRI score of sacroiliac joint

研究概览

简要总结

Axial Spondyloarthritis (SpA) is a kind of inflammatory arthritis which includes ankylosing spondylitis. Common symptoms of axial SpA are inflammatory back pain, morning stiffness, peripheral arthritis, enthesitis. Controlling aforementioned symptoms are one of the goal in treatment, and another goal is preventing bony ankylosis of axial skeleton such as spine. Ankylosis can limit range of motion and lower the quality of life.

Non-steroidal antiinflammatory drug (NSAID) and Tumor necrosis factor (TNF)-a inhibitor are the current treatment options for axial SpA. These medications can improve pain and stiffness of axial SpA patients, however preventing bony ankylosis is not proven. Current study showed attenuating inflammation at early stage could prevent further bony destruction and ankylosis in axial SpA. Present study is designed to discover the therapeutic effect of NSAID whether NSAID could recover the early inflammatory bony change (bone marrow edema at MRI) and prevent further bony change.

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > 4
  • definite bone marrow edema on Sacroiliac joint MRI

排除标准

  • Patients who have underling cancer / infectious disease / kidney disease / liver disease / cardiovascular or cerebrovascular disease
  • Patients who is using TNF-a inhibitor
  • Patients with side effects of NSAID
  • Patients with history of peptic ulcer
  • Patients who can't keep NSAID treatment

研究组 & 干预措施

Celecoxib arm

Experimental

Axial Spondyloarthritis patients who takes celecoxib 400mg for day

干预措施: Celecoxib (Drug)

结局指标

主要结局

Spondyloarthritis Research Consortium of Canada (SPARCC) MRI score of sacroiliac joint

时间窗: Baseline, 6 weeks after, 12 weeks after

Change from baseline SPARCC MRI score of sacroiliac joint at 6 weeks and 12 weeks

次要结局

未报告次要终点

研究者

发起方
Armed Forces Capital Hospital, Republic of Korea
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hong Ki Min

M.D.

Armed Forces Capital Hospital, Republic of Korea

研究点 (1)

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