Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis Results From MRI Finding
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
- 否
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
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
Hong Ki Min
M.D.
Armed Forces Capital Hospital, Republic of Korea
