Clinical and Ultrasonographic Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Patients With Spondyloarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- change from ultrasonographic entesitis score at 3 months
研究概览
简要总结
Biological therapies should be considered in patients with high disease activity despite nonsteroid antiinflammatory drug treatment. The first option among biological therapies is anti-Tumor Necrosis Factor (anti-TNF) drugs. In recent years, anti-TNF treatments have shown that clinical and ultrasonographic enthesitis may improve as well as disease activity, quality of life and acute phase reactants. In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
All patients were evaluated by the researcher who had a 10-year experience of musculoskeletal ultrasonography and is blind to clinical evaluation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spondyloarthritis patients were diagnosed according to 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria
排除标准
- •Severe cardiovascular and respiratory diseases,
- •Severe liver and kidney failure,
- •Pregnancy and lactation,
- •Active infection,
- •Malignancy,
- •Demyelinating diseases,
- •Systemic lupus erythematosus,
- •History of knee, elbow, foot and ankle surgery,
- •Fluoroquinolone, retinoid and fluoride use,
- •Local corticosteroid injection at the examination sites within the six weeks before evaluation
- •Peripheral neuropathy
研究组 & 干预措施
Spondyloarthritis
Spondyloarthritis patients who was initiated TNF alfa blocker
干预措施: TNF Inhibitor (Drug)
结局指标
主要结局
change from ultrasonographic entesitis score at 3 months
时间窗: before and 3 months after anti-TNF treatment
Madrid Sonographic Enthesitis Index was used to screen etheseal sites
次要结局
- Change from Functionality(before and 3 months after anti-TNF treatment)
- Change from disease activity(before and 3 months after anti-TNF treatment)
- Change from quality of life(before and 3 months after anti-TNF treatment)
研究者
Gunay ER
Medical Doctor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization