跳至主要内容
临床试验/NCT06642207
NCT06642207招募中不适用

Effect of IL17 Inhibitor in Comparison With Anti-TNF- α on Platelet Count and Its Association With Disease Activity in Patients With Ankylosing Spondylitis

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Effect of IL17 Inhibitor in comparison with Anti-TNFα on Platelet count

研究概览

简要总结

Ankylosing spondylitis (AS) is a chronic, inflammatory autoimmune disease characterized by axial bone inflammation. The main clinical manifestations include back pain and progressive spinal rigidity, as well as inflammation of the hips, shoulders, and peripheral joints. Also, extra-articular manifestations, such as psoriasis, uveitis, and inflammatory bowel disease (IBD).

Indicators of inflammation such as erythrocyte sedimentation rate (ESR) and Creactive protein (CRP), which are typically elevated in AS patients, particularly when peripheral joints are involved, these tests ultimately do not reflect the disease process and have limited sensitivity and specificity. Disease activity in AS has been measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), which includes only patient-reported measures. The assessment of Spondyloarthritis International society (ASAS) developed a new AS disease activity score (ASDAS) that combines patient-reported assessments with erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Although platelets play important functions in hemostasis and thrombosis, their functions in controlling immunity and inflammation have drawn more attention recently. Platelets are known to have a key role in controlling inflammatory processes in a variety of pathological states. Overactivated platelets can induce inflammation, which in turn can increase the risk of the development of atherosclerosis, thrombosis, and cardiovascular disorders. Inflammatory diseases, including inflammatory bowel disease (IBD), have platelets play a crucial role in their development. The first-line recommended treatment for active AS is NSAIDs.

Tumor necrosis factor (TNF) inhibitors have completely changed the therapy options for patients who have not improved despite receiving standard NSAID treatment. TNF inhibitors can, however, cause tolerability problems in certain patients or inadequate responses in others, and their effectiveness may gradually diminish. Interleukin (IL)-17 inhibitors are among the new therapeutic alternatives that are currently accessible for these individuals.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients fulfill the Assessment in Spondyloarthritis International Society (ASAS) classification criteria for Axial Spondyloarthritis.
  • Patients with disease duration more than 6 months.
  • Patients who failed conventional treatment and on bDMARDs (IL17 or Anti-TNF-α).
  • Age above 16 years old.
  • Patient cooperative and can answer questions.
  • Patients who are able and willing to give written informed consent.

排除标准

  • Other rheumatologic or collagen diseases.
  • Age below 16 years and above 60 years.
  • Uncooperative patients.
  • Patient not able and willing to give written informed consent.
  • Patient with other causes of platelet dysfunction, count irregularity.

结局指标

主要结局

Effect of IL17 Inhibitor in comparison with Anti-TNFα on Platelet count

时间窗: 6 months

Evaluate the effect of IL-17 inhibitor and Anti-TNF-αon platelet count in AS patients.

Platelet count association with disease activity in patients with Ankylosing Spondylitis

时间窗: 6 months

Platelet count as indicator of disease activity and follow up of AS patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manar Gamal Abdelfattah

Effect of IL17 Inhibitor in comparison with Anti-TNF- α on Platelet count and its association with disease activity in patients with Ankylosing Spondylitis

Sohag University

研究点 (1)

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