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临床试验/NCT07272850
NCT07272850尚未招募不适用

Comparison Between Haematological Parameters and Musculoskeletal Ultrasound Findings of Rheumatoid Arthritis Patients Recieving JAK Inhibitors Versus Traditional Treatment

Assiut University0 个研究点目标入组 72 人开始时间: 2025年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
72
主要终点
improvement in musculoskeletal ultrasound scores.

研究概览

简要总结

Rheumatoid arthritis (RA) is a chronic autoimmune disease that affects about 1% of the world's population [1]. The disease is characterized by synovial membrane inflammation. The impact of RA on quality of life is significant, as it can lead to considerable disability, reduced mobility, and an increased risk of additional health complications [2].

CsDMARDs are the first-line drugs for RA treatment, of which methotrexate (MTX) is the cornerstone drug and monotherapy is recommended as the first choice (3).

However, previous studies had shown that 50% of RA patients had poor treatment effect on methotrexate or inadequate response to re-medication after relapse, resulting in drug resistance (4), resulting in no significant relief of symptoms and still high disease activity. EULAR had indicated that interleukin-6 (IL-6) receptor inhibitors and JAK inhibitors may have advantages over other biological disease-modifying anti-rheumatic drugs (bDMARDs) in patients who were not suitable for csDMARDs (5) Therefore, JAK inhibitors is used as monotherapy or combination therapy, which would provide a new strategy for clinical treatment. A few researches evaluated the relationship between PLT, RBC, Hb, red blood cells-platelet ratio (RPR), and the hemoglobin-platelet ratio (HPR) and RA disease activity. There is growing evidence that metrics like RDW and MPV, as well as the platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and others have been considered to be accurate, reliable inflammatory biomarkers in autoimmune illnesses[6,7] US has proven itself to be a useful imaging method for assessing articular and periarticular inflammation in small and large joints throughout the last years High resolution musculoskeletal ultrasound (MSUS), incorporating power Doppler ultrasound (PDUS), has demonstrated to be significantly more accurate than clinical evaluation in visualizing the inflammatory process. Furthermore, relatively few studies have examined ankle joint involvement in individuals with RA who lack symptoms [8].

研究设计

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

入排标准

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

入选标准

  • • RA patients based on the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classifcation criteria for RA.
  • Age; 18-60

排除标准

  • • the presence of other autoimmune diseases (e.g., systemic lupus erythematosus or psoriatic arthritis),
  • history of active infections, malignancy, or chronic diseases affecting hematological
  • parameters (e.g., anemia unrelated to RA, chronic kidney disease)
  • RA patients in remission
  • pregnant and lactating female patients

研究组 & 干预措施

Two groups (1)rheumatoid arthritis receiving JAK inhibitors . (2) rheumatoid arthritis receiving tra

干预措施: JAK inhibitors and traditional treatment of rheumatoid arthritis (Drug)

结局指标

主要结局

improvement in musculoskeletal ultrasound scores.

时间窗: 1 year

changes in hematological parameters as MLR

时间窗: 1 year

MLR were determined by dividing the abso- lute neutrophil count by the absolute lymphocyte count, the absolute platelet count by the absolute lymphocyte count, and the absolute monocyte count by the absolute lymphocyte count, respec- tively

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

Asmaa Gamal Mohamed Abd Elaal

Lecturer

Assiut University

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