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临床试验/NCT07147127
NCT07147127尚未招募不适用

Anti-Citrullinated SR-A Peptide (Anti-csp)Antibody as a Biomarker for Rheumatoid Arthritis.

Walaa sharif Eid Ahmed0 个研究点目标入组 81 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
81
主要终点
To assess the diagnostic performance of anti-Citrullinated SR-A peptide antibody (anti-csp) for rheumatoid arthritis specifically seronegative rheumatoid arthritis patients .

研究概览

简要总结

  1. To measure serum level of anticitrullinated SR-A peptide antibody (anti-CSP) in RA patients compared to healthy controls .
  2. To assess the diagnostic performance of anti-CSP for RA specifically seronegative RA patients.
  3. To evaluate correlation of serum anti-CSP level with disease activity and functional disability scores in RA patients.

详细描述

Rheumatoid arthritis (RA) is a common a chronic autoimmune disease that can lead to joint destruction, disability, and premature mortality .Early diagnosis is crucial for preventing long-term damage and disability.

Anticyclic citrullinated peptide antibody (anti-CCP) and rheumatoid factor (RF) are classical serological markers for the diagnosis of RA and have been integrated into the 2010 (ACR/EULAR) classification criteria for RA . However, they show a modest discriminating power. The sensitivity and specificity are 67% and 95% for antiCCP, and 69% and 85% for RF, respectively . Therefore, there is an unmet need to identify prospective diagnostic biomarkers for RA.

Several biomarkers have been identified in peripheral blood or synovial fluid of RA patients, including collagen, fibrinogen, vimentin, fibronectin, and α-enolase . Their posttranslational modification, in particular citrullination, is essential for the pathogenesis of RA. These citrullinated autoantigens could stimulate the secretion of autoantibodies, namely, anticitrullinated protein antibodies (ACPAs).

•Anti-CCP is one of the most common ACPAs. ACPAs demonstrate arthritogenic potential and perpetuate inflammation in RA through promoting innate immune cells binding ,complement system activation ,neutrophil extracellular traps (NETs) formation ,and osteoclasts activation . Moreover, accumulating experimental evidence revealed the contribution of the glycosylation changes of ACPAs to the systemic inflammation of RA .Several typical glycosylation patterns of ACPAs have also been identified in RA.

Macrophage scavenger receptor A (SR-A, CD204, MSR-1, SCARA1) is a kind of classical pattern recognition receptors (PRRs) primarily expressed on macrophages .Besides its role in innate immunity, accumulating evidence also indicated the functional significance of SR-A in adaptive immunity ,In a large-scale multicenter study, soluble SRA demonstrated a sensitivity of 66.41% and specificity of 91.45% for the diagnosis of RA, with positive predictive value (PPV) of 80.19% and negative predictive value (NPV) of 83.94%

研究设计

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

入排标准

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

入选标准

  • Adults (≥18 years old)

排除标准

  • Patients with other autoimmune or connective tissue diseases (e.g., SLE, SS) .
  • Patients with chronic infections or malignancies .
  • Patients less than18 years old .

结局指标

主要结局

To assess the diagnostic performance of anti-Citrullinated SR-A peptide antibody (anti-csp) for rheumatoid arthritis specifically seronegative rheumatoid arthritis patients .

时间窗: through study completion, an average of 1 year

To evaluate correlation of serum anti-CSP level with disease activity and functional disability scores in RA patients .

时间窗: through study completion, an average of 1 year

次要结局

未报告次要终点

研究者

发起方
Walaa sharif Eid Ahmed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Walaa sharif Eid Ahmed

Assistant Lecturer

Assiut University

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