Anti-citrullinated SR-A Peptide (Anti-csp) Antibody as a Biomarker in Rheumatoid Arthritis (RA).

NCT ID: NCT07147127

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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%

. Detecting autoantibodies directed against CSP (anti- CSP) could therefore provide a new serological tool for RA diagnosis. These antibodies may not only enhance diagnostic accuracy particularly in patients who are seronegative for conventional markers but also shed light on novel mechanisms in RA pathophysiology

Conditions

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Rheumatoid Arthritis (RA)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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27 seropositive patients according to results of rheumatoid factor and anticitrullinated antibodies.

27 seronegative patients according to results of rheumatoid factor and anticitrullinated antibodies.

No interventions assigned to this group

27 seronegative patients according to results of RF and ACCP

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Adults (≥18 years old)

Exclusion Criteria

Patients with other autoimmune or connective tissue diseases (e.g., SLE, SS) .

* Patients with chronic infections or malignancies .
* Patients less than18 years old .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Walaa sharif Eid Ahmed

OTHER

Sponsor Role lead

Responsible Party

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Walaa sharif Eid Ahmed

Assistant Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Walaa Sharif Eid, Resident doctor

Role: CONTACT

01099672421

Maha Gamal Ahmed, Lecturer

Role: CONTACT

0101 4489537

References

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Xie Y, Wei C, Fu D, Zhang W, Du Y, Huang C, Liu S, Yao R, He Z, Zhang S, Jin X, Shen B, Cao L, Wang P, Fang X, Zheng X, Lin H, Wei X, Lin W, Bai M, Zhu D, Li Y, Ding Y, Zhu H, Ye H, He J, Su Y, Jia Y, Wu H, Wang Y, Xing D, Qiu X, Li Z, Hu F. Large-scale multicenter study reveals anticitrullinated SR-A peptide antibody as a biomarker and exacerbator for rheumatoid arthritis. Sci Adv. 2025 Jan 3;11(1):eadr8078. doi: 10.1126/sciadv.adr8078. Epub 2025 Jan 3.

Reference Type BACKGROUND
PMID: 39752500 (View on PubMed)

Other Identifiers

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Anti-csp

Identifier Type: -

Identifier Source: org_study_id

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