Rheumatoid Arthritis (RA)NCT07147127
Anti-citrullinated SR-A Peptide (Anti-csp) Antibody as a Biomarker in Rheumatoid Arthritis (RA).
An observational study of Rheumatoid Arthritis (RA), run by Walaa sharif Eid Ahmed.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Seronegative and seropositive rheumatoid arthritis patients and health control group
Who may be able to join
- Adults (≥18 years old)
Who cannot join
- Patients with other autoimmune or connective tissue diseases (e.g., SLE, SS) .
- Patients with chronic infections or malignancies .
- Patients less than18 years old .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Maha Gamal Ahmed, Lecturer contact
About this study
Official title: Anti-Citrullinated SR-A Peptide (Anti-csp)Antibody as a Biomarker for Rheumatoid Arthritis.
- To measure serum level of anticitrullinated SR-A peptide antibody (anti-CSP) in RA patients compared to healthy controls .
- To assess the diagnostic performance of anti-CSP for RA specifically seronegative RA patients.
- To evaluate correlation of serum anti-CSP level with disease activity and functional disability scores in RA patients.
Read the detailed description
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
- Rheumatoid Arthritis (RA)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 27 seropositive patients according to results of rheumatoid factor and anticitrullinated antibodies. | 27 seronegative patients according to results of rheumatoid factor and anticitrullinated antibodies. | |
| 27 seronegative patients according to results of RF and ACCP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the diagnostic performance of anti-Citrullinated SR-A peptide antibody (anti-csp) for rheumatoid arthritis specifically seronegative rheumatoid arthritis patients .
Measured: 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 .
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walaa sharif Eid Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Walaa sharif Eid Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147127
- Sponsor's protocol ID
- Anti-csp
- Status last verified
- Jul 2025
- First submitted
- 9 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39752500
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Citrullinated SR-A Peptide (Anti-csp)Antibody as a Biomarker for Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT07147127
- Acronym / sponsor ID
- Anti-csp
- Conditions
- Rheumatoid Arthritis (RA)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Walaa sharif Eid AhmedUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To measure serum level of anticitrullinated SR-A peptide antibody (anti-CSP) in RA patients compared to healthy controls .
- To assess the diagnostic performance of anti-CSP for RA specifically seronegative RA patients.
- To evaluate correlation of serum anti-CSP level with disease activity and functional disability scores in RA patients.
Detailed description
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 27 seropositive patients according to results of rheumatoid factor and anticitrullinated antibodies. | – | –27 seronegative patients according to results of rheumatoid factor and anticitrullinated antibodies. |
| 27 seronegative patients according to results of RF and ACCP | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Seronegative and seropositive rheumatoid arthritis patients and health control group
Key inclusion criteria (1 listed)
- Adults (≥18 years old)
Key exclusion criteria (3 listed)
- Patients with other autoimmune or connective tissue diseases (e.g., SLE, SS) .
- Patients with chronic infections or malignancies .
- Patients less than18 years old .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the diagnostic performance of anti-Citrullinated SR-A peptide antibody (anti-csp) for rheumatoid arthritis specifically seronegative rheumatoid arthritis patients .
Time frame: 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 .
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Results publication: PubMed 39752500Xie 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maha Gamal Ahmed, Lecturer contact
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA), run by Walaa sharif Eid Ahmed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walaa Sharif Eid, Resident doctor (01099672421, www.sharifwalaa297@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the diagnostic performance of anti-Citrullinated SR-A peptide antibody (anti-csp) for rheumatoid arthritis specifically seronegative rheumatoid arthritis patients . (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.