NCT07147127

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

August 9, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 28, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

August 9, 2025

Last Update Submit

August 26, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

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

    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 .

    through study completion, an average of 1 year

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Seronegative and seropositive rheumatoid arthritis patients and health control group

You may qualify if:

  • Adults (≥18 years old)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 39752500BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Walaa Sharif Eid, Resident doctor

CONTACT

Maha Gamal Ahmed, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

August 9, 2025

First Posted

August 28, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 28, 2025

Record last verified: 2025-07