Serum Anti-PCOLCE as Novel Diagnostic Biomarker in Rheumatoid Arthritis With Emphasis on Seronegative Patients.

Sponsor
Assiut University
Study ID
NCT07129837
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Clinical evaluation, disease activity and disability scoring, and laboratory testing including RF, anti-CCP, and serum anti-PCOLCE antibody measurement by ELISA. — DIAGNOSTIC_TEST
    For rheumatoid arthritis (RA) patients: participants will undergo comprehensive clinical evaluation including demographic data, detailed history, musculoskeletal and systemic examination, assessment of disease activity using DAS-28 score, functional disability evaluation by modified Health Assessment Questionnaire (mHAQ), and laboratory investigations including CBC, ESR, CRP, rheumatoid factor (RF), anti-cyclic citrullinated peptide (anti-CCP) antibodies, and serum anti-procollagen C-endopeptidase enhancer (anti-PCOLCE) antibodies measured by ELISA. For healthy controls: participants will undergo comprehensive clinical evaluation including demographic data, detailed history, musculoskeletal and systemic examination, and laboratory testing limited to serum anti-PCOLCE antibodies measured by ELISA.

Study Details

Rheumatoid arthritis (RA) is a chronic autoimmune disease that primarily affects synovial joints, leading to pain, swelling, and progressive joint damage. Early diagnosis is critical to prevent irreversible disability. However, up to 30% of RA patients are seronegative for conventional markers such as rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies, creating a diagnostic challenge. This study aims to evaluate the diagnostic performance of serum anti-procollagen C-endopeptidase enhancer (anti-PCOLCE) antibodies in RA patients, with a particular focus on seronegative cases. We will conduct a case-control study involving RA patients and age- and sex-matched healthy controls. Clinical assessments, disease activity scoring, functional disability evaluation, and laboratory testing will be performed. The findings may provide evidence for anti-PCOLCE as a novel biomarker for improved RA diagnosis.

Key Dates

First listed
Aug 19, 2025
Start date
May 31, 2026
Status verified
Aug 2025
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
62 participants (estimated)

Arms

  • Arm: Rheumatoid Arthritis Patients
    Adult patients (≥18 years) diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria.
  • Arm: Healthy Controls
    Age- and sex-matched healthy individuals without rheumatoid arthritis or other autoimmune diseases.

Primary Outcome Measure

Serum anti-PCOLCE antibody levels in rheumatoid arthritis patients versus healthy controls [ Time Frame: Baseline (at the time of enrollment) ]

Central Contacts

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Rheumatoid arthritis trialsRheumatology trialsAutoimmune disease trialsMusculoskeletal disorders trials

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