NCT07129837

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
12mo left

Started May 2026

Shorter than P25 for all trials

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 Progress2%
May 2026May 2027

First Submitted

Initial submission to the registry

August 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

August 12, 2025

Last Update Submit

August 19, 2025

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisSeronegativeElisaAnti-pcolceBiomarker

Outcome Measures

Primary Outcomes (2)

  • Serum anti-PCOLCE antibody levels in rheumatoid arthritis patients versus healthy controls

    To measure serum level of anticitrullinated procollagen C endopeptidase enhancer antibody (anti-PCOLCE) in RA patients compared to healthy controls . To assess the diagnostic performance of anti PCOLCE for RA specifically seronegative RA patients.

    Baseline (at the time of enrollment)

  • measure serum level of anticitrullinated procollagen C endopeptidase enhancer antibody (anti-PCOLCE) in RA patients compared to healthy controls .

    To measure serum level of anticitrullinated procollagen C endopeptidase enhancer antibody (anti-PCOLCE) in RA patients compared to healthy controls . To assess the diagnostic performance of anti PCOLCE for RA specifically seronegative RA. To evaluate correlation of serum anti-PCOLCE level with disease activity and functional disability scores in RA patients .

    At baseline (single measurement at enrollment).

Secondary Outcomes (1)

  • Correlation between serum anti-PCOLCE antibody levels and disease activity scores in RA patients

    At baseline (single assessment at enrollment).

Study Arms (2)

Rheumatoid Arthritis Patients

Adult patients (≥18 years) diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria.

Diagnostic Test: Clinical evaluation, disease activity and disability scoring, and laboratory testing including RF, anti-CCP, and serum anti-PCOLCE antibody measurement by ELISA.

Healthy Controls

Age- and sex-matched healthy individuals without rheumatoid arthritis or other autoimmune diseases.

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.

Also known as: Serum anti citrullinated procollagen c endopeptidase enhancer anti-bodies., Serum Anti-pcolce
Rheumatoid Arthritis Patients

Eligibility Criteria

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

Two groups will be included: rheumatoid arthritis patients attending the Rheumatology, Rehabilitation and Physical Medicine Department at Assiut University Hospital, and age- and sex-matched healthy controls recruited from the community.

You may qualify if:

  • Patients clinically diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • van der Woude D, Young A, Jayakumar K, Mertens BJ, Toes RE, van der Heijde D, Huizinga TW, van der Helm-van Mil AH. Prevalence of and predictive factors for sustained disease-modifying antirheumatic drug-free remission in rheumatoid arthritis: results from two large early arthritis cohorts. Arthritis Rheum. 2009 Aug;60(8):2262-71. doi: 10.1002/art.24661.

    PMID: 19644846BACKGROUND

  • Figus FA, Piga M, Azzolin I, McConnell R, Iagnocco A. Rheumatoid arthritis: Extra-articular manifestations and comorbidities. Autoimmun Rev. 2021 Apr;20(4):102776. doi: 10.1016/j.autrev.2021.102776. Epub 2021 Feb 17.

    PMID: 33609792BACKGROUND

  • Maska L, Anderson J, Michaud K. Measures of functional status and quality of life in rheumatoid arthritis: Health Assessment Questionnaire Disability Index (HAQ), Modified Health Assessment Questionnaire (MHAQ), Multidimensional Health Assessment Questionnaire (MDHAQ), Health Assessment Questionnaire II (HAQ-II), Improved Health Assessment Questionnaire (Improved HAQ), and Rheumatoid Arthritis Quality of Life (RAQoL). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S4-13. doi: 10.1002/acr.20620. No abstract available.

    PMID: 22588760BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Mariam Rezk Lyas Ibrahim, M.B.B.Ch

CONTACT

+20 01115938529mariamrezkrh@gmail.com

Sara Farrag Ahmed, Lecturer

CONTACT

+20 01097767735sara_farrag@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 19, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

August 24, 2025

Record last verified: 2025-08