Rheumatoid ArthritisAnti-pcolce/RANCT07129837
Serum Anti-PCOLCE as Novel Diagnostic Biomarker in Rheumatoid Arthritis With Emphasis on Seronegative Patients.
An observational study of Rheumatoid Arthritis, run by Assiut University.
Trial 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. 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
- What is being tested?
- Clinical evaluation, disease activity and disability scoring, and laboratory testing including RF, anti-CCP, and serum anti-PCOLCE antibody measurement by ELISA.
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- May 2026to May 2027
- How long will I take part?
- 3 Months
- 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: 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.
Who may be able to join
- Patients clinically diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria:
- Exclusion criteria Patients with other autoimmune or connective tissue diseases (e.g., SLE, SS). Patients with chronic infections or malignancies. Patients less than 18 years old.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Rheumatoid arthritis (RA) is an inflammatory disease that primarily affects synovial joints through an autoimmune mechanism. If not treated properly, the disease can lead to bone erosion, joint deformities, and disability. Arthritis can also cause serious extra-articular disorders, including interstitial lung disease, vasculitis, and lymphoma.
The global prevalence of RA is 1%, with 44% of patients incapacitated within ten years. Increasing evidence indicates that early diagnosis and treatment of RA are crucial in preventing or delaying progression to erosive disease.
The production of antibodies to modified self-antigens is a hallmark in RA damage to synovial joints. The diagnosis of RA is based on a combination of clinical, radiographic, and serological findings. Among serological biomarkers, the most widely used are rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies. While anti-CCP antibodies are relatively specific for RA and are included in the 2010 ACR/EULAR classification criteria, they are not present in all patients. Approximately 20-30% of RA patients may test negative for both RF and anti-CCP, is termed seronegative RA (SNRA) emphasizing the need for additional, more sensitive and specific biomarkers, especially in early and seronegative RA.
Antibodies to citrullinated and carbamylated proteins are of particular interest in RA because of their high prevalence, specificity, association with erosive disease, and appearance during the preclinical phase of RA. Citrullination is a physiological posttranslational modification (PTM) best known for its role in gene regulation and skin keratinization. During this process, arginine residues are converted to citrulline by the activity of the peptidylarginine deiminase (PAD) enzymes.
Procollagen C-protease enhancer protein (PCOLCE) is a secretory glycoprotein, which plays an important role in enhancing the activity of procollagen C-Protease and promoting the reconstruction of extracellular matrix.
PCOLCE essential for the maturation of collagen, particularly types I and II. These collagen types are major components of articular cartilage and connective tissues. In the inflammatory environment of RA, PCOLCE can undergo citrullination, potentially converting it into a novel autoantigen.
Emerging evidence suggests that PCOLCE may elicit an autoimmune response in RA patients. Detecting autoantibodies directed against PCOLCE (anti- PCOLCE ) 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
- Being tested
- Clinical evaluation, disease activity and disability scoring, and laboratory testing including RF, anti-CCP, and serum anti-PCOLCE antibody measurement by ELISA.
- Keywords
- Rheumatoid arthritis, Seronegative, Elisa, Anti-pcolce, Biomarker
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluation, disease activity and disability scoring, and laboratory testing including RF, anti-CCP, and serum anti-PCOLCE antibody measurement by ELISA.Diagnostic test
Also called Serum anti citrullinated procollagen c endopeptidase enhancer anti-bodies., Serum Anti-pcolce
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 group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis Patients | Adult patients (≥18 years) diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: At baseline (single measurement at enrollment).
Secondary outcomes (1)
Correlation between serum anti-PCOLCE antibody levels and disease activity scores in RA patients
To assess the relationship between serum anti-procollagen C-endopeptidase enhancer (anti-PCOLCE) antibody levels and clinical disease activity and functional disability scores in RA patients , measured by DAS28-ESR, CDAI, and HAQ-DI scores.
Measured: At baseline (single assessment at enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study startMay 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 62 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Mariam Rezk Lyas Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129837
- Sponsor's protocol ID
- Anti-pcolce in RA
- Acronym
- Anti-pcolce/RA
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19644846Figus 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.
PubMed 33609792Maska 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.
PubMed 22588760
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Anti-PCOLCE as Novel Diagnostic Biomarker in Rheumatoid Arthritis With Emphasis on Seronegative Patients.
- ClinicalTrials.gov ID
- NCT07129837
- Acronym / sponsor ID
- Anti-pcolce/RA / Anti-pcolce in RA
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Seronegative, Elisa, Anti-pcolce, Biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- May 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 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.
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.
Detailed description
Rheumatoid arthritis (RA) is an inflammatory disease that primarily affects synovial joints through an autoimmune mechanism. If not treated properly, the disease can lead to bone erosion, joint deformities, and disability. Arthritis can also cause serious extra-articular disorders, including interstitial lung disease, vasculitis, and lymphoma.
The global prevalence of RA is 1%, with 44% of patients incapacitated within ten years. Increasing evidence indicates that early diagnosis and treatment of RA are crucial in preventing or delaying progression to erosive disease.
The production of antibodies to modified self-antigens is a hallmark in RA damage to synovial joints. The diagnosis of RA is based on a combination of clinical, radiographic, and serological findings. Among serological biomarkers, the most widely used are rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies. While anti-CCP antibodies are relatively specific for RA and are included in the 2010 ACR/EULAR classification criteria, they are not present in all patients. Approximately 20-30% of RA patients may test negative for both RF and anti-CCP, is termed seronegative RA (SNRA) emphasizing the need for additional, more sensitive and specific biomarkers, especially in early and seronegative RA.
Antibodies to citrullinated and carbamylated proteins are of particular interest in RA because of their high prevalence, specificity, association with erosive disease, and appearance during the preclinical phase of RA. Citrullination is a physiological posttranslational modification (PTM) best known for its role in gene regulation and skin keratinization. During this process, arginine residues are converted to citrulline by the activity of the peptidylarginine deiminase (PAD) enzymes.
Procollagen C-protease enhancer protein (PCOLCE) is a secretory glycoprotein, which plays an important role in enhancing the activity of procollagen C-Protease and promoting the reconstruction of extracellular matrix.
PCOLCE essential for the maturation of collagen, particularly types I and II. These collagen types are major components of articular cartilage and connective tissues. In the inflammatory environment of RA, PCOLCE can undergo citrullination, potentially converting it into a novel autoantigen.
Emerging evidence suggests that PCOLCE may elicit an autoimmune response in RA patients. Detecting autoantibodies directed against PCOLCE (anti- PCOLCE ) 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
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis Patients | – | Diagnostic Test: Clinical evaluation, disease activity and disability scoring, and laboratory testing including RF, anti-CCP, and serum anti-PCOLCE antibody measurement by ELISA.Adult patients (≥18 years) diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria. |
| Healthy Controls | – | –Age- and sex-matched healthy individuals without rheumatoid arthritis or other autoimmune diseases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients clinically diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria:
- Exclusion criteria Patients with other autoimmune or connective tissue diseases (e.g., SLE, SS). Patients with chronic infections or malignancies. Patients less than 18 years old.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical evaluation, disease activity and disability scoring, and laboratory testing including RF, anti-CCP, and serum anti-PCOLCE antibody measurement by ELISA.Also: Serum anti citrullinated procollagen c endopeptidase enhancer anti-bodies., Serum Anti-pcolceFor 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. | Diagnostic test | Rheumatoid Arthritis Patients |
Primary outcome
Serum anti-PCOLCE antibody levels in rheumatoid arthritis patients versus healthy controls
Time frame: Baseline (at the time of enrollment)
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.
measure serum level of anticitrullinated procollagen C endopeptidase enhancer antibody (anti-PCOLCE) in RA patients compared to healthy controls .
Time frame: At baseline (single measurement at enrollment).
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 .
1 secondary outcome
Correlation between serum anti-PCOLCE antibody levels and disease activity scores in RA patients
Time frame: At baseline (single assessment at enrollment).
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 24 Aug 2025.
- Background: PubMed 19644846van 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.
- Background: PubMed 33609792Figus 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.
- Background: PubMed 22588760Maska 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Assiut University.
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 2 inclusion and 0 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 24 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 Mariam Rezk Lyas Ibrahim, M.B.B.Ch (+20 01115938529, mariamrezkrh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum anti-PCOLCE antibody levels in rheumatoid arthritis patients versus healthy controls (time frame: Baseline (at the time of enrollment)). 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 NCT07129837, which also lists 3 linked publications.
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 24 Aug 2025.