Rheumatic DiseasesNCT07149194
Accuracy of CBC Derived Markers Against CRP and ESR in Detecting Active Rheumatoid Arthritis in Upper Egypt
An observational study of Rheumatic Diseases, run by Assiut University.
Trial summary
Rheumatoid arthritis (RA) is a chronic autoimmune disease that leads to persistent synovial inflammation, joint destruction, and disability, often with extra-articular manifestations like interstitial pneumonia. It predominantly affects middle-aged individuals, especially women. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- CBC derived markers
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Oct 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
- No healthy volunteers
- Adult, Older adult
Study population: All
Who may be able to join
- 1-Adults aged ≥18 years. 2-Established RA diagnosis according to ACR/EULAR criteria {ACR: American College of Rheumatology, a professional organization of rheumatologists.
- EULAR: European League Against Rheumatism, a European organization for rheumatology.
- 3-Willing to provide informed consent
Who cannot join
- 1-Presence of infection, malignancy, or other autoimmune diseases. 2-Recent use (within 4 weeks) of corticosteroids or immunosuppressive therapy. 3-Pregnant or lactating women.
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
Official title: Assessment of the Accuracy of CBC-Derived Markers Against CRP and ESR in Detecting Active Rheumatoid Arthritis in Upper Egypt"
Rheumatoid arthritis (RA) is a chronic autoimmune disease that leads to persistent synovial inflammation, joint destruction, and disability, often with extra-articular manifestations like interstitial pneumonia. It predominantly affects middle-aged individuals, especially women. Early diagnosis and accurate disease activity assessment are crucial to prevent irreversible joint damage and systemic complications (4).
Clinical tools like the Disease Activity Score in 28 joints (DAS28) are commonly used to monitor RA, relying on inflammatory markers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). However, CRP and ESR can be influenced by factors unrelated to RA, such as infections or anemia, and may not always be available or cost-effective in resource-limited settings (1).
Read more
In recent years, complete blood count (CBC)-derived markers have emerged as affordable and accessible alternatives for assessing systemic inflammation. These include the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), and red cell distribution width (RDW). These indices have shown strong correlations with RA disease activity in various studies, particularly NLR and RDW, which have high sensitivity and specificity for detecting active disease (2-3).
Studies in Egypt have explored the diagnostic accuracy of CBC-derived markers and composite indices like the CRP-to-albumin ratio (CAR) and albumin-to-fibrinogen ratio (AFR). These markers correlate significantly with DAS28 scores, suggesting they may be reliable indicators of RA disease activity in Egyptian patients (1-3).
- Conditions
- Rheumatic Diseases
- Being tested
- CBC derived markers
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC derived markersOther
CBC derived markers against CRP and ESR in detecting active Rheumatoid arthritis
| Study group | Role | What they receive |
|---|---|---|
| Active Rheumatoid arthritis | Not described Receives: Other: CBC derived markers | |
| inactive Rheumatoid arthriti | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnostic accuracy of CBC-derived inflammatory markers in detecting active rheumatoid arthritis in Upper Egypt.
the accuracy of CBC-derived inflammatory markers in diagnosis of active rheumatoid arthritis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Hamdi Fahmi Abd Elhamid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149194
- Sponsor's protocol ID
- CBC markers in RA activity
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Accuracy of CBC-Derived Markers Against CRP and ESR in Detecting Active Rheumatoid Arthritis in Upper Egypt"
- ClinicalTrials.gov ID
- NCT07149194
- Acronym / sponsor ID
- CBC markers in RA activity
- Conditions
- Rheumatic Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 29 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 leads to persistent synovial inflammation, joint destruction, and disability, often with extra-articular manifestations like interstitial pneumonia. It predominantly affects middle-aged individuals, especially women. Early diagnosis and accurate disease activity assessment are crucial to prevent irreversible joint damage and systemic complications (4).
Clinical tools like the Disease Activity Score in 28 joints (DAS28) are commonly used to monitor RA, relying on inflammatory markers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). However, CRP and ESR can be influenced by factors unrelated to RA, such as infections or anemia, and may not always be available or cost-effective in resource-limited settings (1).
In recent years, complete blood count (CBC)-derived markers have emerged as affordable and accessible alternatives for assessing systemic inflammation. These include the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), and red cell distribution width (RDW). These indices have shown strong correlations with RA disease activity in various studies, particularly NLR and RDW, which have high sensitivity and specificity for detecting active disease (2-3).
Studies in Egypt have explored the diagnostic accuracy of CBC-derived markers and composite indices like the CRP-to-albumin ratio (CAR) and albumin-to-fibrinogen ratio (AFR). These markers correlate significantly with DAS28 scores, suggesting they may be reliable indicators of RA disease activity in Egyptian patients (1-3).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Rheumatoid arthritis | – | Other: CBC derived markers |
| inactive Rheumatoid arthriti | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All
Key inclusion criteria (3 listed)
- 1-Adults aged ≥18 years. 2-Established RA diagnosis according to ACR/EULAR criteria {ACR: American College of Rheumatology, a professional organization of rheumatologists.
- EULAR: European League Against Rheumatism, a European organization for rheumatology.
- 3-Willing to provide informed consent
Key exclusion criteria (1 listed)
- 1-Presence of infection, malignancy, or other autoimmune diseases. 2-Recent use (within 4 weeks) of corticosteroids or immunosuppressive therapy. 3-Pregnant or lactating women.
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 |
|---|---|---|
| CBC derived markersCBC derived markers against CRP and ESR in detecting active Rheumatoid arthritis | Other | Active Rheumatoid arthritis |
Primary outcome
the diagnostic accuracy of CBC-derived inflammatory markers in detecting active rheumatoid arthritis in Upper Egypt.
Time frame: baseline
the accuracy of CBC-derived inflammatory markers in diagnosis of active rheumatoid arthritis
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 29 Aug 2025.
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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 Rheumatic Diseases, 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 3 inclusion and 1 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 29 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 Abeer Hamdi Fahmi (01115332487, abeerhamdi69@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the diagnostic accuracy of CBC-derived inflammatory markers in detecting active rheumatoid arthritis in Upper Egypt. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2025.