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NCT Number: NCT07149194

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).

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

CBC derived markers

Other

CBC derived markers against CRP and ESR in detecting active Rheumatoid arthritis

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Abeer Hamdi Fahmi

CONTACT

[email protected]

01115332487

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Assessment of the Accuracy of CBC-Derived Markers Against CRP and ESR in Detecting Active Rheumatoid Arthritis in Upper Egypt"

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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