NCT07149194

Brief 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. 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).

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2025

Typical duration 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 Progress33%
Sep 2025Oct 2027

First Submitted

Initial submission to the registry

August 24, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 24, 2025

Last Update Submit

August 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline

Study Arms (2)

Active Rheumatoid arthritis

Other: CBC derived markers

inactive Rheumatoid arthriti

Interventions

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

Active Rheumatoid arthritis

Eligibility Criteria

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

All

You may qualify if:

  • 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.
  • Willing to provide informed consent

You may not qualify if:

  • Presence of infection, malignancy, or other autoimmune diseases. 2-Recent use (within 4 weeks) of corticosteroids or immunosuppressive therapy. 3-Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rheumatic Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Abeer Hamdi Fahmi

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assessment of accuracy of CBC derived markers against CRP and ESR in detecting active Rheumatoid arthritis in upper Egypt

Study Record Dates

First Submitted

August 24, 2025

First Posted

August 29, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

August 29, 2025

Record last verified: 2025-08