NCT07003451

Novel Biomarkers in Assessment of Interstitial Lung Disease Associated With Rheumatoid Arthritis Patients

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

\- Assess Krebs von den Lungen-6 (KL-6) and Calprotectin as novel biomarkers for diagnosis of ILD among Rheumatoid arthritis patients

Detailed description

Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by small joint synovitis that is estimated to affect 0.3% to 1% of the global population. Extraarticular disease may occur in up to 50% of patients with RA, with pulmonary manifestations among the most common extraarticular features. Interstitial lung disease (ILD) clinically affects up to 10% of patients with RA and subclinically affects up to 40%. RA-ILD typically presents as a usual interstitial pneumonia (UIP) or nonspecific interstitial pneumonia pattern. Diagnosis requires a thorough evaluation, including laboratory and imaging studies; pulmonary function testing (PFT); medication review; occasionally, tissue histopathology; and frequently, multidisciplinary input. Prompt recognition of RA-ILD is crucial because it warrants close monitoring and often necessitates therapeutic alterations. Biomarkers are a promising area of investigation in RA-ILD because they have the potential to advance pathophysiologic understanding and elucidate therapeutic targets, improve disease identification and diagnostic accuracy, facilitate prognostication, and inform treatment decisions. Although imaging and histopathology have important roles that are unlikely to be replaced by biomarkers, they can be nonspecific in RA-ILD, can be impractical to obtain in certain settings, and cannot be scaled for population health efforts. Calprotectin belongs to the S-100 proteins produced by neutrophils, which likely contribute to idiopathic pulmonary fibrosis (IPF) pathogenesis. Calprotectin is a well-established biomarker in inflammatory bowel diseases.

Conditions

• Rheumatoid Arthritis
• Interstitial Lung Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Calprotectin Level	Measurement of calprotectin level to presence and severity of ILD asessed via Warrick's score

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2025-06-04
• Last updated: 2025-08-28

Locations

1 site across 1 country: Egypt