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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-06-01

Brief Summary

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

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Detailed Description

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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

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Rheumatoid Arthritis Interstitial Lung Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Rheumatoid Arthritis with ILD

Rheumatoid arthritis patients with interstitial lung disease diagnosed by high resolution CT and correlated to level of biomarkers

Calprotectin Level

Intervention Type DIAGNOSTIC_TEST

Measurement of calprotectin level to presence and severity of ILD asessed via Warrick's score

Interventions

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Calprotectin Level

Measurement of calprotectin level to presence and severity of ILD asessed via Warrick's score

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of Rheumatoid arthritis, age \> 18 years.

Exclusion Criteria

* Patients who refuse to participate in the study,
* Patients with evidence of worsening or exacerbation of RA over the previous 6 months,
* concomitant diagnosis of an active neoplasia, or
* patients who had previously received radiotherapy,
* End organ failure.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No