Value of KL-6 in Rheumatoid Arthritis-Associated ILD

Recruiting

• Conditions: Rheumatoid Arthritis-Associated Interstitial Lung Disease
• Interventions: Diagnostic Test: Krebs von den Lungen-6 (KL6)

• Registration Number: NCT05979454
• Lead Sponsor: Assiut University

Brief Summary

Evaluation of serum KL6 level in rheumatoid arthritis-associated interstitial lung disease (RA-ILD).

Detailed Description

Rheumatoid arthritis (RA) is one of the most common connective tissue diseases (CTD). Its prevalence is increasing worldwide . It is responsible for a considerable number of hospital visits in Egyptian Hospitals . Pumlonary involvement is common in rheumatoid arthritis (RA). Interstitial lung disease associated rheumatoid arthritis (ILD-RA) is responsible for significant morbidity and mortality .

Krebs von den Lungen 6 (KL-6) is a mucin like glycoprotein that is found mainly on the surface of type II pneumocytes as well as in bronchiolar epithelial cells . It has chemotactic and anti-apoptotic action on fibroblasts , hence, it is considered as a marker of pulmonary epithelial cell injury .

Krebs von den Lungen-6 (KL6) has been found to be a valuable diagnostic tool in many interstitial lung diseases. KL6 was found to be a valuable prognostic marker, as well as a marker for disease severity in idiopathic pulmonary fibrosis (IPF) . KL6 was found useful as well in predicting in-hospital mortality in patients with Acute exacerbation of interstitial lung disease (AE-ILD) . KL-6 serum level can serve as a diagnostic marker for connective tissue disease-associated interstitial lung disease (CTD-ILD). It can be used to monitor effectiveness of medical treatment and patient response to pulse therapy . Its value in Rheumatoid Arthritis-associated Interstitial Lung Disease (RA-ILD) has not yet been adequately investigated.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-07
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• all patients have rheumatoid arthritis-associated interstitial lung disease

Exclusion Criteria

• Patients with any evidence of infection will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid Arthritis-associated Interstitial Lung Disease	Krebs von den Lungen-6 (KL6)	Krebs von den Lungen-6 (KL6)

Primary Outcome Measures

Name	Time	Method
KL-6	one day	detect its serum level

Secondary Outcome Measures

Name	Time	Method
HRCT chest	one day	It will be will be assessed by the radiologist to determine pulmonary involvement.
Spirometry	one day	FEV1, FVC, FVC/FEV1 will be measured.

Trial Locations

Locations (1)

Safaa A Eid; 🇪🇬 Assiut, Egypt