Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease

Recruiting

• Conditions: Rheumatoid Arthritis Associated Interstitial Lung Disease
• Interventions: Diagnostic Test: diagnosis of Interstitial lung disease

• Registration Number: NCT06036537
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

Brief Summary

Rheumatoid arthritis (RA) is one of the most common autoimmune diseases, characterized by chronic inflammatory bone and cartilage destruction. Although treatment including anti-tumor necrosis factor (TNF) and interleukin-6 (IL-6) receptor antibodies has been successful, only 20% to 30% of patients have achieved complete remission. Interstitial lung disease (ILD) is a common complication of rheumatoid arthritis (RA). Approximately 5-10% of RA patients have clinically significant rheumatoid arthritis associated interstitial lung disease (RA-ILD), with a mortality rate of 2-10 times that of RA-non ILD patients. The median survival after diagnosis is between 3-8 years. Although there are multiple biomarkers for RA-ILD, such as anti citrullinated protein antibody (ACPA), MUC5B mutant gene, KL-6, etc., none of these biomarkers can reliably predict the disease and prognostic risk of RA-ILD. Therefore, improving the prediction of RA complicated with ILD and exploring risk factors for the progression and prognosis of RA-ILD can contribute to early diagnosis and treatment, and is of great significance in preventing RA lung injury and death.

This study aims to screen differential serum biomarkers between RA patients and RA-ILD patients through prospective cohort studies, to explore whether these differential serum biomarkers are a risk factor for RA patients complicated with ILD, and whether they affect the clinical prognosis of RA-ILD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Diagnosis of rheumatoid arthritis patients based on the 2010 ACR/EULAR RA classification criteria; 2. age ≥18 years; 3. Interstitial lung disease was diagnosed by lung high resolution computed tomography (HRCT)

Exclusion Criteria

1. age <years; 2. Being treated with urate-lowering medications; 3. Other systemic/organ specific autoimmune diseases other than rheumatoid arthritis (such as SLE, ANCA associated vasculitis, pSS, SSc, myositis, etc.); 4.Tumor, pulmonary tuberculosis, glomerular filtration rate less than 30ml/min/1.73m2

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rheumatoid arthritis	diagnosis of Interstitial lung disease	-

Primary Outcome Measures

Name	Time	Method
Occurrence of interstitial lung disease	2 years	Whether rheumatoid arthritis patients have occurred interstitial lung disease and the time of occurrence of interstitial lung disease

Trial Locations

Locations (1)

Chongqing General Hospital; 🇨🇳 Chongqing, Chongqing, China