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Clinical Trials/NCT06036537
NCT06036537
Recruiting
N/A

Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease

First Affiliated Hospital of Chongqing Medical University1 site in 1 country1,200 target enrollmentJune 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rheumatoid Arthritis Associated Interstitial Lung Disease
Sponsor
First Affiliated Hospital of Chongqing Medical University
Enrollment
1200
Locations
1
Primary Endpoint
Occurrence of interstitial lung disease
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
June 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Chongqing Medical University
Responsible Party
Principal Investigator
Principal Investigator

Xiaocheng Cheng

M.D.

First Affiliated Hospital of Chongqing Medical University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • age \<years;
  • Being treated with urate-lowering medications;
  • 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

Outcomes

Primary Outcomes

Occurrence of interstitial lung disease

Time Frame: 2 years

Whether rheumatoid arthritis patients have occurred interstitial lung disease and the time of occurrence of interstitial lung disease

Study Sites (1)

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