Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease

Sponsor
First Affiliated Hospital of Chongqing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06036537
Collaborator
(none)
1,200
1
24
50

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: diagnosis of Interstitial lung disease

Study Design

Study Type:
Observational
Anticipated Enrollment :
1200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
rheumatoid arthritis

Diagnostic Test: diagnosis of Interstitial lung disease
Serum marker detection,High resolution computed tomography scan

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chongqing General Hospital Chongqing Chongqing China 401147

Sponsors and Collaborators

  • First Affiliated Hospital of Chongqing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiaocheng Cheng, M.D., First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT06036537
Other Study ID Numbers:
  • 1stChongqingMU123
First Posted:
Sep 14, 2023
Last Update Posted:
Sep 14, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2023