Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease

NCT06036537 | Unknown DMC

• 1 other identifier: 1stChongqingMU123
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis Associated Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Occurrence of interstitial lung disease

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

  2 years

Study Arms (1)

rheumatoid arthritis

Diagnostic Test: diagnosis of Interstitial lung disease

Interventions

diagnosis of Interstitial lung disease DIAGNOSTIC_TEST

Serum marker detection，High resolution computed tomography scan

rheumatoid arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

rheumatoid arthritis patients

You may qualify if:

• \. 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)

You may not qualify if:

• \. 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Chongqing General Hospital

Chongqing, Chongqing Municipality, 401147, China

RECRUITING

Related Publications (1)

• Hu Q, Cheng X, Lan Y, Lei H, Niu C, Luo Y. Serum uric acid predictive value and prognostic impact in rheumatoid arthritis' associated interstitial lung disease. Front Med (Lausanne). 2025 Aug 5;12:1623557. doi: 10.3389/fmed.2025.1623557. eCollection 2025.

  PMID: 40837562 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: June 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)