Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease

NCT ID: NCT06036537

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis Associated Interstitial Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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rheumatoid arthritis

diagnosis of Interstitial lung disease

Intervention Type DIAGNOSTIC_TEST

Serum marker detection,High resolution computed tomography scan

Interventions

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diagnosis of Interstitial lung disease

Serum marker detection,High resolution computed tomography scan

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiaocheng Cheng

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chongqing General Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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qiongwen hu, PhD

Role: primary

+86-023-63516483

References

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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.

Reference Type DERIVED
PMID: 40837562 (View on PubMed)

Other Identifiers

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1stChongqingMU123

Identifier Type: -

Identifier Source: org_study_id

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