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Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease

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ClinicalTrials.gov Identifier: NCT06036537
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : September 14, 2023
Sponsor:
Information provided by (Responsible Party):
Xiaocheng Cheng, First Affiliated Hospital of Chongqing Medical University

Study Description
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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
Rheumatoid Arthritis Associated Interstitial Lung Disease Diagnostic Test: diagnosis of Interstitial lung disease

Study Design
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Study Type : Observational
Estimated 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 : June 1, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : June 2025

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Groups and Cohorts
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Group/Cohort Intervention/treatment
rheumatoid arthritis Diagnostic Test: diagnosis of Interstitial lung disease
Serum marker detection，High resolution computed tomography scan


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
rheumatoid arthritis patients
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06036537


Locations
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China, Chongqing
Chongqing General Hospital Recruiting
Chongqing, Chongqing, China, 401147
Contact: qiongwen hu, PhD    +86-023-63516483    huqiongwen1@sina.com   
Sponsors and Collaborators
First Affiliated Hospital of Chongqing Medical University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Xiaocheng Cheng, M.D., First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT06036537    
Other Study ID Numbers: 1stChongqingMU123
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: September 14, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Lung Diseases
Lung Diseases, Interstitial
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Respiratory Tract Diseases