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
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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.
Condition or disease | Intervention/treatment |
---|---|
Rheumatoid Arthritis Associated Interstitial Lung Disease | Diagnostic Test: diagnosis of Interstitial lung disease |
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 |
Group/Cohort | Intervention/treatment |
---|---|
rheumatoid arthritis |
Diagnostic Test: diagnosis of Interstitial lung disease
Serum marker detection,High resolution computed tomography scan |
- 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
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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 |
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
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
China, Chongqing | |
Chongqing General Hospital | Recruiting |
Chongqing, Chongqing, China, 401147 | |
Contact: qiongwen hu, PhD +86-023-63516483 huqiongwen1@sina.com |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |