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Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06036537
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	First Affiliated Hospital of Chongqing Medical University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis Associated Interstitial Lung Disease

Arms & Interventions

Arms

: rheumatoid arthritis

Interventions

Diagnostic Test: - diagnosis of Interstitial lung disease

Serum marker detection，High resolution computed tomography scan

Contact a Trial Team

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