Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time

Study Overview
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Brief Summary
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The purpose of this study is to investigate the link between the lungs and rheumatoid arthritis (RA). Additionally, to understand why RA patients get lung disease, how to treat, and prevent the disease.

Detailed Description
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This study is to learn more about the risk factors for the development of lung disease among patients with rheumatoid arthritis (RA), an auto-immune disease. Additionally, those at heightened risk of developing RA such as in the pre-RA period. This is a prospective and retrospective study, which 420 patients will be enrolled into the study. In-person participation will be up to 4 years, completing different standard of care assessments yearly. Additionally, quality of life questionnaires will be completed every 6 months at 4 time points. Lastly, an extended follow-up will be performed yearly for an additional 6 years, an overall 10 year participation.

Official Title
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Change in Serum and Sputum Biomarkers Over Time in the Development of Rheumatoid Arthritis-associated Lung Disease

Conditions
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Rheumatoid Arthritis, Lung Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Age 18 - 80 years Exclusion Criteria: Subjects who do not speak English Subjects without the capacity to sign the informed consent form (ICF) Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-RA<br>Subjects with interstitial lung disease (ILD) or airways disease, no rheumatoid arthritis (RA), and positive antibodies will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up. In-person Study Assessments Include: Medical History and Physical Exams Quality of Life Questionnaires Collection of blood Radiology Lung Function Test 6 Minute Walk Test Bronchoscopy (Clinically indicated) Sputum (Optional) Musculoskeletal ultrasound (Optional) | |
| RA without LD<br>Subjects with rheumatoid arthritis (RA), and no interstitial lung disease (ILD) or airways disease, will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up. In-person Study Assessments Include: Medical History and Physical Exams Quality of Life Questionnaires Collection of blood Radiology Lung Function Test 6 Minute Walk Test Bronchoscopy (Clinically indicated) Sputum (Optional) Musculoskeletal ultrasound (Optional) | |
| RA-LD<br>Subjects with rheumatoid arthritis (RA) and interstitial lung disease (ILD) or airways disease, will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up. In-person Study Assessments Include: Medical History and Physical Exams Quality of Life Questionnaires Collection of blood Radiology Lung Function Test 6 Minute Walk Test Bronchoscopy (Clinically indicated) Sputum (Optional) Musculoskeletal ultrasound (Optional) | |
| LD Controls<br>Subjects with interstitial lung disease (ILD) or airways disease, no rheumatoid arthritis (RA), and negative antibodies will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up. In-person Study Assessments Include: Medical History and Physical Exams Quality of Life Questionnaires Collection of blood Radiology Lung Function Test 6 Minute Walk Test Bronchoscopy (Clinically indicated) Sputum (Optional) Musculoskeletal ultrasound (Optional) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define which patients with RA (or pre-RA) are at greatest risk for developing RA-related lung disease (LD). |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Interstitial Lung Disease, RA, ILD