Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time (RA-LD)

National Jewish Health

Status: Enrolling

Conditions: Lung Diseases; Rheumatoid Arthritis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03616158

HS-3161

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 - 80 years

Exclusion criteria

1. Subjects who do not speak English
2. Subjects without the capacity to sign the informed consent form (ICF)
3. Pregnant women

Trial design

340 participants in 4 patient groups

Pre-RA

Description:

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: 1. Medical History and Physical Exams 2. Quality of Life Questionnaires 3. Collection of blood 4. Radiology 5. Lung Function Test 6. 6 Minute Walk Test 7. Bronchoscopy (Clinically indicated) 8. Sputum (Optional) 9. Musculoskeletal ultrasound (Optional)

RA without LD

Description:

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: 1. Medical History and Physical Exams 2. Quality of Life Questionnaires 3. Collection of blood 4. Radiology 5. Lung Function Test 6. 6 Minute Walk Test 7. Bronchoscopy (Clinically indicated) 8. Sputum (Optional) 9. Musculoskeletal ultrasound (Optional)

RA-LD

Description:

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: 1. Medical History and Physical Exams 2. Quality of Life Questionnaires 3. Collection of blood 4. Radiology 5. Lung Function Test 6. 6 Minute Walk Test 7. Bronchoscopy (Clinically indicated) 8. Sputum (Optional) 9. Musculoskeletal ultrasound (Optional)

LD Controls

Description:

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: 1. Medical History and Physical Exams 2. Quality of Life Questionnaires 3. Collection of blood 4. Radiology 5. Lung Function Test 6. 6 Minute Walk Test 7. Bronchoscopy (Clinically indicated) 8. Sputum (Optional) 9. Musculoskeletal ultrasound (Optional)