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

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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: 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
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: 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
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: 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
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: 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)

Trial contacts and locations

1

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Central trial contact

Faduma Ahmed, MPH; Jami Henriksen

Data sourced from clinicaltrials.gov

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