Recruiting

Observational Study

Sponsor:

National Jewish Health

Code:

NCT03616158

Conditions

Rheumatoid Arthritis

Lung Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Rheumatoid Arthritis

Lung Diseases

Study ID

NCT03616158

Start date

May 10, 2018

Status verified date

Jun, 2019

Completion date

Dec 1, 2024

Anticipated

Primary completion date

May 10, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

340 participants

Anticipated

Interventions and Outcome Measures

Arms

Pre-RA

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

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

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

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)

Primary outcome measure

  • Define which patients with RA (or pre-RA) are at greatest risk for developing RA-related lung disease (LD). [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Faduma Ahmed, MPH

303-398-1285ahmedf@NJHealth.org

Jami Henriksen

303-398-1233henriksenj@NJHealth.org

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Faduma Ahmed, MPH

303-398-1285ahmedf@NJHealth.org

More Information

Sponsor

National Jewish Health

Last update posted

Jun 6, 2019

Last verified

Jun, 2019

Keywords

  • Rheumatoid arthritis
  • Interstitial Lung Disease
  • RA
  • ILD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Jewish Health on 2019-06-06.