Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time
RA-LD
Change in Serum and Sputum Biomarkers Over Time in the Development of Rheumatoid Arthritis-associated Lung Disease
1 other identifier
observational
340
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2018
CompletedFirst Submitted
Initial submission to the registry
July 31, 2018
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJune 6, 2019
June 1, 2019
5 years
July 31, 2018
June 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Define which patients with RA (or pre-RA) are at greatest risk for developing RA-related lung disease (LD).
10 years
Study Arms (4)
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)
Eligibility Criteria
Subjects are selected for participation in the study because they are diagnosed with or without rheumatoid arthritis and lung disease.
You may qualify if:
- \. Age 18 - 80 years
You may not qualify if:
- Subjects who do not speak English
- Subjects without the capacity to sign the informed consent form (ICF)
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Jewish Healthlead
- Pfizercollaborator
Study Sites (1)
National Jewish Health
Denver, Colorado, 80206, United States
Biospecimen
Blood and sputum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Solomon, MD
National Jewish Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2018
First Posted
August 6, 2018
Study Start
May 10, 2018
Primary Completion
May 10, 2023
Study Completion
December 1, 2024
Last Updated
June 6, 2019
Record last verified: 2019-06