Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time
NCT ID: NCT03616158
Last Updated: 2019-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
340 participants
OBSERVATIONAL
2018-05-10
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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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)
No interventions assigned to this group
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)
No interventions assigned to this group
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)
No interventions assigned to this group
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)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Subjects without the capacity to sign the informed consent form (ICF)
3. Pregnant women
18 Years
80 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
National Jewish Health
OTHER
Responsible Party
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Principal Investigators
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Joshua Solomon, MD
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health
Locations
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National Jewish Health
Denver, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS-3161
Identifier Type: -
Identifier Source: org_study_id
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