Rheumatoid ArthritisRA-LDNCT03616158
Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time
An observational study of Rheumatoid Arthritis and Lung Diseases, run by National Jewish Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis, Lung Diseases
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2018to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Subjects are selected for participation in the study because they are diagnosed with or without rheumatoid arthritis and lung disease.
Who may be able to join
- 1. Age 18 - 80 years
Who cannot join
- Subjects who do not speak English
- Subjects without the capacity to sign the informed consent form (ICF)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Faduma Ahmed, MPH, 303-398-1285, ahmedf@NJHealth.org
Kristen M Demoruelle, MD
About this study
Official title: Change in Serum and Sputum Biomarkers Over Time in the Development of Rheumatoid Arthritis-associated Lung Disease
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.
Read the detailed 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.
- Conditions
- Rheumatoid Arthritis, Lung Diseases
- Keywords
- Rheumatoid arthritis, Interstitial Lung Disease, RA, ILD
- Medical subject headings
- Arthritis, Rheumatoid, Lung Diseases, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define which patients with RA (or pre-RA) are at greatest risk for developing RA-related lung disease (LD).
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start10 May 2018
- Primary completion10 May 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Joshua Solomon, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616158
- Sponsor's protocol ID
- HS-3161
- Acronym
- RA-LD
- Status last verified
- Jun 2019
- First submitted
- 31 Jul 2018
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Serum and Sputum Biomarkers Over Time in the Development of Rheumatoid Arthritis-associated Lung Disease
- ClinicalTrials.gov ID
- NCT03616158
- Acronym / sponsor ID
- RA-LD / HS-3161
- Conditions
- Rheumatoid Arthritis, Lung Diseases
- Keywords
- Rheumatoid arthritis, Interstitial Lung Disease, RA, ILD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 10 May 2018 (actual)
- Primary completion
- 10 May 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects are selected for participation in the study because they are diagnosed with or without rheumatoid arthritis and lung disease.
Key inclusion criteria (1 listed)
- 1. Age 18 - 80 years
Key exclusion criteria (3 listed)
- Subjects who do not speak English
- Subjects without the capacity to sign the informed consent form (ICF)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Define which patients with RA (or pre-RA) are at greatest risk for developing RA-related lung disease (LD).
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Solomon, MD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Lung Diseases, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faduma Ahmed, MPH (303-398-1285, ahmedf@NJHealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.