Rheumatoid ArthritisRAPIDNCT03297775
Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease
An observational study of Rheumatoid Arthritis and Interstitial Lung Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The overall goal of this study is to define the phenotype of Interstitial Lung Disease (ILD), and identify factors that predict radiologic progression in those with subclinical RA-ILD, in patients with rheumatoid arthritis (RA). The investigators hypothesize that there are common core elements (e.g. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Rheumatoid Arthritis, Interstitial Lung Disease
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2017to Jun 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects are selected for participation in the study because they have an active diagnosis of rheumatoid arthritis and are at risk for the development of lung disease.
Who may be able to join
- ≥ 45years old
- Diagnosis of RA using the 2010 American College of Rheumatology (ACR) criteria
Who cannot join
- Inability to give informed consent
- Pregnant women
- History of interstitial lung disease
- Evidence of other causes of diffuse parenchymal lung disease such as infection, drug toxicity, other autoimmune processes, etc.
- Subjects over the age of 90 years old or less than 45 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
Haylie A Lengel, 970-376-8303, haylie.lengel@cuanschutz.edu
Elizabeth O'Brien, 303-875-1844, elizabeth.a.obrien@cuanschutz.edu
About this study
The overall goal of this study is to define the phenotype of Interstitial Lung Disease (ILD), and identify factors that predict radiologic progression in those with subclinical RA-ILD, in patients with rheumatoid arthritis (RA). The investigators hypothesize that there are common core elements (e.g. clinical features, genetic variants, and/or biologic markers) between other forms of ILD (e.g. idiopathic pulmonary fibrosis, IPF) and subclinical RA-ILD that places individuals at risk for the development of lung disease.
- Conditions
- Rheumatoid Arthritis, Interstitial Lung Disease
- Keywords
- Rheumatoid Arthritis, RA, Interstitial Lung Disease, ILD, lung disease, connective tissue disease, CTD, idiopathic pulmonary fibrosis, IPF, airways disease
- Medical subject headings
- Arthritis, Rheumatoid, Lung Diseases, Interstitial, Lung Diseases, Connective Tissue Diseases, Idiopathic Pulmonary Fibrosis
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 |
|---|---|---|
| RA with Sub-clinical ILD | Subjects will be followed annually until study closure. Assessments are as follows: 1. Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life 2. Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT) 3. Radiologic (3-5 yrs FU): HRCT scan of chest 4. Genetic (3-5 yrs FU): Blood sample collection for RNA 5. Biologic (3-5 yrs FU): Blood sample collection for other blood markers | |
| RA with No-ILD | Subjects will be followed annually until study closure. Assessments are as follows: 1. Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life 2. Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT) 3. Radiologic (3-5 yrs FU): HRCT scan of chest 4. Genetic (3-5 yrs FU): Blood sample collection for RNA 5. Biologic (3-5 yrs FU): Blood sample collection for other blood markers Note: Certain follow-up procedures may not occur for every subject and will be determined by the research team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of interstitial lung disease on high resolution CT (HRCT) chest imaging
HRCT scans of the chest will be interpreted by two radiologists and the presence or absence of interstitial lung abnormality will be recorded. When present, abnormalities will be categorized as absent, equivocal, non-fibrotic, or fibrotic, and the extent of any reticular abnormalities will be graded on an 11-point scale (0, 1-10%, 11-20%, etc.). Additionally, the presence or absence of airway disease, centrilobular thickening, mosaic attenuation, and air trapping will be recorded.
Measured: 3-5 years
Secondary outcomes (3)
Progression of lung disease over time
Radiologic progression of lung disease will be determined through a comparison of baseline HRCT chest findings to follow-up HRCT chest findings at the 3-5 year follow-up benchmark. Similar to baseline, follow-up HRCT scans of the chest will be interpreted by 2 different radiologists. Quantitative radiologic progression will be defined as ≥ 10% increase in fibrotic changes from baseline to follow-up - additionally, the percent reticular change, percent honeycomb change, and percent traction bronchiectasis on the follow-up scan will be quantified and recorded.
Radiologic findings of progression will be used in correlation with other clinical features to determine the clinical relevance of the change. The clinical features include - change in cough, change in dyspnea (as measured by UCSD shortness of breath questionnaire), change in FVC percent predicted value, the development of established RA-ILD, or respiratory-related death, over the same time period.
Measured: 3-5 Years
Impact of subclinical RA-ILD on health-related quality of life in RA
The impact of subclinical RA-ILD on health-related quality of life will be measured using subjective patient questionnaires that will be completed at both baseline and follow-up. These questionnaires include - SF-36, St. George Respiratory Questionnaire, and Multi-Dimensional Health Assessment Questionnaire.
Measured: 3-5 Years
Outcome of airways disease
Clinical outcomes will be measured through respiratory assessment (physical exam), changes is dyspnea (based on the University of California San Diego shortness of breath questionnaire), changes in FVC percent predicted values (based on pulmonary function testing), increase in cough (determined using a visual analog scale, where 10 is the worst cough and 0 is no cough), and development of RA-ILD requiring treatment.
Measured: 3-5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start22 Jun 2017
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (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.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joyce S Lee, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297775
- Sponsor's protocol ID
- 16-1097
- Acronym
- RAPID
- Status last verified
- Apr 2026
- First submitted
- 19 Sep 2017
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT03297775
- Acronym / sponsor ID
- RAPID / 16-1097
- Conditions
- Rheumatoid Arthritis, Interstitial Lung Disease
- Keywords
- Rheumatoid Arthritis, RA, Interstitial Lung Disease, ILD, lung disease, connective tissue disease, CTD, idiopathic pulmonary fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Sep 2017 (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 overall goal of this study is to define the phenotype of Interstitial Lung Disease (ILD), and identify factors that predict radiologic progression in those with subclinical RA-ILD, in patients with rheumatoid arthritis (RA). The investigators hypothesize that there are common core elements (e.g. clinical features, genetic variants, and/or biologic markers) between other forms of ILD (e.g. idiopathic pulmonary fibrosis, IPF) and subclinical RA-ILD that places individuals at risk for the development of lung disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA with Sub-clinical ILD | – | –Subjects will be followed annually until study closure. Assessments are as follows: 1. Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life 2. Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT) 3. Radiologic (3-5 yrs FU): HRCT scan of chest 4. Genetic (3-5 yrs FU): Blood sample collection for RNA 5. Biologic (3-5 yrs FU): Blood sample collection for other blood markers |
| RA with No-ILD | – | –Subjects will be followed annually until study closure. Assessments are as follows: 1. Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life 2. Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT) 3. Radiologic (3-5 yrs FU): HRCT scan of chest 4. Genetic (3-5 yrs FU): Blood sample collection for RNA 5. Biologic (3-5 yrs FU): Blood sample collection for other blood markers Note: Certain follow-up procedures may not occur for every subject and will be determined by the research team. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are selected for participation in the study because they have an active diagnosis of rheumatoid arthritis and are at risk for the development of lung disease.
Key inclusion criteria (2 listed)
- ≥ 45years old
- Diagnosis of RA using the 2010 American College of Rheumatology (ACR) criteria
Key exclusion criteria (5 listed)
- Inability to give informed consent
- Pregnant women
- History of interstitial lung disease
- Evidence of other causes of diffuse parenchymal lung disease such as infection, drug toxicity, other autoimmune processes, etc.
- Subjects over the age of 90 years old or less than 45 years old
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
Presence of interstitial lung disease on high resolution CT (HRCT) chest imaging
Time frame: 3-5 years
HRCT scans of the chest will be interpreted by two radiologists and the presence or absence of interstitial lung abnormality will be recorded. When present, abnormalities will be categorized as absent, equivocal, non-fibrotic, or fibrotic, and the extent of any reticular abnormalities will be graded on an 11-point scale (0, 1-10%, 11-20%, etc.). Additionally, the presence or absence of airway disease, centrilobular thickening, mosaic attenuation, and air trapping will be recorded.
3 secondary outcomes
Progression of lung disease over time
Time frame: 3-5 Years
Impact of subclinical RA-ILD on health-related quality of life in RA
Time frame: 3-5 Years
Outcome of airways disease
Time frame: 3-5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Joyce S Lee, MD principal investigator
University of Colorado, Denver
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 Interstitial Lung Disease, run by University of Colorado, Denver 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haylie A Lengel (970-376-8303, haylie.lengel@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of interstitial lung disease on high resolution CT (HRCT) chest imaging (time frame: 3-5 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 1 May 2026.