Rheumatoid ArthritisMOUNTAINNCT06397677
Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease
An observational study of Rheumatoid Arthritis and Interstitial Lung Disease, run by University of Colorado, Denver at 4 sites in United States.
Trial summary
A study to identify patients with Rheumatoid Arthritis - Associated Interstitial Lung Disease (RA-ILD) that are at the highest risk for progression. The goal of the investigators is to recruit a group of patients with RA-ILD and collect information to help us understand more about disease progression. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rheumatoid Arthritis, Interstitial Lung Disease
- What is being tested?
- Research Testing Performed (Laboratory) and Research Testing Performed
- How many people
- 450 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Jan 2024to Jan 2034
- How long will I take part?
- 24 Months
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RA-ILD study patients will be recruited from the University of Colorado Hospital, ILD Clinic (CU, PI: Joyce Lee, MD), in addition to the Rheumatology Clinic at the University of Colorado Hospital. Subjects will additionally be recruited from three unaffiliated ILD centers: University of California San Francisco (UCSF; site PI Dr. Paul Wolters), University of Kansas (KU, site PI Dr. Scott Matson), and University of Michigan (UM, site PI Dr. Justin Oldham).
Who may be able to join
- Multidisciplinary diagnosis of RA-ILD based on the 2010 American College of Rheumatology criteria
- 18 years of age or older
Who cannot join
- Prior medication treatment specifically for RA-ILD
- Inability to give informed consent
- Pregnant women
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Justin Oldham, MD
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Haylie A Lengel, 970-376-8303, haylie.lengel@cuanschutz.edu
Joyce S Lee, MD
- Recruiting
University of Kansas
Kansas City, Kansas, 66103
Scott Matson, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Paul Wolters, MD
About this study
Official title: Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease (MOUNTAIN)
A study to identify patients with Rheumatoid Arthritis - Associated Interstitial Lung Disease (RA-ILD) that are at the highest risk for progression.
The goal of the investigators is to recruit a group of patients with RA-ILD and collect information to help us understand more about disease progression. The investigators will do this using a combination of clinical, radiologic, and biologic features.
Read the detailed description
The central hypothesis is that novel quantitative imaging and specific blood markers will be associated with progressive RA-ILD. The hypothesis will be tested through collection and analysis of peripheral blood, in addition to the analysis of HRCT (high-resolution computed tomography) scans performed as standard of care (clinical) on research subjects.
Procedures performed:
Baseline Year 0: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs
Every 4 months (at clinic visit): Blood sample, questionnaires
Year 1 and Year 2 Follow-ups: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs
- Conditions
- Rheumatoid Arthritis, Interstitial Lung Disease
- Being tested
- Research Testing Performed (Laboratory), Information Collected as Standard of Care, Research Testing Performed
- Medical subject headings
- Arthritis, Rheumatoid, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research Testing Performed (Laboratory)Genetic
Blood collection (DNA, RNA)
Information Collected as Standard of CareDiagnostic test
High Resolution CT Scan (Chest), Pulmonary Function Testing (PFT), 6-Minute Walk Test (6MWT)
Research Testing PerformedOther
Blood collection (non-genetic), Buccal Swab, Rheumatologic Assessment, Pulmonary Assessment, Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients with RA-ILD | Assessments include:
* Clinical: height, weight, oxygen saturation at rest, and 6-minute walk test.
* Rheumatological: study Rheumatologist will document rheumatoid arthritis symptoms and clinical findings at baseline and follow-up.
* Pulmonary Function Testing: data will be collected from clinically performed spirometry and diffusing capacity for carbon monoxide.
* High-resolution computed tomography (HRCT) imaging: HRCT scans will be collected at baseline and 12 months in line with standard of care for treatment of RA-ILD.
* Lab specimens: peripheral blood will be obtained for DNA, RNA, serum, and plasma at baseline and at 12 months for all sites or every 3-4 months in Colorado. Buccal swabs (cheek) will also be collected once each year.
* Information collected: will include demographics, co-morbidities, disease history, medication history, pulmonary function, radiographic imaging, and transplant/survival status through questionnaires and medical chart review. Receives: Genetic: Research Testing Performed (Laboratory); Diagnostic Test: Information Collected as Standard of Care; Other: Research Testing Performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the role of novel quantitative imaging
Through evaluation of baseline CT scans and application of novel quantitative technology, investigators will monitor for specific patterning to identify patients at risk for progression.
Measured: 5-years
Secondary outcomes (3)
Comparing peripheral blood telomere length (PB-TL)
Investigators will test and validate if baseline peripheral blood telomere length (PB-TL) predicts a progressive phenotype in RA-ILD.
Measured: 5-years
Defining peripheral blood transcriptomic profiles
Investigators will define and validate the peripheral blood transcriptomic profile of progressive RA-ILD.
Measured: 5-years
Exploring if a composite profile more accurately identifies progressive RA-ILD
Investigators will use logistic least absolute shrinkage and selection operator (LASSO) to develop a predictive model of RA-ILD progression using demographics, novel imaging, PB-TL and peripheral blood transcriptome.
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start22 Jan 2024
- Primary completionJan 2029 (estimated)
- Study completionJan 2034 (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
- 450 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco, University of Michigan, University of Kansas
- Responsible party
- Sponsor
- Investigators
- Joyce S Lee, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397677
- Sponsor's protocol ID
- 23-0295
- Other IDs
- 1R01HL168126-01
- Acronym
- MOUNTAIN
- Status last verified
- Apr 2024
- First submitted
- 1 Dec 2023
- Last updated
- 3 May 2024
- 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 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease (MOUNTAIN)
- ClinicalTrials.gov ID
- NCT06397677
- Acronym / sponsor ID
- MOUNTAIN / 23-0295
- Conditions
- Rheumatoid Arthritis, Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco, University of Michigan, University of Kansas
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 3 May 2024 (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.
A study to identify patients with Rheumatoid Arthritis - Associated Interstitial Lung Disease (RA-ILD) that are at the highest risk for progression.
The goal of the investigators is to recruit a group of patients with RA-ILD and collect information to help us understand more about disease progression. The investigators will do this using a combination of clinical, radiologic, and biologic features.
Detailed description
The central hypothesis is that novel quantitative imaging and specific blood markers will be associated with progressive RA-ILD. The hypothesis will be tested through collection and analysis of peripheral blood, in addition to the analysis of HRCT (high-resolution computed tomography) scans performed as standard of care (clinical) on research subjects.
Procedures performed:
Baseline Year 0: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs
Every 4 months (at clinic visit): Blood sample, questionnaires
Year 1 and Year 2 Follow-ups: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with RA-ILD | – | Genetic: Research Testing Performed (Laboratory), Diagnostic Test: Information Collected as Standard of Care, Other: Research Testing PerformedAssessments include: * Clinical: height, weight, oxygen saturation at rest, and 6-minute walk test. * Rheumatological: study Rheumatologist will document rheumatoid arthritis symptoms and clinical findings at baseline and follow-up. * Pulmonary Function Testing: data will be collected from clinically performed spirometry and diffusing capacity for carbon monoxide. * High-resolution computed tomography (HRCT) imaging: HRCT scans will be collected at baseline and 12 months in line with standard of care for treatment of RA-ILD. * Lab specimens: peripheral blood will be obtained for DNA, RNA, serum, and plasma at baseline and at 12 months for all sites or every 3-4 months in Colorado. Buccal swabs (cheek) will also be collected once each year. * Information collected: will include demographics, co-morbidities, disease history, medication history, pulmonary function, radiographic imaging, and transplant/survival status through questionnaires and medical chart review. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA-ILD study patients will be recruited from the University of Colorado Hospital, ILD Clinic (CU, PI: Joyce Lee, MD), in addition to the Rheumatology Clinic at the University of Colorado Hospital. Subjects will additionally be recruited from three unaffiliated ILD centers: University of California San Francisco (UCSF; site PI Dr. Paul Wolters), University of Kansas (KU, site PI Dr. Scott Matson), and University of Michigan (UM, site PI Dr. Justin Oldham).
Key inclusion criteria (2 listed)
- Multidisciplinary diagnosis of RA-ILD based on the 2010 American College of Rheumatology criteria
- 18 years of age or older
Key exclusion criteria (3 listed)
- Prior medication treatment specifically for RA-ILD
- Inability to give informed consent
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research Testing Performed (Laboratory)Blood collection (DNA, RNA) | Genetic | Patients with RA-ILD |
| Information Collected as Standard of CareHigh Resolution CT Scan (Chest), Pulmonary Function Testing (PFT), 6-Minute Walk Test (6MWT) | Diagnostic test | Patients with RA-ILD |
| Research Testing PerformedBlood collection (non-genetic), Buccal Swab, Rheumatologic Assessment, Pulmonary Assessment, Questionnaires | Other | Patients with RA-ILD |
Primary outcome
Evaluating the role of novel quantitative imaging
Time frame: 5-years
Through evaluation of baseline CT scans and application of novel quantitative technology, investigators will monitor for specific patterning to identify patients at risk for progression.
3 secondary outcomes
Comparing peripheral blood telomere length (PB-TL)
Time frame: 5-years
Defining peripheral blood transcriptomic profiles
Time frame: 5-years
Exploring if a composite profile more accurately identifies progressive RA-ILD
Time frame: 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 3 May 2024.
- Individual participant dataSharing planned: No
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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.
Joyce S Lee principal investigator
University of Colorado, Denver
4 sites 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 4 sites 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 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: looking for participants now, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
Evaluating the role of novel quantitative imaging (time frame: 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 3 May 2024; AzTrials last refreshed its copy on 26 Oct 2026.