Clinical trial NCT06397677: Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease
Official title: Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease (MOUNTAIN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Interstitial Lung Disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of California, San Francisco
name: University of Michigan
name: University of Kansas
First posted: 2024-05-03
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* Multidisciplinary diagnosis of RA-ILD based on the 2010 American College of Rheumatology criteria
* 18 years of age or older

Exclusion Criteria:

* Prior medication treatment specifically for RA-ILD
* Inability to give informed consent
* Pregnant women

Primary outcomes:
measure: Evaluating the role of novel quantitative imaging
timeFrame: 5-years
Secondary outcomes:
measure: Comparing peripheral blood telomere length (PB-TL)
timeFrame: 5-years
measure: Defining peripheral blood transcriptomic profiles
timeFrame: 5-years
measure: Exploring if a composite profile more accurately identifies progressive RA-ILD
timeFrame: 5-years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Colorado, Denver
name: Joyce S Lee
role: PRINCIPAL_INVESTIGATOR
References: