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NCT Number: NCT06397677

Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease

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.

Recruiting

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Interstitial Lung Disease Joint Diseases Lung Diseases Lung Diseases, Interstitial Musculoskeletal Diseases Respiratory Tract Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Francisco, San Francisco, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Research Testing Performed (Laboratory)

Genetic

Blood collection (DNA, RNA)

Information Collected as Standard of Care

Diagnostic Test

High Resolution CT Scan (Chest), Pulmonary Function Testing (PFT), 6-Minute Walk Test (6MWT)

Research Testing Performed

Other

Blood collection (non-genetic), Buccal Swab, Rheumatologic Assessment, Pulmonary Assessment, Questionnaires

Primary outcomes

  1. 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.

Secondary outcomes

  1. Comparing peripheral blood telomere length (PB-TL)

    Time frame: 5-years

    Investigators will test and validate if baseline peripheral blood telomere length (PB-TL) predicts a progressive phenotype in RA-ILD.

  2. Defining peripheral blood transcriptomic profiles

    Time frame: 5-years

    Investigators will define and validate the peripheral blood transcriptomic profile of progressive RA-ILD.

  3. Exploring if a composite profile more accurately identifies progressive RA-ILD

    Time frame: 5-years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haylie Lengel

CONTACT

[email protected]

970-376-8303

Joyce S Lee

CONTACT

[email protected]

303-724-6109

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of California, San Francisco
  • University of Kansas
  • University of Michigan

Registry information

Official study title

Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease (MOUNTAIN)

Acronym: MOUNTAIN

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
May 3, 2024
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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