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NCT Number: NCT03297775

Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease

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.

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Key information

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Duane Pearson, MD

SUB_INVESTIGATOR

Elizabeth O'Brien

CONTACT

[email protected]

303-875-1844

Haylie A Lengel

CONTACT

[email protected]

970-376-8303

Jason Kolfenbach, MD

SUB_INVESTIGATOR

Joce Lee, MD

PRINCIPAL_INVESTIGATOR

Kevin Deane, MD

SUB_INVESTIGATOR

Kristen Demoruelle, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 45years old
  • Diagnosis of RA using the 2010 American College of Rheumatology (ACR) criteria

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Progression of lung disease over time

    Time frame: 3-5 Years

    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.

  2. Impact of subclinical RA-ILD on health-related quality of life in RA

    Time frame: 3-5 Years

    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.

  3. Outcome of airways disease

    Time frame: 3-5 Years

    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.

Study contacts

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

Haylie A Lengel

CONTACT

[email protected]

970-376-8303

Joyce S Lee, MD

CONTACT

[email protected]

303-724-6109

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Acronym: RAPID

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2017
Registry last updated
May 1, 2026

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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