Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis, Interstitial Lung Disease. Basic parameters: 45 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Presence of interstitial lung disease on high resolution CT (HRCT) chest imaging [Time frame: 3-5 years]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Colorado - Anschutz Medical Campus — Aurora
Identifiers
NCT: NCT03297775 · 16-1097