Lung Disease Associated With Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Rheumatology
Healthy:No
Age Range:21 - Any
Updated:3/20/2019
Start Date:March 1, 1999

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Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Definition of the Natural History of Disease

Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and
fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid
arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.

Patients participating in this study will undergo a series of tests and examinations before
and throughout the study. The tests include blood and urine tests, electrical measures of
heart function (ECG), chest x-rays, CAT scans, nuclear medicine scans, breathing tests,
exercise tests, and fiberoptic bronchoscopy.

The goals of this study are to:

1. Estimate how common pulmonary fibrosis is in patients with rheumatoid arthritis,

2. Describe the natural course of pulmonary fibrosis in patients with rheumatoid arthritis,

3. Estimate the survival rate of patients with pulmonary fibrosis and rheumatoid arthritis,
and

4. Learn more about the factors that contribute to the development or progression fibrotic
lung disease.

Pulmonary fibrosis is an extra-articular manifestation of rheumatoid arthritis whose etiology
remains uncertain. Although the clinical course of many individuals with this disorder can
mimic that observed in patients with idiopathic pulmonary fibrosis, the natural history of
fibrotic lung disease associated with rheumatoid arthritis remains largely undefined. It is
the intent of this clinical protocol to (1) estimate the prevalence of pulmonary fibrosis in
individuals with rheumatoid arthritis, (2) define the natural history of pulmonary fibrosis
in patients with rheumatoid arthritis, (3) estimate the survival rate of individuals with
pulmonary fibrosis and rheumatoid arthritis, and (4) examine pulmonary physiologic,
radiologic, and biochemical markers that predict the development or progression of fibrotic
lung disease.

- INCLUSION CRITERIA:

Non-smokers (never smoked or no smoking within the previous 2 years) who are 21 years of
age or older with any of the following:

Rheumatoid arthritis with biopsy-proven pulmonary fibrosis or;

Rheumatoid arthritis only, or;

Biopsy-proven idiopathic pulmonary fibrosis.

EXCLUSION CRITERIA:

Forced expiratory volume in one second (FEV1) less than 1L.

Inhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal,
beryllium).

Chronic cardiopulmonary disorders other than pulmonary fibrosis.

Other collagen vascular disorders (e.g., systemic lupus erythematosus, scleroderma,
polymyositis, mixed connective tissue disease).

Non-rheumatoid arthritis.

Viral infections associated with pulmonary fibrosis (e.g., hepatitis B, hepatitis C, human
immunodeficiency virus).

Uncorrectable bleeding diathesis.

Pregnancy or lactation.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
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mi
from
Bethesda, MD
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