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| Sponsors and Collaborators: |
National Human Genome Research Institute (NHGRI) National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001876 |
Purpose
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:
| Condition |
|---|
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Pulmonary Fibrosis Rheumatoid Arthritis |
| Study Type: | Observational |
| Official Title: | Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Definition of the Natural History of Disease |
| Estimated Enrollment: | 600 |
| Study Start Date: | February 1999 |
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| Study ID Numbers: | 990056, 99-HG-0056 |
| Study First Received: | November 3, 1999 |
| Last Updated: | December 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001876 |
| Health Authority: | United States: Federal Government |
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Interstitial Lung Disease Collagen Vascular Disease Extracellular Matrix Pulmonary Function |
DTPA Lung Clearance Scan Rheumatoid Arthritis Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis |
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Lung Diseases, Interstitial Autoimmune Diseases Fibrosis Hamman-Rich syndrome Joint Diseases Arthritis, Rheumatoid Vascular Diseases |
Rheumatic Diseases Pulmonary Fibrosis Musculoskeletal Diseases Respiratory Tract Diseases Arthritis Lung Diseases Connective Tissue Diseases |
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Pathologic Processes Immune System Diseases |
