Lung Disease Associated With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT00001876|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : September 29, 2022
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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:
- Estimate how common pulmonary fibrosis is in patients with rheumatoid arthritis,
- Describe the natural course of pulmonary fibrosis in patients with rheumatoid arthritis,
- Estimate the survival rate of patients with pulmonary fibrosis and rheumatoid arthritis, and
- Learn more about the factors that contribute to the development or progression fibrotic lung disease....
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||132 participants|
|Official Title:||Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Definition of the Natural History of Disease|
|Actual Study Start Date :||April 5, 1999|
|Actual Primary Completion Date :||November 9, 2005|
|Actual Study Completion Date :||December 11, 2007|
Patients with rheumatoid arthritis and biopsy-proven pulmonary fibrosis.
Patients with biobsy-proven idiopathic pulmonary fibrosis only.
Patients with rheumatoid arthritis only.
- Prevalence [ Time Frame: Ongoing ]To estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis. Subjects will include patients that have rheumatoid arthritis-only.
- Natural History [ Time Frame: Ongoing ]To define the natural history of pulmonary fibrosis associated with rheumatoid arthritis in a prospective, longitudinal study.
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
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).
Viral infections associated with pulmonary fibrosis (e.g., hepatitis B, hepatitis C, human immunodeficiency virus).
Uncorrectable bleeding diathesis.
Pregnancy or lactation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001876
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Bernadette R Gochuico, M.D.||National Human Genome Research Institute (NHGRI)|
|Responsible Party:||National Human Genome Research Institute (NHGRI)|
|Other Study ID Numbers:||
|First Posted:||November 4, 1999 Key Record Dates|
|Last Update Posted:||September 29, 2022|
|Last Verified:||September 2022|
Interstitial Lung Disease
Collagen Vascular Disease
DTPA Lung Clearance Scan
Respiratory Tract Diseases
Lung Diseases, Interstitial