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 : June 18, 2020
|First Submitted Date||November 3, 1999|
|First Posted Date||November 4, 1999|
|Last Update Posted Date||June 18, 2020|
|Actual Study Start Date||April 5, 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Lung Disease Associated With Rheumatoid Arthritis|
|Official Title||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:
|Detailed Description||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.|
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Subjects will include individuals with (1) rheumatoid arthritis and biopsy-proven pulmonary fibrosis, (2) rheumatoid arthritis-only, and (3) biopsy-proven idiopathic pulmonary fibrosis-only.@@@|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
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.
|Ages||21 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||990056
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )|
|Study Sponsor||National Human Genome Research Institute (NHGRI)|
|Collaborators||National Heart, Lung, and Blood Institute (NHLBI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2, 2020|