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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 : October 31, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

November 3, 1999
November 4, 1999
October 31, 2018
March 1, 1999
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Complete list of historical versions of study NCT00001876 on ClinicalTrials.gov Archive Site
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Lung Disease Associated With Rheumatoid Arthritis
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.
Observational
Observational Model: Cohort
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  • Pulmonary Fibrosis
  • Rheumatoid Arthritis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
600
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  • 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.

Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00001876
990056
99-HG-0056
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National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
National Human Genome Research Institute (NHGRI)
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Bernadette R Gochuico, M.D. National Human Genome Research Institute (NHGRI)
National Institutes of Health Clinical Center (CC)
May 23, 2018