Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Lung Disease Associated With Rheumatoid Arthritis
This study has been completed.
Study NCT00001876.   Last updated on December 2, 2008.
Information provided by National Institutes of Health Clinical Center (CC)
This Tabular View shows the required WHO registration data elements as marked by

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
 
 
 
Pulmonary Fibrosis
Rheumatoid Arthritis
 
3547656,   7740304,   8843862
NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site
 
Completed
600
February 1999
  • 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.

Both
21 Years and older
No
United States
 
NCT00001876
990056
99-HG-0056
National Human Genome Research Institute (NHGRI)
National Heart, Lung, and Blood Institute (NHLBI)
 
National Institutes of Health Clinical Center (CC)
November 2008
November 3, 1999
December 2, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.