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Lung Disease Associated With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001876
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : September 29, 2022
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) )

Study Description
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Brief Summary:

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....

Condition or disease
Pulmonary Fibrosis

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
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Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Combo
Patients with rheumatoid arthritis and biopsy-proven pulmonary fibrosis.
pulmonary fibrosis
Patients with biobsy-proven idiopathic pulmonary fibrosis only.
rheumatoid arthritis
Patients with rheumatoid arthritis only.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Natural History [ Time Frame: Ongoing ]
    To define the natural history of pulmonary fibrosis associated with rheumatoid arthritis in a prospective, longitudinal study.


Eligibility Criteria
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Information from the National Library of Medicine

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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
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.@@@
Criteria
  • 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.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Human Genome Research Institute (NHGRI)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Bernadette R Gochuico, M.D. National Human Genome Research Institute (NHGRI)
More Information
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Additional Information:

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Responsible Party: National Human Genome Research Institute (NHGRI)
ClinicalTrials.gov Identifier: NCT00001876    
Other Study ID Numbers: 990056
99-HG-0056
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) ):
Interstitial Lung Disease
Collagen Vascular Disease
Extracellular Matrix
 Pulmonary Function
DTPA Lung Clearance Scan
Natural History
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial