Lung Disease Associated With Rheumatoid Arthritis

Pulmonary Fibrosis Clinical Trial

Official title:

Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Definition of the Natural History of Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001876
• Other study ID #: 990056
• Secondary ID: 99-HG-0056
• Status: Completed
• Start date: April 5, 1999
• Est. completion date: December 11, 2007

Study information

• Verified date: September 2022
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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....

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 11, 2007
• Est. primary completion date: November 9, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Human Genome Research Institute (NHGRI)	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence	To estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis. Subjects will include patients that have rheumatoid arthritis-only.	Ongoing
Primary	Natural History	To define the natural history of pulmonary fibrosis associated with rheumatoid arthritis in a prospective, longitudinal study.	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page