Lung Disease Associated With Rheumatoid Arthritis

Completed

• Conditions: Pulmonary Fibrosis

• Registration Number: NCT00001876
• Lead Sponsor: National Human Genome Research Institute (NHGRI)

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....

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 Timeline

• Study Start: 1999-04-05
• Study First Submitted: 1999-11-03
• Study First Submitted QC: 1999-11-03
• Study First Posted: 1999-11-04
• Primary Completion: 2005-11-09
• Study Completion: 2007-12-11
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Natural History	Ongoing	To define the natural history of pulmonary fibrosis associated with rheumatoid arthritis in a prospective, longitudinal study.
Prevalence	Ongoing	To estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis. Subjects will include patients that have rheumatoid arthritis-only.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States