Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Definition of the Natural History of Disease
Data Collection
Collected from today forward - ProspectiveConnective Tissue Diseases+7
+ Fibrosis
+ Lung Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 5, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.132 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center
Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps