Lung Disease Associated With Rheumatoid Arthritis

NCT00001876 | Completed

• 2 other identifiers: 99005699-HG-0056
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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. 1.Estimate how common pulmonary fibrosis is in patients with rheumatoid arthritis,
2. 2.Describe the natural course of pulmonary fibrosis in patients with rheumatoid arthritis,
3. 3.Estimate the survival rate of patients with pulmonary fibrosis and rheumatoid arthritis, and
4. 4.Learn more about the factors that contribute to the development or progression fibrotic lung disease....

Conditions

Pulmonary Fibrosis

Keywords

Interstitial Lung Disease; Collagen Vascular Disease; Extracellular Matrix; Pulmonary Function; DTPA Lung Clearance Scan; Natural History

Outcome Measures

Primary Outcomes (2)

• Prevalence

  To estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis. Subjects will include patients that have rheumatoid arthritis-only.

  Ongoing

• Natural History

  To define the natural history of pulmonary fibrosis associated with rheumatoid arthritis in a prospective, longitudinal study.

  Ongoing

Study Arms (3)

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.@@@

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Pulmonary Fibrosis; Lung Diseases, Interstitial; Collagen Diseases

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bernadette R Gochuico, M.D.

  National Human Genome Research Institute (NHGRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: April 5, 1999
• Primary Completion: November 9, 2005
• Study Completion: December 11, 2007
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

US (1)