Specimen Collection for Individuals With Lung Disease Associated With Rheumatoid Arthritis - Tabular View

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 5, 2008
Start Date ^ICMJE	March 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001884 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Specimen Collection for Individuals With Lung Disease Associated With Rheumatoid Arthritis
Official Title ^ICMJE	Specimen Procurement for Individuals With Pulmonary Fibrosis Associated With Rheumatoid Arthritis
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. Researchers hope to improve their understanding of the disease process involved in PF and RA by analyzing specimens collected by bronchoscopy, lung biopsy, lung transplantation, or autopsy from patients with these conditions. The purpose of this study is to collect specimens from rheumatoid arthritis patients with and without pulmonary fibrosis as well as patients with pulmonary fibrosis without associated diseases or cause (idiopathic pulmonary fibrosis).
Detailed Description	The etiology of pulmonary fibrosis in individuals with rheumatoid arthritis is unknown. Analysis of blood and specimens procured by bronchoscopy, lung biopsy, lung transplantation, or post-mortem examination from patients with this disorder will contribute to our understanding of the pathogenetic mechanisms of pulmonary fibrosis in rheumatoid arthritis. The purpose of this protocol is to obtain blood and specimens by bronchoscopy, lung biopsy, lung transplantation, or post-mortem examination from rheumatoid arthritis patients with and without pulmonary fibrosis, individuals with idiopathic pulmonary fibrosis, and healthy research volunteers.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Pulmonary Fibrosis Rheumatoid Arthritis
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *	Michalski JP, McCombs CC, Scopelitis E, Biundo JJ Jr, Medsger TA Jr. Alpha 1-antitrypsin phenotypes, including M subtypes, in pulmonary disease associated with rheumatoid arthritis and systemic sclerosis. Arthritis Rheum. 1986 May;29(5):586-91.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	December 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	INCLUSION CRITERIA: Non-smokers (never smoked or not smoked within the previous 2 years) who are 18 years of age or older with any of the following: RA with PF (biopsy-proven), or RA-only, or Idiopathic PF-only (biopsy-proven), or Healthy research volunteers by history and indicated tests (individuals without history of chronic cardiopulmonary disorder, collagen vascular disease, or bleeding disorder) matched for age (within 5 years) and gender. EXCLUSION CRITERIA: Individuals with any of the following: Forced expiratory volume in one second (FEV(1)) less than 1L. Inhalational exposure to fibrogenic fibers or dusts (i.e., asbestos, silica, coal, beryllium). Chronic cardiopulmonary disorders other than pulmonary fibrosis. Other collagen vascular disorders (i.e., systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease). Non-rheumatoid arthritis. Viral infections associated with PF (i.e., hepatitis B, hepatitis C, human immunodeficiency virus). Uncorrectable bleeding diathesis. Pregnancy or lactation.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001884
Responsible Party
Study ID Numbers ^ICMJE	990068, 99-H-0068
Study Sponsor ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP