NCT00001884

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
8.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2007

Completed
Last Updated

July 2, 2017

Status Verified

December 28, 2007

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

BronchoscopyIdiopathic Pulmonary FibrosisProteasesFibroblast ProliferationReactive ProteinsRheumatoid ArthritisPulmonary Fibrosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University

Boston, Massachusetts, 02118-2354, United States

Location

Related Publications (1)

  • 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. doi: 10.1002/art.1780290502.

    PMID: 3487321BACKGROUND

MeSH Terms

Conditions

Pulmonary FibrosisArthritis, RheumatoidIdiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

March 21, 1999

Study Completion

December 28, 2007

Last Updated

July 2, 2017

Record last verified: 2007-12-28

Locations