NCT00001885

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. Data gathered from previous research studies suggest that genetics may play a role in the development of PF in patients with rheumatoid arthritis. However, the actual genetic factors involved in the disease process have not been identified. The goal of this study is to identify the genetic markers in patients with pulmonary fibrosis and rheumatoid arthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

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

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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

Interstitial Lung DiseaseInherited DiseaseGenetic MarkersAlpha 1 Protease InhibitorDNA MutationsRheumatoid ArthritisPulmonary FibrosisNormal Volunteer

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals 21 years of age or older with any of the following:
  • RA (based on 1987 American College of Rheumatology Revised Criteria for the Classification of RA) with PF (biopsy-proven), or
  • RA-only, or
  • Biopsy-proven idiopathic PF-only, or
  • Healthy research volunteers.

You may not qualify if:

  • Individuals with any of the following:
  • Inhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal, beryllium).
  • Chronic pulmonary 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 PF (e.g., hepatitis B, hepatitis C, human immunodeficiency virus).
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Hakala M. Poor prognosis in patients with rheumatoid arthritis hospitalized for interstitial lung fibrosis. Chest. 1988 Jan;93(1):114-8. doi: 10.1378/chest.93.1.114.

    PMID: 3335140BACKGROUND

MeSH Terms

Conditions

Pulmonary FibrosisArthritis, RheumatoidLung Diseases, InterstitialGenetic Diseases, Inbornalpha 1-Antitrypsin Deficiency

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLiver DiseasesDigestive System DiseasesSubcutaneous EmphysemaEmphysema

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