Clincosm LogoSign in Get a demo

Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT00315380
Collaborator
GlaxoSmithKline (Industry)
500
Enrollment
10
Locations
216
Duration (Months)
50
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA) is a rare immune system disorder that causes asthma, an excessive number of eosinophils (a type of white blood cell) in the blood, and the inflammation of blood vessels, or vasculitis. In order to properly treat EGPA, it is critical that the level of disease activity can be determined over the course of the disease. The purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of this disease in people with EGPA.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    EGPA, also known as allergic granulomatosis angiitis, is a systemic vasculitis. EGPA is marked by three distinct symptoms: asthma; eosinophilia, evidenced by an excessive number of eosinophils in the blood and tissues; and vasculitis involving the skin, lungs, nerves, kidneys, and other organs. Nerve involvement may also occur in EGPA, causing pain, tingling, numbness, and muscle wasting in the hands and feet. Because EGPA patients may not show any visible signs of active disease, current methods of monitoring disease progression usually represent a period of extended inflammation and disease activity. Thus, patients may go untreated during a period of undetectable disease when damage might be preventable. This study will use novel scientific methods to identify new biomarkers that can be used to monitor disease activity in EGPA patients. These biomarkers may be used to help direct clinical care for EGPA patients and assist in future drug development.

    Study visits will occur every 6 months, or annually. Blood and urine collection will occur at every visit. A physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Longitudinal Protocol for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)
    Study Start Date :
    Apr 1, 2006
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    Apr 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Discover biomarkers in EGPA capable of measuring disease activity and response to treatment [Study completion]

    Secondary Outcome Measures

    1. Measure the predictive value of biomarkers for clinical outcome in EGPA [Study completion.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients with a diagnosis of eosinophilic granulomatosis with polyangiitis are eligible for the study.

    Parent or guardian willing to provide informed consent, if applicable

    Exclusion Criteria:
    • Inability to give informed consent and to sign the consent form

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Diego San Diego California United States 92122
    2 National Jewish Health Denver Colorado United States 80206
    3 Brigham and Women's Hospital Boston Massachusetts United States 02215
    4 Mayo Clinic Rochester Minnesota United States 55905
    5 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    6 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    7 University of Pittsburgh Pittsburgh Pennsylvania United States 15260
    8 University of Utah Salt Lake City Utah United States 84112
    9 St. Joseph's Healthcare Hamilton Ontario Canada
    10 Mount Sinai Hospital Toronto Ontario Canada

    Sponsors and Collaborators

    • University of Pennsylvania
    • GlaxoSmithKline

    Investigators

    • Study Chair: Peter A. Merkel, MD, MPH, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Peter Merkel, Professor, University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT00315380
    Other Study ID Numbers:
    • VCRC5506
    First Posted:
    Apr 18, 2006
    Last Update Posted:
    May 17, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peter Merkel, Professor, University of Pennsylvania
    EGPA
    CSS
    Additional relevant MeSH terms:
    Granulomatosis with Polyangiitis
    Systemic Vasculitis
    Churg-Strauss Syndrome

    Study Results

    No Results Posted as of May 17, 2022