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

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Brief Title

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

Official Title

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

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.
    

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 Type

Observational


Primary Outcome

Discover biomarkers in EGPA capable of measuring disease activity and response to treatment

Secondary Outcome

 Measure the predictive value of biomarkers for clinical outcome in EGPA

Condition

Eosinophilic Granulomatosis With Polyangiitis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

500

Start Date

April 2006

Completion Date

April 2024

Primary Completion Date

April 2024

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Peter A. Merkel, MD, MPH, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00315380

Organization ID

VCRC5506


Responsible Party

Principal Investigator

Study Sponsor

University of Pennsylvania

Collaborators

 GlaxoSmithKline

Study Sponsor

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


Verification Date

April 2021