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