Clinical Trial: Determining Disease Activity Biomarkers in Individuals With Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
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 Summary:
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 monthly for the first year, then every 3 months thereafter for the remainder of the study. Blood and urine collection will occur at every visit. A physical exam and medical and medication history will occur every 3 months; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use. Participants may have additional study visits if a disease flare or disease-related complications occur during the study.
Sponsor: University of Pennsylvania
Current Primary Outcome: Discover biomarkers in EGPA capable of measuring disease activity and response to treatment [ Time Frame: Study completion ]
Original Primary Outcome:
Current Secondary Outcome: Measure the predictive value of biomarkers for clinical outcome in EGPA [ Time Frame: Study completion. ]
Original Secondary Outcome:
Information By: University of Pennsylvania
Dates:
Date Received: April 14, 2006
Date Started: April 2006
Date Completion: April 2019
Last Updated: February 21, 2017
Last Verified: February 2017
