Clinical Trial: Determining Disease Activity Biomarkers in Individuals With Polyarteritis Nodosa
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Longitudinal Protocol of Polyarteritis Nodosa
Brief Summary: Polyarteritis nodosa (PAN) is a rare immune system disorder that causes swelling and damage to small- and medium-sized blood vessels in the body. In order to properly treat this disease, 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 disease in people with PAN.
Detailed Summary:
PAN, also known as systemic necrotic vasculitis, was the first recognized form of primary systemic vasculitis. PAN causes the inflammation of small- to medium-sized blood vessels, especially those supplying the nerves, skin, kidneys, gastrointestinal tract, heart, eye, and genitals. Unlike another form of vasculitis called microscopic polyangiitis, PAN does not usually cause glomerulonephritis, a type of kidney disease, or vasculitis in the very smallest blood vessels (arterioles, capillaries, and venules). There are no radiographic or serologic tests that can reliably measure disease activity in PAN. Currently, clinicians must rely on patients' symptoms, signs, laboratory tests, and imaging to guide treatment decisions, but such data are rarely consistently reliable in determining PAN disease activity. This study will use new scientific methods to discover new biomarkers that can be used to monitor disease activity in PAN patients. These biomarkers may be used to help direct clinical care for PAN 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 PAN 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 PAN. [ 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: May 1, 2017
Last Verified: May 2017
