Clinical trial NCT00315380: Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis
Official title: Longitudinal Protocol for Eosinophilic Granulomatosis With Polyangiitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eosinophilic Granulomatosis With Polyangiitis
Churg-Strauss Syndrome
Keywords: EGPA
CSS
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: AstraZeneca
First posted: 2006-04-18
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with eosinophilic granulomatosis with polyangiitis (Churg-Strauss). Enrollment will be sequential and participants will have disease in various stages and of different duration.

Brief summary: Eosinophilic granulomatosis with polyangiitis (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.

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

Primary outcomes:
measure: Discover biomarkers in EGPA capable of measuring disease activity and response to treatment
timeFrame: Study completion
Secondary outcomes:
measure: Measure the predictive value of biomarkers for clinical outcome in EGPA
timeFrame: Study completion.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Pennsylvania
name: Peter A. Merkel, MD, MPH
role: STUDY_CHAIR
References:
citation: Heeringa P, Schreiber A, Falk RJ, Jennette JC. Pathogenesis of pulmonary vasculitis. Semin Respir Crit Care Med. 2004 Oct;25(5):465-74. doi: 10.1055/s-2004-836140.
citation: Radice A, Sinico RA. Antineutrophil cytoplasmic antibodies (ANCA). Autoimmunity. 2005 Feb;38(1):93-103. doi: 10.1080/08916930400022673.
citation: Said G, Lacroix C. Primary and secondary vasculitic neuropathy. J Neurol. 2005 Jun;252(6):633-41. doi: 10.1007/s00415-005-0833-9. Epub 2005 Apr 5.
citation: Doubelt I, Springer JM, Kermani TA, Sreih AG, Burroughs C, Cuthbertson D, Carette S, Khalidi NA, Koening CL, Langford C, McAlear CA, Moreland LW, Monach PA, Shaw DG, Seo P, Specks U, Warrington KJ, Young K, Merkel PA, Pagnoux C. Self-Reported Data and Physician-Reported Data in Patients With Eosinophilic Granulomatosis With Polyangiitis: Comparative Analysis. Interact J Med Res. 2022 May 25;11(1):e27273. doi: 10.2196/27273.