Determining Disease Activity Biomarkers in Individuals With Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)



Status:Recruiting
Healthy:No
Age Range:Any
Updated:3/27/2019
Start Date:April 2006
End Date:April 2019

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

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.

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.

Inclusion Criteria:

- Documented evidence of small vessel vasculitis and at least 4 of the following 6
American College of Rheumatology (ACR) criteria for the diagnosis of eosinophilic
granulomatosis with polyangiitis (Churg-Strauss):

1. Asthma

2. Peak peripheral blood eosinophilia of greater than 10% of total white blood cell
count

3. Peripheral neuropathy attributable to vasculitis

4. Transient pulmonary infiltrates on chest imaging studies

5. Paranasal sinus abnormalities or nasal polyposis

6. Eosinophilic inflammation on tissue biopsy

- Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

- Granulomatosis with polyangiitis (Wegener's)

- Microscopic polyangiitis

- Drug-induced vasculitis

- Hypereosinophilic syndrome

- Sarcoidosis

- Infectious forms of vasculitis

- Takayasu's arteritis

- Giant cell arteritis

- Cogan's syndrome

- Behcet's disease

- Kawasaki disease

- Cryoglobulinemic vasculitis

- Systemic lupus erythematosus

- Rheumatoid arthritis

- Mixed connective tissue disease or any overlapping autoimmune syndrome
We found this trial at
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Curry Koening, MD, MHS
Phone: 801-585-0798
University of Utah Research is a major component in the life of the U benefiting...
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72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Principal Investigator: Paul A. Monach, MD, PhD
Phone: 617-414-2512
Boston University School of Medicine A leader in medical education and research, Boston University School...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Larry Moreland, MD
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Carol A. Langford, MD, MHS
Phone: 216-445-1397
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Hamilton, Ontario
Principal Investigator: Nader A. Khalidi, MD
Phone: 905-522-1155
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Peter Merkel, MD, MPH
Phone: 215-614-4407
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Rochester, Minnesota 55905
Principal Investigator: Ulrich Specks, MD
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