Determining Disease Activity Biomarkers in Individuals With Polyarteritis Nodosa



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 of Polyarteritis Nodosa

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.

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.

Inclusion Criteria:

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

- Diagnosis of vasculitis

- Diagnosis of PAN, meeting at least 1 major criterion and 1 minor criterion OR 2 major
criteria of the following adapted American College of Rheumatology (ACR) criteria that
fall under the diagnosis of PAN and that are not explained by other causes:

MAJOR CRITERIA

1. Arteriographic abnormality

2. Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy

3. Mononeuropathy or polyneuropathy

MINOR CRITERIA

1. Weight loss of more than 4 kg (8.8 lbs)

2. Livedo reticularis, cutaneous ulcerations, or skin nodules

3. Testicular pain or tenderness

4. Myalgias

5. Diastolic blood pressure greater than 90 mm Hg

6. Elevated blood urea nitrogen (BUN) or serum creatinine levels

7. Ischemic abdominal pain

Exclusion Criteria:

- Microscopic polyangiitis

- Granulomatosis with polyangiitis(Wegener's)

- Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)

- Takayasu's arteritis

- Giant cell arteritis

- Cogan's syndrome

- Behcet's disease

- Sarcoidosis

- Kawasaki disease

- Cryoglobulinemic vasculitis

- Systemic lupus erythematosus

- Rheumatoid arthritis

- Mixed connective tissue disease or any overlap autoimmune syndrome

- Presence of antiproteinase 3 or antimyeloperoxidase antineutrophil cytoplasmic
antibodies (ANCA)

- Glomeronephritis

- Alveolar hemorrhage

- Hepatitis B, hepatitis C, or HIV infection

- Any other infectious form of medium vessel vasculitis

- Isolated cutaneous PAN
We found this trial at
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75 Francis street
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(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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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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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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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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200 1st St SW
Rochester, Minnesota 55905
(507) 284-2316
Principal Investigator: Steven R. Ytterberg, MD
Mayo Clinic College of Medicine Mayo Medical School enrolls a select class of 50 medical...
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