Status:
COMPLETED
Determining Disease Activity Biomarkers in Individuals With Polyarteritis Nodosa
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Office of Rare Diseases (ORD)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Polyarteritis Nodosa
Eligibility:
All Genders
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 critica...
Detailed Description
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 sup...
Eligibility Criteria
Inclusion
- 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
- Arteriographic abnormality
- Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy
- Mononeuropathy or polyneuropathy
- MINOR CRITERIA
- Weight loss of more than 4 kg (8.8 lbs)
- Livedo reticularis, cutaneous ulcerations, or skin nodules
- Testicular pain or tenderness
- Myalgias
- Diastolic blood pressure greater than 90 mm Hg
- Elevated blood urea nitrogen (BUN) or serum creatinine levels
- Ischemic abdominal pain
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00315406
Start Date
April 1 2006
End Date
December 1 2019
Last Update
July 12 2022
Active Locations (9)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
3
Mayo Clinic College of Medicine
Rochester, Minnesota, United States, 55905
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195