Determining Disease Activity Biomarkers in Individuals With Polyarteritis Nodosa
Completed
Conditions studied: Polyarteritis Nodosa
In brief
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.
Key facts
- Study ID
- NCT00315406
- Run by
- University of Pennsylvania
- People needed
- 107
- Starts
- 2006-04-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2022-07-12
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Boston University School of Medicine — Boston, Massachusetts, United States
- Mayo Clinic College of Medicine — Rochester, Minnesota, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- University of Utah — Salt Lake City, Utah, United States
- St. Joseph's Healthcare — Hamilton, Ontario, Canada
- Mount Sinai Hospital — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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