Determining Disease Activity Biomarkers in Individuals With Polyarteritis Nodosa

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 06-002036
    NCT ID: NCT00315406
    Sponsor Protocol Number: RDCRN 5504

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

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
      • 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 
  • Must agree to share samples with other researchers

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Warrington, M.D.

Closed for enrollment

Contact information:

Jane Jaquith C.C.R.C.

(507)284-4502

jaquith.jane@mayo.edu

More information

Publications

  • Necrotizing vasculitis occurs as a primary phenomenon in connective tissue disorders and cognate fields, including polyarteritis nodosa and the Churg and Strauss syndrome variant, rheumatoid arthritis, systemic lupus and Wegener's granulomatosis. In all these conditions focal and multifocal neuropathy occur as a consequence of destruction of the arterial wall and occlusion of the lumen of small epineurial arteries. Vasculitis may also complicate the course of other conditions ranging from infection with the HIV and with the B and C hepatitis viruses to diabetes and sarcoidosis. Pathologically polymorphonuclear cells are present in the infiltrates of the vessel wall in primary necrotizing vasculitis, while in secondary vasculitis the inflammatory infiltrate is mainly composed of mononuclear cells. In all instances symptomatic vasculitis requires corticosteroid to control the inflammatory process and prevent further ischemic nerve lesions. Read More on PubMed
  • Polyarteritis nodosa is one of the earliest forms of systemic vasculitis described. It is characterized by segmental necrotizing arterial lesions affecting medium-sized and small-sized arteries. Active necrotizing lesions are frequently associated with chronic reparative lesions. Current convention would exclude patients with necrotizing glomerular lesions from this category. An aneurysm may form when the arterial wall is sufficiently weakened by the necrotizing process. Any organ may be affected; however, pulmonary involvement is very uncommon. Significant potential exists for end organ injury resulting from ischemia, infarcts, and hemorrhage. A variety of other primary systemic vasculitidies, secondary forms, such as connective tissue disease associated, and organ limited forms, have been identified that may exhibit similar arterial lesions including aneurysm formation. Establishing a definitive diagnosis of polyarteritis nodosa is therefore challenging, and mandates dialogue between the pathologist and the clinician primed with pertinent clinical and laboratory data. Fortunately, with early diagnosis and aggressive treatment with cytotoxic agents, the prognosis of polyarteritis nodosa has substantially improved. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20147704

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