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临床试验/NCT00315393
NCT00315393已完成不适用

Determining Disease Activity Biomarkers in Individuals With Granulomatosis With Polyangiitis (Wegener's) and Microscopic Polyangiitis

University of Pennsylvania8 个研究点 分布在 2 个国家目标入组 1,046 人开始时间: 2006年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,046
试验地点
8
主要终点
Discover biomarkers in GPA/MPA capable of measuring disease activity and response to treatment.

研究概览

简要总结

Granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA) are two rare immune system disorders that cause the inflammation of blood vessels, or vasculitis. In order to properly treat these diseases, 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 GPA or MPA.

详细描述

GPA and MPA are two autoimmune disorders that cause systemic vasculitis. GPA commonly affects the upper respiratory tract, the lungs, and the kidneys. MPA is marked by kidney inflammation, weight loss, skin lesions, nerve damage, and fever. Many patients with WG or MPA show no visible symptoms of active disease; it is known that underlying subclinical disease activity leads to long-term damage in these patients. Also, because it is difficult to monitor WG and MPA disease activity, it is difficult for clinicians to know when and how to treat these patients. This study will use new scientific methods to identify new biomarkers that can be used to monitor disease activity in GPA and MPA patients. These biomarkers may be used to help direct clinical care for GPA and MPA 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosis of GPA or MPA. Widely accepted diagnostic criteria, as opposed to classification criteria or definitions, have not been developed for GPA and MPA.
  • For diagnosis of GPA, meets at least 2 of the following 5 modified American College of Rheumatology (ACR) criteria:
  • Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood
  • Abnormal chest radiograph with nodules, fixed infiltrates, or cavities
  • Urinary sediment with microhematuria or red cell casts
  • Granulomatous inflammation within the wall of an artery or in the perivascular area on biopsy
  • Antineutrophil cytoplasmic antibody (ANCA) positive by enzyme immunoassay for either PR3- or MPO-ANCA
  • For diagnosis of MPA, meets the Chapel Hill Consensus Conference Definition for MPA:
  • Necrotizing vasculitis, with few or no immune deposits, that affects small vessels (i.e., capillaries, venules, arterioles)
  • Necrotizing arteritis involving small- and medium-sized arteries may be present
  • Necrotizing glomerulonephritis is very common
  • Pulmonary capillaritis often occurs
  • Parent or guardian willing to provide informed consent, if applicable

排除标准

  • Simultaneous diagnoses of both GPA and MPA
  • Granulomatosis with polyangiitis (Churg-Strauss)
  • Takayasu's arteritis
  • Giant cell arteritis
  • Polyarteritis nodosa
  • Cogan's syndrome
  • Behcet's disease
  • Sarcoidosis
  • Kawasaki disease
  • Tuberculosis or any atypical mycobacterial infections
  • Deep fungal infections
  • Lymphoma, lymphomatoid granulomatosis, or any other type of cancer that mimics anti-neutrophil cytoplasmic antibody-associated vasculitis (AAVs)
  • Cryoglobulinemic vasculitis
  • Systemic lupus erythematosus
  • Rheumatoid arthritis
  • Mixed connective tissue disease or any overlapping autoimmune syndrome

结局指标

主要结局

Discover biomarkers in GPA/MPA capable of measuring disease activity and response to treatment.

时间窗: Study completion

次要结局

  • Measure the predictive value of biomarkers for clinical outcome in GPA/MPA(Study completion.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Merkel

Professor

University of Pennsylvania

研究点 (8)

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