Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener's) and Microscopic Polyangiitis
Completed
Conditions studied: Granulomatosis With Polyangiitis, Microscopic Polyangiitis, Wegener's
In brief
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.
Key facts
- Study ID
- NCT00315393
- Run by
- University of Pennsylvania
- People needed
- 1046
- 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…
- 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
You may not qualify if…
- 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
Where it is running
- Boston University School of Medicine — Boston, Massachusetts, United States
- Mayo Clinic — 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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