Status:
COMPLETED
Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener's) and Microscopic Polyangiitis
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Office of Rare Diseases (ORD)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Granulomatosis With Polyangiitis
Microscopic Polyangiitis
Eligibility:
All Genders
Brief Summary
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 prop...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
1046 Patients enrolled
Trial Details
Trial ID
NCT00315393
Start Date
April 1 2006
End Date
December 1 2019
Last Update
July 12 2022
Active Locations (8)
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1
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104