Microscopic Polyangiitis Clinical Trial
Official title:
Determining Disease Activity Biomarkers in Individuals With Granulomatosis With Polyangiitis (Wegener's) and Microscopic Polyangiitis
Verified date | July 2022 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1046 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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: 1. Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood 2. Abnormal chest radiograph with nodules, fixed infiltrates, or cavities 3. Urinary sediment with microhematuria or red cell casts 4. Granulomatous inflammation within the wall of an artery or in the perivascular area on biopsy 5. 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: 1. Necrotizing vasculitis, with few or no immune deposits, that affects small vessels (i.e., capillaries, venules, arterioles) 2. Necrotizing arteritis involving small- and medium-sized arteries may be present 3. Necrotizing glomerulonephritis is very common 4. Pulmonary capillaritis often occurs - Parent or guardian willing to provide informed consent, if applicable Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Healthcare | Hamilton | Ontario |
Canada | Mount Sinai Hospital | Toronto | Ontario |
United States | Boston University School of Medicine | Boston | Massachusetts |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Rare Diseases (ORD), Rare Diseases Clinical Research Network |
United States, Canada,
Borgmann S, Haubitz M. Genetic impact of pathogenesis and prognosis of ANCA-associated vasculitides. Clin Exp Rheumatol. 2004;22(6 Suppl 36):S79-86. Review. — View Citation
Cooley P, Taylor KH, Czika W, Seifer C, Taylor JF. Analysis of a biomarker for Wegener's granulomatosis. Int J Immunogenet. 2005 Aug;32(4):237-43. — View Citation
Jagiello P, Gross WL, Epplen JT. Complex genetics of Wegener granulomatosis. Autoimmun Rev. 2005 Jan;4(1):42-7. Review. — View Citation
Radice A, Sinico RA. Antineutrophil cytoplasmic antibodies (ANCA). Autoimmunity. 2005 Feb;38(1):93-103. Review. — View Citation
Stone JH, Rajapakse VN, Hoffman GS, Specks U, Merkel PA, Spiera RF, Davis JC, St Clair EW, McCune J, Ross S, Hitt BA, Veenstra TD, Conrads TP, Liotta LA, Petricoin EF 3rd; Wegener's Granulomatosis Etanercept Trial Research Group. A serum proteomic approach to gauging the state of remission in Wegener's granulomatosis. Arthritis Rheum. 2005 Mar;52(3):902-10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Discover biomarkers in GPA/MPA capable of measuring disease activity and response to treatment. | Study completion | ||
Secondary | Measure the predictive value of biomarkers for clinical outcome in GPA/MPA | Study completion. |
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