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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00315393
Other study ID # VCRC5505
Secondary ID U54AR057319
Status Completed
Phase
First received
Last updated
Start date April 2006
Est. completion date December 2019

Study information

Verified date July 2022
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 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.


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, 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.


Recruitment information / eligibility

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

Study Design


Locations

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

Sponsors (4)

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

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (5)

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

Outcome

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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