Abstract

This is a randomized clinical trial of any therapy for Wegener's Granulomatosis (WG). The purpose of the study is to test whether blockade of TNF alpha results in clinical improvement in patients with limited and severe WG. The investigators will test the ability of etanercept to induce and maintain remission as standard therapies are tapered. The investigators plan to measure clinical outcome based on the standardized Birmingham vasculitis activity score (BVAS) instrument. They also plan to measure tapering of steroids and immunosuppressants as secondary outcomes. The trial combines two unique resources, the International Network for the Study of Systemic Vasculitides and the Centers for Clinical Studies at John Hopkins University. The study will be a double-blind, placebo-controlled, multicenter study involving 190 patients.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research and Development Contracts (N01)
Project #
N01AR092240-003
Application #
6359382
Study Section
Project Start
1999-09-30
Project End
2004-06-30
Budget Start
2000-09-28
Budget End
2002-09-29
Support Year
Fiscal Year
2000
Total Cost
$828,621
Indirect Cost

  Institution

Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218

  Publications

Rhee, Rennie L; Davis, John C; Ding, Linna et al. (2018) The Utility of Urinalysis in Determining the Risk of Renal Relapse in ANCA-Associated Vasculitis. Clin J Am Soc Nephrol 13:251-257
Clain, J M; Hummel, A M; Stone, J H et al. (2017) Immunoglobulin (Ig)M antibodies to proteinase 3 in granulomatosis with polyangiitis and microscopic polyangiitis. Clin Exp Immunol 188:174-181
Hinkofer, Lisa C; Hummel, Amber M; Stone, John H et al. (2015) Allosteric modulation of proteinase 3 activity by anti-neutrophil cytoplasmic antibodies in granulomatosis with polyangiitis. J Autoimmun 59:43-52
Tomasson, Gunnar; Davis, John C; Hoffman, Gary S et al. (2014) Brief report: The value of a patient global assessment of disease activity in granulomatosis with polyangiitis (Wegener's). Arthritis Rheumatol 66:428-32
Tomasson, Gunnar; Boers, Maarten; Walsh, Michael et al. (2012) Assessment of health-related quality of life as an outcome measure in granulomatosis with polyangiitis (Wegener's). Arthritis Care Res (Hoboken) 64:273-9
Silva, Francisco; Seo, Philip; Schroeder, Darrell R et al. (2011) Solid malignancies among etanercept-treated patients with granulomatosis with polyangiitis (Wegener's): long-term followup of a multicenter longitudinal cohort. Arthritis Rheum 63:2495-503
Clowse, Megan E B; Copland, Susannah C; Hsieh, Tsung-Cheng et al. (2011) Ovarian reserve diminished by oral cyclophosphamide therapy for granulomatosis with polyangiitis (Wegener's). Arthritis Care Res (Hoboken) 63:1777-81
Tomasson, Gunnar; Lavalley, Michael; Tanriverdi, Kahraman et al. (2011) Relationship between markers of platelet activation and inflammation with disease activity in Wegener's granulomatosis. J Rheumatol 38:1048-54
Suppiah, Ravi; Judge, Andrew; Batra, Rajbir et al. (2011) A model to predict cardiovascular events in patients with newly diagnosed Wegener's granulomatosis and microscopic polyangiitis. Arthritis Care Res (Hoboken) 63:588-96
Finkielman, J D; Merkel, P A; Schroeder, D et al. (2009) Glycosylation of proteinase 3 (PR3) is not required for its reactivity with antineutrophil cytoplasmic antibodies (ANCA) in Wegener's granulomatosis. Clin Exp Rheumatol 27:S45-52

Showing the most recent 10 out of 24 publications