The primary objective of this mentored clinical scientist development award is to acquire the skills and expertise needed to become an independent investigator in the rheumatic diseases. To accomplish this objective, the candidate has carefully constructed a training program designed to foster growing independence as a clinical investigator. This program combines formal didactics in clinical investigation with clinical research under the guidance of the sponsor, Dr. John Stone. The candidate's development will also be fostered by an Advisory Committee comprised of senior clinical investigators who bring with them expertise in rheumatic illness, disease assessment, and clinical research. The scientific objective of this proposal is designed to address a critical but unmet need in vasculitis research for rigorously validated outcomes measures. This proposal focuses on the development and validation of an instrument to assess the long-term consequences (i.e. """"""""damage"""""""") associated with ANCA-associated vasculitis. The instrument will be created from a data-driven process supplemented by consensus of international experts, and will be validated in a clinical trial of these diseases. This career development program has been designed to allow the candidate to accomplish three major goals: 1. To broaden and solidify the skills necessary to become an independent clinical investigator. 2. To become an expert in the design and conduct of clinical trials. 3. To foster partnerships with collaborators in the United States and Europe. At the end of this career development program, the candidate will be well positioned to become an independent clinical investigator.

National Institute of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Mentored Patient-Oriented Research Career Development Award (K23)
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Application #
Study Section
Special Emphasis Panel (ZAR1-EHB-H (M1))
Program Officer
Witter, James
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Johns Hopkins University
Internal Medicine/Medicine
Schools of Medicine
United States
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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
Wallace, Zachary S; Miloslavsky, Eli M; Cascino, Matthew et al. (2017) Effect of Disease Activity, Glucocorticoid Exposure, and Rituximab on Body Composition During Induction Treatment of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Care Res (Hoboken) 69:1004-1010
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
Fussner, Lynn A; Hummel, Amber M; Schroeder, Darrell R et al. (2016) Factors Determining the Clinical Utility of Serial Measurements of Antineutrophil Cytoplasmic Antibodies Targeting Proteinase 3. Arthritis Rheumatol 68:1700-10
Unizony, Sebastian; Villarreal, Miguel; Miloslavsky, Eli M et al. (2016) Clinical outcomes of treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis based on ANCA type. Ann Rheum Dis 75:1166-9
Miloslavsky, E M; Specks, U; Merkel, P A et al. (2015) Outcomes of nonsevere relapses in antineutrophil cytoplasmic antibody-associated vasculitis treated with glucocorticoids. Arthritis Rheumatol 67:1629-36
Geetha, Duvuru; Specks, Ulrich; Stone, John H et al. (2015) Rituximab versus cyclophosphamide for ANCA-associated vasculitis with renal involvement. J Am Soc Nephrol 26:976-85
Langford, Carol A; Monach, Paul A; Specks, Ulrich et al. (2014) An open-label trial of abatacept (CTLA4-IG) in non-severe relapsing granulomatosis with polyangiitis (Wegener's). Ann Rheum Dis 73:1376-9
Miloslavsky, E M; Specks, U; Merkel, P A et al. (2014) Rituximab for the treatment of relapses in antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheumatol 66:3151-9
Miloslavsky, E M; Specks, U; Merkel, P A et al. (2013) Clinical outcomes of remission induction therapy for severe antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum 65:2441-9

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