Abstracts tagged "clinical trial"

Abstract Number: 1770 • ACR Convergence 2021
Interim Analysis of Cohort 1 in the Mesenchymal Stromal Cell Trial in Systemic Lupus Erythematosis: Safety and Data Management During the Pandemic
Gary Gilkeson¹, Diane Kamen¹, S Sam Lim², Rosalind Ramsey-Goldman³, Kenneth Kalunian⁴, Saira Sheikh⁵, Mariko Ishimori⁶ and Daniel Wallace⁷, ¹Medical University of South Carolina, Charleston, SC, ²Department of Medicine, Division of Rheumatology, Emory University School of Medicine, Atlanta, GA, ³Northwestern University, Chicago, IL, ⁴UC San Diego, La Jolla, CA, ⁵University of North Carolina Thurston Arthritis Research Center, and Department of Medicine, Division of Rheumatology, Allergy and Immunology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, ⁶Cedars-Sinai Health System, Los Angeles, CA, ⁷Attune Health, Beverly Hills, CA
Background/Purpose: There is heightened interest in the use of mesenchymal stromal cells (MSCs) for the treatment of autoimmune diseases. There are a number of reports…
Abstract Number: 1874 • ACR Convergence 2021
Using 18F-fluorodeoxyglucose Positron Emission Tomography to Standardize Clinical Trial Recruitment in Takayasu’s Arteritis
Kaitlin Quinn¹, Hugh Alessi², Emily Rose³, Mark A. Ahlman⁴, Christopher Redmond⁴, Yiming Luo⁴, Ertugrul Cagri bolek⁵, Carol Langford⁶, Cristina Ponte⁷, Peter Merkel⁸ and Peter Grayson⁹, ¹National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Washington, DC, ²National Institutes of Health, Bethesda, Maryland, ³Case Western, Cleveland Heights, OH, ⁴National Institutes of Health, Bethesda, MD, ⁵Vasculitis Translational Research Program, NIAMS, NIH, US, Lanham, MD, ⁶Cleveland Clinic, Moreland Hills, OH, ⁷Hospital de Santa Maria, Lisbon, Portugal, ⁸University of Pennsylvania, Philadelphia, PA, ⁹National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Bethesda, MD
Background/Purpose: Disease activity assessment can be challenging in Takayasu’s arteritis (TAK), which can lead to difficulty in determining eligibility for enrollment into randomized clinical trials…
Abstract Number: L09 • ACR Convergence 2020
A Phase 2a Randomized, Double-blind, Placebo-controlled Study of Ziritaxestat in Early Diffuse Cutaneous Systemic Sclerosis (NOVESA)
Dinesh Khanna¹, Christopher Denton², Daniel Furst³, Maureen Mayes⁴, Marco Matucci-Cerinic⁵, Vanessa Smith⁶, Dick de Vries⁷, Liesbeth Deberdt⁸, Pieter‑Jan Stiers⁸, Niyati Prasad⁸ and Sohail Ahmed⁹, ¹University of Michigan, Ann Arbor, MI, ²Royal Free Hospital, University College London, London, United Kingdom, ³David Geffen School of Medicine at UCLA, Los Angeles, CA, ⁴University of Texas Health Science Center at Houston, Houston, TX, ⁵Università degli Studi di Firenze, Firenze, Italy, ⁶Ghent University Hospital, Ghent, Belgium, ⁷Galapagos BV, Leiden, Netherlands, ⁸Galapagos NV, Mechelen, Belgium, ⁹Ahmed Science Medicine, Basel, Switzerland
Background/Purpose: There is a high unmet need for systemic sclerosis (SSc) treatments. Ziritaxestat (ziri; GLPG1690) is an autotaxin inhibitor with a novel mechanism of action.…
Abstract Number: L10 • ACR Convergence 2020
Targeting Plasmacytoid Dendritic Cells Improves Cutaneous Lupus Erythematosus Skin Lesions and Reduces Type I Interferon Levels: Results of a Phase 1 Study of VIB7734
Victoria Werth¹, Jodi Karnell², William Rees², Nanette Mittereder³, Li Yan², Yanping Wu³, Jorn Drappa², Gabor Illei² and John Ratchford², ¹University of Pennsylvania, Philadelphia, PA, ²Viela Bio, Gaithersburg, MD, ³Viela Bio, Gaithersburg
Background/Purpose: Plasmacytoid dendritic cells (pDCs) secrete large amounts of type I interferon (IFN) and other cytokines upon activation. pDCs migrate to sites of active disease…
Abstract Number: L11 • ACR Convergence 2020
Tofacitinib for the Treatment of Adult Patients with Ankylosing Spondylitis: Primary Analysis of a Phase 3, Randomized, Double-blind, Placebo-controlled Study
Atul Deodhar¹, Paula Sliwinska-Stanczyk², Huji Xu³, Xenofon Baraliakos⁴, Lianne Gensler⁵, Dona Fleishaker⁶, Lisy Wang⁶, Joseph Wu⁶, Sujatha Menon⁶, Cunshan Wang⁶, Oluwaseyi Dina⁷, Lara Fallon⁸, Keith S Kanik⁶ and Désirée van der Heijde⁹, ¹Oregon Health & Science University, Portland, OR, ²Reumatika Centrum Reumatologii, Warszawa, Poland, ³Shanghai Changzheng Hospital, Shanghai, China (People's Republic), ⁴Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum, Germany, ⁵University of California San Francisco, San Francisco, CA, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer Inc, New York, NY, ⁸Pfizer Inc, Montreal, QC, Canada, ⁹Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Tofacitinib is an oral JAK inhibitor that is being investigated for the treatment of adult patients (pts) with AS.Methods: This Phase 3, randomized, double-blind…
Abstract Number: 0236 • ACR Convergence 2020
Safety and Usability of Infliximab Administration by Auto-injector (AI) and Pre-filled Syringe (PFS) in Patients with Active Rheumatoid Arthritis (RA): Patient-reported Experience from a Multicenter, Randomized Controlled Pivotal Trial
Rene Westhovens¹, DaeHyun Yoo², Piotr Wiland³, Marek Zawadzki⁴, Delina Ivanova⁵, Alfredo Berrocal Kasay⁶, Elias Chalouhi⁷, Eva Balázs⁸, SangJoon Lee⁹, SungHyun Kim⁹, JeeHye Suh⁹, NooRi Han⁹ and HoJae Lee⁹, ¹University Hospitals Leuven, Belgium, Leuven, Belgium, ²Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, ³Medical Univeristy, Wroclaw, Poland, ⁴Medical Univeristy, Dpt of Rheumatology , Wroclaw, Wroclaw, Poland, ⁵Diagnostic-Consultative Center Aleksandrovska EOOD, Sofia, Bulgaria, ⁶ABK Reuma SRL, LIMA, Peru, ⁷Clinica Internacional Sede Lima, Lima, Peru, ⁸Dr. Bugyi István Hospital, Szentes, Hungary, ⁹Celltrion, Inc., Incheon, Republic of Korea
Background/Purpose: The subcutaneous (SC) formulation of CT-P13 received marketing authorization for RA from the EMA by demonstrating non-inferiority compared to CT-P13 intravenous for efficacy in…
Abstract Number: 0515 • ACR Convergence 2020
A Proof of Concept Study to Assess the Efficacy of Tocilizumab in Combination with Ultra-Short Glucocorticoid Administration to Treat Newly Diagnosed Giant Cell Arteritis – a 24 Week Analysis
Lisa Christ¹, Luca Seitz¹, Lukas Buetikofer², Godehard Scholz¹, Adela-Cristina Sarbu¹, Jennifer Amsler¹, Florian Kollert¹, Stephan Reichenbach¹ and Peter Villiger¹, ¹Department of Rheumatology, Immunology and Allergology, University of Bern, Inselspital, Switzerland, Bern, Switzerland, ²Clinical Trials Unit, University of Bern, Bern, Switzerland, Bern, Switzerland
Background/Purpose: Two randomized controlled trials [Villiger et al. Lancet 2016; Stone et al. NEJM 2017] demonstrated a glucocorticoid (GC)-sparing effect of tocilizumab (TCZ) of at…
Abstract Number: 0860 • ACR Convergence 2020
PREVAIL 1: A Multiple Ascending Dose Study in Normal Healthy Volunteers of PRV-3279, a Novel Bispecific DART Molecule Targeting CD32B and CD79B on B Cells, with Potential for Treatment of SLE
Paul Dunford¹, Gail Comer¹, Ralph Raymond¹, Donald Jung¹, Paul Moore², Francisco Leon¹ and Joan Merrill³, ¹Provention Bio, Oldwick, NJ, ²MacroGenics, Rockville, MD, ³Oklahoma Medical Research Foundation, Oklahoma City, OK
Background/Purpose: B-cell targeted therapeutics have proven efficacious in the treatment of autoimmune disorders. A desired improvement in efficacy and safety necessitate the development of alternate,…
Abstract Number: 1094 • ACR Convergence 2020
Long Term Open Label Extension of Study of Tofacitinib in Refractory Dermatomyositis
Julie Paik¹, Jemima Albayda¹, Eleni Tiniakou¹, Grazyna Purwin¹, Andrew Koenig² and Lisa Christopher-Stine¹, ¹Johns Hopkins University, Baltimore, MD, ²Pfizer Inc, New York City, NY
Background/Purpose: Tofacitinib is a pan-JAK inhibitor that demonstrated safety and efficacy in a 12 week open label trial of 10 subjects with refractory dermatomyositis (NCT03002649).…
Abstract Number: 1482 • ACR Convergence 2020
Joint Safety with Tanezumab: Integrated Analyses from Randomized Controlled Phase 3 Studies in Patients with Osteoarthritis
John Carrino¹, Timothy McAlindon², Eric Vignon³, Mark Brown⁴, Aimee Burr⁴, Robert Fountaine⁴, Glenn Pixton⁵, Lars Viktrup⁶, Christine West⁷ and Kenneth Verburg⁸, ¹Hospital for Special Surgery, Hackensack, NJ, ²Tufts Medical Center, Boston, MA, ³Université Claude Bernard Lyon 1, Pierre Benite, France, ⁴Pfizer Inc., Groton, CT, ⁵Pfizer Inc., Morrisville, NC, ⁶Eli Lilly and Company, Indianapolis, IN, ⁷Pfizer Inc, Groton, CT, ⁸Pfizer Inc, Groton
Background/Purpose: Tanezumab, a monoclonal antibody that inhibits nerve growth factor, has been shown effective in the management of osteoarthritis (OA) pain.1,2 Due to the potential…
Abstract Number: 1843 • ACR Convergence 2020
Integrated Efficacy of the AURORA 1 and AURA-LV Trials Confirms Voclosporin Rapid Proteinurea Reduction in the Presence of Low-Dose Steroids
Ellen M Ginzler¹, Joshua Kaplan², Laura Lisk³, Ray Federico⁴, Neil Solomons⁵ and Robert Huizinga⁵, ¹SUNY Downstate Health Sciences University, Brooklyn, ²Rutgers University, New Brunswick, NJ, ³Aurinia Pharmaceuticals Inc., Victoria, BC, Canada, ⁴Aurinia Pharmaceuticals, Inc., Victoria, Canada, ⁵Aurinia Pharmaceuticals, Victoria, BC, Canada
Background/Purpose: Voclosporin (VCS) is a novel calcineurin inhibitor (CNI) with a favorable metabolic profile and a consistent predictable dose response potentially eliminating the need for…
Abstract Number: 0201 • ACR Convergence 2020
A Multicenter, Randomized, Placebo-controlled, Double-blind Phase 2 Study of SHR0302 versus Placebo in Chinese Subjects with Moderate to Severe Active Rheumatoid Arthritis (RA)
Xiaofeng Zeng¹, Ying Jiang², Ying Yang³ and Hanying Li⁴, ¹Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China (People's Republic), ²Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Beijing, China (People's Republic), ³Jiangsu Hengrui Medicine Co., Ltd, Guangzhou, China (People's Republic), ⁴Jiangsu Hengrui Medicine Co., Ltd, Shanghai, China (People's Republic)
Background/Purpose: Proinflammatory cytokine activation of JAK/STAT signal pathway is critical in the pathogenesis and progression of RA. SHR0302, a potent and selective inhibitor of JAK1,…
Abstract Number: 0237 • ACR Convergence 2020
Safety Profile of Upadacitinib up to 3 Years of Exposure in Patients with Rheumatoid Arthritis
Stanley Cohen¹, Ronald F Van Vollenhoven², Jeffrey Curtis³, Leonard Calabrese⁴, Cristiano AF Zerbini⁵, Yoshiya Tanaka⁶, Louis Bessette⁷, Casey Schlacher⁸, Tim Shaw⁹, John Liu⁹, Jeffrey Enejosa⁹, Yanna Song¹⁰ and Gerd Burmester¹¹, ¹Metroplex Clinical Research Center, Dallas, TX, ²Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, Netherlands, ³Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, ⁴Cleveland Clinic, Cleveland, OH, ⁵Centro Paulista de Investigacao Clinica (CEPIC), Sao Paulo, Brazil, ⁶The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁷Laval University, Quebec, Canada, ⁸AbbVie Inc., Lake Forest, IL, ⁹AbbVie Inc., North Chicago, IL, ¹⁰AbbVie Inc., North Chicago,, IL, ¹¹Charité University Hospital Berlin, Berlin, Germany
Background/Purpose: The safety and efficacy of upadacitinib (UPA), an oral JAK inhibitor, was evaluated in the phase 3 SELECT clinical program, which included 5 randomized,…
Abstract Number: 0546 • ACR Convergence 2020
Stepping up for Inflammatory Arthritis (SUFIA): A Pilot Trial to Test Behavioral Economics Strategy to Increase Physical Activity in Inflammatory Arthritis
Alexis Ogdie¹, Kathleen Bush¹, Michael George¹, Mitesh Patel¹, William Nowell², Kelly Gavigan³, Jeffrey Curtis⁴ and Joshua Baker⁵, ¹University of Pennsylvania, Philadelphia, PA, ²Global Healthy Living Foundation, New York City, NY, ³Global Healthy Living Foundation, Upper Nyack, NY, ⁴Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, ⁵Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: Regular physical activity may have benefits for patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA), but patients with active disease are often reluctant…
Abstract Number: 0862 • ACR Convergence 2020
Voclosporin Does Not Decrease Mycophenolic Acid Concentrations in Patients with SLE
Teun van Gelder¹, Robert Huizinga², Neil Solomons² and Laura Lisk³, ¹Leiden University Medical Centre, Leiden, Zuid-Holland, Netherlands, ²Aurinia Pharmaceuticals, Victoria, BC, Canada, ³Aurinia Pharmaceuticals Inc., Victoria, BC, Canada
Background/Purpose: Voclosporin (VCS) is a novel calcineurin inhibitor, structurally similar to cyclosporine A (CsA). In a Phase 3 clinical trial in patients with active lupus…

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