Abstracts tagged "clinical trial"

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: 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: 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: 0204 • ACR Convergence 2020
Pharmacokinetics and Safety of CT-P17, a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar, in Comparison with EU-Approved Adalimumab and US-Licensed Adalimumab; Results of a Phase 1, Randomized, Double-blind, Three-arm, Single-dose Study in Healthy Subjects
KyungSang Yu¹, InJin Jang¹, HyeongSeok Lim², JangHee Hong³, MinGul Kim⁴, MinKyu Park⁵, Anhye Kim⁶, MinSoo Park⁷, JaeYong Chung⁸, JongLyul Ghim⁹, SeungHwan Lee¹, SeokKyu Yoon², InSun Kwon³, Daniel Furst*¹⁰, Edward C Keystone¹¹, SangJoon Lee¹², SungHyun Kim¹², YunJu Bae¹², JungBin Cha¹³, HyeJin Kang¹³ and Jonathan Kay¹⁴, ¹Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea, ²College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea, ³Chungnam National University Hospital, Daejeon, Republic of Korea, ⁴College of Medicine, Jeonbuk National University, Jeonbuk, Republic of Korea, ⁵Chungbuk National University Hospital, Cheongju, Republic of Korea, ⁶CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea, ⁷Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea, ⁸Seoul National University Bundang Hospital, Seongnam, Republic of Korea, ⁹Inje University Busan Paik Hospital, Busan, Republic of Korea, ¹⁰Department of Medicine, Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA, Los Angeles, CA, ¹¹Mount Sinai Hospital, Toronto, ON, Canada, ¹²Celltrion, Inc., Incheon, Republic of Korea, ¹³Celltion, Inc., Incheon, Republic of Korea, ¹⁴University of Massachusetts Medical School, Worcester, MA
Background/Purpose: CT-P17 was developed as the first biosimilar of the high concentration (100 mg/mL), citrate-free formulation of reference adalimumab. The purpose of this study was…
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…
Abstract Number: 1201 • ACR Convergence 2020
Effect of Filgotinib on Pain in Patients with Rheumatoid Arthritis: Results from Phase 3 Clinical Trials
Peter Taylor¹, Arthur Kavanaugh², Peter Nash³, Janet Pope⁴, Beatrix Bartok⁵, Ken Hasegawa⁵, Shangbang Rao⁵, Sander Strengholt⁶ and Rene Westhovens⁷, ¹Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²Division of Rheumatology, Allergy, & Immunology, University of California San Diego Medical School, San Diego, CA, ³School of Medicine Griffith University, Brisbane, Queensland, Australia, ⁴Department of Medicine, University of Western Ontario, St. Joseph's Health Centre, London, ON, Canada, ⁵Gilead Sciences, Inc., Foster City, CA, ⁶Galapagos BV, Leiden, Netherlands, ⁷University Hospitals Leuven, Belgium, Leuven, Belgium
Background/Purpose: RA patients (pts) often suffer substantial pain despite ongoing treatment (tx) and regard pain control as a top tx goal. Filgotinib (FIL)—a potent, oral…
Abstract Number: 1490 • ACR Convergence 2020
Pain Rating Variability and Response to Treatment in Osteoarthritis Clinical Trials
Camila Pinto¹, Joana Barroso² and Thomas Schnitzer³, ¹Department of Physiology, Northwestern University Feinberg School of Medicine, Chicago, IL, ²Department of Physiology, Northwestern University, Feinberg School of Medicine, Chicago, IL, ³Northwestern University Feinberg School of Medicine, Chicago, IL
Background/Purpose: Despite the known high inter- and intra-patient variability in analgesic responses in chronic pain, most interventional pain studies rely on single time point pain…
Abstract Number: 1847 • ACR Convergence 2020
Delayed and Immediate Release Prednisone Decrease Fatigue Comparably in Patients with Systemic Lupus Erythematosus
Hope Rainey¹, Kristy Bell¹, Violeta Rus², Daniel Wallace³, Claire Dykas¹, Mary Mora¹, Maggy Comberg¹ and Peter Lipsky¹, ¹AMPEL BioSolutions LLC., Charlottesville, VA, ²University of Maryland School of Medicine, Baltimore, MD, ³Cedars-Sinai Medical Center/UCLA, Los Angeles, CA
Background/Purpose: Morning stiffness and fatigue are common symptoms in patients with SLE. Increased cytokines and disturbed sleep patterns may contribute to morning symptoms and fatigue…

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