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Abstracts tagged "clinical trial"

  • Abstract Number: 0208 • ACR Convergence 2020

    Efficacy and Safety of Filgotinib for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: 52-Week Results

    Bernard Combe1, Alan Kivitz2, Yoshiya Tanaka3, Désirée van der Heijde4, J-Abraham Simon-Campos5, Herbert S. Baraf6, Uma Kumar7, Franziska Matzkies8, Beatrix Bartok8, Lei Ye8, Ying Guo9, Chantal Tasset10, John S. Sundy8, Angelika Jahreis8, Neelufar Mozaffarian11, Robert Landewé12, Sang-Cheol Bae13, Edward C Keystone14 and Peter Nash15, 1University of Montpellier, Montpellier, France, 2Altoona Center for Clinical Research/Altoona Arthritis and Osteoporosis Center, Duncansville, PA, 3The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, 4Leiden University Medical Center, Leiden, Netherlands, 5Köhler & Milstein Research, Mérida, Mexico, 6The Ctr for Rheumatology and Bone Research, Wheaton, MD, 7All India Institute of Medical Sciences, New Delhi, India, 8Gilead Sciences, Inc., Foster City, CA, 9Gilead Sciences, Inc., Foster City, 10Galapagos NV, Mechelen, Belgium, 11Ichnos Sciences, Paramus, 12Amsterdam University Medical Center & Zuyderland Hospital, Amsterdam, Netherlands, 13Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 14Mount Sinai Hospital, Toronto, ON, Canada, 15School of Medicine Griffith University, Brisbane, Queensland, Australia

    Background/Purpose: Filgotinib (FIL) is an oral, potent, selective Janus kinase 1 (JAK1) inhibitor. FINCH 1 (NCT02889796) assessed FIL efficacy and safety in patients (pts) with…
  • Abstract Number: 0280 • ACR Convergence 2020

    Compliance and Validation of Patient Reported Outcome Information Collected from Lupus Patients Using a Mobile Application

    Kristy Bell1, Claire Dykas1, Hope Rainey1, Maggy Comberg1, Mary Mora1 and Peter Lipsky1, 1AMPEL BioSolutions LLC., Charlottesville, VA

    Background/Purpose: Patient Reported Outcomes (PROs) can provide critical data in measuring the impact of a disease on an individual as well as the quality of…
  • Abstract Number: 0599 • ACR Convergence 2020

    Evaluation of Telephone Consultations in Germany as an Additional Tool in Outpatient Rheumatology Clinics During the COVID-19 Pandemic

    Ulrich Drott1, Axel Braner1, Thomas Kollewe2, Harald Burkhardt3 and Florian Meier1, 1Department of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany, Frankfurt, Germany, 2J. W. Goethe-Universität Frankfurt, FB Medizin, Frankfurter Arbeitsstelle für Medizindidaktik, Frankfurt, Germany, Frankfurt, Germany, 3Department of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany, Frankfurt am Main, Germany

    Background/Purpose: The Covid-19 pandemic holds multiple challenges for the healthcare system. Quick adoptions and adjustments are the mainstays during these times. Hygiene management and plans…
  • Abstract Number: 0874 • ACR Convergence 2020

    A Multi-Center, Randomized, Double-blind, Placebo-controlled Dose-ranging Study Evaluating Efficacy and Safety of SHR-1314 in Subjects with Moderate-to-Severe Plaque Psoriasis

    Chunlei Zhang1, Kexiang Yan2, Qingchun Diao3, Qing Guo4, Hongzhong Jin5, Sen Yang6, Xiang Chen7, Tiechi Lei8, Jianhua Wu9, Hong Yu10, Min Zheng11, Xinghua Gao12, Robert Sinclair13, Delilah Alonso14, Yi Zhu15, Qian Xu15 and Jinhua Xu2, 1Department of Dermatology, Peking University Third Hospital, Beijing, China (People's Republic), 2Huashan Hospital Affiliated to Fudan University, Shanghai, China (People's Republic), 3Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China (People's Republic), 4Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China (People's Republic), 5Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China (People's Republic), 6The First Affiliated Hospital of Anhui Medical University, Hefei, China (People's Republic), 7Xiangya Hospital, Central South University, Changsha, China (People's Republic), 8Renmin Hospital of Wuhan University, Hubei General Hospital, Wuhan, China (People's Republic), 9Changhai Hospital of Shanghai, Shanghai, China (People's Republic), 10Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China (People's Republic), 11The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China (People's Republic), 12The 1st Hospital of China Medical University, Shenyang, China (People's Republic), 13Sinclair Dermatology, East Melbourne, Australia, 14Revival Research, Doral, 15Jiangsu Hengrui Medicine Co., Ltd, Shanghai, China (People's Republic)

    Background/Purpose: SHR-1314 is a humanized monoclonal immunoglobulin (IgG1/κ isotype) targeting human interleukin-17A (IL-17A). Preliminary data from phase I study has shown that single dose of…
  • Abstract Number: 1208 • ACR Convergence 2020

    Utility of Measuring the Immunogenicity to CT-P13 for Subcutaneous Use in Patients with Active Rheumatoid Arthritis: 1-Year Results 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, ChanKyoung Hwang9 and DaeSeok Choi9, 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: Novel subcutaneous infliximab (CT-P13 SC) was developed to augment the flexibility in the therapeutic use of infliximab and non-inferiority (NI) of CT-P13 SC versus…
  • Abstract Number: 1557 • ACR Convergence 2020

    Lymphatics as a Biomarker of Joint Physiology: Near-Infrared Imaging of Indocyanine Green Identifies Novel Routes of Lymphatic Drainage from Metacarpophalangeal Joints in Healthy Human Hands

    H. Mark Kenney1, Gregory Dieudonne1, Ronald Wood1, Edward Schwarz1, Christopher Ritchlin2 and Homaira Rahimi3, 1University of Rochester Medical Center, Rochester, 2Department of Medicine, University of Rochester Medical Center, Rochester, NY, 3University of Rochester Medical Center, Rochester, NY

    Background/Purpose: In our previous work, we discovered that patients with active hand RA have reduced lymphatic drainage of indocyanine green (ICG) from the web spaces…
  • Abstract Number: 1990 • ACR Convergence 2020

    Janus Kinase (JAK) Inhibition with Baricitinib in Refractory Juvenile Dermatomyositis

    Hanna Kim1, Lylan Bergeron2, Samantha Dill2, Michelle O'Brien2, Laura Vian3, Minal Jain4, Manuk Manukyan2, Xiaobai Li5, Shajia Lu3, Wanxia L. Tsai3, Kalyani Mishra Thakur6, Yinghui Shi6, Massimo Gadina7, April Brundidge2, Michelle Millwood2, Lisa G. Rider8 and Robert Colbert2, 1Juvenile Myositis Pathogenesis and Therapeutics Unit / NIAMS / National Institutes of Health, Bethesda, MD, 2Pediatric Clinical Trials Unit and Office of Clinical Director, NIAMS, NIH, Bethesda, MD, 3Translational Immunology Section, NIAMS, NIH, Bethesda, MD, 4Rehabilitation Medicine Department, Physical Therapy Section, Clinical Research Center, NIH, Bethesda, MD, 5Biostatistics and Clinical Epidemiology Service, Clinical Center, NIH, Bethesda, MD, 6Office of Clinical Director, NIAMS, NIH, Bethesda, MD, 7National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH, Bethesda, MD, 8Environmental Autoimmunity Group, Clinical Research Branch, NIEHS, NIH, Garrett Park, MD

    Background/Purpose: Juvenile dermatomyositis (JDM) is a systemic autoimmune disease with a prominent interferon (IFN) signature. Treatment often requires prolonged high-dose steroids and other immunosuppressive medications.…
  • Abstract Number: 0209 • ACR Convergence 2020

    Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate: Results at 84 Weeks

    Josef Smolen1, Paul Emery2, William Rigby3, Yoshiya Tanaka4, Juan Vargas5, Nemanja Damjanov6, Manish Jain7, Yanna Song8, Nasser Khan9, Jeffrey Enejosa9 and Stanley Cohen10, 1Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, 2Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK, Leeds, United Kingdom, 3Dartmouth College, Norwichi, VT, 4The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, 5Quantum Research, Puerto Varas, Chile, 6University of Belgrade Medical School, Belgrade, Serbia, 7Great Lakes Clinical Trials, Chicago, IL, 8AbbVie Inc., North Chicago,, IL, 9AbbVie Inc., North Chicago, IL, 10Metroplex Clinical Research Center, Dallas, TX

    Background/Purpose: In the SELECT-MONOTHERAPY trial, upadacitinib (UPA), an oral JAK inhibitor, demonstrated significantly greater efficacy compared to continuing methotrexate (MTX) when used as monotherapy over…
  • Abstract Number: 0347 • ACR Convergence 2020

    In Two Phase-3 Trials, Guselkumab Reduced Fatigue over 52 Weeks in Patients with Psoriatic Arthritis and Demonstrated Independent Treatment Effects on Fatigue After Adjustment for Clinical Response (ACR20)

    Proton Rahman1, Philip Helliwell2, Atul Deodhar3, Alexa Kollmeier4, Elizabeth Hsia5, Bei Zhou6, Xiwu Lin6, Chenglong Han6 and Philip Mease7, 1Memorial University of Newfoundland, Department of Medicine, St John's, Canada, 2Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 3Oregon Health & Science University, Portland, OR, 4Janssen Research & Development, LLC, La Jolla, CA, 5Janssen Research & Development, LLC and University of Pennsylvania Medical Center, Spring House, PA, 6Janssen Research & Development, LLC, Spring House, PA, 7Seattle Rheumatology Associates, P.L.L.C., Seattle, WA

    Background/Purpose: DISCOVER 1 & 2 are phase-3 trials of guselkumab (GUS, an IL-23 inhibitor) in patients with psoriatic arthritis (PsA). In both trials, treatment with…
  • Abstract Number: 0649 • ACR Convergence 2020

    A Multicenter, Open-Label, Efficacy and Safety Study of Pegloticase in Patients with Uncontrolled Gout Who Have Undergone Kidney Transplantation: Early Data Report

    Abdul Abdellatif1, Lin Zhao2, Paul Peloso3, Katya Cherny2, Brad Marder2, John Scandling4 and Kenneth Saag5, 1Baylor College of Medicine, Division of Nephrology, Houston, TX, 2Horizon Therapeutics plc, Lake Forest, IL, 3Horizon Therapeutics plc, Gurnee, IL, 4Stanford Medicine, Department of Nephrology, Stanford, CA, 5University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, Birmingham, AL

    Background/Purpose: Gout’s high prevalence in kidney transplant (KT) recipients has been associated with heavy residual urate burden, decreased urate excretion related to reduced renal function,…
  • Abstract Number: 0875 • ACR Convergence 2020

    Secukinumab Provides Sustained Improvements in Subgroup Analyses of Joint Tenderness and Swelling in Patients with Psoriatic Arthritis: 5‑Year Results from the Phase 3 FUTURE 2 Study

    Iain McInnes1, Hector Chinoy2, Darren Asquith3, Abigail White3 and Corine Gaillez4, 1Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, 2The University of Manchester, Manchester, United Kingdom, 3Novartis Pharmaceuticals UK Ltd., London, United Kingdom, 4Novartis Pharma AG, Basel, Switzerland

    Background/Purpose: Secukinumab, a fully human monoclonal antibody that neutralizes interleukin‑17A, has shown long-term efficacy and tolerability in patients with psoriatic arthritis (PsA) in FUTURE 2.…
  • Abstract Number: 1211 • ACR Convergence 2020

    Relationship Between Changes in Lipid Levels and Improvement in Disease Activity Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib Treatment: Pooled Analysis of Data from Two Phase 3 Studies

    Christina Charles-Schoeman1, Jon Giles2, Nancy Lane3, Ernest Choy4, Heidi Camp5, Yanna Song6, Samuel Anyanwu5 and Iain McInnes7, 1University of California, Los Angeles, Los Angeles, CA, 2Columbia University, New York, NY, 3University of California, Davis, Sacramento, CA, 4CREATE Centre, Cardiff University, Cardiff, Wales, United Kingdom, 5AbbVie Inc., North Chicago, IL, 6AbbVie Inc., North Chicago,, IL, 7Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom

    Background/Purpose: Upadacitinib (UPA) is an oral Janus kinase (JAK) inhibitor engineered to have greater selectivity for JAK1 vs JAK2, JAK3, and tyrosine kinase 2, and…
  • Abstract Number: 1630 • ACR Convergence 2020

    Long-term Safety of Tildrakizumab in Patients with Moderate to Severe Plaque Psoriasis: Incidence of Confirmed Major Adverse Cardiovascular Events Through 3 Years (148 Weeks) from Two Phase 3 Trials

    Lars Iversen1, Christopher EM Griffiths2, Andrea Peserico3, Ignasi Pau-Charles4, Andrew Blauvelt5, Diamant Thaçi6 and Kristian Reich7, 1Aarhus University Hospital, Aarhus, Denmark, 2The University of Manchester, Manchester, United Kingdom, 3DIMED University of Padua, Padua, Italy, 4Almirall R&D, Barcelona, Spain, 5Oregon Medical Research Center, Portland, OR, 6Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, 7Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation®, Hamburg, Germany

    Background/Purpose: Tildrakizumab (TIL) is a high-affinity anti–interleukin-23p19 monoclonal antibody that is approved for the treatment of moderate to severe plaque psoriasis. The objective of this…
  • Abstract Number: 1995 • ACR Convergence 2020

    Non-invasive Vagus Nerve Stimulation Improves Signs and Symptoms of Rheumatoid Arthritis: Results of a Pilot Study

    Sara Marsal1, Hector Corominas2, Juan Jose De Agustin De Oro3, Carolina Perez Garcia4, Maria Lopez Lasanta3, Helena Borrell3, Delia Reina5, Raimon Sanmartí6, Francisco Javier Narváez7, Clara Franco-Jarava8, Charles Peterfy9, Jose Antonio Narvaez10, Vivek Sharma11, Konstantinos Alataris11, Mark Genovese12 and Matthew Baker13, 1Hospital Universitari Vall d'Hebron, Barcelona, Spain, 2Institut Rec. Hospital de la Santa Creu I Sant Pau., Barcelona, Spain, 3Hospital Universitari Vall d’Hebron, Barcelona, Spain, 4Hospital Universitari Parc Salut Mar, Barcelona, Spain, 5Hospital Moises Broggi, Barcelona, Spain, 6Hospital Universitari Clínic de Barcelona, Barcelona, Catalonia, Spain, 7Hospital Bellvitge, BARCELONA, Spain, 81Hospital Universitari Vall d’Hebron, Barcelona, Spain, 9Spire Sciences, Inc., Boca Raton, FL, 10Clinica Diagonal, Barcelona, Spain, 11Vorso Corp, Redwood CIty, CA, 12Stanford University Medical Center, Palo Alto, CA, 13Stanford University, Menlo Park, CA

    Background/Purpose: Vagus nerve stimulation (VNS) has been shown to improve rheumatoid arthritis (RA) disease severity in patients with refractory disease (1,2). A multi-center pilot study…
  • Abstract Number: 0210 • ACR Convergence 2020

    Long-term Safety and Efficacy of Sarilumab over 5 Years in Patients with Rheumatoid Arthritis Refractory to Tumor Necrosis Factor Inhibitors

    Roy Fleischmann1, Karina Maslova2, Henry Leher3, Amy Praestgaard2 and Gerd Burmester4, 1Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, 2Sanofi, Cambridge, MA, 3Regeneron Pharmaceuticals, Inc, Tarrytown, NY, 4Charité University Hospital Berlin, Berlin, Germany

    Background/Purpose: Sarilumab is a human IL-6 receptor (IL-6R) inhibitor approved for the treatment of adults with moderate to severely active RA. In the TARGET study…
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All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

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