Abstracts tagged "clinical trial"

Abstract Number: 1739 • ACR Convergence 2021
SLE Treatment History and Anifrolumab Efficacy by Baseline Standard Therapies in Patients with SLE from 2 Phase 3 Trials
Susan Manzi¹, Richard Furie², Eric Morand³, Yoshiya Tanaka⁴, Gabriel Abreu⁵, Catharina Lindholm⁵ and Raj Tummala⁶, ¹Allegheny Health Network, Pittsurgh, PA, ²Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ³Monash University, Melbourne, Australia, ⁴University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁶BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD
Background/Purpose: In the phase 3 TULIP-1 and TULIP-2 trials, anifrolumab, a type I IFN receptor mAb, improved disease activity versus placebo in patients with moderate…
Abstract Number: 1801 • ACR Convergence 2021
The Effect of Ixekizumab versus Adalimumab on Individual Components of the ACR Composite Score, with and Without Concomitant Methotrexate or Other Conventional Synthetic DMARDs at 52 Weeks in Patients with Psoriatic Arthritis
Elaine Husni¹, Sona Kamat², Keri Stenger³, Rebecca Bolce³, Thorsten Holzkaemper⁴, Cameron Helt³, So Young Park³, Jeffrey Lisse⁵ and Luca Idolazzi⁶, ¹Cleveland Clinic, Cleveland, OH, ²St Louis University, Saint Louis, MO, ³Eli Lilly and Company, Indianapolis, IN, ⁴Eli Lilly and Company, Bad Homburg, Germany, ⁵Eli Lilly and Company, Tucson, AZ, ⁶University of Verona, Verona, Italy
Background/Purpose: It is important to understand how to select among the multiple treatment options for active psoriatic arthritis (PsA). Since individual patient domains may influence…
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: 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…
Abstract Number: 0348 • ACR Convergence 2020
Biologics History and Sex Are Linked to Golimumab Discontinuation in Axial Spondyloarthritis: A Sub-Analysis of the Post-Registration GO-Practice Study
Philippe Bertin¹, Philippe Goupille², Florence Tubach³, Eric Lespessailles⁴, Naoual Harid⁵, Saannya Sequeira⁶, Jean-Marie Fayette⁶, Bruno Fautrel⁷ and Rene-Marc Flipo⁸, ¹Limoges University Hospital, Limoges, France, ²CHU Tours, department of rheumatology, Tours, France, ³Pierre Louis Institute of Epidemiology and Public Health, INSERM 1136, Sorbonne University and Centre of Pharmacoepidemiology, Pitié Salpêtrière Hospital, APHP.Sorbonne University, Paris, Ile-de-France, France, ⁴Regional Hospital and University of Orleans, Orléans, France, ⁵MSD France Puteaux, Puteaux, Ile-de-France, France, ⁶ClinSearch, Malakoff, Ile-de-France, France, ⁷Sorbonne University, INSERM, IPLES; Pitié-Salpêtrière Hospital, Paris, Ile-de-France, France, ⁸Lille University Hospital, Lille, France
Background/Purpose: Golimumab (GLM) is the latest anti-TNFα to be indicated for treating rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). The post-registration GO-PRACTICE…
Abstract Number: 0677 • ACR Convergence 2020
A Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled GOut Receiving Pegloticase (MIRROR): 12-Month Results of an Open-Label Study
John Botson¹, Paul Peloso², Katie Obermeyer³, Brian LaMoreaux³, Lin Zhao³, Michael Weinblatt⁴ and Jeff Peterson⁵, ¹Orthopedic Physicians Alaska, Anchorage, AK, ²Horizon Therapeutics plc, Gurnee, IL, ³Horizon Therapeutics plc, Lake Forest, IL, ⁴Brigham and Women's Hospital, Boston, MA, ⁵Western Washington Medical Group Arthritis Clinic, Bothell, WA
Background/Purpose: Consistent, though limited, published data suggests that methotrexate (MTX) improves treatment response in patients treated with pegloticase for uncontrolled (refractory) gout. Recent case series1-3…

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