Abstracts tagged "Randomized Trial"

Abstract Number: 1113 • ACR Convergence 2022
Remibrutinib (LOU064) in Sjögren’s Syndrome: Safety and Efficacy Results from a 24‑Week Placebo-controlled Proof-of-Concept Study
Thomas Dörner¹, Antónia Szántó², Jui-Cheng Tseng³, Martin Kaul⁴, Ilona Pylvaenaeinen⁵, Malika Hanser⁶, Nasri Abdallah⁶, Bruno Cenni⁶ and Richard Siegel⁶, ¹Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany, ²Debreceni Egyetem Klinikai Centrum, Debrecen, Hungary, ³Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ⁴Independent Consultant, Neustadt, Germany, ⁵Early Development Analytics, Novartis Pharmaceutical AG, Basel, Switzerland, ⁶Novartis Institutes for BioMedical Research, Basel, Switzerland
Background/Purpose: Sjögren's syndrome (SS) is a systemic autoimmune disease of unknown etiology characterized by B-cell hyperactivation, lymphoid infiltration, progressive destruction of exocrine glands, and various…
Abstract Number: 2008 • ACR Convergence 2022
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of Dazodalibep (VIB4920/HZN4920) in Patients with Rheumatoid Arthritis Having Inadequate Response to Conventional/Biological DMARDs
Alan Kivitz¹, Liangwei Wang², Ilias Alevizos², Michele Gunsior², Judith Falloon² and Gabor Illei³, ¹Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, ²Horizon Therapeutics, Gaithersburg, MD, ³Horizon Therapeutics, Rockville, MD
Background/Purpose: Dazodalibep (DAZ), a non-antibody biologic antagonist of CD40L, led to higher/durable response rates vs. placebo (PBO) in a double-blind, Phase 1b trial of patients…
Abstract Number: 0286 • ACR Convergence 2022
Efficacy and Safety of Upadacitinib in Patients Across Races with Rheumatoid Arthritis: A Post Hoc Analysis of Six Phase 3 Clinical Trials
Grace Wright¹, Eduardo Mysler², Iris Navarro-Millan³, Yoshiya Tanaka⁴, Samuel Anyanwu⁵, Jianzhong Liu⁵, Oishi Tanjinatus⁵, Andrew Garrison⁵ and Alvin Wells⁶, ¹Association of Women in Rheumatology, New York, NY, ²Department of Rheumatology, OMI (Medical Research Organization), Buenos Aires, Argentina, ³Weill Cornell Medicine, New York, NY, ⁴University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, ⁵AbbVie, Inc., North Chicago, IL, ⁶Aurora Rheumatology and Immunotherapy Center, Franklin, WI
Background/Purpose: RA affects diverse patient populations with varying disease severity and treatment responses. However, data on treatment response to advanced therapies by race are limited.1…
Abstract Number: 1229 • ACR Convergence 2022
Erosion Score and Erosive Joint Number Using Radiography: Clinical Implications in Patients with ACPA+ Early RA Treated with Abatacept
Chahin Pachai¹, Sean E Connolly², Yoshiya Tanaka³, Vivian Bykerk⁴, Tom Huizinga⁵, Gustavo Citera⁶, Clifton O. Bingham III⁷, Shuyan Du¹, Godehard Hoexter⁸, Paul Emery⁹, Subhashis Banerjee¹ and Roy Fleischmann¹⁰, ¹Bristol Myers Squibb, Princeton, NJ, ²Bristol-Myers Squibb, Morrisville, PA, ³University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, ⁴Hospital for Special Surgery, New York, NY, ⁵Leiden University Medical Center, Leiden, Netherlands, ⁶Instituto de Rehabilitación Psicofísica (IREP), Buenos Aires, Argentina, ⁷Johns Hopkins University, Baltimore, MD, ⁸Bristol Myers Squibb GmbH & Co. KGaA, Munich, Germany, ⁹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ¹⁰University of Texas Southwestern Medical Center and Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: Inhibition of structural joint damage progression is a key outcome measure in RA clinical trials. This can be assessed by progression of joint erosion…
Abstract Number: 2116 • ACR Convergence 2022
Assessment of the Ultrasound and Clinical Response to Apremilast Using a Joint-periarticular-nail Ultrasound Index and Clinical Evaluation in Patients with Active Psoriatic Arthritis
Juan Josè de Agustin¹, Gustavo Añez¹, delia reina², Sergi Heredia³, Felipe Julio Ramirez Garcia⁴, Andrea Cuervo⁵, Jesus Rodriguez⁶, Carmen Moragues⁶, Patricia Moya⁷, Mireia Moreno⁸, Marta Arévalo⁸, Manel Pujol⁹, Georgina Salvador⁹, Noemi Busquets¹⁰, andres Ponce¹⁰, Ana Maria Laiz Alonso⁷ and MAria Pascual Pastor¹¹, ¹Vall D'hebron University Hospital, Barcelona, Spain, ²Complex Hospitalari Moisès Broggi, Sant Joan Despí, Catalonia, Spain, ³Complex Hospitalari Moisès Broggi, Sant Joan Despi, Catalonia, Spain, ⁴Hospital Clínic, Barcelona, Spain, ⁵Hospital Clínico y Provincial de Barcelona, Barcelona, Spain, ⁶Hospital Bellvitge, Hospitalet de Llobregat, Spain, ⁷Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, ⁸Parc Tauli Hospital Universitari, Sabadell, Catalonia, Spain, ⁹Hospital Universitario MútuaTerrassa, Terrassa, Spain, ¹⁰Hospital General de Granollers, Granollers, Spain, ¹¹Hospital Universitari Vall d'Hebron, Barcelona, Spain
Background/Purpose: Psoriatic arthritis (PsA) is a chronic inflammatory disease involving joint and enthesis disease. Ultrasound (US) has demonstrated its useful tool for the diagnosis of…
Abstract Number: 0287 • ACR Convergence 2022
Association Between Short-Term Response to Upadacitinib Treatment and Long-Term Clinical Outcomes in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Tumor Necrosis Factor Inhibitor Therapy
Christina Charles-Schoeman¹, Roy Fleischmann², Stephen Hall³, Arthur Kavanaugh⁴, Andrea Rubbert-Roth⁵, Ryan DeMasi⁶, Sara Penn⁶, Andrew Garrison⁶, Samuel Anyanwu⁶, Radames Sierra-Zorita⁷ and Ricardo Xavier⁸, ¹Division of Rheumatology, University of California, Los Angeles, Santa Monica, CA, ²University of Texas Southwestern Medical Center and Metroplex Clinical Research Center, Dallas, TX, ³Emeritus Research and Monash University, Melbourne, Australia, ⁴University of California San Diego, La Jolla, CA, ⁵Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland, ⁶AbbVie, Inc., North Chicago, IL, ⁷University of Puerto Rico, San Juan, Puerto Rico, ⁸Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
Background/Purpose: Early predictors of response to treatment with upadacitinib (UPA), an oral Janus kinase inhibitor, could help to optimize a treat-to-target approach in patients with…
Abstract Number: 1424 • ACR Convergence 2022
Cost-Effectiveness of a Progressive Spacing of Tocilizumab or Abatacept in Patients with Rheumatoid Arthritis in Sustained Remission: A Medico-Economic Analysis of the ToLEDo Trial
Joanna KEDRA¹, Lina El Houari¹, Florence Tubach¹, Benjamin granger¹ and Bruno Fautrel², ¹Sorbonne Université, INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique, PEPITES, F75013, Paris, France, Paris, France, ²Sorbonne University Paris, France and Pierre Louis Institute of Epidemiology and Public Health, Paris, France, Paris, France
Background/Purpose: Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) progressive tapering is a real opportunity in people living with rheumatoid arthritis (RA) having achieved remission both from…
Abstract Number: 2146 • ACR Convergence 2022
Efficacy of Upadacitinib in Patients with Psoriatic Arthritis and Prior Exposure to Anti-TNF Therapy in the SELECT-PsA 2 Trial Through 2 Years
Philip J Mease¹, Rodrigo Luppino Assad², Shigeyoshi Tsuji³, Pascal Richette⁴, Arathi Setty⁵, Erin McDearmon-Blondell⁶, Tianming Gao⁵, Sandra Ciecinski⁶ and Filip Van den bosch⁷, ¹Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ²Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil, ³Department of Orthopaedics and Rheumatology, Nippon Life Hospital, Osaka, Japan, ⁴Department of Rheumatology, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Paris, France, ⁵AbbVie, Inc., North Chicago, IL, ⁶AbbVie, Inc., Mettawa, IL, ⁷Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium
Background/Purpose: Patients with psoriatic arthritis (PsA) who experience anti-TNF failure and switch to another TNF inhibitor as second- or third-line therapy typically show poorer responses…
Abstract Number: 0293 • ACR Convergence 2022
Long-term Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs: Results Through 5 Years from SELECT-BEYOND
Ronald van Vollenhoven¹, Stephen Hall², Alvin Wells³, Sebastian Meerwein⁴, Yanna Song⁵, Jessica Suboticki⁶ and Roy Fleischmann⁷, ¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ²Emeritus Research and Monash University, Melbourne, Australia, ³Aurora Rheumatology and Immunotherapy Center, Franklin, WI, ⁴AbbVie Deutschland GmbH & Co KG, LUDWIGSHAFEN, Germany, ⁵AbbVie, Inc., North Chicago, IL, ⁶AbbVie, Inc., Mettawa, IL, ⁷Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: The primary treatment goal for patients with rheumatoid arthritis (RA) is sustained remission (REM), but low disease activity (LDA) is considered an appropriate target…
Abstract Number: 1435 • ACR Convergence 2022
Effectiveness of Combination Therapy with Tocilizumab and Low-Dose Prednisolone as an Induction Therapy in Biologics-Naïve Patients with Rheumatoid Arthritis: A Prospective, Randomized, Controlled, Open-Label, Multicenter Study
Kazuhiro Yokota¹, Hayato Nagasawa², Yuji Akiyama³ and Toshihide Mimura⁴, ¹Department of Rheumatology and Applied Immunology, Faculty of Medicine, Saitama Medical University, Iruma Saitama, ²Nagasawa Clinic, Kawagoe, Japan, ³Department of Rheumatology and Applied Immunology, Faculty of Medicine, Saitama Medical University, Iruma Saitama, Japan, ⁴Department of Rheumatology and Applied Immunology, Faculty of Medicine, Saitama Medical University, Saitama, Japan
Background/Purpose: Efficacy and safety of tocilizumab (TCZ) in the treatment of rheumatoid arthritis (RA) has demonstrated in randomized controlled trials. However, the clinical response to…
Abstract Number: 2151 • ACR Convergence 2022
Izokibep Demonstrates Clinically Relevant Efficacy Benefits on Enthesitis, Dactylitis and Nail Outcomes in Active PsA Patients: A 16-week Randomized, Placebo-controlled Trial
Kurt de Vlam¹, Peter Taylor², Philip J Mease³, Paul Peloso⁴, Dieter Wetzel⁵, Nicolai Brun⁵, Brian Wiens⁶, Jan Brandt-Juergens⁷, Edit Drescher⁸, Eva Dokoupilova⁹, Anna Rowinska-Osuch¹⁰, Nadia Abdel- Kader Martin¹¹ and Frank Behrens¹², ¹University Hospitals Leuven, Leuven, Belgium, ²University of Oxford, Oxford, United Kingdom, ³Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ⁴ACELYRIN, Naples, FL, ⁵Affibody AB, Solna, Sweden, ⁶ACELYRIN, Inc., Los Angeles, CA, ⁷Rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁸Veszprem Megyei Csolnoky Ferenc Korhaz, Budapest, Hungary, ⁹Medical Plus, s.r.o. & Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Brno, Prague, Czech Republic, ¹⁰ETG Network, Warsaw, Poland, ¹¹Hospital Infanta Luisa Quiron, Rheumatology, Sevilla, Spain, ¹²Rheumatology University Hospital & Fraunhofer Institute Translational Medicine and Pharmacology, Goethe-University Frankfurt, Frankfurt Am Main, Germany
Background/Purpose: PsA is a chronic, inflammatory disease with multiple manifestations, with arthritis and skin involvement. Other areas of inflammation include enthesitis, dactylitis and nail involvement.…
Abstract Number: L05 • ACR Convergence 2021
Phase 2 Study Results from a Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate Efficacy and Safety of Tigulixostat, a Novel Non-purine Selective Xanthine Oxidase Inhibitor, in Gout Patients with Hyperuricemia
Robert Terkeltaub¹, JuneSik Mune², Jieun Lee³ and Kenneth Saag⁴, ¹VA/UCSD, San Diego, CA, ²LG Chem, Ltd., Seoul, ³LG Chem, Ltd., Seoul, South Korea, ⁴The University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Gout can be effectively managed by inhibiting synthesis of uric acid. Tigulixostat is a novel non-purine selective xanthine oxidase inhibitor which lowers production of…
Abstract Number: L10 • ACR Convergence 2021
A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease
joshua solomon¹, Felix Woodhead², Sonye Danoff³, Shana Haynes-Harp⁴, Tanvi Naik⁵, Cathie Spino⁵, Shelley Hurwitz⁶, Rie Maurer⁶, Daniel Chambers⁷, Martin Kolb⁸, Hiliary Goldberg⁶ and Ivan Rosas⁴, ¹National Jewish Health, Denver, CO, ²University of Leicester, Leicester, United Kingdom, ³Johns Hopkins University, Baltimore, MD, ⁴Baylor College of Medicine, Houston, TX, ⁵University of Michigan, Ann Arbor, MI, ⁶Brigham and Womens Hospital, Boston, MA, ⁷University of Queensland, Brisbane, Australia, ⁸McMaster University, Hamilton, ON, Canada
Background/Purpose: Rheumatoid arthritis-associated interstitial lung disease (RA-ILD) is a prevalent and morbid condition leading to premature death in 10% of those affected. The TRAIL1 trial…
Abstract Number: L19 • ACR Convergence 2021
Secukinumab in Giant Cell Arteritis: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial
Nils Venhoff¹, Wolfgang Schmidt², Raoul Bergner³, Jürgen Rech⁴, Leonore Unger⁵, Hans-Peter Tony⁶, Meryl Mendelson⁷, Christian Sieder⁸, Meron Maricos⁸ and Jens Thiel⁹, ¹Department of Rheumatology and Clinical Immunology, Vasculitis Center Freiburg, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany, ²Immanuel Krankenhaus Berlin, Medical Center for Rheumatology Berlin-Buch, Lindenberger Weg 19, 13125 Berlin, Germany, Berlin, Germany, ³Medizinische Klinik A, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany, ⁴Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054,, Erlangen, Germany, ⁵Medical Department 1, Städtisches Klinikum Dresden, Dresden, Germany, ⁶Department of Medicine 2, Rheumatology and Clinical Immunology Oberduerrbachertstr. 697080, Wuerzburg, Germany, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁸Novartis Pharma GmbH, Nuremberg, Germany, ⁹Department of Rheumatology and Clinical Immunology, Vasculitis Center Freiburg, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany; Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
Background/Purpose: Little is known about glucocorticoid-sparing agents in giant cell arteritis (GCA) except for IL-6 inhibition. Secukinumab (SEC) has shown significant improvements in the signs…
Abstract Number: L21 • ACR Convergence 2021
Rituximab versus Conventional Therapeutic Strategy for Remission Induction in Eosinophilic Granulomatosis with Polyangiitis: A Double-blind, Randomized, Controlled Trial
Benjamin Terrier¹, Gregory Pugnet², Claire de Moreuil³, Bernard Bonnotte⁴, Ygal Benhamou⁵, Elisabeth Diot⁶, Dominique Chauveau², Pierre Duffau⁷, Nicolas Limal⁸, Antoine Neel⁹, Geoffrey Urbanski¹⁰, Noemie Jourde-Chiche¹¹, Nicolas Martin-Silva¹², Francois Maurier¹³, Arsene Mekinian¹⁴, Nicolas Schleinitz¹¹, Felix Ackermann¹⁵, Anne-Laure Fauchais¹⁶, Antoine Froissart¹⁷, Thomas Le Gallou¹⁸, Yurdagul Uzunhan¹⁹, Jean-Francois Viallard⁷, Alice Berezne²⁰, Laurent Chiche²¹, Bruno Crestani¹⁴, Guillaume Direz²², Cecile-Audrey Durel²³, Pascal Godmer²⁴, Jean-Emmanuel Kahn²⁵, Marc Lambert²⁶, Thomas Quemeneur²⁷, Jacques Cadranel¹⁴, Pierre Charles²⁸, Antoine Dossier¹⁴, Lea Jilet²⁹, Loic Guillevin¹⁴, Hendy Abdoul²⁹ and Xavier Puechal¹⁴, ¹Cochin Hospital, Paris, France, ²CHU, Toulouse, France, ³CHU, Brest, France, ⁴CHU, Dijon, France, ⁵CHU, Rouen, France, ⁶CHU, Tours, France, ⁷CHU, Bordeaux, France, ⁸CHU, Creteil, France, ⁹CHU, Nantes, France, ¹⁰CHU, Angers, France, ¹¹CHU, Marseille, France, ¹²CHU, Caen, France, ¹³CH, Metz, France, ¹⁴CHU, Paris, France, ¹⁵Hopital Foch, Suresnes, France, ¹⁶CHU, Limoges, France, ¹⁷CHIC, Creteil, France, ¹⁸CHU, Rennes, France, ¹⁹CHU, Bobigny, France, ²⁰CH, Annecy, France, ²¹CH, Marseille, France, ²²CH, Le Mans, France, ²³CHU, Lyon, France, ²⁴CH, Vannes, France, ²⁵CHU, Boulogne, France, ²⁶CHRU, Lille, France, ²⁷CH, Valenciennes, France, ²⁸CH, Paris, France, ²⁹URC, Paris, France
Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is an eosinophilic ANCA-associated vasculitis.Glucocorticoids, alone or in combination with cyclophosphamide in severe forms, induce remission in most patients…

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