Abstracts tagged "Randomized Trial"

Abstract Number: 1636 • ACR Convergence 2023
Dazodalibep, a CD40L Antagonist, in Subjects with Sjögren’s Having Moderate-to-Severe Systemic Disease Activity: Full Crossover Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study
E. William St. Clair¹, Liangwei Wang², Ilias Alevizos², William A. Rees², Alan Baer³, Wan-Fai Ng⁴, Ghaith Noaiseh⁵ and Chiara Baldini⁶, ¹Duke University Medical Center, Durham, NC, ²Horizon Therapeutics, Rockville, MD, ³Johns Hopkins University School of Medicine, Baltimore, MD, ⁴NIHR Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom, ⁵University of Kansas Medical Center, Kansas City, KS, ⁶University of Pisa, Pisa, Italy
Background/Purpose: Dazodalibep (DAZ) is a non-antibody fusion protein that acts as a CD40L antagonist and blocks costimulatory signals between immune cells, including T cells, B…
Abstract Number: 2155 • ACR Convergence 2023
The Impact of Filgotinib on Disease Activity Outcomes with Concomitant Pain Control in the Phase 3 FINCH Studies
Peter C. Taylor¹, Arthur Kavanaugh², Peter Nash³, Janet Pope⁴, Georg Pongratz⁵, Bruno Fautrel⁶, Rieke Alten⁷, Ken Hasegawa⁸, Shangbang Rao⁹, Dick de Vries¹⁰, Pieter-Jan Stiers¹¹, Chris Watson¹² and René Westhovens¹³, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA, ³School of Medicine, Griffith University, Brisbane, Australia, ⁴University of Western Ontario, London, ON, Canada, ⁵Faculty of Medicine, Regensburg University, Regensburg, Germany, Regensburg, Germany, ⁶Sorbonne Université APHP, Paris, France, ⁷Department of Internal Medicine and Rheumatology, Schlosspark Klinik, University Medicine Berlin, Berlin, Germany, ⁸Global Medical Affairs Research, Gilead Sciences, Inc., Foster City, CA, ⁹Biostatistics, Gilead Sciences, Inc., Foster City, CA, ¹⁰Research and Development, Clinical Research, Galapagos BV, Leiden, Netherlands, ¹¹Biostatistics, Galapagos NV, Mechelen, Belgium, ¹²Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹³Department of Rheumatology, KU Leuven, Skeletal Biology and Engineering Research Center, Leuven, Belgium
Background/Purpose: Patients (pts) with rheumatoid arthritis (RA) often experience substantial pain despite treatment, and consider pain control an important treatment outcome. This post hoc analysis…
Abstract Number: L05 • ACR Convergence 2022
Effect of Denosumab on Structure Modification in Erosive Hand Osteoarthritis: Results of a 48-Week, Monocentric, Randomized, Placebo-controlled, Double-blind Phase 2 Study and Open Label Extension Phase
Ruth Wittoek¹, August Verbruggen², Tine Vanhaverbeke² and Dirk Elewaut³, ¹Dept. of Rheumatology, Ghent University Hospital, Ghent University, Ghent, Oost-Vlaanderen, Belgium, ²Ghent University Hospital, Ghent, Belgium, ³Ghent University and VIB Center for Inflammation Research, Ghent, Belgium
Background/Purpose: Erosive hand osteoarthritis (OA) is a disabling disease with limited therapeutic options. Denosumab, a Receptor Activator of Nuclear Factor kappa-b Ligand inhibitor, affects bone…
Abstract Number: L07 • ACR Convergence 2022
Telitacicept, a Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), in Systemic Lupus Erythematosus (SLE): Results of a Phase 3 Study
Di Wu¹, Jing Li¹, Dong Xu¹, Li Wang¹, Jianmin Fang², Dan Ross³ and Fengchun Zhang⁴, ¹Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China, Beijing, China, ²Shanghai Tongji Hospital, Tongji University, Shanghai 200065, China School of Life Science and Technology, Tongji University, Shanghai 200092, China, Shanghai, China, ³RemeGen Co., San Diego, CA, ⁴Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China; Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China, Beijing, China
Background/Purpose: Telitacicept is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor…
Abstract Number: L14 • ACR Convergence 2022
Bimekizumab Maintains Improvements in Efficacy Endpoints and Has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies
Xenofon Baraliakos¹, Atul Deodhar², Désirée van der Heijde³, Marina Magrey⁴, Walter Maksymowych⁵, Tetsuya Tomita⁶, Huji Xu⁷, Marga Oortgiesen⁸, Ute Massow⁹, Carmen Fleurinck¹⁰, Alicia M Ellis⁸, Tom Vaux¹¹, Julie Shepherd-Smith¹¹, Alexander Marten⁹ and Lianne S Gensler¹², ¹Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, ²Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ³Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁴Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, US, Richfield, OH, ⁵Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka City, Osaka City, Osaka, Japan, ⁷Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China (People's Republic), ⁸UCB Pharma, Morrisvile, NC, ⁹UCB Pharma, Monheim am Rhein, Nordrhein-Westfalen, Germany, ¹⁰UCB Pharma, Brussels, Brussels Hoofdstedelijk Gewest, Belgium, ¹¹UCB Pharma, Slough, United Kingdom, ¹²Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL‑17A. In the phase 3 BE MOBILE 1 and 2…
Abstract Number: L15 • ACR Convergence 2022
Effect of Secukinumab versus Adalimumab Biosimilar on Radiographic Progression in Patients with Radiographic Axial Spondyloarthritis: A Randomized Phase IIIb Study
Xenofon Baraliakos¹, Mikkel Østergaard², Denis Poddubnyy³, Désirée van der Heijde⁴, Atul Deodhar⁵, Pedro M. Machado⁶, Victoria Navarro-Compán⁷, Kay Geert Hermann⁸, Mitsumasa Kishimoto⁹, Eun Young Lee¹⁰, Lianne S Gensler¹¹, Uta Kiltz¹, Marco Eigenmann¹², Patricia Pertel¹³, Aimee Readie¹⁴, Hanno B. Richards¹², Brian Porter¹⁵ and Juergen Braun¹, ¹Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, ²Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, ³Charité - Universitätsmedizin Berlin and German Rheumatism Research Centre, Berlin, Germany, ⁴Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁵Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁶Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, United Kingdom, ⁷Department of Rheumatology, University Hospital La Paz, IdiPaz, Madrid, Spain, ⁸Department of Radiology, University Hospital Charité - Campus Mitte, Charitéplatz, Berlin, Germany, ⁹Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, ¹⁰Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea, ¹¹Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, ¹²Novartis Pharma AG, Basel, Switzerland, ¹³Novartis Pharma AG, Reinach, Switzerland, ¹⁴Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁵Novartis Pharmaceuticals Corporation, Far Hills, NJ
Background/Purpose: Biologics are clinically efficacious in patients (pts) with axial spondyloarthritis (axSpA) including radiographic axSpA (r-axSpA). Limited data exist on the effect of biologics in…
Abstract Number: 0229 • ACR Convergence 2022
The Effect of Interactive E-learning on Resident’s Practical Performance in Musculoskeletal Ultrasound- a Randomized Study
Stine Maya Dreier Carstensen¹, Søren Just², Marie Velander³, Lars Konge⁴, Martin Slusarczyk Hubel⁵, Thiusius Rajeeth Savarimuthu⁵, Mogens Pfeiffer Jensen⁶, Mikkel Østergaard⁷ and Lene Terslev⁸, ¹Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Copenhagen University Hospital – Rigshospitalet Glostrup, Glostrup, Denmark, ²Medicinsk Afdeling Svendborg Sygehus OUH, Odense, Denmark, ³Section of Rheumatology, Department of Medicine, Svendborg Hospital - Odense University Hospital (OUH), Svendborg, Denmark, ⁴Copenhagen Academy for Medical Education and Simulation The Capital Region of Denmark, Copenhagen, Denmark, ⁵SDU Robotics, Mærsk Mc-Kinney Møller Instituttet, Syddansk Universitet, Odense, Odense, Denmark, ⁶Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Copenhagen University Hospital – Rigshospitalet Glostrup, Copenhagen, Denmark, ⁷Rigshospitalet, University of Copenhagen, Glostrup, Denmark, ⁸Copenhagen University Hospital Glostrup, Glostrup, Denmark
Background/Purpose: Musculoskeletal ultrasound (MSUS) is a complex procedure to master and requires both extensive theoretical knowledge and hands-on training. E-learning supplements hands-on training by providing…
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…

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Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. Academic institutions, private organizations and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part a scientific presentation or presentation of additional new information that will be available at the time of the meeting) is under embargo until Saturday, November 11, 2023.

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