Abstracts tagged "clinical trial"

Abstract Number: 0694 • ACR Convergence 2025
Treatment of Sjögren’s disease by blocking FcRn: clinical and translational data from RHO, a phase 2 randomized, placebo controlled, double-blind, proof-of-concept study with efgartigimod
isabelle peene¹, Gwenny Verstappen², Joke Deprez³, Frans Kroese², Suzanne Arends², Andrew Kelly⁴, Lana Vandersarren⁵, Edward Bowen⁶, Julie Jacobs⁷, Paul Meyvisch⁸, Dirk Elewaut⁹ and Hendrika Bootsma¹⁰, ¹University Hospital Ghent, Ghent, Belgium, ²University Medical Center Groningen, Groningen, Netherlands, ³Ghent University, Ghent, Belgium, ⁴Argenx, Philadelphia, PA, ⁵Argenx, Boston, MA, ⁶IQVIA, Stevenage, United Kingdom, ⁷argenx, Ravels, Belgium, ⁸argenx, Ghent, Belgium, ⁹VIB Center for Inflammation Research, and Ghent University Hospital, Department of Rheumatology, Ghent, Belgium, ¹⁰UMCG, Groningen, Netherlands
Background/Purpose: Background/Purpose Sjögren’s disease (SjD) is a chronic, systemic autoimmune disease characterized by lymphocytic infiltration and progressive, immune-mediated dysfunction of the exocrine glands. Immunoglobulin (Ig)…
Abstract Number: 0567 • ACR Convergence 2025
Sonelokimab in Biologic-Experienced Patients With Active Psoriatic Arthritis: Results From a Phase 2 Trial (ARGO) and Study Design of a Phase 3 Trial (IZAR-2) in Patients With Inadequate Response or Intolerance to Biologic TNFi, Including a Risankizumab Reference Arm
Atul Deodhar¹, Laure Gossec², Philip J. Mease³, Xenofon Baraliakos⁴, Lihi Eder⁵, Alan Kivitz⁶, Helena Marzo-Ortega⁷, Frank Behrens⁸, Ana-Maria Orbai⁹, Georg Schett¹⁰, Arthur Kavanaugh¹¹, Dennis McGonagle¹², Christopher Ritchlin¹³, Nuala Brennan¹⁴, Ben Porter-Brown¹⁴, Eva Cullen¹⁴, Matthew R. Thomas¹⁴, Marius Albulescu¹⁴, Alex Godwood¹⁴, Kristian Reich¹⁵ and Laura Coates¹⁶, ¹Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ²Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France, ³Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁴Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁵University of Toronto, Toronto, ON, Canada, ⁶Altoona Center for Clinical Research, Duncansville, PA, ⁷NIHR Leeds Biomedical Research Centre, The Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, Leeds, United Kingdom, ⁸Rheumatology, Immunology - Inflammation Medicine, University Hospital Goethe-University & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany, ⁹Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ¹⁰Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, Erlangen, Germany, ¹¹University of California, San Diego, School of Medicine, San Diego, CA, ¹²Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, Leeds, United Kingdom, ¹³University of Rochester Medical Center, Canandaigua, NY, ¹⁴MoonLake Immunotherapeutics AG, Zug, Switzerland, ¹⁵MoonLake Immunotherapeutics AG and Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, Zug, Switzerland, ¹⁶Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom
Background/Purpose: Sonelokimab (SLK), a novel Nanobody that binds to both IL-17A and IL-17F with similarly high affinity, is designed to target difficult-to-reach sites of inflammation.…
Abstract Number: 0776 • ACR Convergence 2025
Efficacy and Safety of Upadacitinib in Giant Cell Arteritis: 2-Year Results From the Re-Randomized, Double-Blind SELECT-GCA Phase 3 Trial
Wolfgang Schmidt¹, Arathi Setty², Christian Dejaco³, Andrea Rubbert-Roth⁴, Maria Cid⁵, Tomonori Ishii⁶, Avani D. Joshi², Nathaniel Zerad², Aditi Kadakia⁷, Shaofei Zhao², Weihan Zhao², Ivan Lagunes², Charles Phillips⁸, Daniel Blockmans⁹ and Peter Merkel¹⁰, ¹Immanuel Krankenhaus Berlin, Medical Centre for Rheumatology Berlin-Buch; Waldfriede Hospital, Rheumatology, Berlin, Germany, ²AbbVie Inc, North Chicago, IL, ³Medical University of Graz, Department of Rheumatology, Graz, Austria; Department of Rheumatology, Hospital of Brunico (SABES-ASDAA), Brunico, Italy, ⁴Division of Rheumatology and Immunology, Cantonal Hospital St Gallen, St Gallen, Switzerland, ⁵Department of Autoimmune Diseases (member of European Reference Network RITA), Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain, ⁶Division of Hematology and Rheumatology, Tohoku Medical and Pharmaceutical University, Sendai, Japan, ⁷AbbVie Inc, Woburn, MA, ⁸AbbVie Inc, Princeton, NJ, ⁹Department of General Internal Medicine, University Hospitals Leuven; Department of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium, ¹⁰University of Pennsylvania, Philadelphia, PA

Background/Purpose: In the SELECT-GCA phase 3 trial, treatment of patients with GCA with upadacitinib 15 mg (UPA15) demonstrated superior rates of disease remission, fewer disease…
Abstract Number: 0381 • ACR Convergence 2025
Improving Participation in The Lupus Foundation of America’s Research Accelerated by You (RAY) Patient Registry By Understanding Patient Preference in Communication Strategies
Safoah Agyemang¹, Melicent Miller¹, Tori Justin², Lydia Oberholtzer² and Joy Buie¹, ¹Lupus Foundation of America, Washington, DC, ²Sharp Insight LLC, Montgomery County, MD
Background/Purpose: The purpose of Research Accelerated by You (RAY) is to amplify awareness about clinical research and trials and ensure lupus patient partnership in therapeutic…
Abstract Number: 2624 • ACR Convergence 2025
Results of Large Multi-Site Pragmatic Clinical Trial Comparing Corticosteroids or Blinded Lidocaine-only Injections in Treating Osteoarthritis of the Knee
Joshua Baker¹, Katherine Wysham², Mercedes Quinones³, Bryant England⁴, Kaitian Jin¹, Marianna Olave⁵, Sarah Wetzel⁶, Rachel Gillcrist⁷, Criswell Lavery¹, Natalie Keller⁸, Kimberly Hayes⁹, Bridget Kramer⁴, Hannah Brubeck¹⁰, Bibiana Ateh¹¹, Daniel K. White¹², Alexis Ogdie¹³, Rui Xiao¹, Tuhina Neogi¹⁴ and Carla Scanzello¹, ¹University of Pennsylvania, Philadelphia, PA, ²VA PUGET SOUND/UNIVERSITY OF WASHINGTON, Seattle, WA, ³Washington DC VA Medical Center, Bethesda, MD, ⁴University of Nebraska Medical Center, Omaha, NE, ⁵Brown University, Philadelphia, PA, ⁶Drexel University, Pittsburgh, PA, ⁷Dartmouth College, Lebanon, NH, ⁸University of Oklahoma, Philadelphia, PA, ⁹Teachers College, Columbia University, Philadelphia, PA, ¹⁰VA Puget Sound Health Care System, Seattle, WA, ¹¹Washington VA Medical Center, Washington, District of Columbia, ¹²University of Delaware, Newark, DE, ¹³Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Wilmington, DE, ¹⁴Boston University School of Medicine, Boston, MA
Background/Purpose: Intra-articular corticosteroids are widely used for routine management of chronic pain from knee osteoarthritis (KOA), though estimates of their benefit vary widely. We aimed…
Abstract Number: 2393 • ACR Convergence 2025
Improving Clinical Outcomes In SLE Arthritis Trials: Post-Hoc Analysis Of A Prospective Intervention Study
Samuel Wood¹, Khaled Mahmoud², Md Yuzaiful Md Yusof², Philip Conaghan², Elizabeth Hensor² and Ed Vital³, ¹University of Leeds, Leeds Institute for Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, ²University of Leeds, Leeds, United Kingdom, ³University of Leeds, Leeds, England, United Kingdom
Background/Purpose: Musculoskeletal (MSK) manifestations of SLE are the most frequently assessed domain in clinical trials. Optimal MSK assessment is contested; candidates include the binary or…
Abstract Number: 2281 • ACR Convergence 2025
Effectiveness of Upadacitinib in Patients with Rheumatoid Arthritis in Canadian Real-World Practice: Final Results from the CLOSE-UP Post-Marketing Observational Study
Louis Bessette¹, Andrew Chow², Raman Rai³, Hugues Allard-Chamard⁴, Pauline Boulos⁵, Guylaine Roy⁶ and Dalinda Liazoghli⁶, ¹Centre de l'Ostéoporose et de Rhumatologie de Québec, Quebec, QC, Canada, ²Credit Valley Rheumatology, Mississauga, McMaster University, Hamilton, University of Toronto, Toronto, ON, Canada, ³Drs. Rai & Sekhon Medicine Professional Corporation, Brampton, ON, Canada, ⁴Université de Sherbrooke, Sherbrooke, Canada, ⁵McMaster University, Hamilton, ON, Canada, ⁶AbbVie Corporation, Saint-Laurent, QC, Canada
Background/Purpose: Upadacitinib (UPA) is an oral, selective Janus kinase (JAK)-inhibitor proven effective and well-tolerated in patients with rheumatoid arthritis (RA) in 6 randomized clinical trials.…
Abstract Number: 1998 • ACR Convergence 2025
Reduction in Tophi Observed in Patients with Uncontrolled Gout Treated with NASP: Results from Phase 3 DISSOLVE Studies
Herbert Baraf¹, Puja Khanna², Frédéric Lioté³, Rehan Azeem⁴, Wesley DeHaan⁵, Ben Peace⁶, Hugues Santin-Janin⁷, Bhavisha Desai⁸ and Alan Kivitz⁹, ¹The Center for Rheumatology and Bone Research, Rheumatology, Wheaton, Maryland, USA; Division of Rheumatology, The George Washington University, Washington, DC, ²Division of Rheumatology, University of Michigan, Ann Arbor, MI, ³Université Paris Cité-Inserm UMR¹¹³² & Rheumatology Department, GH Paris Saint Joseph & Institut Arthur Vernes, Paris, France, ⁴Global MACD, Sobi Inc., Waltham, MA, ⁵Sobi, Inc, Waltham, MA, ⁶Statistical Science, Sobi, Stockholm, Sweden, ⁷Sobi, BASEL, Switzerland, ⁸Sobi, Glastonbury, CT, ⁹Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: Patients (pts) with uncontrolled gout (UG) and tophi experience joint pain, impaired function and poor quality of life (Schlesinger et al. Semin Arthritis Rheum…
Abstract Number: 1538 • ACR Convergence 2025
Safety, Pharmacodynamics, and Efficacy of a Novel Plasmacytoid Dendritic Cells Targeting Antibody in Healthy Adults and Patients with SLE or Cutaneous Lupus Erythematosus with Active Skin Lesions: A First-In-Human Study of KK4277
Minoru Hasegawa¹, Jun Kinoshita², Shigeki Otsubo³, Kana Yamada³ and Ehsanollah Esfandiari⁴, ¹Division of Medicine, University of Fukui, Yoshida-gun, Fukui, Japan, ²Kyowa Kirin Co., Ltd., Chiyoda-ku, Tokyo, Japan, ³Kyowa Kirin Co., Ltd., Tokyo, Japan, ⁴Kyowa kirin International plc, London, United Kingdom
Background/Purpose: Plasmacytoid dendritic cells (pDCs) are known to be the main source of type 1 interferon (IFN), which is the cause of various autoimmune diseases.…
Abstract Number: 1374 • ACR Convergence 2025
AZD1163, a Novel Bispecific Human Antibody Targeting PAD2/4 Enzymes Responsible for Generating Citrullinated Protein Auto-antigens in Rheumatoid Arthritis, Demonstrates Dose-dependent Inhibition of Systemic PAD Activity in Healthy Volunteers
Susanne Prothon¹, Jacob Leander¹, Ulla Seppälä¹, Eduard Molins², Mia Collins¹, Nicholas White³, Ivonne Puente¹, Andre Santa Maria¹, Gary Sims⁴, David Han⁵, Obada Al Hamdan⁶, Ronald Goldwater⁷, Emon Khan⁸ and David Close⁹, ¹AstraZeneca, Gothenburg, Sweden, ²AstraZeneca, Barcelona, Spain, ³AstraZeneca, Cambridge, United Kingdom, ⁴AstraZeneca, Gaithersburg, ⁵Parexel, Los Angeles, ⁶Parexel, Berlin, Germany, ⁷Parexel, Baltimore, ⁸BioPharmaceuticals R&D, Late Respiratory and Immunology, AstraZeneca, Academy House, Cambridge, United Kingdom, ⁹AstraZeneca, Royston, United Kingdom
Background/Purpose: AZD1163 is a novel bispecific antibody that inhibits the activity of extracellular Peptidyl Arginine Deiminases (PADs) 2 and 4, enzymes responsible for protein citrullination…
Abstract Number: 0692 • ACR Convergence 2025
A Randomised Open Label Pilot Trial Comparing Mycophenolate Mofetil with no Immunosuppression in Limited Cutaneous Systemic Sclerosis (MINIMISE-Pilot)
Christopher Denton¹, Philip Yee², medha kanitkar³, Charlotte Clarke⁴, Saiam Ahmed⁴, Voon H. Ong³, Francesco Del Galdo⁵, John Pauling⁶, Marina Anderson⁷, Muditha Samaranayaka⁸, Michael Hughes⁹, Smita Bhat¹⁰, Bridget Griffiths¹¹, MAYA BUCH¹², David D'Cruz¹³, Ariane Herrick¹⁴, Madelon Vonk¹⁵, Nicholas Feemantle⁴ and Dehbi Hakim-Moulay⁴, ¹University College London, UK, London, United Kingdom, ²Division of Medicine, Centre for Rheumatology, University College London, London, England, United Kingdom, ³Division of Medicine, Centre for Rheumatology, University College London, London, United Kingdom, ⁴University College London, London, United Kingdom, ⁵University of Leeds, Leeds, United Kingdom, ⁶North Bristol NHS Trust, Bristol, United Kingdom, ⁷Lancaster University and NHS University Hospitals of Liverpool Group, Liverpool, United Kingdom, ⁸Salford Royal Hospital, Salford, United Kingdom, ⁹Division of Musculoskeletal and Dermatological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK, Manchester, England, United Kingdom, ¹⁰Ninewells Hospital Dundee, Dundee, Scotland, United Kingdom, ¹¹Ninewells Hospital Dundee, Newcastle, England, United Kingdom, ¹²UNIVERSITY OF MANCHESTER, MANCHESTER, United Kingdom, ¹³Kings College London, London, United Kingdom, ¹⁴The University of Manchester, UK, Aberdeen, United Kingdom, ¹⁵Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands
Background/Purpose: Mycophenolate mofetil (MMF) is recommended for skin in diffuse cutaneous (dc)SSc, and for lung fibrosis in SSc, but patients with limited cutaneous (lc)SSc are…
Abstract Number: 0563 • ACR Convergence 2025
Efficacy and Safety of Guselkumab in Patients with Active Psoriatic Arthritis and Inadequate Response and/or Intolerance to One Prior Tumor Necrosis Factor Inhibitor
Alexis Ogdie¹, Joseph F Merola², Philip J. Mease³, Christopher Ritchlin⁴, Jose U. Scher⁵, Kimberly Parnell Lafferty⁶, Daphne Chan⁷, Soumya Chakravarty⁸, Wayne Langholff⁹, Yanli Wang⁹, Olivia Choi, MD, PhD, FAAD⁷, Yevgeniy Krol¹⁰ and Alice Gottlieb¹¹, ¹Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Wilmington, DE, ²Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ³Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁴University of Rochester Medical Center, Canandaigua, NY, ⁵New York University School of Medicine, New York, NY, ⁶Johnson & Johnson, Dermatology, Horsham, PA, ⁷Johnson & Johnson, Horsham, PA, USA, Horsham, PA, ⁸Johnson & Johnson, Horsham, PA, USA; Drexel University College of Medicine, Philadelphia, PA, USA, Villanova, PA, ⁹Johnson & Johnson, Biostatistics, Spring House, PA, ¹⁰Johnson & Johnson, Horsham, PA, ¹¹Department of Dermatology, UT Southwestern Medical Center, Dallas, TX
Background/Purpose: Guselkumab (GUS), a fully human IL-23p19-subunit inhibitor, has demonstrated efficacy in significantly improving psoriatic arthritis (PsA) signs and symptoms with two dosing regimens: 100…
Abstract Number: 0545 • ACR Convergence 2025
Temporal trends in the phenotype and treatment outcomes in axial spondyloarthritis patients included in randomized clinical trials over 25 years: a systematic literature review and meta-regression analysis
Omar-Javier Calixto¹, Uta Kiltz², Brikena Lalazi³, Franziska Neinert³, Philipp Sewerin⁴ and Xenofon Baraliakos², ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Cellular and Molecular Immunology Group (InmuBo), Universidad El Bosque, Herne, Nordrhein-Westfalen, Germany, ²Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ³Rheumazentrum Ruhrgebiet, Herne, Germany, ⁴Rheumazentrum Ruhrgebiet Herne; Ruhr-Universität Bochum, Germany, Herne, Germany
Background/Purpose: The phenotypes of axial spondyloarthritis (axSpA) and clinical responses to placebo and study drugs in randomized controlled trials (RCTs) have changed over time. We…
Abstract Number: 0377 • ACR Convergence 2025
New efforts to incorporate patient-reported outcomes into clinical trials for lupus therapeutics
Patti Katz¹, Anca Askanase², Nandan Baruah³, Wen-Hung Chen⁴, Nicole Cooper⁵, Anna Fisch³, Lili Garrard⁶, Meenakshi Jolly⁷, Veronica Vargas Lupo⁸, Carla Menezes⁹, Judith Mills³, Hoang Nguyen¹⁰, Teodora Staeva⁵, Josephine Park¹¹ and Zahi Touma¹², ¹UCSF, San Rafael, CA, ²Columbia University Medical Center, New York, NY, ³Lupus Voices Council, Lupus Accelerating Breakthroughs Consortium, New York, ⁴GlaxoSmithKline, Philadelphia, PA, ⁵Lupus Research Alliance, New York, ⁶FDA, CDER, SIlver Spring, MD, ⁷Rush University, Chicago, ⁸Lupus Voices Council, Lupus Research Alliance, New York, NY, ⁹Lupus Therapeutics, New York, NY, ¹⁰Lupus Research Alliance, New York, NY, ¹¹EMDSerono, Boston, MA, ¹²University of Toronto, Toronto, ON, Canada
Background/Purpose: Lupus Accelerating Breakthroughs Consortium (Lupus ABC) was formed by the Lupus Research Alliance as a public private partnership of people living with lupus, investigators,…
Abstract Number: 2614 • ACR Convergence 2025
Impact of Vagus Nerve-Mediated Neuroimmune Modulation on structural joint damage using Gd-MRI RAMRIS imaging in Biologic-Experienced Patients with Rheumatoid Arthritis
Charles Peterfy, MD, PhD¹, John Tesser², Yaakov Levine³, Melissa Evangelista⁴, Vibeke Strand⁵, Michael Weinblatt⁶ and David Chernoff⁷, ¹Spire Sciences, Inc., Boca Raton, FL, ²Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ³SetPoint Medical, Valencia, CA, ⁴SetPoint Medical Corporation, Valencia, CA, ⁵Stanford University School of Medicine, Palo Alto CA, Portola Valley, CA, ⁶Brigham and Women's Hospital/ Harvard Medical School, Waban, MA, ⁷SetPoint Medical, Sausalito, CA
Background/Purpose: Previously reported results from RESET-RA (ClinicalTrials.gov, NCT04539964) showed neuroimmune modulation via electrical stimulation of the left vagus nerve using an implantable device to treat…

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