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Abstracts tagged "clinical trial"

  • Abstract Number: 2361 • ACR Convergence 2025

    Secondary Outcomes from a Series of N-of-1 NSAID Trials in Axial Spondyloarthritis: Functional, Quality-of-Life, and Safety Results from a Bayesian Analysis

    Mark Hwang1, Seokhun Kim2, Shervin Assassi3, Joyce Samuel1, Charles Green1, Jon Tyson2 and John Reveille4, 1UTHealth Houston, Houston, TX, 2UTHealth Houston, Houston, 3Division of Rheumatology, UTHealth Houston, Houston, Texas, USA, Houston, TX, 4Department of Medicine, University of Texas Medical Center, Houston, TX

    Background/Purpose: We previously reported primary outcomes from a Bayesian series of N-of-1 trials comparing celecoxib, meloxicam, and naproxen in axial spondyloarthritis (axSpA), demonstrating improved ASDAS…
  • Abstract Number: 2103 • ACR Convergence 2025

    PCRX-201 High-Capacity Adenovirus Serotype 5 Gene Therapy Demonstrates Sustained Clinical Efficacy and Safety in Patients With Knee Osteoarthritis

    Stanley Cohen1, Philip Conaghan2, Marc C. Hochberg3, Alan Kivitz4, MiJeong Kim5, Nino Joy6, Shoshanna Jiang6, Mary DiGiorgi7, Jonathan Slonin6 and Derek Slonin6, 1Metroplex Clinical Research Center, dallas, TX, 2University of Leeds, Leeds, United Kingdom, 3Marc C. Hochberg University of Maryland School of Medicine, Baltimore, MD, 4Altoona Center for Clinical Research, Duncansville, PA, 5Pacira BioSciences, Inc., Brisbane, 6Pacira BioSciences, Inc., Brisbane, CA, 7Pacira BioSciences, Inc, Brisbane, CA

    Background/Purpose: Knee OA is a common disease affecting ~15 million people in the United States. There is an urgent unmet need for additional OA treatments…
  • Abstract Number: 1925 • ACR Convergence 2025

    Associations between Representation and Quality in Clinical Trials for Systemic Lupus Erythematosus

    Joshua Skydel1, Anna Leland2, Reshma Ramachandran3, Fotios Koumpouras3 and Joshua Wallach2, 1Yale-New Haven Hospital, New Haven, CT, 2Rollins School of Public Health, Atlanta, GA, 3Yale School of Medicine, New Haven, CT

    Background/Purpose: Drug development in SLE is informed by US Food and Drug Administration recommendations for study design, enrollment, and efficacy endpoints. However, persistent challenges to…
  • Abstract Number: 1519 • ACR Convergence 2025

    Post-hoc Analysis of Sustained Response Over Time in Systemic Lupus Erythematosus Patients Treated with Cenerimod in CARE (Phase 2 B) Study

    Anca Askanase1, Bruno Flamion2, Ouali Berkani2 and Cecile Dubois2, 1Columbia University Medical Center, New York, NY, 2Viatris Innovation, Allschwil, Switzerland

    Background/Purpose: Cenerimod is a highly selective S1P1 receptor modulator which is undergoing trials for potential therapeutic benefits in autoimmune disease, including Systemic Lupus Erythematous (SLE).…
  • Abstract Number: 1356 • ACR Convergence 2025

    Use of (MSB11456), the first tocilizumab biosimilar approved for rheumatoid arthritis: 6-month data from an international observational study

    Jonathan Kay1, Eugen feist2, Ernest Choy3, Joerg Kaufmann4, Ernest Wong5, Hector Corominas6, René-Marc Flipo7, Jérôme Avouac8, María América López Lasanta9, Joelle Monnet10, Peter Baker11, Maria Romanova Michailidi12, Fabrizio Dolfi11 and Graziella Pourcel13, 1UMass Chan Medical School, Worcester, MA, 2Helios Department of Rheumatology, Vogelsang-Gommern, Germany, 3Division of Infection and Immunity, CREATE Centre, Cardiff University, Cardiff, United Kingdom, 4NA, Ludwigsfelde, Germany, 5Portsmouth Hospitals University NHS Trust, Portsmouth, United Kingdom, 6Hospital de Sant Pau, Barcelona, Spain, 7Université de Lille, CHU Lille, Service de rhumatologie, Lille, France, Lille, France, 8Hôpital Cochin, AP-HP Centre - Université Paris Cité, Paris, France, 9Hospital Universitario Vall d´Hebron, Barcelona, Spain, 10Fresenius Kabi SwissBioSim, Eysins, Switzerland, 11Fresenius Kabi Biopharma, Eysins, Switzerland, 12University of Geneva, Eysins, Switzerland, 13Fresenius Kabi Biopharma, Eyzins, France

    Background/Purpose: Although most healthcare professionals are convinced of the quality, safety, and favorable economic impact of biosimilars, their routine use is not yet widespread. MSB11456…
  • Abstract Number: 0663 • ACR Convergence 2025

    iPSC-Derived Off-the-Shelf anti-CD19 CAR T cells Deliver Improved Clinical Outcomes in Lupus with Reduced or No Conditioning Chemotherapy

    Parastoo Fazeli1, Jennifer Medlin2, Andrew BitMansour3, Debra Zack4, Rebecca Elstrom5, Bertha Villa5, Lilly Wong6, John Goulding7, Nicholas Brookhouser5, Trever Greene5, Cara Bickers5, Carol Wong5, Beatrice Ferguson5, Tom Lee5, Jode Goodridge5, Marie Hu8, Veronika Bachanova8, Jeffrey Miller9, Bahram Valamehr6, Matthew Lunning10 and Vaneet Sandhu5, 1UMN, ST PAUL, MN, 2University of Nebraska Medical Center, Omaha, NE, 3Fate Therapeutics, Inc., San Carlos, CA, 4Fate Therapeutics, Inc., Solana Beach, CA, 5Fate Therapeutics, Inc., San Diego, 6Fate Therapeutics, Inc., San Diego, CA, 7Fate Therapeutics, San Diego, 8University of Minnesota, Minneapolis, 9University of Minnesota, Minneaspolis, MN, 10University of Nebraska, Omaha

    Background/Purpose: Anti-CD19 chimeric antigen receptor (CAR) T cell therapy shows promise in autoimmune disease. However, autologous CAR T-cell therapy is limited by prolonged pre- and…
  • Abstract Number: 0891 • ACR Convergence 2025

    MEthotrexate versus TOcilizumab for treatment of Giant cell Arteritis (METOGiA trial): a multicenter, randomized, controlled trial.

    Maxime Samson1, Abderrahmane Bourredjem2, Rodérau Outh3, Vincent Grobost4, François Lifermann5, Guillaume DIREZ6, Emmanuel Ribeiro7, Eric Oziol8, Valerie Devauchelle9, Mikael Ebbo10, Nicolas Limal11, Romain Paule12, Boris Bienvenu13, Antoine Poulet13, Sébastien Miranda14, Ygal Benhamou14, Thomas Quemeneur15, Claire Dingremont16, Andre Ramon17, Bernard Simorre8, Quitterie Reynaud18, Christian AGARD19, Olivier Espitia20, Arsène Mekinian21, Jean-François Alexandra22, Emilie Berthoux23, Laurent Perard23, Antoine Baudet24, Rafik Mesbah25, David Lacôte-Delarbre26, Julien Stievenart27, Marc André27, Jean Sébastien Allain28, Rolland Jaussaud29, Julie Magnant30, Amélie Servettaz31, Hubert De Boysson32, Marc Ruivard4, Benjamin Terrier33, Alexis REGENT34, Amélie Cransac35, Isabelle Fournel36, Hervé Devilliers36 and Bernard Bonnotte37, 1CHU Dijon Bourgogne, Dijon, France, 2Centre d'Investigation Clinique, CHU Dijon, Dijon, France ; INSERM, CIC 1432, Module Epidémiologie Clinique, Dijon, France, 3Department of Internal Medicine, Centre Hospitalier de Perpignan, Perpignan, France., Clermont-Ferrand, France, 4Internal medicine, CHU Clermont Ferrand Estaing, Clermont Ferrand, France, 5Internal Medicine, CH de Dax, Dax, France, 6Rheumatology, CH Le Mans, Le Mans, France, 7Internal medicine and clinical immunology, CHU Bordeaux, Hôpital Saint-André, Bordeaux, France, 8Internal Medicine, CH Bézier, Bézier, France, 9UBO, Brest, France, 10Internal Medicine, Marseille-APHM, hôpital La Timone, Marseille, France, 11Internal Medicine, CHU Henri Mondor, Créteil, France, 12Hospital Foch, Service de medicine interne, Suresnes, Paris, Suresnes, France, 13Internal Medicine, Hôpital Saint Joseph, Marseille, France, 14Internal Medicine, CHU Rouen, Rouen, France, 15Nephrology and Internal Medicine, CH Valenciennes, Valenciennes, France, 16Internal Medicine, Groupement hospitalier Tarbes-Lourdes, Tarbes, France, 17Rheumatology, Université Bourgogne Europe, CHU Dijon Bourgogne, Dijon, France, 18Internal medicine and vascular diseases, Hospices Civils de Lyon, Lyon, France, 19Internal medicine, Nantes University Hospital, Nantes, France, 20CHU de Nantes, Nantes, France, 21Department of Internal Medicine, Inflammation-Immunopathology-Biotherapy Department (DMU i3), Saint-Antoine University Hospital, 75012 Paris, France, Paris, France, 22Internal Medicine, Hôpital Bichat, APHP, Paris, France, 23Internal Medicine, Saint Luc Saint Joseph Hospital, Lyon, France, 24Internal Medicine, CH Annecy, Annecy, France, 25Nephrology, CH Boulogne sur Mer, Boulogne sur Mer, France, 26Internal Medicine, Hôpital d’instruction des armées Saint Anne, Toulon, France, 27Internal Medicine, CHU Clermont Ferrand Gabriel Montpied, Clermont Ferrand, France, 28Internal Medicine and Clinical Immunology, CH Saint Malo, Saint Malo, France, 29Internal Medicine and Clinical Immunology, CHU Nancy, Nancy, France, 30Internal Medicine, CHU Tours, Tours, France, 31Internal Medicine, CHU Reims, Reims, France, 32Internal Medicine, CHU Caean, Caen, France, 33Cochin Hospital, Paris, France, 34Hopital Cochin, Paris, France, 35Pharmacy, CHU Dijon Bourgogne, Dijon, France, 36Centre d'Investigation Clinique, CHU Dijon, Dijon, France ; INSERM, CIC 1432, Module Epidémiologie Clinique, Dijon, France, 37Internal medicine and clinical immunology, Université Bourgogne Europe , CHU Dijon Bourgogne, Dijon, France

    Background/Purpose: This trial aimed to compare the efficacy and safety of methotrexate (MTX) vs. tocilizumab (TCZ), in combination with glucocorticoid (GC), in patients with giant…
  • Abstract Number: 0501 • ACR Convergence 2025

    Phase 1b Study of SBT777101, an Engineered CAR-T-Regulatory Cell Product, in Patients With Rheumatoid Arthritis: Interim Demographics and Safety

    Sarah Baxter1, Ari Bitton2, Victor Yuan2, Fawad Aslam3, Gregory Challener4, Jonathan Graf5, Melissa Griffith6, Tamiko Katsumoto7, Minna Kohler8, Elena Massarotti9, Larry Moreland10, Allison Rosenthal11, Jeffrey Sparks9, Steven Vlad12, Janeth Yinh13, Andrew Clauw14, Sally Arai15, Alexander Carvidi5, Angela Chavez16, Olivia Gabriel17, Rita Gyurko17, Megan Hall18, Jennifer Seifert19, Emma Stainton15, Michelle Blake1, Sabrina Fox-Bosetti2, Mark Fromhold1, Mindy Jensen20, Herve Lebrec2, Sean O'Bryan2, Amanda Pace21, Mei-Lun Wang2, Yuanyuan Xiao2, Joseph Arron2 and Jeffrey Bluestone22, 1Sonoma Biotherapeutics, Seattle, WA, 2Sonoma Biotherapeutics, San Francisco, CA, 3Mayo Clinic, Arizona, Scottsdale, AZ, 4MGH, Boston, MA, 5UCSF, San Francisco, CA, 6University of Colorado, Aurora, CO, 7Division of Immunology and Rheumatology, Stanford University, Millbrae, CA, 8Massachusetts General Hospital, Harvard Medical School, Boston, MA, 9Brigham and Women's Hospital, Boston, MA, 10University of Colorado, Denver, CO, 11Mayo Clinic, Phoenix, 12Tufts Medicine, Boston, MA, 13Massachusetts General Hospital, Boston, MA, 14Univ of Colorado, Aurora, CO, 15Stanford, Palo Alto, CA, 16Tufts, Boston, MA, 17BWH, Boston, MA, 18Mayo, Scottsdale, AZ, 19University of Colorado and Oklahoma Medical Research Foundation, Aurora, CO, 20Sonoma Bio, Seattle, 21Sonoma Bio, Seattle, WA, 22Sonoma Biotherapeutics, South San Francisco, CA

    Background/Purpose: Regulatory T cells (Tregs) modulate inflammation, maintain self-tolerance, and promote tissue repair, and thus hold promise as a versatile therapeutic tool. Autologous polyclonal Tregs…
  • Abstract Number: 0310 • ACR Convergence 2025

    Evaluate Safety, Tolerability, and Pharmacodynamics of a Single Intra-Articular Injection of GNSC-001 Gene Therapy in Subjects with Knee Osteoarthritis: 12-month Results from DONATELLO

    Annahita Keravala1, Philip Conaghan2, shanna jackson1, sharmila Vijay1, Thomas Chalberg3, Jeyanesh Tambiah4 and Laurie Halligan1, 1Genascence, Palo Alto, CA, 2University of Leeds, Leeds, United Kingdom, 3Genascence Corp, Palo Alto, CA, 4Genascence, San Diego, CA

    Background/Purpose: IL-1 contributes significantly to osteoarthritis (OA) pathology, driving inflammation and cartilage degradation. Prior therapies targeting IL-1 have shown limited success due to inadequate drug…
  • Abstract Number: 2576 • ACR Convergence 2025

    Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH) Study: Anti-inflammatory cytokine signals related to decreased arthritis disease activity over time

    Alfonso Sucerquia1, Jose Forero2, Juan Alzate1, Adrienne Poon3, Gary Firestein4, Larry Moreland5, Andres Cadena6, Jose Lara6, Octavio pizarro6, Jesus Godoy6, Liliana Encinales7, David Boyle8, Evelyn Mendoza9, Carlos Herrera10 and Aileen Chang3, 1The George Washington University, Arlington, 2The George Washington University, Arlington, VA, 3The George Washington University, Washington, 4University of California, San Diego, San Diego, CA, 5University of Colorado, Denver, CO, 6Clinica de la Costa, Barranquilla, Colombia, 7Allied Research Society, Barranquilla, Colombia, 8University of California, San Diego, San Diego, 9Universidad Libre de Barranquilla, Barranquilla, Colombia, 10The George Washington University, Alexandria

    Background/Purpose: The MARCH study evaluates the efficacy of methotrexate monotherapy in patients with chikungunya-associated arthritis and aims to elucidate its pathologic mechanism via cytokine analysis.…
  • Abstract Number: 2362 • ACR Convergence 2025

    Long-Term Efficacy and Safety of Risankizumab for csDMARD-IR Patients With Active Psoriatic Arthritis: 244-Week Results From the KEEPsAKE 1 Trial

    Mauro Keiserman1, Kim Papp2, Douglas White3, Angela Crowley4, Joseph F Merola5, Hayley Barnard6, Ana Biljan7, Thomas Iyile8, Lingfeng luo6, Douglas Ashley6, Arathi Setty8, Hayato Yamazaki6 and Frank Behrens9, 1Rheumatology Section, Pontifical Catholic University, School of Medicine, Porto Alegre, Brazil, 2Probity Medical Research and Alliance Clinical Trials, Waterloo, and Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada, 3Rheumatology Department, Waikato Hospital, Hamilton, New Zealand, 4Willow Rheumatology and Wellness, Willowbrook, IL, 5Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, 6AbbVie Inc., North Chicago, IL, 7AbbVie Inc., Buffalo Grove, IL, 8AbbVie Inc, North Chicago, IL, 9Goethe-University & Fraunhofer ITMP, Frankfurt, Germany

    Background/Purpose: Risankizumab (RZB), an anti-interleukin 23p19 monoclonal antibody, is approved for the treatment of adults with active PsA. We report the efficacy and safety of…
  • Abstract Number: 2101 • ACR Convergence 2025

    LEVI-04, a Novel Neurotrophin-3 Inhibitor, Demonstrates Clinically Meaningful Improvements in Pain and Physical Function across a Range of OA Outcomes, Including the Staircase-Evoked Pain Procedure (StEPP)

    Philip Conaghan1, nathaniel katz2, Asger Bihlet3, Laus W Wullum4, Kerry af Forselles5, C Michael Perkins5, Bernadette Hughes6, Claire Herholdt7 and Iwona Bombelka8, 1University of Leeds, Leeds, United Kingdom, 2Rin Sof Innovation, Ltd, Boston, MA, 3NBCD A/S, Herlev, Denmark, 4Omicron A/S, Copenhagen, Denmark, 5Levicept, Sandwich, United Kingdom, 6Levicept, Ashtead, United Kingdom, 7Levicept Ltd, Ashtead, United Kingdom, 8Levicept, Sandwich, Kent, United Kingdom

    Background/Purpose: When evaluating new osteoarthritis (OA) therapies, we need to understand their clinical meaningfulness. LEVI-04, a first-in-class p75 neurotrophin receptor-Fc fusion protein that primarily inhibits…
  • Abstract Number: 1769 • ACR Convergence 2025

    Classification of Relapses of Eosinophilic Granulomatosis with Polyangiitis After Two-Years of Treatment with Anti-Interleukin-5/Receptor Therapy

    Christian Pagnoux1, Arnaud Bourdin2, Bernhard Hellmich3, Nader Khalidi4, David Jackson5, David Jayne6, Parameswaran Nair7, Ulrich Specks8, Benjamin Terrier9, Lena Börjesson Sjö10, Priya Jain11, Aadarsh Lal12, Sofia Necander13, Claire Walton14, Michael Wechsler15 and Peter Merkel16, 1Mount Sinai Hospital, University Health Network, Toronto, and Canadian Vasculitis Research Network (CanVasc), Toronto, ON, Canada, 2Department of Respiratory Diseases, Montpellier University Hospitals, Arnaud de Villeneuve Hospital, Montpellier, France, 3Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, 4Department of Medicine, McMaster University and St. Joseph’s Healthcare, Hamilton, Canada, 5Guy’s Severe Asthma Centre, Guy's and St Thomas’ NHS Trust, London, and School of Immunology and Microbial Sciences, King's College London, London, United Kingdom, 6University of Cambridge, Cambridge, United Kingdom, 7Department of Medicine, McMaster University and St. Joseph’s Healthcare, Hamilton, ON, Canada, 8Mayo Clinic, Rochester, MN, 9Cochin Hospital, Paris, France, 10Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca,, Gothenburg, Sweden, 11BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, 12Respiratory & Immunology, AstraZeneca, Bengaluru, Karnataka, India, 13Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, 14Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, 15Department of Medicine, National Jewish Health, Denver, 16University of Pennsylvania, Philadelphia, PA

    Background/Purpose: Results from the ongoing open-label extension (OLE) of the MANDARA trial (NCT04157348) have demonstrated the efficacy of two years of anti-interleukin-5/receptor (anti-IL-5/R) therapies in…
  • Abstract Number: 1466 • ACR Convergence 2025

    Impact of Bimekizumab on Spinal MRI Inflammation and Structural Lesions in Patients with Radiographic Axial Spondyloarthritis: 2-Year CANDEN Scoring Results from a Phase 3 Study and Its Open-Label Extension

    Walter P. Maksymowych1, Robert G. W. Lambert2, Victoria Navarro-Compan3, Xenofon Baraliakos4, Jason Coarse5, Natasha de Peyrecave6 and Mikkel Ostergaard7, 1Department of Medicine, University of Alberta, 568 Heritage Building, Edmonton, AB, Canada, 2University of Alberta, Department of Radiology & Diagnostic Imaging, Edmonton, AB, Canada, 3Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, 4Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, 5UCB, Morrisville, NC, 6UCB, Brussels, Belgium, 7Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark, and Copenhagen Center for Arthritis Research, Center for Rheumatology, Rigshospitalet, Glostrup, Denmark

    Background/Purpose: Spinal inflammation and structural progression are key features of radiographic axial spondyloarthritis (r-axSpA).1 Canada-Denmark (CANDEN) scoring enables anatomical-based assessments of MRI inflammatory and structural…
  • Abstract Number: 1353 • ACR Convergence 2025

    Phase 3 Study of the Efficacy, Safety and Immunogenicity of the Proposed Tocilizumab Biosimilar RGB-19, Intravenously Administered to Participants With Active Rheumatoid Arthritis: 52-Week Data

    Gerd Burmester1, Hiroaki Matsuno2, Ernest Choy3, Masato Okada4, Roshan Dias5, Károly Horvát-Karajz5, Gordana Dancer5, Yusuke Karibe6, Suguru Masuda6, Joachim Kiefer5 and Paul Emery7, 1Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, 2Matsuno Clinic for Rheumatic Disease, Toyama, and Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan, 3Division of Infection and Immunity, CREATE Centre, Cardiff University, Cardiff, United Kingdom, 4Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan, 5Gedeon Richter Plc, Budapest, Hungary, 6Mochida Pharmaceutical Co., Ltd, Tokyo, Japan, 7University of Leeds, Leeds, England, United Kingdom

    Background/Purpose: RGB-19 is a proposed biosimilar to tocilizumab, a monoclonal antibody that competitively inhibits the binding of interleukin-6 (IL-6) to its receptor. Results of a…
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Embargo Policy

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.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, 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 of editorial news coverage) is under media embargo until 10:00 AM CT on October 25. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

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