ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: 0987 • ACR Convergence 2022

    A Randomized Placebo-Controlled Phase 1 Study in Healthy Adult Volunteers of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-303, a Potent Dual BAFF/APRIL Antagonist for the Treatment of Systemic Lupus Erythematosus and Other Autoantibody-Associated Diseases

    Stacey Dillon1, Pille Harrison2, Jason Lickliter3, Kristi Manjarrez1, Alina Smith1, Mary Lessig1, Lori Blanchfield1, Russell Sanderson1, Allison Chunyk1, Tiffany Blair1, Amanda Enstrom1, Martin Wolfson1, Mark Rixon1, Hany Zayed4, Rupert Davies1 and Stanford Peng1, 1Alpine Immune Sciences, Seattle, WA, 2Alpine Immune Sciences, Taunton, United Kingdom, 3Nucleus Network, Melbourne, Australia, 4Alpine Immune Sciences, San Francisco, CA

    Background/Purpose: B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) are tumor necrosis factor (TNF) superfamily members that bind TACI (transmembrane activator and CAML…
  • Abstract Number: 1427 • ACR Convergence 2022

    Impact of Upadacitinib versus Abatacept on Individual Disease Outcomes in Patients with Rheumatoid Arthritis and Inadequate Responses to Biologic DMARDs

    Ronald van Vollenhoven1, Andrea Rubbert-Roth2, Stephen Hall3, Ricardo Xavier4, Anna K Shmagel5, Yanna Song5, Samuel Anyanwu5 and Vibeke Strand6, 1Amsterdam University Medical Centers, Amsterdam, Netherlands, 2Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland, 3Emeritus Research and Monash University, Melbourne, Australia, 4Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil, 5AbbVie, Inc., North Chicago, IL, 6Stanford University School of Medicine, Stanford, CA

    Background/Purpose: The phase 3 SELECT-CHOICE trial of patients with rheumatoid arthritis (RA) and prior inadequate response to biologic DMARD(s) (bDMARD-IR) demonstrated superiority of the JAK…
  • Abstract Number: 1614 • ACR Convergence 2022

    Females with Non-Radiographic but Not with Radiographic Axial Spondyloarthritis Are Less Likely to Achieve Inactive Disease State Than Males: Results from a Multicountry Prospective Observational Study

    Denis Poddubnyy1, Joachim Sieper2, Servet Akar3, Santiago Muñoz-Fernández4, Hildrun Haibel2, Torsten Diekhoff5, Mikhail Protopopov6, Elisabeth Altmaier7, Fabiana Ganz8 and Robert Inman9, 1Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, 2Charité - Universitätsmedizin, Berlin, Berlin, Germany, 3Izmir Katip Celebi University School of Medicine, Izmir, Turkey, 4Servicio de Reumatología, Hospital Universitario Infanta Sofía, Universidad Europea, Madrid, Spain, 5Department of Radiology, Charité-Universitätsmedizin Berlin, Berlin, Germany, 6Charité Universitätsmedizin Berlin, Berlin, Germany, 7GKM Gesellschaft für Therapieforschung mbH, Munich, Germany, 8AbbVie, Inc., Luzern, Switzerland, 9University Health Network, Toronto, ON, Canada

    Background/Purpose: Emerging evidence suggests that men and women experience axial spondyloarthritis (axSpA) differently. Some studies suggested that the probability of treatment response was lower in…
  • Abstract Number: 1899 • ACR Convergence 2022

    A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (OA-10) to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

    Yusuf Yazici1, Christopher Swearingen2, Heli Ghandehari3, Victor Lopez4, ismail simsek5, Mark Fineman6, Sarah Kennedy7, Jeyanesh Tambiah8 and Timothy McAlindon9, 1New York University School of Medicine, La Jolla, CA, 2Samumed LLC, San Diego, CA, 3Biosplice Therapeutics, Inc., San Diego, CA, 4Biosplice Therapeutics, Santa Clarita, CA, 5Alpine Immunesciences, San Diego, CA, 6Biosplice Therapeutics, San Diego, CA, 7Biosplice Therapeutics, Inc, San Diego, CA, 8Biosplice Ther Inc., San Diego, CA, 9Tufts Medical Center, Arlington, MA

    Background/Purpose: Knee osteoarthritis (OA) is a common joint disorder associated with pain, disability, and joint damage. There remains a large unmet need for treatments that…
  • Abstract Number: 2108 • ACR Convergence 2022

    Changes in Serum Cytokines by Week 24 Correlate with Long-Term Efficacy of Guselkumab Through Two Years in Bio-Naïve Adults with PsA

    Stefan Siebert1, Georg Schett2, Siba P. Raychaudhuri3, Monica Guma4, Warner Chen5, Sheng Gao5, Soumya Chakravarty6, May Shawi7 and Proton Rahman8, 1Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, Scotland, United Kingdom, 2Universitätsklinikum Erlangen, Erlangen, Germany, 3Rheumatology, Allergy, and Clinical Immunology, University of California Davis, School of Medicine, Sacramento, CA, 4Division of Rheumatology, Allergy, and Immunology, Department of Medicine, University of California San Diego, La Jolla, CA, 5Janssen Research and Development, LLC, Spring House, PA, 6Janssen Scientific Affairs, LLC; Drexel University College of Medicine, Villanova, PA, 7Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, 8Memorial University, St. John's, NL, Canada

    Background/Purpose: The IL-23p19 inhibitor guselkumab has shown robust efficacy vs placebo (PBO) in the phase 3 DISCOVER-1 and DISCOVER-2 studies of adults with active PsA,1,2…
  • Abstract Number: 2235 • ACR Convergence 2022

    Clinical Impact of a Digital Behavioral Therapy for Fibromyalgia Management in a Decentralized Trial

    Yifei Dai1, Michael Rosenbluth2, Michael Gendreau3, Nicolette Vega4, Zunera Ghalib4, Allison Kraus4 and Brian Keefe5, 1Swing Therapeutics, Gainesville, FL, 2Swing Therapeutics, San Francisco, CA, 3GENDREAU CONSULTING, LLC, Poway, CA, 4Swing Therapeutics, San Francisco, 5Swing Therapeutics, New York, NY

    Background/Purpose: Cognitive behavioral therapy (CBT) has demonstrated level 1A evidence for management of fibromyalgia (FM). Acceptance and Commitment Therapy (ACT), a form of CBT, has…
  • Abstract Number: 0173 • ACR Convergence 2022

    Cutaneous Manifestations, Clinical Trials, Safety Efficacy and Safety of Lenabasum in the Phase 3 DeterMine Trial in Dermatomyositis

    Victoria Werth1, Barbara White2, Josef Concha3, Josh Dan1, Nancy Dgetluck2, Kathleen Hally2, Scott Constantine2, Rohit Aggarwal4, David Fiorentino5, Ingrid Lundberg6 and Chester Oddis7, 1Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, 2Corbus Pharmaceuticals, Norwood, MA, 3Universiity of Pennsylvania/Dermatology, Philadelphia, PA, 4University of Pittsburgh, Division of Rheumatology, Pittsburgh, PA, 5Stanford university/Department of Dermatology, Palo Alto, CA, 6Karolinska Institute, Stockholm, Sweden, 7University of Pittsburgh, Pittsburgh, PA

    Background/Purpose: Safe and effective treatments are of significant unmet need in DM. Lenabasum, a CB2 agonist that activates resolution of inflammation, improved skin disease, patient-reported…
  • Abstract Number: 0357 • ACR Convergence 2022

    Voclosporin Is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations

    Hans-Joachim Anders1, Raymond Federico2, Vanessa Birardi3 and Henry Leher3, 1University of Munich, Munich, Germany, 2Aurinia Pharmaceuticals, Inc., Victoria, BC, Canada, 3Aurinia Pharmaceuticals Inc, Rockville, MD

    Background/Purpose: Pooled data from the Phase 2 AURA-LV and Phase 3 AURORA 1 studies demonstrated that adding voclosporin, a novel calcineurin inhibitor, to mycophenolate mofetil…
  • Abstract Number: 0522 • ACR Convergence 2022

    Cohort Enrichment Strategies for Progressive Interstitial Lung Disease in Systemic Sclerosis from EUSTAR

    Anna-Maria Hoffmann-Vold1, Cathrine Brunborg1, Paolo Airò2, Lidia P. Ananyeva3, László Czirják4, Serena Guiducci5, Eric Hachulla6, MENGTAO LI7, Carina Mihai8, Gabriela Riemekasten9, Petros P. Sfikakis10, Gabriele Valentini11, Otylia Kowal-Bielecka12, Yannick Allanore13 and Oliver Distler8, 1Oslo University Hospital, Oslo, Norway, 2Rheumatology and Clinical Immunology Unit, ASST Spedali Civili, Brescia, Italy, 3V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia, 4Medical school of Pécs, Pecs, Hungary, 5University of Firenze, Firenze, Italy, 6University of Lille, Lille, France, 7Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, National Clinical Research Center for Dermatologic and Immunologic Diseases, Ministry of Science & Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, State Key Laboratory of Complex Severe and Rare Diseases, Ministry of Science & Technology, Beijing, China, 8Department of Rheumatology, University Hospital Zurich, University of Zurich, Zürich, Switzerland, 9University Clinic Schleswit-Holstein (UKSH), Luebeck, Germany, 10Joint Academic Rheumatology Program, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece, 11Università della Campania “Luigi Vanvitelli”, Napoli, Italy, 12Medical University of Bialystok, Bialystok, Poland, 13Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France, Paris, France

    Background/Purpose: Enrichment strategies from clinical trials for progressive systemic sclerosis-associated interstitial lung disease (SSc-ILD) have been partly successful but have not been tested in a…
  • Abstract Number: 0989 • ACR Convergence 2022

    Regulatory T Cell Defects in SLE and Therapy with a Novel IL-2 Mutein: Phase 1 Clinical Results with Efavaleukin Alfa

    Nandita Sarkar1, Xuguang Hu1, Nadia Tchao1, Richard Furie2, Alan Kivitz3, Stanley B Cohen4 and Kevin Gorski5, 1Amgen Inc., South San Francisco, CA, 2Northwell Health, Great Neck, NY, 3Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, 4Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, 5Amgen, Inc., Thousand Oaks, CA

    Background/Purpose: Regulatory T cells (Treg) are critical for maintaining self-tolerance and preventing autoimmunity, and IL-2 is essential for their development, survival and suppressive function. Defects…
  • Abstract Number: 1431 • ACR Convergence 2022

    Impact of Tofacitinib on Fracture Risk in Rheumatoid Arthritis

    Karen E Hansen1, Mahta Mortezavi2, Edward Nagy3, Cunshan Wang4, Carol A Connell4, Zaher Radi5, Heather J Litman6, Giovanni Adami7 and Maurizio Rossini7, 1Rheumatology Division, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, 2Pfizer Inc, New York, NY, 3Pfizer Ltd, Tadworth, United Kingdom, 4Pfizer Inc, Groton, CT, 5Pfizer Inc., Cambridge, MA, 6CorEvitas, LLC, Waltham, MA, 7Rheumatology Unit, Department of Medicine, University of Verona, Verona, Italy

    Background/Purpose: Preclinical data suggest that tofacitinib stimulates osteoblast function and would have a protective effect on bone health and fracture risk in RA.1 We report…
  • Abstract Number: 1639 • ACR Convergence 2022

    A Phase 3, 56-Week, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial (OA-11) to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint Injected in the Target Knee Joint of Moderate to Severe Osteoarthritis Participants

    Yusuf Yazici1, Christopher Swearingen2, Heli Ghandehari3, Jon Britt4, ismail simsek5, Mark Fineman6, Sarah Kennedy2, Jeyanesh Tambiah7 and Timothy McAlindon8, 1New York University School of Medicine, La Jolla, CA, 2Biosplice Therapeutics, Inc, San Diego, CA, 3Biosplice Therapeutics, Inc., San Diego, CA, 4Biosplice Therapeutics, Inc., Los Angeles, CA, 5Alpine Immunesciences, San Diego, CA, 6Biosplice Therapeutics, San Diego, CA, 7Biosplice Ther Inc., San Diego, CA, 8Tufts Medical Center, Arlington, MA

    Background/Purpose: Knee osteoarthritis (OA) is a common joint disorder associated with pain, disability, and joint damage. There remains a large unmet need for treatments that…
  • Abstract Number: 1900 • ACR Convergence 2022

    CoLchicine for Treatment of OsteoArthritis of the Knee (CLOAK)-A Double-blind, Placebo-controlled Trial

    Jonathan Samuels1, Michael Pillinger2, Michael Toprover3, Svetlana Krasnokutsky Samuels4, Apoorva Patil5, Fernando Bomfim6, Renata La Rocca Vieira6, David Wei5, Sydney Catron5, Maryfe coronel5, Annie Kim5 and Sarah Moussavi5, 1NYU Langone, Rye Brook, NY, 2NYU Grossman School of Medicine, New York, NY, 3Division of Rheumatology, New York University Grossman School of Medicine and Rheumatology Section, New York Harbor Health Care System, New York Campus of the U.S. Department of Veterans Affairs, New York, NY, 4Westmed, Rye Brook, NY, 5NYU Langone Health, New York, NY, 6NYU Langone, New York, NY

    Background/Purpose: Knee osteoarthritis (OA) is an inflammatory disease, with a probable role for IL-1b. Calcium and urate crystals may promote OA by activating the NLRP3…
  • Abstract Number: 2109 • ACR Convergence 2022

    Domains Contributing to Minimal Disease Activity Non-Achievement in Patients with Psoriatic Arthritis Receiving Golimumab: Post Hoc Analysis of a Phase 3, Randomized, Double-blind, Placebo-controlled Study

    Arthur Kavanaugh1, Gordon Lam2, Lai-shan Tam3, Natalie Shiff4, Youngja Lee5, Ana-Maria Bravo Perdomo6, May Shawi7, Elizabeth Hsia8, Emmanouil Rampakakis9 and Carlos Enrique Toro Gutiérrez10, 1University of California San Diego, La Jolla, CA, 2Arthritis and Osteoporosis Consultants of the Carolinas; Clinical Affiliate, Atrium Health and the Wake Forest School of Medicine, Cornelius, NC, 3The Chinese University of Hong Kong, Hong Kong, China, 4Janssen Scientific Affairs, LLC, Horsham, PA, USA/ Department of Community Health and Epidemiology, College of Medicine, University of Saskatchewan, Saskatoon, Canada, Philadelphia, PA, 5Immunology Medical Affairs, Janssen Asia Pacific, Yongsan-gu, Seoul, Republic of Korea, 6Immunology Medical Affairs, Janssen Latin America, Columbia, Colombia, 7Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, 8Janssen Research and Development, LLC; University of Pennsylvania School of Medicine, Kennett Square, PA, 9McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, 10Internal Medicine and Rheumatology, Reference Center for Osteoporosis, Rheumatology & Dermatology. Pontificia Javeriana University, Calí, Colombia

    Background/Purpose: Sustained minimal disease activity (MDA) is only achieved by a small portion of PsA patients (pts). Levels of disease activity consistent with MDA may…
  • Abstract Number: 2245 • ACR Convergence 2022

    Feasibility and Efficacy of a Peer Education Program to Improve Patient Engagement in Lupus Clinical Trials

    Saira Sheikh1, Caroline Donovan2, Carla Menezes2, Albert T. Roy2, Andrew Simkus3, Diane Gross4, Anca Askanase5, Rosalind Ramsey-Goldman6, Vikas Majithia7, Nicole Wanty3, Annie McNeill3, Kristen Holtz3 and S. Sam Lim8, 1University of North Carolina at Chapel Hill, Chapel Hill, NC, 2Lupus Therapeutics, LLC, New York, NY, 3KDH Research & Communication, Atlanta, GA, 4Lupus Research Alliance, New York, NY, 5Columbia University Medical Center, New York, NY, 6Northwestern University Feinberg School of Medicine, Chicago, USA, Chicago, IL, 7University of Mississippi Medical Center, Ridgeland, MS, 8Emory University, Atlanta, GA

    Background/Purpose: To assess outcomes related to Lupus Therapeutics' Patient Advocates for Lupus Studies (LT-PALS) a peer-to-peer clinical trial (CT) education program designed to improve CT…
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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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