ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: 1909 • ACR Convergence 2022

    Corticosteroids with or Without Hyaluronic Acid Injections in the Treatment of Trapeziometacarpal (TMC) Osteoarthritis : The Randomised Multicentre RHIZ’ART Trial Study Protocol

    Grégoire Cormier1, Amelie Denis2, CHARLES LESKE3, Stephane Varin1, Jerome Dimet4, Lucie Planche1 and Benoit Le Goff5, 1CHD Vendee, La Roche Sur Yon, France, 2CH Le Mans, Le Mans, France, 3Hospital, Cholet, France, 4CH Mont de Marsan, Mont de Marsan, France, 5CHU Nantes, Nantes, France

    Background/Purpose: Trapeziometacarpal osteoarthritis is highly prevalent (affects 10 to 25% of people). Treatment modalities consist of non-pharmacological and pharmacological measures, including either corticosteroid or hyaluronic…
  • Abstract Number: 2113 • ACR Convergence 2022

    Improvement in Key PsA Core Domains with Guselkumab Treatment in an Enriched Population of ACR20 Non-Responders at Week 24: Post Hoc Analysis of Two Phase 3 Studies

    Dennis McGonagle1, Derek Haaland2, Philip Helliwell3, A. Marilise Marrache4, May Shawi5, Emmanouil Rampakakis6, Peter Nash7, Fedra Irazoque Palazuelos8 and Arthur Kavanaugh9, 1Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; National Institute for Health Research, Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, 2The Waterside Clinic, Oro Medonte, ON, Canada, 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 4Janssen Inc., Dollard-des-Ormeaux, QC, Canada, 5Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, 6McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, 7School of Medicine, Griffith University, Sunshine Coast, Australia, 8Angeles Mocel Hospital; Universidad Autónoma de México, Ciudad de México, Mexico, 9University of California San Diego, La Jolla, CA

    Background/Purpose: Despite available PsA treatments, a portion of PsA patients (pts) does not achieve improvements in PsA signs and symptoms according to ACR response criteria.…
  • 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: 0365 • ACR Convergence 2022

    Improvements in Skin Manifestations with BIIB059 Measured by CLASI in Participants with Cutaneous Lupus Erythematosus (CLE): Exploratory Analyses of the Phase 2, Randomized, Double-Blind, Placebo-Controlled LILAC Study (Part B)

    Victoria Werth1, Ronald van Vollenhoven2, Richard Furie3, Filippa Nyberg4, Kenneth Kalunian5, Sandra Navarra6, Juanita Romero-Diaz7, Wenbin Zhu8, Catherine Barbey9, Cristina Musselli8 and Nathalie Franchimont8, 1University of Pennsylvania and Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, 2Amsterdam University Medical Centers, Amsterdam, Netherlands, 3Northwell Health, Great Neck, NY, 4Karolinska University Hospital, Stockholm, Sweden, 5University of California San Diego, La Jolla, CA, 6University of Santo Tomas, Manila, Philippines, 7Instituto Nacional de Ciencias Medicas y Nutricion SZ, Ciudad de México, Mexico, 8Biogen, Cambridge, MA, 9Biogen, Baar, Switzerland

    Background/Purpose: BIIB059 is a humanized monoclonal antibody against BDCA2, a receptor exclusively expressed on plasmacytoid dendritic cells, which are implicated in the pathogenesis of cutaneous…
  • Abstract Number: 0543 • ACR Convergence 2022

    An Exploratory Analysis of the Potential Disconnect Between Objective Inflammatory Response and Clinical Response Following Certolizumab Pegol Treatment in Patients with Active Axial Spondyloarthritis

    Martin Rudwaleit1, Filip Van den bosch2, Helena Marzo-Ortega3, Victoria Navarro-Compán4, Rachel Tham5, Thomas Kumke6, Lars Bauer6, Mindy Kim7 and Lianne Gensler8, 1University of Bielefeld, Klinikum Bielefeld, Bielefeld; Germany Klinikum Bielefeld and Charité Berlin, Germany, and Gent University, Gent, Belgium, 2Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium, 3Leeds Teaching Hospitals Trust and University of Leeds, Leeds, United Kingdom, 4Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, 5UCB Pharma, Slough, UK, Overland Park, KS, 6UCB Pharma, Monheim am Rhein, Germany, 7UCB Pharma, Smyrna, GA, 8Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA

    Background/Purpose: In clinical trials of axial spondyloarthritis (axSpA), composite measures such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) response criteria, Assessment of Spondyloarthritis international…
  • Abstract Number: 1002 • ACR Convergence 2022

    Investigation of Pharmacodynamic Biomarkers in a Phase 2b Study in Patients with Moderate to Severe SLE Treated with the S1P1 Receptor Modulator Cenerimod

    Daniel Strasser1, clélia Cahuzac2, peter Cornelisse2, Ouali Berkani2, Peter Groenen2 and Mark Murphy2, 1Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland, 2Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland

    Background/Purpose: Sphingosine-1-phosphate (S1P) regulates lymphocyte egress from lymphoid organs into circulation. In a SLE proof-of-concept study, cenerimod—a potent, selective S1P1 receptor modulator—reduced circulating antibody-secreting cells…
  • Abstract Number: 1521 • ACR Convergence 2022

    Long-term Follow-Up of Participants of the Phase II Study That Evaluated Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis (ASSET Trial)

    Nadine Sarsam1, Sindhu R. Johnson2, Lorinda Chung3, Suzanne Kafaja4, Janet Pope5, Robyn Domsic6, Maureen Mayes7, Nora Sandorfi8, Virginia Steen9, Flavia Castelino10, Faye Hant11, Suiyuan Huang1 and Dinesh Khanna12, 1University of Michigan, Ann Arbor, MI, 2Division of Rheumatology, Department of Medicine, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western and Mount Sinai Hospitals; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada, 3Stanford University, Stanford, CA, 4UCLA Department of Medicine, Division of Rheumatology, Los Angeles, CA, 5University of Western Ontario, London, ON, Canada, 6University of Pittsburgh, Pittsburgh, PA, 7Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, TX, 8University of Pennsylvania, Philadelphia, PA, 9Georgetown University School of Medicine, Washington, DC, 10Massachusetts General Hospital, Boston, MA, 11Medical University of South Carolina, Charleston, SC, 12Division of Rheumatology, Department of Internal Medicine, Scleroderma Program, University of Michigan, Ann Arbor, MI

    Background/Purpose: Abatacept (ABA) is a cytotoxic T-lymphocyte-associated molecule-4 immunoglobulin fusion protein which has been shown to induce regression of dermal fibrosis in patients with systemic…
  • Abstract Number: 1798 • ACR Convergence 2022

    Health-Related Quality of Life Improvements Resulting from a Treat-to-Target Strategy in the Management of Gout: Post- Hoc Analysis of a Multicenter, Randomized, Double-Blind, Non-Inferiority Trial

    Lindsay Helget1, James O'Dell1, Jeff Newcomb1, Maria Androsenko2, Mary Brophy2, Anne Davis-Karim3, Bryant England1, Ryan Ferguson2, Michael Pillinger4, Tuhina Neogi5, Paul Palevsky6, Hongsheng Wu2 and Ted Mikuls7, 1University of Nebraska Medical Center, Omaha, NE, 2VA Boston Cooperative Studies Program Coordinating Center, Boston, MA, 3VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, 4NYU Grossman School of Medicine, New York, NY, 5Boston University School of Medicine, Boston, MA, 6University of Pittsburgh School of Medicine, Pittsburgh, Pittsburgh, 7Division of Rheumatology, University of Nebraska Medical Center, Omaha, NE

    Background/Purpose: The ACR recommends a treat-to-target strategy in gout management, centered on the titration of urate lowering therapy (ULT) to a goal serum urate (SU)…
  • Abstract Number: 1974 • ACR Convergence 2022

    Which ACR Response Definition Should Be Used for Disease Activity Claims in Approval Studies of Rheumatoid Arthritis? A Systematic Evaluation

    Andreas Kerschbaumer1, Victoria Konzett2, Josef Smolen1 and Daniel Aletaha3, 1Medical University of Vienna, Vienna, Austria, 2Division of Rheumatology / Department of Medicine III / Medical University of Vienna, Vienna, Austria, 3Medical University Vienna, Wien, Austria

    Background/Purpose: The American College of Rheumatology (ACR) response definition was developed in 1995 by Felson et al. as a composite outcome and has been the…
  • Abstract Number: 2114 • ACR Convergence 2022

    Early Clinical Improvement as Predictor of Long-term Health-Related Quality of Life in Psoriatic Arthritis Patients Treated with Guselkumab: Post Hoc Analysis Through 2 Years of a Phase 3 Study

    Iain B McInnes1, Enrique R Soriano2, Lai-shan Tam3, Natalie Shiff4, May Shawi5, Emmanouil Rampakakis6 and Jeffrey Curtis7, 1Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, United Kingdom, 2Rheumatology Unit and University Institute, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, 3The Chinese University of Hong Kong, Hong Kong, China, 4Janssen Scientific Affairs, LLC; Community Health and Epidemiology, University of Saskatchewan, Philadelphia, PA, 5Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, 6McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, 7University of Alabama at Birmingham, Division of Immunology and Rheumatology, Birmingham, AL

    Background/Purpose: Patients (pts) with PsA experience lower quality of life than both the general population and pts with psoriasis alone1,2. Recent PsA treatment recommendations highlight…
  • Abstract Number: 0294 • ACR Convergence 2022

    Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and Inadequate Response or Intolerance to Biologic DMARDs: Results Through 5 Years from the SELECT-BEYOND Study

    Roy Fleischmann1, Sebastian Meerwein2, Christina Charles-Schoeman3, BERNARD COMBE4, Stephen Hall5, Nasser Khan6, Kyle Carter7, Heidi Camp8 and Andrea Rubbert-Roth9, 1Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, 2AbbVie Deutschland GmbH & Co KG, LUDWIGSHAFEN, Germany, 3Division of Rheumatology, University of California, Los Angeles, Santa Monica, CA, 4Montpellier University, Montpellier, France, 5Emeritus Research and Monash University, Melbourne, Australia, 6AbbVie, Inc., Abbott Park, IL, 7AbbVie, Inc., North Chicago, IL, 8Abbvie, Winnetka, IL, 9Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland

    Background/Purpose: To evaluate the long-term efficacy and safety of upadacitinib (UPA) over 5 yrs among patients with rheumatoid arthritis (RA) in a long-term extension (LTE)…
  • Abstract Number: 0366 • ACR Convergence 2022

    Phase II Trial of Enpatoran in Patients Hospitalized with COVID-19 Pneumonia

    John McKinnon1, Joel Santiaguel2, Claudia Murta De Oliveira3, Dongzi Yu4, Mukhy Khursheed5, Flavie Moreau6, Lena Klopp-Schulze7, Jamie Shaw8, Sanjeev Roy9 and Amy Kao10, 1Department of Medicine, Henry Ford Hospital, Detroit, MI, 2Internal Medicine, Quirino Memorial Medical Center, Quezon City, Philippines, 3Ambulatório de Pesquisa Clínica, Santa Casa de Misericórdia, Belo Horizonte, Brazil, 4Global Clinical Development, EMD Serono, Billerica, MA, 5Global Patient Safety, Merck Serono Ltd., an affiliate of Merck KGaA, Darmstadt, Germany, 6Global Biostatistics, EMD Serono, Billerica, MA, 7Translational Medicine, the healthcare business of Merck KGaA, Darmstadt, Germany, 8Translational Medicine, EMD Serono, Billerica, MA, 9Global Clinical Development, Ares Trading SA, an affiliate of Merck KGaA, Darmstadt, Germany, 10EMD Serono, Billerica, MA

    Background/Purpose: Enpatoran is a selective and potent dual toll-like receptor (TLR) 7/8 inhibitor in development for the treatment of cutaneous and systemic lupus erythematosus (CLE/SLE).…
  • Abstract Number: 0544 • ACR Convergence 2022

    Bimekizumab Improves Signs and Symptoms, Including Inflammation, in Patients with Active Non-Radiographic Axial Spondyloarthritis: 24-Week Efficacy & Safety from a Phase 3, Multicenter, Randomized, Placebo Controlled Study

    Atul Deodhar1, Désirée van der Heijde2, Lianne Gensler3, Huji Xu4, Karl Gaffney5, Hiroaki Dobashi6, Walter P Maksymowych7, Martin Rudwaleit8, Marina Magrey9, Dirk Elewaut10, Marga Oortgiesen11, Carmen Fleurinck12, Natasha de Peyrecave13, Alicia Ellis14, Thomas Vaux15, Julie Shepherd-Smith15 and Xenofon Baraliakos16, 1Oregon Health & Science University, Portland, OR, USA, Portland, OR, 2Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Leiden, Netherlands, 3Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, 4Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China, 5Norfolk and Norwich University Hospital NHS Trust, Norfolk, United Kingdom, 6Division of Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Faculty of Medicine, Kagawa, Kagawa, Japan, 7Department of Medicine, University of Alberta, Edmonton, AB, Canada, 8University of Bielefeld, Klinikum Bielefeld, Bielefeld; Germany Klinikum Bielefeld and Charité Berlin, Germany, and Gent University, Gent, Belgium, 9Case Western Reserve University, University Hospitals, Richfield, OH, 10Department of Rheumatology, Ghent University Hospital, Belgium, VIB-UGent Center for Inflammation Research, Ghent University, Heusden, Belgium, 11UCB Pharma, Raleigh, NC, 12UCB Pharma, Brussels, Belgium, Oosterzele, Belgium, 13UCB Pharma, Brussels, Belgium, 14UCB Pharma, Raleigh, 15UCB Pharma, Slough, United Kingdom, 16Rheumazentrum Ruhrgebiet Herne, Herne, Germany

    Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. In patients (pts) with active ankylosing spondylitis (AS), BKZ…
  • Abstract Number: 1010 • ACR Convergence 2022

    Comparison of Established and New, Preliminarily Proposed ASAS Cut-Offs for Inflammatory MRI Lesions in the Sacroiliac Joints of Axial Spondyloarthritis Patients and Implications for Recruitment in Clinical Studies

    Xenofon Baraliakos1, Pedro Machado2, Lars Bauer3, Bengt Hoepken3, Mindy Kim4, Thomas Kumke3, Rachel Tham5 and Martin Rudwaleit6, 1Rheumazentrum Ruhrgebiet Herne, Herne, Germany, 2University College London, London, United Kingdom, 3UCB Pharma, Monheim am Rhein, Germany, 4UCB Pharma, Smyrna, GA, 5UCB Pharma, Slough, UK, Overland Park, KS, 6University of Bielefeld, Klinikum Bielefeld, Bielefeld; Germany Klinikum Bielefeld and Charité Berlin, Germany, and Gent University, Gent, Belgium

    Background/Purpose: The Assessment of SpondyloArthritis international Society (ASAS) recently proposed preliminary, more stringent, data-driven definitions for active and structural MRI lesions of the sacroiliac joint…
  • Abstract Number: 1528 • ACR Convergence 2022

    Nintedanib in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) and Organ Damage: Data from the SENSCIS Trial

    Janet Pope1, Susanna Proudman2, Wendy Stevens3, Joerg Henes4, Rozeta Simonovska5, Margarida Alves6 and Yannick Allanore7, 1University of Western Ontario, London, ON, Canada, 2Rheumatology Unit, Royal Adelaide Hospital, and Discipline of Medicine, University of Adelaide, Adelaide, Australia, 3Department of Rheumatology, St Vincent’s Hospital, Melbourne, Australia, Melbourne, Australia, 4Center for Interdisciplinary Clinical Immunology, Rheumatology and Auto-inflammatory Diseases (INDIRA), University Hospital Tübingen, Tübingen, Germany, 5mainanalytics GmbH, Sulzbach (Taunus), Germany, Sulzbach (Taunus), Germany, 6Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, 7Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France, Paris, France

    Background/Purpose: The Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI) was developed to quantify organ damage in patients with SSc. We assessed outcomes in the SENSCIS…
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