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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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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