Abstracts tagged "clinical trial"

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…
Abstract Number: 1807 • ACR Convergence 2022
Reduction in Monosodium Urate Crystal Deposit Volume During the MIRROR RCT Trial in Patients Treated with Pegloticase Plus Methotrexate Co-therapy: A Serial Dual-Energy Computed Tomography (DECT) Analysis
Nicola Dalbeth¹, John Botson², kenneth saag³, Ada Kumar⁴, Lissa Padnick-Silver⁵, Brian LaMoreaux⁵ and Fabio Becce⁶, ¹University of Auckland, Auckland, New Zealand, ²Orthopedic Physicians Alaska, Anchorage, AK, ³University of Alabama at Birmingham, Birmingham, AL, ⁴Horizon Therapeutics, Deerfield, IL, ⁵Horizon Therapeutics plc, Deerfield, IL, ⁶Lausanne University Hospital (CHUV), Lausanne, Switzerland
Background/Purpose: Dual-energy computed tomography (DECT) can reliably visualize and quantify monosodium urate (MSU) crystal deposits in gout patients.1 Two MIRROR open-label trial (pegloticase + oral…
Abstract Number: 1985 • ACR Convergence 2022
The BEGIN Study: A Double-blind, Multi-center, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks of Treatment with AP1189 in Early Rheumatoid Arthritis (RA) Patients with Active Joint Disease
Thomas Jonassen¹, Irene Sandholdt², Birgitte Telmer² and Ellen-Margrethe Hauge³, ¹SynAct Pharma, Holte, Denmark, ²CroxxMed, Hørsholm, Denmark, ³Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
Background/Purpose: Melanocortin (MC) type 1 and type 3 receptor stimulation is associated with anti-inflammatory activity and the promotion of inflammatory resolution. AP1189 is novel biased…
Abstract Number: 2115 • ACR Convergence 2022
Early Skin and Early Enthesitis Responses in Psoriatic Arthritis Patients Treated with Guselkumab Associate with Long-term Response: Post Hoc Analysis Through 2 Years of a Phase 3 Study
Laura Coates¹, Julio Ramírez², Dennis McGonagle³, Sibel Aydin⁴, Miriam Zimmermann⁵, Francois Nantel⁶, May Shawi⁷, Emmanouil Rampakakis⁸, Peter Nash⁹ and Philip J Mease¹⁰, ¹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom, ²Arthritis Unit, Rheumatology Department, Hospital Clinic, Barcelona, Spain, ³University of Leeds, Leeds, UK, Leeds, United Kingdom, ⁴University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada, ⁵Immunology, Janssen Scientific Affairs, LLC, Zug, Switzerland, ⁶Nantel MedSci Consult, Montréal, QC, Canada, ⁷Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁸McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, ⁹School of Medicine, Griffith University, Sunshine Coast, Australia, ¹⁰Swedish Medical Center/Providence St. Joseph Health, Seattle, WA
Background/Purpose: Guselkumab (GUS), an IL-23p19 inhibitor, has demonstrated efficacy in PsA across key Group for Research and Assessment of Psoriasis (PsO) and Psoriatic Arthritis (GRAPPA)-recommended…
Abstract Number: 0295 • ACR Convergence 2022
Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic DMARDs: Results Through 5 Years from the SELECT-NEXT Study
Gerd Burmester¹, Filip Van den bosch², John Tesser³, Anna K Shmagel⁴, Yuanyuan Duan⁴, Nasser Khan⁵, Heidi Camp⁶ and Alan Kivitz⁷, ¹Charité University Medicine Berlin, Berlin, Germany, ²Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium, ³Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie, Inc., Abbott Park, IL, ⁶Abbvie, Winnetka, IL, ⁷Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: In the phase 3 SELECT-NEXT study, upadacitinib (UPA) demonstrated efficacy at wk 12 and sustained efficacy up to wk 60 in patients with rheumatoid…
Abstract Number: 0371 • ACR Convergence 2022
A Phase 2, Double-blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101/Lenabasum in Systemic Lupus Erythematosus, an Autoimmunity Centers of Excellence Study (ALE09)
Meggan Mackay¹, Robert Zurier², Diane Kamen³, Fotios Koumpouras⁴, Anca Askanase⁵, Kenneth Kalunian⁶, Steffan Schulz⁷, Giovanni Franchin⁸, Nancy Olsen⁹, Andreea Coca¹⁰, Roberto Caricchio¹¹, Maureen McMahon¹², Maria Dall'Era¹³, Amit Saxena¹⁴, Megan Clowse¹⁵, Stanley Ballou¹⁶, Linna Ding¹⁷, Beverly Welch¹⁸, Jessica Springer¹⁹, Andrew Shaw¹, Lynette Keyes-Elstein²⁰, Kaitlyn Steinmiller²¹, Amanda Mickey²¹, Cynthia Aranow¹ and Betty Diamond¹, ¹Feinstein Institutes for Medical Research, Manhasset, NY, ²Feinstein Institutes, Wyckoff, NJ, ³Medical University of South Carolina, Charleston, SC, ⁴Yale School of Medicine, New Haven, CT, ⁵Columbia University Medical Center, New York, NY, ⁶University of California San Diego, La Jolla, CA, ⁷Univ Pennsylvania, Philadelphia, PA, ⁸BronxCare, Feinstein Institutes, Manhasset, NY, ⁹Penn State University/Milton S Hershey, Hershey, PA, ¹⁰UPMC, Pittsburgh, PA, ¹¹Lewis Katz School of Medicine at Temple University, Philadelphia, PA, ¹²University of California Los Angeles, Los Angeles, CA, ¹³University of California, Division of Rheumatology, San Francisco, CA, ¹⁴NYU School of Medicine, New York, NY, ¹⁵Duke University, Durham, NC, ¹⁶Case Western Reserve University - Metro Health, Cleveland, OH, ¹⁷NIH NIAID, Rhockvile, MD, ¹⁸NIAID/NIH, Bethesda, MD, ¹⁹NIH/NIAID, Rockville, MD, ²⁰Rho, Chapel Hill, NC, ²¹Rho Inc, Durham, NC
Background/Purpose: Musculoskeletal (MSK) symptoms are common in SLE, often associate with debilitating pain requiring immunosuppressive treatment. JBT-101 is a non-psychotropic, non-immunosuppressive, cannabinoid receptor 2 agonist…
Abstract Number: 0546 • ACR Convergence 2022
COmparison of the Effect of Treatment with NSAIDs Added to Anti-TNF Therapy versus Anti-TNF Therapy Alone on Progression of StrUctural Damage in the Spine over Two Years in Patients with Ankylosing Spondylitis (CONSUL): An Open-Label, Randomized Controlled, Multicenter Trial
Fabian Proft¹, Bukrhard Muche², valeria Rios-Rodriguez³, Murat Torgutalp⁴, Mikhail Protopopov⁵, Joachim Listing⁶, Maryna Verba⁷, Jan Brandt-Juergens⁸, Uta Kiltz⁹, Maren Sieburg¹⁰, Swen Jacki¹¹, Joachim Sieper⁴ and Denis Poddubnyy¹, ¹Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ²Charité University Hospital, CCM, Berlin, Germany, ³Charité-Universitätsmedizin Berlin, Berlin, Germany, ⁴Charité - Universitätsmedizin, Berlin, Berlin, Germany, ⁵Charité Universitätsmedizin Berlin, Berlin, Germany, ⁶German Rheumatism Research Centre, Epidemiology Unit, Berlin, Germany, ⁷Charité – Universitätsmedizin Berlin, Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Berlin, Germany, ⁸Rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁹Rheumazentrum Ruhrgebiet, Herne, Germany, ¹⁰Rheumatologische Facharztpraxis, Magdeburg, Germany, ¹¹Rheumatologische Schwerpunktpraxis, Tübingen, Germany
Background/Purpose: There is some evidence that NSAIDs, in particular celecoxib (CEL), might possess not only symptomatic efficacy but also disease-modifying properties in ankylosing spondylitis (AS),…

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