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Abstracts tagged "Randomized Trial"

  • Abstract Number: 0584 • ACR Convergence 2021

    High Number of Comorbidities and Concomitant Medications at Baseline in the Glucocorticoid Low-dose Outcome in Rheumatoid Arthritis (GLORIA) Study: An Older Population with Rheumatoid Arthritis

    Maarten Boers1, Linda Hartman1, Daniela Opris-Belinski2, Reinhard Bos3, Marc Kok4, Jose Pereira da Silva5, Eduard N Griep6, Ruth Klaasen7, Cornelia F. Allaart8, Paul Baudoin9, Hennie Raterman10, Zoltan Szekanecz11, Frank Buttgereit12, Pavol Masaryk13, L. Thomas Klausch1, Sabrina Paolino14, Annemarie Schilder15, Willem Lems16 and Maurizio Cutolo14, 1Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, 2Carol Davila University, Bucharest, Romania, 3Department of Rheumatology, Medical Centre Leeuwarden, Leeuwarden, Netherlands, 4Maasstad Hospital, Rotterdam, Netherlands, 5University of Coimbra | UC · Clínica Universitária de Reumatologia. Faculty of Medicine, Columbia, Portugal, 6Antonius Hospital, Leeuwarden, Netherlands, 7Meander Medical Center, Amersfoort, Netherlands, 8Leiden University Medical Center, Leiden, Netherlands, 9Reumazorg ZWN, Almere, Netherlands, 10Northwest Clinics, Alkmaar, Netherlands, 11Division of Rheumatology, University of Debrecen, Faculty of Medicine, Debrecen, Hungary, 12Charité – Universitätsmedizin Berlin, Berlin, Germany, 13National Institute for the Rheumatic Diseases, Bratislava, Slovakia, 14Laboratory of Experimental Rheumatology and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, IRCCS Polyclinic San Martino Hospital, Genoa, Italy, 15Medical Centre Leeuwarden, Leeuwarden, Netherlands, 16VUmc, Amsterdam, Netherlands

    Background/Purpose: Older people are often underrepresented in trials because the generally high number of comorbid conditions (1). The objective of this abstract is to document…
  • Abstract Number: 1692 • ACR Convergence 2021

    Long-Term Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: 3-year Results from the SELECT-EARLY Study

    Ronald F van Vollenhoven1, Tsutomu Takeuchi2, Jacob Aelion3, Nilmo Chavez4, Pablo Mannucci5, Atul Singhal6, Jerzy Swierkot7, Alan Friedman8, Nasser Khan8, Yihan Li9, Xianwei Bu9, Justin Klaff8 and Vibeke Strand10, 1Amsterdam University Medical Centers, Department of Rheumatology and Clinical Immunology, Rheumatology and Immunology Center ARC, Amsterdam, Netherlands, 2Div. Rheumatology, Keio University, Tokyo, Japan, 3Arthritis Clinic and West Tennessee Research Institute, Jackson, TN, 4Instituto Guatemalteco de Seguridad Social, Ciudad de Guatemala, Guatemala, 5Aprillus Asistencia e Investigación, Buenos Aires, Argentina, 6Southwest Rheumatology Research LLC, Dallas, TX, 7Department of Rheumatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland, 8AbbVie Inc., North Chicago, IL, 9AbbVie Inc., North Chicago, 10Stanford University School of Medicine, Portola Valley, CA

    Background/Purpose: Upadacitinib (UPA), an oral Janus kinase inhibitor, demonstrated significant improvements in signs, symptoms, and structural inhibition as monotherapy (mono) vs methotrexate (MTX) in MTX-naïve…
  • Abstract Number: 0674 • ACR Convergence 2021

    A Behavioral Intervention to Improve Gout Outcomes in African Americans with Gout: A 12-month Multicenter, Randomized Controlled Trial

    Jasvinder Singh1, Kenneth Saag1, Joshua Baker2, Amy Joseph3, Seth Eisen4 and Terence Shaneyfelt1, 1University of Alabama at Birmingham, Birmingham, AL, 2University of Pennsylvania, Philadelphia, PA, 3Washington University / St. Louis VA, St Louis, MO, 4Washington University School of Medicine, St Louis, MO

    Background/Purpose: Gout outcomes and severity are worst in African Americans compared to Caucasians with gout. Racial Disparities in gout are well-described. Few or no data…
  • Abstract Number: 1694 • ACR Convergence 2021

    Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs

    Ronald van Vollenhoven1, Stephen Hall2, Alvin Wells3, Sebastian Meerwein4, Yanna Song5, Jessica Suboticki5 and Roy Fleischmann6, 1Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, 2Emeritus Research and Monash University, Melbourne, Australia, Melbourne, Australia, 3Rheumatology and Immunotherapy Center, Franklin, WI, 4AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, 5AbbVie Inc., North Chicago, IL, 6Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX

    Background/Purpose: Sustained clinical remission (REM) is the primary treatment goal for patients with rheumatoid arthritis (RA), with low disease activity (LDA) being an appropriate target…
  • Abstract Number: 0675 • ACR Convergence 2021

    Urate-lowering Therapy for Prevention of Gout: Prespecified Analyses from the CKD-FIX Trial

    Anushree Tiku1, Neil Boudville2, Fiona Brown3, Alan Cass4, Phiilip Clarke5, Richard Day6, Janak de Zoysa7, Bettina Douglas8, Randall Faull9, David Harris10, Carmel Hawley11, Graham Jones6, John Kanellis3, Elaine Pascoe11, Suetonia Palmer12, Vlado Perkovic13, Gopala Rangan10, Donna Reidlinger11, Laura Robison11, Robert Walker14, Giles Walters15, David Johnson11, Sunil Badve13 and Nicola Dalbeth7, 1The George Institute of Australia, Sydney, Australia, 2University of Western Australia, Perth, Australia, 3Monash University, Melbourne, Australia, 4Menzies School of Health Research, Darwin, Australia, 5University of Oxford, Oxford, United Kingdom, 6University of New South Wales, Sydney, Australia, 7University of Auckland, Auckland, New Zealand, 8Princess Alexandra Hospital, Brisbane, Australia, 9University of Adelaide, Adelaide, Australia, 10University of Sydney, Sydney, Australia, 11University of Queensland, Brisbane, Australia, 12University of Otago, Christchurch, New Zealand, 13The George Institute for Global Health, Sydney, Australia, 14University of Otago, Dunedin, New Zealand, 15The Canberra Hospital, Canberra, Australia

    Background/Purpose: The CKD-FIX randomized controlled trial showed that allopurinol did not slow decline of estimated glomerular filtration rate (eGFR) over 104 weeks in patients with…
  • Abstract Number: 1703 • ACR Convergence 2021

    AP1189: A Novel Oral Biased Melanocortin Agonist with Anti-inflammatory and Pro-resolving Effect for the Treatment of Rheumatoid Arthritis

    Thomas Jonassen1, Thierry Duvauchelle1, Birgitte Telmer2, Irene Sandholdt2, Thomas Boesen1 and Ellen-Margrethe Hauge3, 1SynAct Pharma, Holte, Denmark, 2CroxxMed, Hørsholm, Denmark, 3Aarhus University Hospital, Aarhus, Denmark

    Background/Purpose: Melanocortin (MC) type 1 and type 3 receptor stimulation is associated with anti-inflammation and promotion of inflammatory resolution. AP1189 is a biased MC type…
  • Abstract Number: 0695 • ACR Convergence 2021

    Safety and Tolerability of IVIg (Octagam 10%) in Patients with Active Dermatomyositis. Results of a Randomized, Double-Blind, Placebo-Controlled Phase III Trial

    Rohit Aggarwal1, Christina Charles-Schoeman2, Joachim Schessl3, Zsuzsanna Bata-Csorgo4, Mazen Dimachkie5, Zoltan Griger6, Sergey Moiseev7, Chester Oddis1, Elena Schiopu8, Jiri Vencovsky9, Irene Beckmann10, Elisabeth Clodi10, Todd Levine11 and and the ProDERM Investigators12, 1University of Pittsburgh, Pittsburgh, PA, 2Department of Medicine, University of California, Los Angeles, Los Angeles, CA, 3Friedrich-Baur-Institut/Medical University Munich, München, Germany, 4University of Szeged, Faculty of Medicine, Szeged, Hungary, 5University of Kansas Medical Center, Kansas City, KS, 6University of Debrecen, Debrecen, Hungary, 7First Moscow State Medical University, Moscow, Russia, 8University of Michigan, Ann Arbor, MI, 9Institute of Rheumatology, Prague, Czech Republic, 10Octapharma PPG, Vienna, Austria, 11Phoenix Neurological Associates, LTD, Phoenix, AZ, 12Different Institutions in several countries, Vienna, Austria

    Background/Purpose: Dermatomyositis (DM) is a chronic systemic autoimmune disease with characteristic skin rash and muscle weakness. Intravenous immunoglobulin (IVIg) has long been used as adjuvant…
  • Abstract Number: 1708 • ACR Convergence 2021

    The Efficacy and Safety of Piclidenoson vs Methotrexate in Early Rheumatoid Arthritis: Phase 3 Randomized, Double-blind, Placebo-controlled Study

    Tatiana Reitblat1, Alexandra Gurman- Balbir2, Zivit Harpaz3, Motti Farbstein3, Michael Silverman3, William Kerns3 and Pnina Fishman3, 1Barzilai Medical Center, Ashkelon, Israel, 2Rambam Medical Center, Haifa, Israel, 3Can-Fite BioPharma, Petah Tikva, Israel

    Background/Purpose: Piclidenoson, a highly selective A3 adenosine receptor (A3AR) agonist, demonstrated safety and efficacy in phase 2 clinical studies in rheumatoid arthritis (RA) and psoriasis.…
  • Abstract Number: 0733 • ACR Convergence 2021

    A New Wearable Transcutaneous Electrical Nerve Stimulation Device (actiTENS®) Is More Efficient and Better Tolerated Than Weak Opioids in the Treatment of Knee Osteoarthritis Pain

    Emmanuel Maheu1, Sandrine Soriot-Thomas2, Eric Noël3, Hervé Ganry4, Eric Lespessailles5 and Bernard Cortet6, 1Saint-Antoine Hospital, Paris, France, 2CHU Amiens Picardie, Amiens, France, 3Santy Orthopaedic Center, Lyon, France, 4Hergan Consulting 4U, Amiens, France, 5CH Orléans, ORLEANS, France, 6CHU Lille, Lille, France

    Background/Purpose: Knee osteoarthritis (KOA) is a frequent disease for which therapeutic possibilities are limited. In current recommendations, the first-line analgesic is acetaminophen. However, its low…
  • Abstract Number: 1786 • ACR Convergence 2021

    Association of the Improvement of Synovitis and Enthesitis with Quality of Life/Patient Reported Outcomes in Patients with PsA Treated with Ixekizumab

    Lars Erik Kristensen1, Dennis McGonagle2, Martin Rudwaleit3, Hideto Kameda4, Thorsten Holzkaemper5, Celine El Baou6 and Josef Smolen7, 1Bispebjerg-Frederiksberg Hospital, Copenhagen,, Denmark, 2University of Leeds, Leeds, United Kingdom, 3Bielefeld University, Rheumatology, Klinikum Bielefeld, Berlin, Germany, 4Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan, 5Eli Lilly and Company, Bad Homburg, Germany, 6Eli Lilly and Company, Indianapolis, IN, 7Medical University of Vienna, Vienna, Austria

    Background/Purpose: PsA is an inflammatory rheumatic disease with manifestations including synovitis and enthesitis. During extensive study programs, IXE has shown a treatment effect across domains…
  • Abstract Number: 0814 • ACR Convergence 2021

    Patient Characteristics, Efficacy, and Treatment Patterns of Tofacitinib Monotherapy in Patients with RA: Contextualization of Randomized Controlled Trial Results with Real-world Data

    Janet Pope1, Axel Finckh2, Lucia Silva-Fernández3, Peter Mandl4, Haiyun Fan5, Jose L Rivas6, Monica Valderrama6 and María Montoro6, 1University of Western Ontario, London, ON, Canada, 2University Hospital of Geneva, Geneve - Vesenaz, Switzerland, 3Hospital Universitari Son Espases, Palma de Mallorca, Spain, 4Division of Rheumatology, Medical University of Vienna, Vienna, Austria, 5Pfizer Inc, Collegeville, PA, 6Pfizer SLU, Madrid, Spain

    Background/Purpose: Randomized controlled trials (RCTs) have long been considered the gold standard for clinical research, but can be complemented with real-world data (RWD) to further…
  • Abstract Number: 1802 • ACR Convergence 2021

    Comparison of Axial and Peripheral Manifestations in Patients with Psoriatic Arthritis and Ankylosing Spondylitis in Upadacitinib Clinical Trials

    Xenofon Baraliakos1, Atul Deodhar2, Roberto Ranza3, Simona Rednic4, Francesco Ciccia5, Fabiana Ganz6, Tianming Gao6, Apinya Lertratanakul6, In-Ho Song6, Andrew Ostor7 and Laura Coates8, 1Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, 2Oregon Health & Science University, Portland, OR, 3Hospital de Clinicas, Universidade Federal de Uberlândia, Uberlandia, MG, Brazil, 4Emergency Clinical County Hospital, Rheumatology and Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania, 5University of Campania “Luigi Vanvitelli", Naples, Italy, 6Abbvie Inc., North Chicago, IL, 7Monash University, Cabrini Hospital, and Emertius Research, Malvern, Australia, 8Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom

    Background/Purpose: Axial, peripheral, and other disease manifestations often overlap between psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Upadacitinib (UPA) is an oral Janus kinase inhibitor…
  • Abstract Number: 0825 • ACR Convergence 2021

    An Investigator-initiated Multicenter Randomized Study in Early Rheumatoid Arthritis of Active Conventional Therapy versus Three Biological Treatments: 48 Week Clinical and Radiographic Results of the NORD-STAR Trial

    Mikkel Ostergaard1, Ronald van Vollenhoven2, Anna Rudin3, Merete Hetland4, Marte S Heiberg5, Dan Nordström6, Michael Nurmohamed7, Bjorn Gudbjornsson8, Lykke Ørnbjerg9, Pernille Bøyesen10, Inge Olsen11, Kristina Lend12, Kim Hørslev-Petersen13, Till Uhlig14, Tuulikki Sokka-Isler15, Gerdur Grondal8, Simon Krabbe16, Joakim Lindqvist17, Inger Gjertsson18, Daniel Glinatsi9, Meliha Kapetanovic19, Anna-Birgitte Aga10, Francesca Faustini20, Pinja Parmanne21, Tove Lorenzen22, Cagnotto Giovanni23, Johan Back24, Oliver Hendricks25, Daisy Vedder26, Tuomas Rannio27, Emma Grenholm28, Maud Kristine Ljoså29, Eli Brodin30, Hanne Merete Lindegaard31, Annika Söderbergh32, Milad Rizk33, Elsa Hermansson34, Per Larsson35, Line Uhrenholt36, Søren Andreas Just37, David John Stevens38, Trine Bay Laurberg39, Gunnstein Bakland40, Espen Haavardsholm41 and Jon Lampa17, 1Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, and Department of Clinical Medicine, University of Copenhagen, Glostrup, Denmark, 2Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, 3Rheumatology Clinic, Sahlgrenska University Hospital, Sahlgrenska Academy of University of Gothenburg, Gothenburg, Sweden, 4DANBIO and COPECARE, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, 5Diakonhjemmet Hospital, Oslo, Norway, 6Division of Internal Medicine and Rheumatology, Helsinki University Hospital, Helsinki, Finland, 7Reade and Amsterdam University Medical Center, location VUmc, Amsterdam, Netherlands, 8Landspitali University Hospital, University of Iceland, Reykjavik, Iceland, 9Copenhagen Center for Arthritis Research, COPECARE, Glostrup, Denmark, 10Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 11Oslo University Hospital, Oslo, Norway, 12Department of Medicine, Rheumatology Unit, The Karolinska Institute, Stockholm, Sweden, 13King Christian X's Hospital for Rheumatic Diseases, Gråsten, Denmark, 14Diakonhjemmet Hospital, University of Oslo, Oslo, Norway, 15University of Eastern Finland, Jyväskylä Central Hospital, Jyväskylä, Finland, 16Radiologisk Afdeling, Herlev Universitetshospital, Herlev, Denmark, 17Karolinska University Hospital, Stockholm, Sweden, 18Dept. of Rheumatology, Sahlgrenska University Hospital, Gothenborg, Sweden, 19Dept. of Clinical Sciences, Skåne University Hospital, Lund, Sweden, 20Dept. of Medicine, Rheumatology, Karolinska University Hospital, Stockholm, Sweden, 21Division of Rheumatology, Helsinki University Hospital, Helsinki, Finland, 22Dept. of Rheumatology, Silkeborg University Hospital, Silkeborg, Denmark, 23Dept. of Clinical Sciences, Skåne University Hospital, Malmö, Sweden, 24Dept. of Medical Sciences, Uppsala University Hospital, Uppsala, Sweden, 25Danish Hospital for Rheumatic Diseases, Sønderborg, Denmark, 26Dept. of Rheumatology, Reade, Amsterdam, Netherlands, 27Finland Central Hospital, Jyväskylä, Finland, 28Dept. of Rheumatology, Falunl, Falun, Sweden, 29Dept. of Rheumatology, Ålesund Hospital, Ålesund, Norway, 30Dept. of Rheumatology, Haukeland University Hospital, Haukeland, Norway, 31Rheumatology Research Unit, Odense University Hospital, Odense, Denmark, 32Dept. of Rheumatology, Örebro University Hospital, Örebro, Sweden, 33Rheumatology Clinic, Västmanlands Hospital Västerås, Västerås, Sweden, 34Dept. of Rheumatology, Linköping University Hospital, Linköping, Sweden, 35Academic Specialist Center, Stockholm, Sweden, 36Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark, 37Section of Rheumatology, Dept. of Medicine, Svendborg Hospital, Svendborg, Denmark, 38Dept. of Rheumatology, University Hospital of Trondheim, Trondheim, Norway, 39Dept. of Rheumatology, Aarhus University Hospital, Aarhus, Denmark, 40Dept. of Rheumatology, University Hospital of North Norway, Tromsø, Norway, 41[email protected], Oslo, Norway

    Background/Purpose: The optimal first-line treatment of patients (pts) with early rheumatoid arthritis (eRA) is yet to be established. The main objectives were to assess and…
  • Abstract Number: 1833 • ACR Convergence 2021

    Risk of Major Adverse Cardiovascular Events (MACE) with Biologic and Targeted Synthetic Antirheumatic Agents in Psoriatic Arthritis: A Systematic Review and Network Meta-analysis

    Muhammad Ajmal1, Jawad Bilal1, Syed Arsalan Ahmed Naqvi2, Irbaz Bin Riaz3, Zaina Shahid4, Kaneez Zahra Rubab Khakwani1, Yi-Shao Liu5, Sandipan Bhattacharjee5, Roxanne Bogucka5, Noureen Asghar6 and Kent Kwoh1, 1University of Arizona, Tucson, AZ, 2Dow University of Health Sciences, Karachi, Pakistan, 3Mayo Clinic, Phoenix, AZ, 4Lehigh Valley Health Network, Allentown, PA, 5University of Texas at Austin, Austin, TX, 6Dow University of Health Sciences, Karachi

    Background/Purpose: The efficacy of biologics and targeted synthetic disease modifying antirheumatic agents approved for treatment of psoriatic arthritis (PsA) is well documented, but cardiovascular safety…
  • Abstract Number: 0831 • ACR Convergence 2021

    Safety and Efficacy of Tofacitinib vs TNF Inhibitors in RA Patients Aged 50 Years or Older with One or More Cardiovascular Risks: Results from a Phase 3b/4 Randomized Safety Trial

    Steven R Ytterberg1, Deepak L Bhatt2, Ted Mikuls3, Gary G Koch4, Jose L Rivas5, Rebecca Germino6, Sujatha Menon6, Yanhui Sun7, Cunshan Wang6, Andrea B Shapiro8, Keith S Kanik6, Carol A Connell6 and Roy Fleischmann9, 1Division of Rheumatology, Mayo Clinic, Rochester, MN, 2Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, 3University of Nebraska Medical Center, Omaha, NE, 4Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, 5Pfizer SLU, Madrid, Spain, 6Pfizer Inc, Groton, CT, 7Pfizer CRDC, Shanghai, China (People's Republic), 8Pfizer Inc, Peapack, NJ, 9Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX

    Background/Purpose: ORAL Surveillance (NCT02092467) was mandated by the US Food and Drug Administration to assess the relative risk of tofacitinib vs TNF inhibitors (TNFi), based…
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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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