ACR Meeting Abstracts

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Abstracts tagged "Randomized Trial"

  • 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: 1435 • ACR Convergence 2022

    Effectiveness of Combination Therapy with Tocilizumab and Low-Dose Prednisolone as an Induction Therapy in Biologics-Naïve Patients with Rheumatoid Arthritis: A Prospective, Randomized, Controlled, Open-Label, Multicenter Study

    Kazuhiro Yokota1, Hayato Nagasawa2, Yuji Akiyama3 and Toshihide Mimura4, 1Department of Rheumatology and Applied Immunology, Faculty of Medicine, Saitama Medical University, Iruma Saitama, 2Nagasawa Clinic, Kawagoe, Japan, 3Department of Rheumatology and Applied Immunology, Faculty of Medicine, Saitama Medical University, Iruma Saitama, Japan, 4Department of Rheumatology and Applied Immunology, Faculty of Medicine, Saitama Medical University, Saitama, Japan

    Background/Purpose: Efficacy and safety of tocilizumab (TCZ) in the treatment of rheumatoid arthritis (RA) has demonstrated in randomized controlled trials. However, the clinical response to…
  • Abstract Number: 2151 • ACR Convergence 2022

    Izokibep Demonstrates Clinically Relevant Efficacy Benefits on Enthesitis, Dactylitis and Nail Outcomes in Active PsA Patients: A 16-week Randomized, Placebo-controlled Trial

    Kurt de Vlam1, Peter Taylor2, Philip J Mease3, Paul Peloso4, Dieter Wetzel5, Nicolai Brun5, Brian Wiens6, Jan Brandt-Juergens7, Edit Drescher8, Eva Dokoupilova9, Anna Rowinska-Osuch10, Nadia Abdel- Kader Martin11 and Frank Behrens12, 1University Hospitals Leuven, Leuven, Belgium, 2University of Oxford, Oxford, United Kingdom, 3Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, 4ACELYRIN, Naples, FL, 5Affibody AB, Solna, Sweden, 6ACELYRIN, Inc., Los Angeles, CA, 7Rheumatologische Schwerpunktpraxis, Berlin, Germany, 8Veszprem Megyei Csolnoky Ferenc Korhaz, Budapest, Hungary, 9Medical Plus, s.r.o. & Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Brno, Prague, Czech Republic, 10ETG Network, Warsaw, Poland, 11Hospital Infanta Luisa Quiron, Rheumatology, Sevilla, Spain, 12Rheumatology University Hospital & Fraunhofer Institute Translational Medicine and Pharmacology, Goethe-University Frankfurt, Frankfurt Am Main, Germany

    Background/Purpose: PsA is a chronic, inflammatory disease with multiple manifestations, with arthritis and skin involvement. Other areas of inflammation include enthesitis, dactylitis and nail involvement.…
  • Abstract Number: L05 • ACR Convergence 2021

    Phase 2 Study Results from a Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate Efficacy and Safety of Tigulixostat, a Novel Non-purine Selective Xanthine Oxidase Inhibitor, in Gout Patients with Hyperuricemia

    Robert Terkeltaub1, JuneSik Mune2, Jieun Lee3 and Kenneth Saag4, 1VA/UCSD, San Diego, CA, 2LG Chem, Ltd., Seoul, 3LG Chem, Ltd., Seoul, South Korea, 4The University of Alabama at Birmingham, Birmingham, AL

    Background/Purpose: Gout can be effectively managed by inhibiting synthesis of uric acid. Tigulixostat is a novel non-purine selective xanthine oxidase inhibitor which lowers production of…
  • Abstract Number: L10 • ACR Convergence 2021

    A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease

    joshua solomon1, Felix Woodhead2, Sonye Danoff3, Shana Haynes-Harp4, Tanvi Naik5, Cathie Spino5, Shelley Hurwitz6, Rie Maurer6, Daniel Chambers7, Martin Kolb8, Hiliary Goldberg6 and Ivan Rosas4, 1National Jewish Health, Denver, CO, 2University of Leicester, Leicester, United Kingdom, 3Johns Hopkins University, Baltimore, MD, 4Baylor College of Medicine, Houston, TX, 5University of Michigan, Ann Arbor, MI, 6Brigham and Womens Hospital, Boston, MA, 7University of Queensland, Brisbane, Australia, 8McMaster University, Hamilton, ON, Canada

    Background/Purpose: Rheumatoid arthritis-associated interstitial lung disease (RA-ILD) is a prevalent and morbid condition leading to premature death in 10% of those affected. The TRAIL1 trial…
  • Abstract Number: L19 • ACR Convergence 2021

    Secukinumab in Giant Cell Arteritis: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial

    Nils Venhoff1, Wolfgang Schmidt2, Raoul Bergner3, Jürgen Rech4, Leonore Unger5, Hans-Peter Tony6, Meryl Mendelson7, Christian Sieder8, Meron Maricos8 and Jens Thiel9, 1Department of Rheumatology and Clinical Immunology, Vasculitis Center Freiburg, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany, 2Immanuel Krankenhaus Berlin, Medical Center for Rheumatology Berlin-Buch, Lindenberger Weg 19, 13125 Berlin, Germany, Berlin, Germany, 3Medizinische Klinik A, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany, 4Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054,, Erlangen, Germany, 5Medical Department 1, Städtisches Klinikum Dresden, Dresden, Germany, 6Department of Medicine 2, Rheumatology and Clinical Immunology Oberduerrbachertstr. 697080, Wuerzburg, Germany, 7Novartis Pharmaceuticals Corporation, East Hanover, NJ, 8Novartis Pharma GmbH, Nuremberg, Germany, 9Department of Rheumatology and Clinical Immunology, Vasculitis Center Freiburg, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany; Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University of Graz, Graz, Austria

    Background/Purpose: Little is known about glucocorticoid-sparing agents in giant cell arteritis (GCA) except for IL-6 inhibition. Secukinumab (SEC) has shown significant improvements in the signs…
  • Abstract Number: L21 • ACR Convergence 2021

    Rituximab versus Conventional Therapeutic Strategy for Remission Induction in Eosinophilic Granulomatosis with Polyangiitis: A Double-blind, Randomized, Controlled Trial

    Benjamin Terrier1, Gregory Pugnet2, Claire de Moreuil3, Bernard Bonnotte4, Ygal Benhamou5, Elisabeth Diot6, Dominique Chauveau2, Pierre Duffau7, Nicolas Limal8, Antoine Neel9, Geoffrey Urbanski10, Noemie Jourde-Chiche11, Nicolas Martin-Silva12, Francois Maurier13, Arsene Mekinian14, Nicolas Schleinitz11, Felix Ackermann15, Anne-Laure Fauchais16, Antoine Froissart17, Thomas Le Gallou18, Yurdagul Uzunhan19, Jean-Francois Viallard7, Alice Berezne20, Laurent Chiche21, Bruno Crestani14, Guillaume Direz22, Cecile-Audrey Durel23, Pascal Godmer24, Jean-Emmanuel Kahn25, Marc Lambert26, Thomas Quemeneur27, Jacques Cadranel14, Pierre Charles28, Antoine Dossier14, Lea Jilet29, Loic Guillevin14, Hendy Abdoul29 and Xavier Puechal14, 1Cochin Hospital, Paris, France, 2CHU, Toulouse, France, 3CHU, Brest, France, 4CHU, Dijon, France, 5CHU, Rouen, France, 6CHU, Tours, France, 7CHU, Bordeaux, France, 8CHU, Creteil, France, 9CHU, Nantes, France, 10CHU, Angers, France, 11CHU, Marseille, France, 12CHU, Caen, France, 13CH, Metz, France, 14CHU, Paris, France, 15Hopital Foch, Suresnes, France, 16CHU, Limoges, France, 17CHIC, Creteil, France, 18CHU, Rennes, France, 19CHU, Bobigny, France, 20CH, Annecy, France, 21CH, Marseille, France, 22CH, Le Mans, France, 23CHU, Lyon, France, 24CH, Vannes, France, 25CHU, Boulogne, France, 26CHRU, Lille, France, 27CH, Valenciennes, France, 28CH, Paris, France, 29URC, Paris, France

    Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is an eosinophilic ANCA-associated vasculitis.Glucocorticoids, alone or in combination with cyclophosphamide in severe forms, induce remission in most patients…
  • 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…
  • Abstract Number: 1863 • ACR Convergence 2021

    Consistent Efficacy with Apremilast in Men and Women to Treat Oral Ulcers Associated with Behçet’s Syndrome: Results from Phase 3 Researching Oral Apremilast Safety and Efficacy in Behçet’s Disease (RELIEF) Study

    Gülen Hatemi1, Alfred Mahr2, Mitsuhiro Takeno3, Doyoung Kim4, Melike Melikoğlu5, Sue Cheng6, Sven Richter6, Shauna Jardon7, Maria Paris6, Mindy Chen6 and Yusuf Yazici8, 1Istanbul University‒Cerrahpaşa, Cerrahpaşa Medical School and Behçet’s Disease Research Center, İstanbul, Turkey, 2Kantonsspital St. Gallen, St.Gallen, Switzerland, 3Musashi Kosugi Hospital, Kawasaki, Japan, 4Yonsei University College of Medicine and Severance Hospital, Seoul, Republic of Korea, 5Istanbul University‒Cerrahpaşa, İstanbul, Turkey, 6Amgen Inc., Thousand Oaks, CA, 7Amgen Inc., Gilbert, AZ, 8New York University School of Medicine, New York, NY

    Background/Purpose: Painful, recurring oral ulcers (OU) associated with Behçet’s syndrome negatively affect quality of life (QoL). Differences across sexes were reported in the frequency of…
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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.

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