ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: 1214 • ACR Convergence 2020

    Association Between Changes in C-reactive Protein at Week 12 and Patient-Reported Outcomes at Week 24 with Sarilumab Therapy Across Three Pivotal Phase 3 Studies

    John Tesser1, Grace Wright2, Vibeke Strand3, Jeffrey Kaine4, Karina Maslova5, Gregory St John6, Kerri Ford5, Amy Praestgaard5 and Ernest Choy7, 1Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, 2Association of Women in Rheumatology, New York, NY, 3Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, 4Independent Rheumatology Consultant, Sapphire, NC, 5Sanofi, Cambridge, MA, 6Regeneron Pharmaceuticals Inc, Tarrytown, NY, 7CREATE Centre, Cardiff University, Cardiff, Wales, United Kingdom

    Background/Purpose: Evaluation of response to RA therapy at 12 weeks after initiation is recommended in treatment guidelines. CRP response after 12 weeks of therapy may…
  • Abstract Number: 1644 • ACR Convergence 2020

    Radiographic Exclusionary Findings During Screening for Three Phase III Trials of Subcutaneous Tanezumab in Patients with Moderate to Severe Hip or Knee Osteoarthritis

    Ali Guermazi1, Frank Roemer2, Andrew Kompel1, Luis Diaz3, Michel Crema4, Mark Brown5, Anne Hickman5, Glenn Pixton6, Lars Viktrup7, Robert Fountaine5, Aimee Burr5, Sarah Sherlock5 and Christine West8, 1Boston University School of Medicine, Boston, MA, 2Boston University School of Medicine, Boston, MA, and Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany, Erlangen, Germany, 3Boston Veteran Affairs Healthcare System, Boston, MA, 4Boston University School of Medicine, Paris, France, 5Pfizer Inc., Groton, CT, 6Pfizer Inc., Morrisville, NC, 7Eli Lilly and Company, Indianapolis, IN, 8Pfizer Inc, Groton, CT

    Background/Purpose: Tanezumab is a nerve growth factor monoclonal antibody in development for osteoarthritis (OA). Following a clinical hold due to concerns around adverse joint events,…
  • Abstract Number: 2026 • ACR Convergence 2020

    Efficacy and Safety of Upadacitinib versus Placebo and Adalimumab in Patients with Active Psoriatic Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Anti-Rheumatic Drugs: A Double-Blind, Randomized Controlled Phase 3 Trial

    Iain McInnes1, Jaclyn K Anderson2, Marina Magrey3, Joseph Merola4, Yi Liu5, Mitsumasa Kishimoto6, Slawomir Jeka7, Cesar Pacheco Tena8, Xin Wang2, Liang Chen2, Patrick Zueger2, Aileen Pangan9 and Frank Behrens10, 1Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, 2AbbVie Inc., North Chicago, IL, 3Case Western Reserve University School of Medicine, Cleveland, OH, 4Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, 5West China Hospital of Sichuan University, Sichuan, China (People's Republic), 6Department Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, 72nd Univ Hospital, CM UMK, Bydgoszcz, Poland, 8Universidad Autonoma de Chihuahua, Chihuahua, Chihuahua, Mexico, 9Abbvie Inc., La Grange, IL, 10CIRI/Rheumatology & Fraunhofer IME, Research Division Translational Medicine and Pharmacology, Goethe University Hospital, Frankfurt, Hessen, Germany

    Background/Purpose: Upadacitinib (UPA), an oral, reversible, JAK inhibitor approved to treat rheumatoid arthritis (RA), is under evaluation for psoriatic arthritis (PsA). We assess efficacy and…
  • Abstract Number: 0212 • ACR Convergence 2020

    Long-Term Safety and Effectiveness of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 72 Weeks

    Roy Fleischmann1, In-Ho Song2, Jeffrey Enejosa3, Eduardo Mysler4, Louis Bessette5, Patrick Durez6, Andrew Östör7, Jerzy Swierkot8, Yanna Song9 and Mark Genovese10, 1Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, 2AbbVie Inc., North Chicago, IL, 3AbbVie Inc., Evanston, IL, 4Organización Medica de Investigación, Buenos Aires, Argentina, 5Laval University, Quebec, Canada, 6Division of Rheumatology, Cliniques Universitaires Saint-Luc, Bruxelles, Belgium, 7Cabrini Medical Center, Monash University, Malvern, Victoria, Australia, 8Wroclaw Medical University, Wroclaw, Poland, 9AbbVie Inc., North Chicago,, IL, 10Stanford University Medical Center, Palo Alto, CA

    Background/Purpose: We report safety/efficacy of upadacitinib (UPA) vs adalimumab (ADA) up to 72 weeks (wks) in patients (pts) with rheumatoid arthritis from the ongoing long-term…
  • Abstract Number: 0355 • ACR Convergence 2020

    Collagen Turnover Markers Are Associated with Active Psoriatic Arthritis and Decrease with Guselkumab Treatment in a Phase-3 Clinical Trial

    Georg Schett1, Matthew J. Loza2, Arumugam Palanichamy2, Oliver FitzGerald3, Christopher Ritchlin4, Frédéric Baribaud5 and Kristen Sweet5, 1Friedrich-Alexander-Universität Erlangen- Nuremberg, Erlangen, Germany, 2Janssen Research & Development, LLC, Spring House, 3Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland, 4Department of Medicine, University of Rochester Medical Center, Rochester, NY, 5Janssen Research & Development, LLC, Spring House, PA

    Background/Purpose: Guselkumab (GUS), an interleukin-23p19-subunit monoclonal antibody, demonstrated efficacy compared to placebo (PBO) in reducing skin and musculoskeletal signs and symptoms in patients with active…
  • Abstract Number: 0713 • ACR Convergence 2020

    Longitudinal Effectiveness of Abatacept in JIA: Results from an Ongoing JIA Registry

    Daniel J Lovell1, Hermine Brunner2, Nikolay Tzaribachev3, Esi Morgan2, Gabriele Simonini4, Thomas Griffin5, Ekaterina Alexeeva6, John Bohnsack7, Andrew Zeft8, Gerd Horneff9, Richard Vehe10, Valda Stanevicha11, Stacey Tarvin12, Maria Trachana13, Adam Huber14, Ilonka Orban15, Jason Dare16, Ivan Foeldvari17, Pierre Quartier18, Alyssa Dominique19, Tzuyung Douglas Kou19, Robert Wong19, Alberto Martini20 and Nicolino Ruperto20, 1PRCSG, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 2Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 3Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany, 4Anna Meyer Children's Hospital, Firenze, Italy, 5Levine Children's Hospital, Charlotte, NC, 6Scientific Center of Children’s Health of RAMS, Moscow, Russia, 7University of Utah and Primary Children's Hospital, Cincinnati, OH, 8Cleveland Clinic, Cleveland, OH, 9Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany, 10University of Minnesota, Minneapolis, MN, 11Riga Stradins University, Riga, Latvia, 12Riley Children’s Health, Indianapolis, IN, 13Aristotle University of Thessaloniki, Thessaloníki, Greece, 14Dalhousie University, Halifax, NS, Canada, 15National Institute of Rheumatology and Physiotherapy, Budapest, Hungary, 16University of Arkansas for Medical Sciences, Little Rock, AR, 17Hamburg Centre for Pediatric and Adolescent Rheumatology, Hamburg, Germany, 18Necker-Enfants Malades University Hospital, Assistance Publique-Hopitaux de Paris, Paris, France, 19Bristol-Myers Squibb Company, Princeton, NJ, 20PRINTO, Istituto Giannina Gaslini, Genova, Italy

    Background/Purpose: Abatacept is a selective T-cell co-stimulation modulator approved for use in JIA. Efficacy and safety of abatacept in patients with JIA has been demonstrated…
  • Abstract Number: 0894 • ACR Convergence 2020

    Efficacy and Safety of Neihulizumab (AbGn-168H) in Patients with Active Psoriatic Arthritis: 24-week Results from a Phase II Open Label Study

    Stanley Cohen1, Justus Fiechtner2, Philip Mease3, Jeffrey Kaine4, Arthur Kavanaugh5, Yi-Lin (Irene) Cheng6, Claire Chou6, Ting-Ying Cheng7, Shih-Yao Lin6 and Mark Genovese8, 1University of Texas Southwestern Medical School at Dallas, and Metroplex Clinical Research Center, Dallas, TX, 2Michigan State University, Grand Rapids,, MI, 3Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, 4Sarasota Arthritis Research Center, Sapphire, NC, 5UC San Diego Health System, San Diego, CA, 6AltruBio, Taipei, Taiwan (Republic of China), 7AltruBio, Redwood City, CA, 8Stanford University Medical Center, Palo Alto, CA

    Background/Purpose: Neihulizumab is a novel immune checkpoint agonistic antibody that binds to human CD162 (PSGL-1), thereby preferentially inducing apoptosis in late stage activated T cells.…
  • Abstract Number: 1220 • ACR Convergence 2020

    Increased Serum Levels of Circulating Vimentin and Citrullinated Vimentin Are Differently Regulated by Tocilizumab and Methotrexate Monotherapies in Rheumatoid Arthritis

    Patryk J. Drobinski1, Anne C. Bay-Jensen2, Anne S. Siebuhr3 and Morten A. Karsdal3, 1University of Copenhagen/Nordic Bioscience, Copenhagen, Denmark, 2Nordic Bioscience, Herlev, Denmark, 3Nordic Bioscience A/S, Herlev, Denmark

    Background/Purpose: Presence of citrullinated protein fragments in the circulation of patients with Rheumatoid Arthritis (RA) is a highly disease-specific phenomenon. Vimentin is often a target…
  • Abstract Number: 1739 • ACR Convergence 2020

    Patients with Early Rheumatoid Arthritis Considered to Have a Favourable Risk Profile and Treated According to a Step-up Strategy Have an Increased Risk of Chronic Analgesic Consumption

    Sofia Pazmino1, Annelies Boonen2, Diederik De Cock1, Veerle Stouten1, Delphine Bertrand1, Johan Joly3, Rene Westhovens4 and Patrick Verschueren5, 1KU Leuven, Leuven, Belgium, 2Maastricht University Medical Center, Maastricht, Netherlands, 3University Hospitals Leuven, Leuven, Vlaams-Brabant, Belgium, 4University Hospitals Leuven, Belgium, Leuven, Belgium, 5University Hospital Leuven, Leuven, Belgium

    Background/Purpose: Pain remains the highest priority for improvement to patients with Rheumatoid Arthritis (RA). Analgesic prescription in RA was historically a stand-alone approach and afterwards…
  • Abstract Number: 2027 • ACR Convergence 2020

    Efficacy and Safety of Tildrakizumab, a High-Affinity Anti–Interleukin-23p19 Monoclonal Antibody, in Patients with Active Psoriatic Arthritis in a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study

    Philip Mease1, Saima Chohan2, Ferran J. García Fructuoso3, Alice Gottlieb4, Michael Luggen5, Proton Rahman6, Siba Raychaudhuri7, Richard Chou8, Alan Mendelsohn9, Stephen Rozzo9 and Ana-Maria Orbai10, 1Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, 2Arizona Arthritis and Rheumatology Research, PLLC, Pheonix, AZ, 3Hospital CIMA Sanitas, Barcelona, Spain, 4Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, 5Cincinnati Rheumatic Disease Study Group, Inc, and Univ of Cincinnati College of Medicine, Cincinnati, OH, 6Memorial University of Newfoundland, Department of Medicine, St John's, Canada, 7Division of Rheumatology, Allergy & Clinical Immunology, University of California School of Medicine, Davis, and VA Medical Center Sacramento, Sacramento, CA, 8Division of Allergy, Immunology and Rheumatology, University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY, 9Sun Pharmaceutical Industries, Inc., Princeton, NJ, 10Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD

    Background/Purpose: Tildrakizumab (TIL), a high-affinity anti–interleukin-23p19 monoclonal antibody, is approved to treat moderate to severe plaque psoriasis.1 The efficacy and safety of TIL up to…
  • Abstract Number: 0213 • ACR Convergence 2020

    Sustainability of Response to Upadacitinib as Monotherapy or in Combination Among Patients with Rheumatoid Arthritis and Prior Inadequate Response to Conventional Synthetic DMARDs

    Arthur Kavanaugh1, Maya Buch2, Bernard Combe3, Louis Bessette4, In-Ho Song5, Yanna Song6, Jessica Suboticki5 and Peter Nash7, 1Division of Rheumatology, Allergy, & Immunology, University of California San Diego Medical School, San Diego, CA, 2Centre of Musculoskeletal Research, School of Biological Sciences, University of Manchester, Manchester, United Kingdom, 3University of Montpellier, Montpellier, France, 4Laval University, Quebec, Canada, 5AbbVie Inc., North Chicago, IL, 6AbbVie Inc., North Chicago,, IL, 7School of Medicine Griffith University, Brisbane, Queensland, Australia

    Background/Purpose: To assess long-term sustainability of responses to upadacitinib (UPA), a JAK inhibitor, with or without background csDMARD(s) in patients (pts) with rheumatoid arthritis (RA).Methods:…
  • Abstract Number: 0361 • ACR Convergence 2020

    Response to Treatment with Ixekizumab in Patients with Active Non-Radiographic Axial Spondyloarthritis Based on HLA-B27 Status and Disease Duration

    Victoria Navarro-Compán1, Jose Maldonado-Cocco2, Proton Rahman3, Andris Kronbergs4, David Sandoval4, So Young Park4, Theresa Hunter4 and Marina Magrey5, 1Hospital Universitario La Paz IdiPaz, Madrid, Pais Vasco, Spain, 2University of Buenos Aires School of Medicine, Buenos Aires, Argentina, 3Memorial University of Newfoundland, Department of Medicine, St John's, Canada, 4Eli Lilly and Company, Indianapolis, 5Case Western Reserve University School of Medicine, Cleveland, OH

    Background/Purpose: In this analysis, we evaluate the efficacy of ixekizumab at week 16 in patients with non-radiographic axial spondyloarthritis (nr-axSpA) with or without baseline HLA-B27…
  • Abstract Number: 0717 • ACR Convergence 2020

    Predictors of Clinical Remission in Children with Extended Oligoarticular Arthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis Treated with Etanercept in the CLIPPER Studies

    Jelena Vojinovic1, Vyacheslav Chasnyk1, Joke Dehoorne1, Violeta Panaviene1, Jonathan Akikusa2, Tadej Avcin1, Jeffrey Chaitow1, Bernard Lauwerys1, Jordi Antón1, Inmaculada Penades1, Berit Flato1, Alina Boteanu3, Hans-Iko Huppertz1, Juan Jaller1, Daniela Graham4, Cecilia Borlenghi5, Bonnie Vlahos6, Chuanbo Zang6 and Nicolino Ruperto2, 1Paediatric Rheumatology International Trials Organisation (PRINTO), Genoa, Italy, 2PRINTO, Istituto Giannina Gaslini, Genova, Italy, 3Hospital Universitario Ramón y Cajal, Madrid, Spain, 4Pfizer, Groton, PA, 5Pfizer, New York, NY, 6Pfizer, Collegeville, PA

    Background/Purpose: CLIPPER is an ongoing, 8-year, phase 3b, multicenter, open-label study of the safety and efficacy of etanercept in the treatment of juvenile idiopathic arthritis…
  • Abstract Number: 0900 • ACR Convergence 2020

    Achievement of Low Disease Activity According to BASDAI with Ixekizumab in Patients with Axial Spondyloarthritis: 16-Week Results from the COAST Trials

    Denis Poddubnyy1, Xavier Juanola2, Clément Prati3, Hagen Russ4, Yves Schymura4, Soyi Liu-Leage5, Mani Haschemi Nassab4 and Jean Dudler6, 1Charité – Universitätsmedizin Berlin, Berlin, Germany, 2Rheumatology Service, University Hospital Bellvitge, IDIBELL, Barcelona, Spain, Barcelona, Spain, 3Service de Rhumatologie, Hôpital Jean-Minjoz , Besançon, France, Besançon, France, 4Eli Lilly and Company, Indianapolis, Indiana, USA, Indianapolis, IN, 5Eli Lilly and Company, Indianapolis, IN, 6Department of Rheumatology, HFR Fribourg - Hospital Cantonal, Fribourg, Switzerland, Fribourg, Switzerland

    Background/Purpose: The efficacy of ixekizumab (IXE), a selective interleukin-17A antagonist, was assessed in patients (pts) with axial SpA (axSpA) in three Phase 3, randomized, double-blind,…
  • Abstract Number: 1231 • ACR Convergence 2020

    Radiographic Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib as Monotherapy or in Combination with Methotrexate: Results at 2 Years

    Charles Peterfy1, Vibeke Strand2, Mark Genovese3, Alan Friedman4, Jeffrey Enejosa4, Stephen Hall5, Eduardo Mysler6, Patrick Durez7, Xenofon Baraliakos8, Tim Shaw4, Yanna Song9, Yihan Li4 and In-Ho Song4, 1Spire Sciences, Inc., Boca Raton, FL, 2Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, 3Stanford University Medical Center, Palo Alto, CA, 4AbbVie Inc., North Chicago, IL, 5Cabrini Medical Centre, Monash University and Emeritus Research, Malvern, Victoria, Australia, 6Organización Medica de Investigación, Buenos Aires, Argentina, 7Division of Rheumatology, Cliniques Universitaires Saint-Luc, Bruxelles, Belgium, 8Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, 9AbbVie Inc., North Chicago,, IL

    Background/Purpose: For patients with rheumatoid arthritis (RA), long‑term prevention of structural joint damage is a key treatment goal.1 In the SELECT-EARLY and SELECT-COMPARE trials, upadacitinib…
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