Abstracts tagged "clinical trial"

Abstract Number: 1639 • ACR Convergence 2020
Preliminary Baseline Subject Demographics and Disease Characteristics in a Phase 3 Clinical Trial of the Safety and Efficacy of Lenabasum in Dermatomyositis (DETERMINE)
Victoria Werth¹, Chester Oddis², David Fiorentino³, Nancy Dgetluck⁴, Quinn Dinh⁵, Michael Tillinger⁶, Barbara White⁵ and Ingrid Lundberg⁷, ¹University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, ²Department of Medicine, Division of Rheumatology, University of Pittsburgh, Pittsburgh, PA, ³Department of Dermatology, Stanford University, Redwood City, CA, ⁴Corbus Pharmaceuticals, Inc., Norwood, MA, ⁵Corbus Pharmaceuticals, Norwood, MA, ⁶Corbus Pharmaceuticals Inc., Norwood, MA, ⁷Division of Rheumatology, Department of Medicine, Karolinska Institutet,, Stockholm, Sweden
Background/Purpose: There is significant unmet need for new treatments to achieve disease control in dermatomyositis (DM), because of limited efficacy or toxicity of immunosuppressive agents…
Abstract Number: 2002 • ACR Convergence 2020
Incidence and Risk Factors for Herpes Zoster in Rheumatoid Arthritis Patients Receiving Upadacitinib
Kevin Winthrop¹, Peter Nash², Kunihiro Yamaoka³, Eduardo Mysler⁴, Leonard Calabrese⁵, Nasser Khan⁶, Jeffrey Enejosa⁶, Yanna Song⁷, Jessica Suboticki⁶ and Jeffrey Curtis⁸, ¹Oregon Health & Science University, Portland, OR, ²School of Medicine Griffith University, Brisbane, Queensland, Australia, ³Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan, ⁴Organización Medica de Investigación, Buenos Aires, Argentina, ⁵Cleveland Clinic, Cleveland, OH, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., North Chicago,, IL, ⁸Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Upadacitinib (UPA) is an oral JAK inhibitor approved for the treatment of rheumatoid arthritis (RA). The background rate of herpes zoster (HZ) in patients…
Abstract Number: 0211 • ACR Convergence 2020
Efficacy and Safety of Upadacitinib in Patients from China, Brazil, and South Korea with Rheumatoid Arthritis Who Have Had Inadequate Response to Conventional Synthetic Disease-modifying Antirheumatic Drugs
Xiaofeng Zeng¹, Dongbao Zhao², Sebastiao Radominski³, Mauro Keiserman⁴, Chang Keun Lee⁵, Sebastian Meerwein⁶, Jeffrey Enejosa⁷, Yunxia Sui⁷, Mohamed-Eslam Mohamed⁷ and Won Park⁸, ¹Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China (People's Republic), ²Shanghai Changhai Hospital, Shanghai, China (People's Republic), ³Universidade Federal do Paraná, Curitiba, Brazil, ⁴Pontificial Catholic University, Porto Alegre, Brazil, ⁵Asan Medical Center, Seoul, Republic of Korea, ⁶Pharmaceutical Development, AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany, ⁷AbbVie Inc., North Chicago, IL, ⁸Inha University, Incheon, Republic of Korea
Background/Purpose: This Phase 3, randomized, double-blind, placebo (PBO)-controlled study assessed the efficacy and safety of upadacitinib (UPA) in combination with csDMARDs in patients with rheumatoid…
Abstract Number: 0349 • ACR Convergence 2020
Pooled Safety Results from Two Phase-3 Trials of Guselkumab in Patients with Psoriatic Arthritis Through 1 Year
Christopher Ritchlin¹, Proton Rahman², Philip Helliwell³, Wolf-Henning Boehncke⁴, Iain McInnes⁵, Alice Gottlieb⁶, Shelly Kafka⁷, Alexa Kollmeier⁸, Elizabeth Hsia⁹, Xie Xu¹⁰, May Shawi¹¹, Shihong Sheng¹², Prasheen Agarwal¹², Bei Zhou¹², Paraneedharan Ramachandran¹³ and Philip Mease¹⁴, ¹Department of Medicine, University of Rochester Medical Center, Rochester, NY, ²Memorial University of Newfoundland, Department of Medicine, St John's, Canada, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁴Geneva University Hospitals, Geneva, Switzerland, ⁵Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, ⁶Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ⁷Janssen Scientific Affairs, LLC, Horsham, PA, ⁸Janssen Research & Development, LLC, La Jolla, CA, ⁹Janssen Research & Development, LLC and University of Pennsylvania Medical Center, Spring House, PA, ¹⁰Janssen Research & Development, LLC, San Marcos, CA, ¹¹Janssen Global Services, LLC, Toronto, ON, Canada, ¹²Janssen Research & Development, LLC, Spring House, PA, ¹³Janssen Research & Development, LLC, Horsham, ¹⁴Seattle Rheumatology Associates, P.L.L.C., Seattle, WA
Background/Purpose: DISCOVER 1 & 2, two double-blind, phase 3, psoriatic arthritis (PsA) trials of guselkumab (GUS, an IL-23 inhibitor), demonstrated significant improvement with GUS vs…
Abstract Number: 0683 • ACR Convergence 2020
Pharmacokinetics of Pegloticase and Methotrexate Polyglutamate(s) in Patients with Uncontrolled Gout Receiving Pegloticase and Co-treatment of Methotrexate
Yang Song¹, Yan Xin¹, Michael Weinblatt², Jason Chamberlain¹, Katie Obermeyer³, Lin Zhao³, Colleen Canavan³, Paul Peloso⁴ and Srini Ramanathan¹, ¹Horizon Therapeutics plc, South San Francisco, CA, ²Brigham and Women's Hospital, Boston, MA, ³Horizon Therapeutics plc, Lake Forest, IL, ⁴Horizon Therapeutics plc, Gurnee, IL
Background/Purpose: In an open-label trial in adult patients with uncontrolled gout (MIRROR open-label [OL] trial) evaluating pegloticase co-treatment with methotrexate (MTX), 78.6% patients maintained serum…
Abstract Number: 0880 • ACR Convergence 2020
Ixekizumab Improves Signs and Symptoms of Patients with Radiographic and Non-radiographic Axial Spondyloarthritis and Extra-articular Manifestation of Enthesitis Through 16 Weeks
Georg Schett¹, Filip Van den Bosch², Xenofon Baraliakos³, David Sandoval⁴, Vladimir Geneus⁴, Rebecca Bolce⁴, Soyi Liu-Leage⁵, Andris Kronbergs⁴ and Philip Mease⁶, ¹Friedrich-Alexander-Universität Erlangen- Nuremberg, Erlangen, Germany, ²Ghent University Hospital, Ghent, Belgium, ³Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany, ⁴Eli Lilly and Company, Indianapolis, ⁵Eli Lilly and Company, Indianapolis, IN, ⁶Seattle Rheumatology Associates, P.L.L.C., Seattle, WA
Background/Purpose: Axial SpA (axSpA) is a chronic inflammatory disease affecting the spine and sacroiliac (SI) joints and has two subtypes that represent the spectrum of…
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…

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