Abstracts tagged "Randomized Trial"

Abstract Number: 0199 • ACR Convergence 2022
Izokibep, a Novel IL-17A Inhibitor, Improves Patient-reported Outcomes – 16-Week Results from a Placebo-controlled Phase 2 Study in Patients with Active Psoriatic Arthritis
Peter Taylor¹, Frank Behrens², Philip J Mease³, Dieter Wetzel⁴, Paul Peloso⁵, Nicolai Brun⁴, Brian Wiens⁶, Jan Brandt-Juergens⁷, Edit Drescher⁸, Eva Dokoupilova⁹, Anna Rowińska-Osuch¹⁰, Nadia Abdel- Kader Martin¹¹ and Kurt de Vlam¹², ¹University of Oxford, Oxford, United Kingdom, ²Rheumatology University Hospital & Fraunhofer Institute Translational Medicine and Pharmacology, Goethe-University Frankfurt, Frankfurt Am Main, Germany, ³Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ⁴Affibody AB, Solna, Sweden, ⁵ACELYRIN, Naples, FL, 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 - Rheumatology, Warsaw, Poland, ¹¹Hospital Infanta Luisa Quiron, Rheumatology, Sevilla, Spain, ¹²University Hospitals Leuven, Leuven, Belgium
Background/Purpose: Izokibep is a unique IL-17A inhibitor with high potency and small molecular size designed to overcome the limitations of monoclonal antibodies. IL-17 is a…
Abstract Number: 1036 • ACR Convergence 2022
Efficacy and Safety of Tofacitinib in Patients with Psoriatic Arthritis or Ankylosing Spondylitis by History of Cigarette Smoking
Alexis Ogdie¹, Lars Erik Kristensen², Enrique R Soriano³, Servet Akar⁴, Yanhui Sun⁵, David Gruben⁶, Lara Fallon⁷, Cassandra D Kinch⁸ and Dafna Gladman⁹, ¹Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ²The Parker Institute, Copenhagen University Hospital, Copenhagen, Denmark, ³Rheumatology Unit and University Institute, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁴Izmir Katip Celebi University School of Medicine, Izmir, Turkey, ⁵Pfizer CRDC, Shanghai, China, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer Inc, Montréal, QC, Canada, ⁸Pfizer Canada ULC, Kirkland, Canada, ⁹Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada
Background/Purpose: In patients (pts) with PsA and AS, smoking may be associated with an increased comorbidity burden, and greater responses to TNF inhibitors (TNFi) are…
Abstract Number: 2002 • ACR Convergence 2022
Do SMS and Email Reminders Increase the Rate of Seasonal Influenza Vaccination in RA Patients Treated with Biologics: A Nested Randomized Controlled Trial Within the ART Registry?
Raphaèle Seror¹, Gabriel Baron², Sylvie Miconnet³, Rakiba Belkhir³, Martin Soubrier⁴, pascale thevenot⁵, andre basch⁶, Marie Truchetet⁷, Pascal Claudepierre⁸, Emmanuelle Dernis⁹, Hubert Marotte¹⁰, René-Marc Flipo¹¹, Olivier Brocq¹², Jacques Morel¹³, CARINE SALLIOT¹⁴, Bruno Fautrel¹⁵, Alain Saraux¹⁶, CHARLES LESKE¹⁷, Naïma Hamamouche¹⁸, Thierry schaeverbeke¹⁹, Xavier Mariette²⁰, Adeline Ruyssen-Witrand²¹ and Philippe Ravaud²², ¹University Hospital Paris-Saclay, Le Kremlin Bicêtre, France, ²AP-HP Hôtel Dieu Hospital, Université Paris Descartes, Paris, France, ³Rheumatology departement, Bicêtre, Paris-Saclay university, Le Kremlin Bicêtre, France, ⁴Gabriel-Montpied Hospital, Clermont-Ferrand, France, ⁵French Society of rheumatology, Paris, France, ⁶Infirmerie Protestante de Lyon, Caluire-et-Cuire, France, ⁷Bordeaux University Hospital, Bordeaux, France, ⁸Paris Est Creteil University, Creteil, France, ⁹LE MANS general hospital, LE MANS, France, ¹⁰INSERM 1059, Saint-Etienne, France, ¹¹CHU Lille, Boulogne-Billancourt, France, ¹²Rheumatology- CH Princesse Grace, Monaco, Monaco, ¹³University and CHU Montpellier, Montpellier, France, ¹⁴CHR orleans, Orleans, France, ¹⁵Sorbonne University Paris, France and Pierre Louis Institute of Epidemiology and Public Health, Paris, France, Paris, France, ¹⁶CHU Brest, Brest, France, ¹⁷Hospital, Cholet, France, ¹⁸e-health Services Sanoïa, Gémenos, France, ¹⁹CHU de Bordeaux, Bordeaux, France, ²⁰Paris-Saclay University, Rueil Malmaison, Ile-de-France, France, ²¹CHU de Toulouse, Toulouse, France, ²²Université Paris Cité, Hôtel-Dieu, Paris, France
Background/Purpose: In patients treated with biologics, vaccination against influenza is recommended. However, vaccination coverage remains very low. The use of automatic digital reminders is an…
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: 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.…

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