Abstracts tagged "Randomized 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: 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: 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: 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: 0441 • ACR Convergence 2021
A Randomized, Double-blind, Placebo-controlled Study of Arimoclomol in Patients with Inclusion Body Myositis
Pedro Machado¹, Richard Barohn², Michael McDermott³, Thomas Blaetter⁴, Tom Lloyd⁵, Aziz Shaibani⁶, Miriam Freimer⁷, Anthony Amato⁸, Emma Ciafaloni³, Sarah Jones⁹, Tahseen Mozaffar¹⁰, Summer Gibson¹¹, Matthew Wicklund¹², Todd Levine¹³, Claus Sundgreen⁴, Tim Carstensen⁴, Karen Bonefeld⁴, Anders Jørgensen⁴, Karina Phonekeo⁴, Andrew Heim¹⁴, Laura Herbelin¹⁴, Michael Hanna¹⁵ and Mazen Dimachkie¹⁴, ¹Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, United Kingdom, ²University of Missouri - Columbia, Columbia, MO, ³University of Rochester, Rochester, NY, ⁴Orphazyme A/S, Copenhagen, Denmark, ⁵Johns Hopkins University, Baltimore, MD, ⁶Nerve and Musle Center, Houston, TX, ⁷Ohio State University, Columbus, OH, ⁸Brigham and Women's Hospital, Boston, MA, ⁹University of Virginia, Charlottesville, VA, ¹⁰University of California Irvine, Irvine, CA, ¹¹University of Utah, Salt Lake City, UT, ¹²University of Colorado, Denver, CO, ¹³Phoenix Neurological Associates, Phoenix, AZ, ¹⁴University of Kansas Medical Center, Kansas City, KS, ¹⁵University College London, London, United Kingdom
Background/Purpose: Inclusion body myositis (IBM) is the most common idiopathic inflammatory myopathy occurring in patients over the age of 45 years. Since immune suppression has…
Abstract Number: 1212 • ACR Convergence 2021
Prediction of 1-Year Intravenous Abatacept Retention in Patients with RA Using Novel Machine Learning Techniques: Directionality and Importance of Predictors
Rieke Alten¹, Claire Behar², Christine Boileau³, Pierre Merckaert⁴, Ebenezer Afari⁵, Virginie Vannier-Moreau⁶, Anael Ohayon⁶, Sean Connolly⁷, Aurelie Najm⁸, Pierre Antoine Juge⁹, Gengyuan Liu⁷, Angshu Rai¹⁰, Yedid Elbez¹¹ and Karissa Lozenski⁷, ¹Schlosspark-Klinik University, Berlin, Germany, ²Tulsy, Paris, France, ³Excelya, Boulogne-Billancourt, France, ⁴Data Revenue GmbH, Berlin, Germany, ⁵Private Practice, Brunoy, France, ⁶Bristol Myers Squibb, Rueil-Malmaison, France, ⁷Bristol Myers Squibb, Princeton, NJ, ⁸Institute of Infection, Immunity and Inflammation, College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom, ⁹Hopital Bichat-Claude Bernard, Service de Rhumatologie, Paris, France, ¹⁰Bristol Myers Squibb (at the time of analysis), Princeton, NJ, ¹¹Deepscover, Puteaux, France
Background/Purpose: In the ACTION study (NCT02109666), previous multivariable Cox proportional-hazards regression models showed that predictors of 1-year retention to intravenous abatacept treatment included: patient global…
Abstract Number: 0453 • ACR Convergence 2021
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-Week Integrated Results from 2 Phase 3, Randomized, Double-blind Clinical Trials for CsDMARD-IR and Bio-IR Patients
Andrew Ostor¹, Kim Papp², Mireia Moreno³, Cathy Spargo⁴, Lisa Barcomb⁵, Ahmed M. Soliman⁵, Wenjing Lu⁶, Ann Eldred⁵ and Lars Erik Kristensen⁷, ¹Monash University, Cabrini Hospital, and Emertius Research, Melbourne, Australia, ²K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada, ³Rheumatology Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí, Universitat Autònoma de Barcelona, Barcelona, Spain, ⁴Vincent Pallotti Hospital, Johannesburg, South Africa, ⁵Abbvie Inc., North Chicago, IL, ⁶AbbVie Inc., North Chicago, ⁷The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Frederiksberg, Denmark
Background/Purpose: Risankizumab (RZB) is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit. RZB is being investigated…
Abstract Number: 1290 • ACR Convergence 2021
Validation of a Novel Lupus Multivariable Outcome Score as an Outcome Measure for Systemtic Lupus Erythematosus Trials
Michal Abrahamowicz¹ and Peter Lipsky², ¹McGill University, Montréal, QC, Canada, ²AMPEL BioSolutions, Charlottesville, VA
Background/Purpose: Development of effective new Systemic Lupus Erythematosus (SLE) treatments requires a validated responder index responsive to clinically meaningful change and relevant to clinical practice.…
Abstract Number: 0488 • ACR Convergence 2021
Efficacy and Safety of Brepocitinib (Tyrosine Kinase 2/Janus Kinase 1 Inhibitor) for the Treatment of Active Psoriatic Arthritis: Results from a Phase 2b Randomized Controlled Trial
Philip Mease¹, Philip S Helliwell², Paula Silwinska-Stanczyk³, Malgorzata Miakisz⁴, Andrew Ostor⁵, Elena Peeva⁶, Michael Vincent⁶, Vanja Sikirica⁷, Randall Winnette⁸, Ruolun Qiu⁶, Gang Li⁷, Gang Feng⁶, Jean Beebe⁶ and David Martin⁶, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³REUMATIKA – Centrum Reumatologii NZOZ, Warsaw, Poland, ⁴Twoja Przychodnia Centrum Medyczne Nowa Sol, Nowa Sol, Poland, ⁵Monash University, Cabrini Hospital & Emeritus Research, Melbourne, Australia, ⁶Pfizer Inc, Cambridge, MA, ⁷Pfizer Inc, Collegeville, PA, ⁸Pfizer Inc, New York, NY
Background/Purpose: Brepocitinib is a small-molecule tyrosine kinase 2/Janus kinase 1 inhibitor that has shown promising results in an oral formulation for plaque psoriasis and alopecia…
Abstract Number: 1359 • ACR Convergence 2021
Risk of Respiratory Tract Infections with Biologic and Targeted Synthetic Antirheumatic Agents in Psoriatic Arthritis: A Systematic Review and Network Meta-analysis
Yi-Shao Liu¹, Jawad Bilal², Muhammad Ajmal², Syed Arsalan Ahmed Naqvi³, Zaina Shahid⁴, Kaneez Zahra Rubab Khakwani², Farva Gondal⁵, Irbaz Bin Riaz⁶, Sandipan Bhattacharjee¹, Roxanne Bogucka¹ and C. Kent Kwoh⁷, ¹University of Texas at Austin, Austin, TX, ²University of Arizona, Tucson, AZ, ³Dow University of Health Sciences, Karachi, Pakistan, ⁴Lehigh Valley Health Network, Allentown, PA, ⁵University of Arizona College of Medicine, Tucson, AZ, ⁶Mayo Clinic, Phoenix, AZ, ⁷University of Arizona College of Medicine, Tuscon, AZ
Background/Purpose: A variety of biologic and targeted synthetic disease modifying antirheumatic agents have been widely used among patients with psoriatic arthritis (PsA). Due to the…
Abstract Number: 0496 • ACR Convergence 2021
Safety and Efficacy of Rituximab for Systemic Sclerosis: A Double-Blind, Parallel-Group Comparison, Investigators Initiated Confirmatory Randomized Clinical Trial (DESIRES Study)
Satoshi Ebata¹, Ayumi Yoshizaki¹, Koji Oba², Kosuke Kashiwabara³, Keiko Ueda³, Yukari Umemura⁴, Takeyuki Watadani⁵, Takemichi Fukasawa¹, Shunsuke Miura¹, Asako Yoshizaki-Ogawa¹, Yoshihide Asano¹, Naoko Okiyama⁶, Masanari Kodera⁷, Minoru Hasegawa⁸ and Shinichi Sato¹, ¹Department of Dermatology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan, ²Department of Biostatistics, School of Public Health, Graduate School of Medicine, and Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, Japan, ³Clinical Research Support Center, The Tokyo University Hospital, Tokyo, Japan, ⁴Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan, ⁵Department of Diagnostic Radiology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan., Tokyo, Japan, ⁶Department of Dermatology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan., Ibaraki, Japan, ⁷Department of Dermatology, Japan Community Health Care Organization Chukyo Hospital, Aichi, Japan., Aichi, Japan, ⁸Department of Dermatology, Division of Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan., Fukui, Japan
Background/Purpose: Systemic sclerosis (SSc) is a systemic autoimmune disease belonging to collagen diseases, characterized by fibrosis of various organs including the skin and lungs, and…
Abstract Number: 1585 • ACR Convergence 2021
Suprascapular Nerve Block for the Treatment of Adhesive Capsulitis
Ernst Shanahan¹, Elizabeth Briggs¹, Tiffany Gill², Catherine Hill³ and Tim Morris⁴, ¹SA Health, Adelaide, Australia, ²University of Adelaide, Adelaide, Australia, ³Queen Elizabeth Hospital, Woodville, Australia, ⁴Flinders University, Adelaide, Australia
Background/Purpose: To investigate the value of suprascapular nerve block (SSNB) as a treatment option for adhesive capsulitis.Methods: Patients with adhesive capsulitis confirmed by a rheumatologist…
Abstract Number: 0497 • ACR Convergence 2021
Efficacy in Patient Subgroups in the INCREASE Trial, a Phase III Trial to Evaluate Inhaled Treprostinil in Patients with Pulmonary Hypertension Due to Parenchymal Lung Disease
Victor Tapson¹, Steven Nathan², Reda Girgis³, James Runo⁴, Remzi Bag⁵, Arunabh Talwar⁶, Peter Smith⁷, Lisa Edwards⁷, Christine Park⁷ and Aaron Waxman⁸, ¹Cedars-Sinai, Los Angeles, CA, ²Inova Fairfax, Falls Church, VA, ³Michigan State University, Lansing, MI, ⁴University of Wisconsin, Madison, WI, ⁵University of Chicago, Chicago, IL, ⁶Hofstra Northwell School of Medicine, Hempstead, NY, ⁷United Therapeutics Corporation, Durham, NC, ⁸Brigham and Women's Hospital, Boston, MA
Background/Purpose: INCREASE was a 16-week trial evaluating the safety and efficacy of inhaled treprostinil (iTRE) in patients with pulmonary hypertension associated with interstitial lung disease…
Abstract Number: 1678 • ACR Convergence 2021
Favorable Balance of Benefit and Harm of Long-Term, Low Dose Prednisolone Added to Standard Treatment in Rheumatoid Arthritis Patients Aged 65+: The Pragmatic, Multicenter, Placebo-Controlled GLORIA Trial
Maarten Boers¹, Linda Hartman¹, Daniela Opris-Belinski², Reinhard Bos³, Marc Kok⁴, Jose Pereira da Silva⁵, Ed Griep⁶, Ruth Klaasen⁷, Cornelia F. Allaart⁸, Paul Baudoin⁹, Hennie Raterman¹⁰, Zoltan Szekanecz¹¹, Frank Buttgereit¹², Pavol Masaryk¹³, L. Thomas Klausch¹, Sabrina Paolino¹⁴, Annemarie Schilder³, Willem Lems¹⁵ and Maurizio Cutolo¹⁴, ¹Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, ²Carol Davila University, Bucharest, Romania, ³Medical Center Leeuwarden, Leeuwarden, Netherlands, ⁴Maasstad Hospital, Rotterdam, Netherlands, ⁵University of Coimbra | UC · Clínica Universitária de Reumatologia. Faculty of Medicine, Columbia, Portugal, ⁶Antonius Hospital, Sneek, Netherlands, ⁷Meander Medical Center, Amersfoort, Netherlands, ⁸Leiden University Medical Center, Leiden, Netherlands, ⁹Reumazorg Flevoland, Emmeloord, 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, ¹⁵VUmc, Amsterdam, Netherlands
Background/Purpose: Low-dose glucocorticoid (GC) therapy is widely used in rheumatoid arthritis (RA) but the balance of benefit and harm is still unclear. We studied the…
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…

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