Abstracts tagged "Randomized Trial"

Abstract Number: 0924 • ACR Convergence 2021
Efficacy and Safety of Upadacitinib in Patients with Active Ankylosing Spondylitis: 2-Year Results from a Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension
Désirée van der Heijde¹, Atul Deodhar², Walter Maksymowych³, Joachim Sieper⁴, Filip Van den Bosch⁵, Tae-Hwan Kim⁶, Mitsumasa Kishimoto⁷, Andrew Ostor⁸, Bernard Combe⁹, Yunxia Sui¹⁰, Yuanyuan Duan¹¹, Alvina D. Chu¹¹ and In-Ho Song¹², ¹Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, ²Oregon Health & Science University, Portland, OR, ³Department of Medicine, University of Alberta, Alberta, Canada, Edmonton, AB, Canada, ⁴Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ⁵Dept. of Rheumatology - Ghent University Hospital, Ghent, Belgium, Ghent, Belgium, ⁶Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, ⁷Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, ⁸Monash University, Cabrini Hospital, and Emertius Research, Malvern, Australia, ⁹Montpellier University, Montpellier, France, ¹⁰AbbVie, North Chicago, IL, ¹¹AbbVie Inc, North Chicago, ¹²AbbVie Inc., North Chicago, IL
Background/Purpose: The objective of this long-term analysis of the SELECT-AXIS 1 study was to report safety and efficacy of upadacitinib (UPA) in active AS through…
Abstract Number: 1940 • ACR Convergence 2021
Malignancies in Patients Aged ≥ 50 Years with RA and ≥ 1 Additional Cardiovascular Risk Factor: Results from a Phase 3b/4 Randomized Safety Study of Tofacitinib vs TNF Inhibitors
Jeffrey Curtis¹, Kunihiro Yamaoka², Yi-Hsing Chen³, Levent M Gunay⁴, Naonobu Sugiyama⁵, Carol A Connell⁶, Cunshan Wang⁶, Joseph Wu⁶, Sujatha Menon⁶, Ivana Vranic⁷ and Juan J Gomez-Reino⁸, ¹Division of Clinical Immunology and Rheumatology, Department of Medicine, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, ²School of Medicine, Department of Rheumatology and Infectious Diseases, Kitasato University, Sagamihara, Japan, ³Taichung Veterans General Hospital, Taichung, Taiwan (Republic of China), ⁴Pfizer Inc, Istanbul, Turkey, ⁵Pfizer Japan Inc, Tokyo, Japan, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer Inc, Tadworth, Surrey, United Kingdom, ⁸Hospital Clínico Universitario, Santiago de Compostela, Spain
Background/Purpose: ORAL Surveillance (NCT02092467) was a post-authorization safety study to assess the relative risk of tofacitinib vs TNF inhibitors (TNFi), based on observed increases in…
Abstract Number: 0193 • ACR Convergence 2021
Tocilizumab for the Treatment of Familial Mediterranean Fever – a Randomized, Double Blind, Placebo-controlled Phase II Study
Jorg Henes¹, Sebastian Saur², David Kofler³, Martin Krusche⁴, Theodoros Xenitidis⁵, Christoph Meisner⁶, Claudia Kedor⁷, Ina Koetter⁸, Hendrik Schulze-Koops⁹ and Eugen Feist¹⁰, ¹University Hospital Tuebingen, Tuebingen, Germany, ²Universtiy Hostpiatl Tübingen, Tuebingen, Germany, ³Division of Rheumatology and Clinical Immunology, Department I of Internal Medicine; University Hospital Cologne, Cologne, Germany, ⁴Charite Berlin, Berlin, Germany, ⁵University Hospital Tuebingen, Rheumatology, Tuebingen, Germany, ⁶University Tuebingen, Statistics, Tuebingen, Germany, ⁷Charite University Hospital Berlin, Berlin, Germany, ⁸University Hospital Hamburg Eppendorf, Hamburg, Germany, ⁹Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany, ¹⁰Helios Department of Rheumatology, Vogelsang-Gommern, Germany
Background/Purpose: Familial Mediterranean Fever (FMF) is the most common auto-inflammatory disease characterized by chronic inflammation, recurrent episodes of fever, abdominal and thoracic pain due to…
Abstract Number: 0957 • ACR Convergence 2021
Vitamin D and Marine n-3 Fatty Acid Supplementation and Prevention of Autoimmune Disease in the VITAL Randomized Controlled Trial
Jill Hahn¹, Nancy Cook², Erik Alexander³, Sonia Friedman³, Vadim Bubes³, Joseph Walter³, Gregory Kotler³, I-Min Lee³, JoAnn Manson³ and Karen Costenbader⁴, ¹Harvard T.H. Chan School of Public Health, Boston, MA, ²Brigham and Womens' Hospital, Boston, MA, ³Brigham and Women's Hospital/ Harvard Medical School, Boston, MA, ⁴Brigham and Women's Hospital, Belmont, MA
Background/Purpose: In observational studies, vitamin D has been inconsistently associated with reduced risk of several autoimmune diseases, and a large randomized, controlled trial has been…
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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