Abstracts tagged "Randomized Trial"

Abstract Number: 1863 • ACR Convergence 2021
Consistent Efficacy with Apremilast in Men and Women to Treat Oral Ulcers Associated with Behçet’s Syndrome: Results from Phase 3 Researching Oral Apremilast Safety and Efficacy in Behçet’s Disease (RELIEF) Study
Gülen Hatemi¹, Alfred Mahr², Mitsuhiro Takeno³, Doyoung Kim⁴, Melike Melikoğlu⁵, Sue Cheng⁶, Sven Richter⁶, Shauna Jardon⁷, Maria Paris⁶, Mindy Chen⁶ and Yusuf Yazici⁸, ¹Istanbul University‒Cerrahpaşa, Cerrahpaşa Medical School and Behçet’s Disease Research Center, İstanbul, Turkey, ²Kantonsspital St. Gallen, St.Gallen, Switzerland, ³Musashi Kosugi Hospital, Kawasaki, Japan, ⁴Yonsei University College of Medicine and Severance Hospital, Seoul, Republic of Korea, ⁵Istanbul University‒Cerrahpaşa, İstanbul, Turkey, ⁶Amgen Inc., Thousand Oaks, CA, ⁷Amgen Inc., Gilbert, AZ, ⁸New York University School of Medicine, New York, NY
Background/Purpose: Painful, recurring oral ulcers (OU) associated with Behçet’s syndrome negatively affect quality of life (QoL). Differences across sexes were reported in the frequency of…
Abstract Number: 0122 • ACR Convergence 2021
Clinical Impact of a Digital Behavioral Therapy for Fibromyalgia Management: A Randomized Controlled Trial
Stephanie Catella¹, Michael Gendreau², Nicolette Vega¹, Allison Kraus¹, Michael Rosenbluth¹, Sherry Soefje³, Shishuka Malhotra⁴ and Lesley Arnold⁵, ¹Swing Therapeutics, San Francisco, CA, ²Gendreau Consulting, LLC, Poway, CA, ³Excell Research, Oceanside, CA, ⁴Neuro-Behavioral Clinical Research, North Canton, OH, ⁵University of Cincinnati, Cincinnati, OH
Background/Purpose: Recommendations for fibromyalgia management include both pharmacologic and nonpharmacologic treatments. Cognitive behavioral therapy (CBT) has demonstrated level 1A evidence for fibromyalgia management, though access…
Abstract Number: 0837 • ACR Convergence 2021
Sustainability of Response Between Upadacitinib and Adalimumab in Patients with Rheumatoid Arthritis: Results Through 3 Years from the SELECT-COMPARE Trial
Peter Nash¹, Arthur Kavanaugh², Maya Buch³, Bernard Combe⁴, Louis Bessette⁵, In-Ho Song⁶, Tim Shaw⁷, Yanna Song⁶, Jessica Suboticki⁶ and Roy Fleischmann⁸, ¹Griffith University, Brisbane, Australia, ²University of California San Diego, La Jolla, CA, ³University of Leeds, Leeds, United Kingdom, ⁴CHU Montpellier Montpellier University, Montpellier, France, ⁵Laval University, Québec City, QC, Canada, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., North Chicago, ⁸Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: The primary treatment target for patients with active rheumatoid arthritis (RA) is sustained clinical remission (REM) or low disease activity (LDA).1,2 A greater proportion…
Abstract Number: 1926 • ACR Convergence 2021
Effectiveness of the Making It Work™ Program at Improving Absenteeism in Workers with Inflammatory Arthritis – Results of a Randomized Controlled Trial
Andre Luquini¹, Yufei Zheng², Hui Xie², Catherine L. Backman³, Pamela Rogers⁴, Alex Kwok⁴, Astrid Knight⁴, Monique Gignac⁵, Dianne Mosher⁶, Linda Li³, John Esdaile⁷, Carter Thorne⁸ and Diane Lacaille², ¹University of British Columbia / Arthritis Research Canada, Fort Saint John, BC, Canada, ²Arthritis Research Canada, Richmond, BC, Canada, ³University of British Columbia, Vancouver, BC, Canada, ⁴Arthritis Research Canada / UBC, Vancouver, BC, Canada, ⁵Institute for Work & Health, Toronto, ON, Canada, ⁶University of Calgary, Calgary, AB, Canada, ⁷Arthritis Research Canada, Vancouver, BC, Canada, ⁸Southlake Regional Health Centre, Newmarket, ON, Canada
Background/Purpose: Despite advances in treatment, absenteeism remains a major problem for workers living with inflammatory arthritis (IA), leading to reduced income and quality of life.…
Abstract Number: 0183 • ACR Convergence 2021
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-Week Results from the Phase 3, Randomized, Double-blind Clinical Trial for CsDMARD-IR and Bio-IR Patients
Merav Lidar¹, Jacob Aelion², Gareth Scott Tarr³, Kim Papp⁴, Lisa Barcomb⁵, Ahmed M. Soliman⁵, Wenjing Lu⁶, Ann Eldred⁵ and Andrew Ostor⁷, ¹Chaim Sheba Medical Center, Ramat Gan, Israel, ²Arthritis Clinic and West Tennessee Research Institute, Jackson, TN, ³Winelands Medical Research Centre and the Institute of Orthopaedics and Rheumatology (IOR), Winelands Medi-Clinic Orthopaedic Hospital, Stellenbosch, South Africa, ⁴K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada, ⁵Abbvie Inc., North Chicago, IL, ⁶AbbVie Inc., North Chicago, ⁷Monash University, Cabrini Hospital, and Emertius Research, Malvern, Australia
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: 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: L08 • ACR Convergence 2020
Long Term Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Chronic Gout: The Febuxostat versus Allopurinol Streamlined Trial (on Behalf of the FAST Investigators)
Thomas MacDonald¹, Isla Mackenzie¹, George Nuki² and Ian Ford³, ¹University of Dundee, Dundee, Scotland, United Kingdom, ²University of Edinburgh, Edinburgh, Scotland, United Kingdom, ³University of Glasgow, Glasgow, Scotland, United Kingdom
Background/Purpose: Febuxostat and allopurinol are uric acid lowering agents. Following concerns about the cardiovascular safety of febuxostat, the European Medicines Agency (EMA) recommended a post-authorization…
Abstract Number: L09 • ACR Convergence 2020
A Phase 2a Randomized, Double-blind, Placebo-controlled Study of Ziritaxestat in Early Diffuse Cutaneous Systemic Sclerosis (NOVESA)
Dinesh Khanna¹, Christopher Denton², Daniel Furst³, Maureen Mayes⁴, Marco Matucci-Cerinic⁵, Vanessa Smith⁶, Dick de Vries⁷, Liesbeth Deberdt⁸, Pieter‑Jan Stiers⁸, Niyati Prasad⁸ and Sohail Ahmed⁹, ¹University of Michigan, Ann Arbor, MI, ²Royal Free Hospital, University College London, London, United Kingdom, ³David Geffen School of Medicine at UCLA, Los Angeles, CA, ⁴University of Texas Health Science Center at Houston, Houston, TX, ⁵Università degli Studi di Firenze, Firenze, Italy, ⁶Ghent University Hospital, Ghent, Belgium, ⁷Galapagos BV, Leiden, Netherlands, ⁸Galapagos NV, Mechelen, Belgium, ⁹Ahmed Science Medicine, Basel, Switzerland
Background/Purpose: There is a high unmet need for systemic sclerosis (SSc) treatments. Ziritaxestat (ziri; GLPG1690) is an autotaxin inhibitor with a novel mechanism of action.…
Abstract Number: L11 • ACR Convergence 2020
Tofacitinib for the Treatment of Adult Patients with Ankylosing Spondylitis: Primary Analysis of a Phase 3, Randomized, Double-blind, Placebo-controlled Study
Atul Deodhar¹, Paula Sliwinska-Stanczyk², Huji Xu³, Xenofon Baraliakos⁴, Lianne Gensler⁵, Dona Fleishaker⁶, Lisy Wang⁶, Joseph Wu⁶, Sujatha Menon⁶, Cunshan Wang⁶, Oluwaseyi Dina⁷, Lara Fallon⁸, Keith S Kanik⁶ and Désirée van der Heijde⁹, ¹Oregon Health & Science University, Portland, OR, ²Reumatika Centrum Reumatologii, Warszawa, Poland, ³Shanghai Changzheng Hospital, Shanghai, China (People's Republic), ⁴Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum, Germany, ⁵University of California San Francisco, San Francisco, CA, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer Inc, New York, NY, ⁸Pfizer Inc, Montreal, QC, Canada, ⁹Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Tofacitinib is an oral JAK inhibitor that is being investigated for the treatment of adult patients (pts) with AS.Methods: This Phase 3, randomized, double-blind…
Abstract Number: 0220 • ACR Convergence 2020
Impact of Concomitant Glucocorticoids on the Clinical Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: An Ad Hoc Analysis of Data from Three Phase 3 Studies
Bernard Combe¹, Frank Buttgereit², Andrew Östör³, Ricardo Xavier⁴, Alain Saraux⁵, Capucine Daridon⁶, Kirsten Famulla⁷, Yanna Song⁸, Ivan Lagunes-Galindo⁹ and Gerd Burmester¹⁰, ¹University of Montpellier, Montpellier, France, ²Charité University Medicine, Berlin, Germany, ³Cabrini Medical Center, Monash University, Malvern, Victoria, Australia, ⁴Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rio Grande do Sul, Rio Grande do Sul, Brazil, ⁵Department of Rheumatology, UBO, CHU, INSERM 1227 (LBAI), Brest, France, ⁶AbbVie France, Rungis, France, ⁷AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, ⁸AbbVie Inc., North Chicago,, IL, ⁹AbbVie Inc., North Chicago, IL, ¹⁰Charité University Hospital Berlin, Berlin, Germany
Background/Purpose: Glucocorticoid (GC) therapy has strong anti-inflammatory effects and helps slow radiographic progression in RA1; however, GCs can be associated with adverse events (AEs) such…

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