Abstracts tagged "Randomized Trial"

Abstract Number: 1654 • ACR Convergence 2023
A Peer Health Coached Resilience-Based Energy Management Program Was Effective in Improving Fatigue and Other Outcomes in People with Systemic Sclerosis: Results of a Randomized Controlled Trial
Susan Murphy¹, Yen Chen², Mary Alore², Sheri Hicks², Adam Pape², Afton Hassett², Anna Kratz², Daniel Whibley², Alexandra Harper³, Suiyuan Huang², Gina Jay², Shannen Bolde² and Dinesh Khanna², ¹University of Michigan, Plymouth, MI, ²University of Michigan, Ann Arbor, MI, ³University of Michigan, Ypsilanti Charter Twp, MI
Background/Purpose: Systemic sclerosis (SSc), a rare autoimmune condition, has a high chronic symptom burden that can have dramatic, life-altering effects on function and quality of…
Abstract Number: 2169 • ACR Convergence 2023
Cost-utility of a Progressive Spacing of Tocilizumab or Abatacept in Patients with Rheumatoid Arthritis in Sustained Remission: A Medico-economic Analysis of the Towards the Lowest Efficacious Dose Trial
Joanna Kedra¹, Benjamin Granger², Lina El Houari³, Florence Tubach⁴ and Bruno Fautrel⁵, ¹Sorbonne Université, IPLESP, and Pitié-Salpêtrière Hospital, Paris, France, ²Sorbonne Université, INSERM, and Pitié Salpêtrière Hospital, Paris, France, ³Institut Pierre Louis d’Epidémiologie et de Santé Publique, Paris, France, ⁴Centre de pharmaco-épidémiologie de l'APHP, Paris, France, ⁵Sorbonne Université APHP, Paris, France
Background/Purpose: Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) progressive tapering is a real opportunity in people living with rheumatoid arthritis (RA) having achieved remission both from…
Abstract Number: 0480 • ACR Convergence 2023
Non-random Sampling in Rheumatology Randomized Controlled Trials: Evidence of Concerning Trial Conduct?
Victoria Le¹, Mats Junek², Mike Putman³, Maximilian Casey¹, Kenrick Manswell¹, Jay Goldsher¹, Elizabeth Nettleton¹, Desh Nepal¹ and Sanket Shah¹, ¹Medical College of Wisconsin, Milwaukee, WI, ²McMaster University, Hamilton, ON, Canada, ³Division of Rheumatology, Medical College of Wisconsin, Milwaukee, WI
Background/Purpose: Non-random sampling of baseline variables in randomized controlled trials (RCTs) may be due unintentional errors, stratified randomization strategies, or data fabrication. Prior studies have…
Abstract Number: 1197 • ACR Convergence 2023
Efficacy and Safety of a Single Intra-Articular Injection of MM-II, a Novel Suspension of Large, Empty, Multilamellar Liposomes, in People with Painful Knee OA: Results of a 26-Week, Phase 2b, Placebo-Controlled, Double-Blind, Randomized Trial
Schnitzer Thomas¹, Helene Rovsing², Edith Lau³, Sidsel Boll⁴, Ballari Brahmachari⁵, Richard Chou⁶, Tarini Joshi⁵, Roni Wechsler⁷, Siu-Long Yao⁵, Sveta Weiner⁵, Asger Bihlet⁸ and Philip Conaghan⁹, ¹Northwestern University Feinberg School of Medicine, Chicago, IL, ²Sanos Clinic, Gandrup, Denmark, ³Hong Kong Center for Clinical Research, Hong Kong, China, ⁴Sanos Clinic, Vejle, Denmark, ⁵Sun Pharmaceutical Industries, Inc., Princeton, NJ, ⁶Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, NY, ⁷Moebius Medical, Tel Aviv, Israel, ⁸NBCD, Soeborg, Denmark, ⁹University of Leeds, Leeds, United Kingdom
Background/Purpose: Safe and effective therapies are needed for OA pain. MM-II, a novel suspension of large, empty, multilamellar liposomes composed of dimyristoylphosphatidylcholine and dipalmitoylphosphatidylcholine, effectively…
Abstract Number: 1677 • ACR Convergence 2023
Two-week Break in Methotrexate Treatment and COVID-19 Vaccine Response. Results of the Vaccine Response on off Methotrexate (VROOM) Study, an Open Label, Prospective, Two-arm Parallel-group, Multi-center, Superiority, Randomized Controlled Trial
Abhishek Abhishek¹, Nicholas Peckham², Corinna Pade³, Joseph Gibbons³, Lucy Cureton², Anne Francis², Vicki Barber², Jennifer Williams², duncan Appelbe², lucy Eldridge², patrick Julier², daniel Altmann⁴, James Bluett⁵, Tim Brooks⁶, Laura Coates², ines Rombach⁷, Amanda Semper⁶, Ashley Otter⁶, Ana Valdes¹, Jonathan Nguyen-Van-Tam¹, Hywel Williams¹, Aine McKnight³, Rosemary Boyton⁴ and jonathan Cook², ¹University of Nottingham, Nottingham, United Kingdom, ²University of Oxford, Oxford, United Kingdom, ³Queen Mary University of London, London, United Kingdom, ⁴Imperial College London, London, United Kingdom, ⁵University of Manchester, Manchester, United Kingdom, ⁶UK Health Security Agency, Porton Down, United Kingdom, ⁷University of Sheffield, Sheffield, United Kingdom
Background/Purpose: Immunosuppressive treatments inhibit vaccine-induced immunity. We evaluated if a two-week interruption of methotrexate treatment immediately after COVID-19 booster improved antibody response against spike protein…
Abstract Number: 2229 • ACR Convergence 2023
Individual Entheseal Points Have Differential Frequency of Involvement and Impact on Patient Reported Outcomes in Patients with Active Psoriatic Arthritis: Pooled Analysis of Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Studies
Laura Coates¹, Iain McInnes², Sibel Aydin³, Mitsumasa Kishimoto⁴, Philip J. Mease⁵, May Shawi⁶, Miriam Zimmermann⁷, Emmanouil Rampakakis⁸, Frederic Lavie⁹ and Dennis McGonagle¹⁰, ¹University of Oxford, Oxford, United Kingdom, ²University of Glasgow, Glasgow, United Kingdom, ³Department of Medicine, Ottawa Hospital Riverside Campus, Ottawa, ON, Canada, ⁴Kyorin University School of Medicine, Yokohoma, Japan, ⁵Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁶Immunology, Janssen Research & Development, LLC, Titusville, NJ, ⁷Immunology, Janssen Medical Affairs, LLC, Zug, Switzerland, ⁸McGill University, Department of Pediatrics / JSS Medical Research, Scientific Affairs, Montreal, QC, Canada, ⁹The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France, ¹⁰Leeds Biomedical Research Centre, University of Leeds, Leeds, United Kingdom
Background/Purpose: In patients with mono/oligoarticular psoriatic arthritis (PsA), swelling or tenderness of specific joints can be associated with poorer patient-reported outcomes (PROs) and physician global…
Abstract Number: 0518 • ACR Convergence 2023
Tofacitinib Efficacy and Safety in Patients with Ankylosing Spondylitis by Baseline C-Reactive Protein Levels: A Post Hoc Analysis
Atul Deodhar¹, Xenofon Baraliakos², Marina Nighat Magrey³, Lianne Gensler⁴, Amit V. Thorat⁵, Surya Pemmaraju⁶, Mary Jane Cadatal⁷ and Peter Nash⁸, ¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ²Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ³Case Western Reserve University, University Hospitals, Cleveland, OH, ⁴University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ⁵Pfizer Australia, Sydney, Australia, ⁶Pfizer Inc., Chennai, Tamil Nadu, India, ⁷Pfizer Inc., Manila, Philippines, ⁸School of Medicine, Griffith University, Brisbane, Australia
Background/Purpose: Elevated baseline (BL) CRP levels can predict treatment response in patients (pts) with AS. Tofacitinib is a Janus kinase inhibitor for the treatment of…
Abstract Number: 1335 • ACR Convergence 2023
Effectiveness of Longstanding Exercise Therapy versus Usual Care in People with Rheumatoid Arthritis and Severe Functional Limitations: A Randomized Controlled Trial (L-EXTRA)
Max Teuwen¹, Salima van Weely¹, Thea Vliet Vlieland², Manja van Wissen¹, Wilfred Peter¹, Alfons den Broeder³, Dirkjan van Schaardenburg⁴, Wilbert van den Hout¹, Cornelia van den Ende³ and Maaike gademan¹, ¹Leiden University Medical Center, Leiden, Netherlands, ²Leids University Medical Center, Leiden, Netherlands, ³Sint Maartenskliniek, Nijmegen, Netherlands, ⁴Reade, Amsterdam, Netherlands
Background/Purpose: Supervised exercise therapy is an effective and safe treatment option for people with rheumatoid arthritis (RA). However, most studies involve interventions of relatively short…
Abstract Number: 1688 • ACR Convergence 2023
Izokibep Demonstrates Major Disease Control on ACR70, PASI100 and Enthesitis Resolution in Patients with Active Psoriatic Arthritis Treated Through 46 Weeks
Philip J. Mease¹, Peter C. Taylor², Kurt de Vlam³, Paul M. Peloso⁴, Apinya Lertratanakul⁵, Dieter Wetzel⁶, Nikolai Brun⁷, Brian Wiens⁸, Jan Brandt-Juergens⁹, Edit Drescher¹⁰, Eva Dokoupilova¹¹, Anna Rowińska-Osuch¹², Nadia Abdel-Kader Martin¹³ and Frank Behrens¹⁴, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ²Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ³University Hospitals Leuven, Leuven, Belgium, ⁴ACELYRIN, INC., Naples, FL, ⁵ACELYRIN, Chicago, IL, ⁶toclinco GmbH, Freiburg im Breisgau, Germany, ⁷Affibody AB, Solna, Sweden, ⁸ACELYRIN, Inc., Half Moon Bay, CA, ⁹rheumatologische Schwerpunktpraxis, Berlin, Germany, ¹⁰Csolnoky Ferenc Hospital / Vital Medical Center Private Clinci, Veszprém, Hungary, ¹¹Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology; MEDICAL PLUS sro, Brno, Czech Republic, ¹²ETG Warszawa, Warsaw, Poland, ¹³Hospital Quironsalud Infanta Luisa, Sevilla, Spain, ¹⁴Goethe University, Division of Rheumatology, University Hospital and Fraunhofer Institute for Translational Medicine & Pharmacology, Frankfurt, Germany
Background/Purpose: IL-17 inhibition demonstrates efficacy in multiple disease domains in psoriatic arthritis. Izokibep is a unique IL-17A inhibitor with high IL-17A binding affinity (KD= 0.3…
Abstract Number: 2238 • ACR Convergence 2023
Longitudinal Effect of Guselkumab on Biomarkers of Inflammation and Cardiovascular Risk in Bionaive Patients with Active Psoriatic Arthritis and High Systemic Inflammatory Burden: Post-hoc Analysis of a Phase 3, Randomized, Double-blind, Placebo-Controlled Study
Arthur Kavanaugh¹, Enrique Soriano², Jan Dutz³, Carlo Selmi⁴, Emmanouil Rampakakis⁵, Natalie shiff⁶, Francois Nantel⁷, Frederic Lavie⁸ and Laura Coates⁹, ¹Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA, ²Rheumatology Section, Internal Medicine Services, Hospital Italiano de Buenos Aires, and University Institute Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ³Department of Dermatology and Skin Science, Vancouver General Hospital, Vancouver, BC, Canada, ⁴Rheumatology and Clinical Immunology, Humanitas Research Hospital / Internal Medicine, Humanitas University, Rozzano, Italy, ⁵McGill University, Department of Pediatrics / JSS Medical Research, Scientific Affairs, Montreal, QC, Canada, ⁶Immunology, Janssen Scientific Affairs, LLC / Adjunct, Community Health and Epidemiology, University of Saskatchewan, Horsham, PA, ⁷Nantel Medsci Consult, Consultant, Montreal, QC, Canada, ⁸The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France, ⁹University of Oxford, Oxford, United Kingdom
Background/Purpose: Psoriatic arthritis (PsA) has been associated with an increased risk of cardiovascular (CV) disease, likely due to accelerated atherosclerosis secondary to chronic inflammation.1 As…
Abstract Number: L05 • ACR Convergence 2022
Effect of Denosumab on Structure Modification in Erosive Hand Osteoarthritis: Results of a 48-Week, Monocentric, Randomized, Placebo-controlled, Double-blind Phase 2 Study and Open Label Extension Phase
Ruth Wittoek¹, August Verbruggen², Tine Vanhaverbeke² and Dirk Elewaut³, ¹Dept. of Rheumatology, Ghent University Hospital, Ghent University, Ghent, Oost-Vlaanderen, Belgium, ²Ghent University Hospital, Ghent, Belgium, ³Ghent University and VIB Center for Inflammation Research, Ghent, Belgium
Background/Purpose: Erosive hand osteoarthritis (OA) is a disabling disease with limited therapeutic options. Denosumab, a Receptor Activator of Nuclear Factor kappa-b Ligand inhibitor, affects bone…
Abstract Number: L07 • ACR Convergence 2022
Telitacicept, a Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), in Systemic Lupus Erythematosus (SLE): Results of a Phase 3 Study
Di Wu¹, Jing Li¹, Dong Xu¹, Li Wang¹, Jianmin Fang², Dan Ross³ and Fengchun Zhang⁴, ¹Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China, Beijing, China, ²Shanghai Tongji Hospital, Tongji University, Shanghai 200065, China School of Life Science and Technology, Tongji University, Shanghai 200092, China, Shanghai, China, ³RemeGen Co., San Diego, CA, ⁴Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China; Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China, Beijing, China
Background/Purpose: Telitacicept is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor…
Abstract Number: L14 • ACR Convergence 2022
Bimekizumab Maintains Improvements in Efficacy Endpoints and Has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies
Xenofon Baraliakos¹, Atul Deodhar², Désirée van der Heijde³, Marina Magrey⁴, Walter Maksymowych⁵, Tetsuya Tomita⁶, Huji Xu⁷, Marga Oortgiesen⁸, Ute Massow⁹, Carmen Fleurinck¹⁰, Alicia M Ellis⁸, Tom Vaux¹¹, Julie Shepherd-Smith¹¹, Alexander Marten⁹ and Lianne S Gensler¹², ¹Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, ²Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ³Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁴Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, US, Richfield, OH, ⁵Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka City, Osaka City, Osaka, Japan, ⁷Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China (People's Republic), ⁸UCB Pharma, Morrisvile, NC, ⁹UCB Pharma, Monheim am Rhein, Nordrhein-Westfalen, Germany, ¹⁰UCB Pharma, Brussels, Brussels Hoofdstedelijk Gewest, Belgium, ¹¹UCB Pharma, Slough, United Kingdom, ¹²Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL‑17A. In the phase 3 BE MOBILE 1 and 2…
Abstract Number: L15 • ACR Convergence 2022
Effect of Secukinumab versus Adalimumab Biosimilar on Radiographic Progression in Patients with Radiographic Axial Spondyloarthritis: A Randomized Phase IIIb Study
Xenofon Baraliakos¹, Mikkel Østergaard², Denis Poddubnyy³, Désirée van der Heijde⁴, Atul Deodhar⁵, Pedro M. Machado⁶, Victoria Navarro-Compán⁷, Kay Geert Hermann⁸, Mitsumasa Kishimoto⁹, Eun Young Lee¹⁰, Lianne S Gensler¹¹, Uta Kiltz¹, Marco Eigenmann¹², Patricia Pertel¹³, Aimee Readie¹⁴, Hanno B. Richards¹², Brian Porter¹⁵ and Juergen Braun¹, ¹Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, ²Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, ³Charité - Universitätsmedizin Berlin and German Rheumatism Research Centre, Berlin, Germany, ⁴Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁵Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁶Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, United Kingdom, ⁷Department of Rheumatology, University Hospital La Paz, IdiPaz, Madrid, Spain, ⁸Department of Radiology, University Hospital Charité - Campus Mitte, Charitéplatz, Berlin, Germany, ⁹Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, ¹⁰Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea, ¹¹Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, ¹²Novartis Pharma AG, Basel, Switzerland, ¹³Novartis Pharma AG, Reinach, Switzerland, ¹⁴Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁵Novartis Pharmaceuticals Corporation, Far Hills, NJ
Background/Purpose: Biologics are clinically efficacious in patients (pts) with axial spondyloarthritis (axSpA) including radiographic axSpA (r-axSpA). Limited data exist on the effect of biologics in…
Abstract Number: 0294 • ACR Convergence 2022
Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and Inadequate Response or Intolerance to Biologic DMARDs: Results Through 5 Years from the SELECT-BEYOND Study
Roy Fleischmann¹, Sebastian Meerwein², Christina Charles-Schoeman³, BERNARD COMBE⁴, Stephen Hall⁵, Nasser Khan⁶, Kyle Carter⁷, Heidi Camp⁸ and Andrea Rubbert-Roth⁹, ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²AbbVie Deutschland GmbH & Co KG, LUDWIGSHAFEN, Germany, ³Division of Rheumatology, University of California, Los Angeles, Santa Monica, CA, ⁴Montpellier University, Montpellier, France, ⁵Emeritus Research and Monash University, Melbourne, Australia, ⁶AbbVie, Inc., Abbott Park, IL, ⁷AbbVie, Inc., North Chicago, IL, ⁸Abbvie, Winnetka, IL, ⁹Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland
Background/Purpose: To evaluate the long-term efficacy and safety of upadacitinib (UPA) over 5 yrs among patients with rheumatoid arthritis (RA) in a long-term extension (LTE)…

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