Abstracts tagged "Randomized Trial"

Abstract Number: 1020 • ACR Convergence 2023
An Increase in Safety Outcome Trials and the Issue of Informed Consent
Ayse Ozdede¹, Sinem Nihal Esatoglu² and Hasan Yazici³, ¹Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Internal Medicine, Division of Rheumatology, İstanbul, Turkey, ²Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Internal Medicine, Division of Rheumatology, Istanbul, Turkey, ³Academic Hospital, Istanbul, Turkey
Background/Purpose: The randomized controlled trial (RCT remains a most important research tool and a necessary document for drug licensing. Informed consent is an integral component…
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: 0519 • ACR Convergence 2023
Long-Term Safety and Efficacy of Bimekizumab in Patients with Active Ankylosing Spondylitis: 5-Year Results from a Phase 2b Study and Its Open-Label Extension
Atul Deodhar¹, Victoria Navarro-Compán², Denis Poddubnyy³, Lianne Gensler⁴, Sofia Ramiro⁵, Tetsuya Tomita⁶, Helena Marzo-Ortega⁷, Carmen Fleurinck⁸, Thomas Vaux⁹, Ute Massow¹⁰, Désirée van der Heijde⁵ and Xenofon Baraliakos¹¹, ¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ²Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ³Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁴University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ⁵Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka, Japan, ⁷NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁸UCB Pharma, Oosterzele, Belgium, ⁹UCB Pharma, Slough, United Kingdom, ¹⁰UCB Pharma, Monheim am Rhein, Germany, ¹¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Bimekizumab (BKZ), a monoclonal IgG1 antibody, selectively inhibits IL-17F in addition to IL17A. BKZ has demonstrated clinical efficacy and safety up to 3 years…
Abstract Number: 1343 • ACR Convergence 2023
Cardiovascular (CV) and Malignancy Events in the Filgotinib Rheumatoid Arthritis (RA) Clinical Development Program up to 8.3 Years
Xavier Mariette¹, Sven Borchmann², Sandrine Aspeslagh³, Jaime Calvo- Alén⁴, Richard Moriggl⁵, Zoltan Szekanecz⁶, Francesco De Leonardis⁷, Nadia Verbruggen⁸, Paul Van Hoek⁹, Marc Schmalzing¹⁰, Andreas Stallmach¹¹, Christina Charles-Schoeman¹², Vijay Rajendran¹³, Christine Rudolph⁹, Chris Watson¹⁴, Yoshiya Tanaka¹⁵ and Ernest Choy¹⁶, ¹Université Paris-Saclay, Le Kremlin-Bicêtre, France, ²Department of Internal Medicine, University of Cologne, Cologne, Germany, ³Department of Medical Oncology, UZ Brussel, Brussels, Belgium, ⁴Rheumatology, Bioaraba Research Unit, Hospital Universitario Araba, Vitoria, Spain, ⁵Institute of Animal Breeding and Genetics, University of Veterinary Medicine, Vienna, Austria, ⁶Division of Rheumatology, University of Debrecen, Debrecen, Hungary, ⁷Medical Affairs, Galapagos GmbH, Basel, Switzerland, ⁸Biostatistics, Galapagos NV, Mechelen, Belgium, ⁹Medical Safety, Galapagos NV, Mechelen, Belgium, ¹⁰University Hospital, Rheumatology/Clinical Immunology, Department of Internal Medicine II, Würzburg, Germany, ¹¹Department of Internal Medicine, Jena University Hospital, Jena, Germany, ¹²UCLA Medical Center, Santa Monica, CA, ¹³Clinical Research, Galapagos NV, Mechelen, Belgium, ¹⁴Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹⁵University of Occupational and Environmental Health, Kitakyushu, Japan, ¹⁶Section of Rheumatology, Cardiff University, Cardiff, United Kingdom
Background/Purpose: Filgotinib (FIL) is a Janus kinase (JAK) 1 preferential inhibitor for the treatment of RA. Data from the ORAL Surveillance post-marketing study (NCT02092467) suggest…
Abstract Number: 1827 • ACR Convergence 2023
Revolutionizing Fibromyalgia Treatment: Exploring the Efficacy of a New FDA Cleared Photoceutical Device
Timothy Demchak¹, Ernesto Leal-Junior², Neide Ribeiro², Heliodora Casalechi², Douglas Johnson³ and Shaiane Tomazoni⁴, ¹Indiana State University, Terre Haute, IN, ²Nove de Julho University, São Paulo, Brazil, ³Multi Radiance Medical, Solon, OH, ⁴University of Bergen, Bergen, Norway
Background/Purpose: Fibromyalgia syndrome effects 2-8% of the general population and is characterized by specific tender points. FM annual economic impact $12-$14 billion.Current treatments are only…
Abstract Number: 2320 • ACR Convergence 2023
Predicting Remission and Low Disease Activity Attainment in Patients with Systemic Lupus Erythematosus
Raffaele Da Mutten¹, Nursen Cetrez², Julius Lindblom², Shereen Oon³, Dionysis Nikolopoulos¹, Mandana Nikpour⁴ and Ioannis Parodis², ¹Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, ²Karolinska Institutet, Stockholm, Sweden, ³St Vincent's Hospital, Fitzroy, Australia, ⁴The University of Melbourne at St. Vincent’s Hospital Melbourne, Departments of Medicine and Rheumatology, Melbourne, Australia
Background/Purpose: Response to therapy in SLE varies significantly and presents a considerable challenge in terms of predictability. Development of predictive models with ability to accurately…

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