Abstracts tagged "Randomized Trial"

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)…
Abstract Number: 1579 • ACR Convergence 2022
The TICOG Study: Tight Control of Gout – A Randomized, Controlled Trial of Targeted versus Conventional Treatment for Gout Including Ultrasonography
Sarah Black, Natalie McKee, Jonathan McKnight, Annmarie McShane, Adrian Pendleton, Taggart Alister and Gary Wright, Musgrave Park Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland, United Kingdom
Background/Purpose: Gout is a common inflammatory arthritis triggered by deposition of monosodium urate crystals in joints, bone and soft tissues, with a prevalence of 1-4%…
Abstract Number: 2188 • ACR Convergence 2022
The Effect of Group-based Cognitive Behavioral Therapy for Insomnia in People with Rheumatoid Arthritis: A Randomized Controlled Trial
Kristine Latocha¹, Katrine Loeppenthin², Mikkel Østergaard³, poul jennum⁴, Merete L Hetland⁵, Henrik Rogind⁶, Tine Lundbak⁶, Julie Midtgaard⁷, Robin Christensen⁸ and Bente Esbensen⁵, ¹Copenhagen University Hospital - Rigshospitalet, Glostrup, Denmark, ²Department of Oncology, Copenhagen University Hospital - Rigshospitalet, Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark, ³Rigshospitalet, University of Copenhagen, Glostrup, Denmark, ⁴Danish Center for Sleep Medicine, Department of Clinical Neurophysiology, Copenhagen University Hospital - Rigshospitalet, Glostrup,Department of Clinical Medicine, University of Copenhagen, Copenhagen, ⁵Rigshospitalet, Glostrup, Denmark, ⁶Center for Rheumatology and Spine Diseases, Copenhagen University Hospital -Rigshospitalet, Glostrup, Denmark, ⁷Mental Health Centre Glostrup, University of Copenhagen, Glostrup,Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark, ⁸Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Denmark
Background/Purpose: Insomnia is highly prevalent in people with rheumatoid arthritis (RA) and may exacerbate symptoms and burdens, such as fatigue, depressive symptoms, and pain (1).…
Abstract Number: 0295 • ACR Convergence 2022
Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic DMARDs: Results Through 5 Years from the SELECT-NEXT Study
Gerd Burmester¹, Filip Van den bosch², John Tesser³, Anna K Shmagel⁴, Yuanyuan Duan⁴, Nasser Khan⁵, Heidi Camp⁶ and Alan Kivitz⁷, ¹Charité University Medicine Berlin, Berlin, Germany, ²Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium, ³Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie, Inc., Abbott Park, IL, ⁶Abbvie, Winnetka, IL, ⁷Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: In the phase 3 SELECT-NEXT study, upadacitinib (UPA) demonstrated efficacy at wk 12 and sustained efficacy up to wk 60 in patients with rheumatoid…
Abstract Number: 1597 • ACR Convergence 2022
Achievement of Different Treatment Targets with Izokibep Demonstrates Efficacy Benefits in Patients with Active Psoriatic Arthritis: Results from a 16-Week Randomized, Placebo-Controlled Phase 2 Clinical Trial
Frank Behrens¹, Peter Taylor², Philip J Mease³, Paul Peloso⁴, Dieter Wetzel⁵, Nicolai Brun⁵, Brian Wiens⁶, Jan Brandt-Juergens⁷, Edit Drescher⁸, Eva Dokoupilova⁹, Anna Rowińska-Osuch¹⁰, Nadia Abdel- Kader Martin¹¹ and Kurt de Vlam¹², ¹Rheumatology University Hospital & Fraunhofer Institute Translational Medicine and Pharmacology, Goethe-University Frankfurt, Frankfurt Am Main, Germany, ²University of Oxford, Oxford, United Kingdom, ³Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ⁴ACELYRIN, Naples, FL, ⁵Affibody AB, Solna, Sweden, ⁶ACELYRIN, Inc., Los Angeles, CA, ⁷Rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁸Veszprem Megyei Csolnoky Ferenc Korhaz, Budapest, Hungary, ⁹Medical Plus, s.r.o. & Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Brno, Prague, Czech Republic, ¹⁰ETG Network - Rheumatology, Warsaw, Poland, ¹¹Hospital Infanta Luisa Quiron, Rheumatology, Sevilla, Spain, ¹²University Hospitals Leuven, Leuven, Belgium
Background/Purpose: Psoriatic arthritis (PsA) is a chronic, inflammatory disease with multiple clinical manifestations (arthritis, spondylitis, enthesitis, dactylitis, skin, nails). IL-17 inhibitors have shown efficacy across…

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