Abstracts tagged "Randomized Trial"

Abstract Number: 1731 • ACR Convergence 2024
Baricitinib in the Treatment of Adult Idiopathic Inflammatory Myopathy: A Randomized, Treatment Delayed-Start Clinical Trial
hector Chinoy¹, Ashma Krishan¹, Yvonne Sylvestre¹, James Lilleker², Patrick Gordon³, Sarah Tansley⁴, Athiveeraramapandian Prabu⁵, Aamir Aslam⁶, Andrew Snedden⁷ and Janine Lamb⁸, ¹The University of Manchester, Manchester, United Kingdom, ²Northern Care Alliance NHS Trust, Salford, United Kingdom, ³nhs, London, United Kingdom, ⁴University of Bath, Bath, United Kingdom, ⁵Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, United Kingdom, ⁶Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁷Northern Care Alliance NHS Foundation Trust, Salford, United Kingdom, ⁸University of Manchester, UK, Manchester, United Kingdom
Background/Purpose: The aim of the study was to assess the effects of baricitinib, a JAK1/2 inhibitor, following 24 weeks of active treatment on disease activity…
Abstract Number: 2352 • ACR Convergence 2024
Bimekizumab Treatment Was Efficacious to 2 Years Regardless of Duration of axSpA Symptoms: Results from Two Phase 3 Studies
Sofia Ramiro¹, Fabian Proft², Raj Sengupta³, Astrid van Tubergen⁴, Anna Molto⁵, Lianne S Gensler⁶, Mitsumasa Kishimoto⁷, Vanessa Taieb⁸, Diana Voiniciuc⁹, Ute Massow¹⁰ and Victoria Navarro Compán¹¹, ¹Leiden University Medical Center, Bunde, Netherlands, ²Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ³Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ⁴Department of Medicine, Division of Rheumatology, Maastricht University Medical Center, Maastricht, Netherlands, ⁵Groupe Hospitalier Cochin, AP-HP, Paris, France, ⁶Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁷Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, ⁸UCB Pharma, Colombes, France, ⁹UCB Pharma, Slough, United Kingdom, ¹⁰UCB Pharma, Monheim am Rhein, Germany, ¹¹La Paz University Hospital, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain
Background/Purpose: Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, showed efficacy to Week (Wk) 52 in patients (pts) with…
Abstract Number: 2675 • ACR Convergence 2024
Which Arthralgia Patients at Risk for RA Benefited from Treatment with Methotrexate?; Results from the TREAT EARLIER Trial
Stijn Claassen¹, Quirine Dumoulin², Kasper Glas³, Esmeralda Molenaar⁴, Hanna van Steenbergen¹ and Annette van der Helm-van Mil⁵, ¹Leiden University Medical Center, Leiden, Netherlands, ²Leiden University Medical Centre, Leiden, Zuid-Holland, Netherlands, ³Reumazorg Zuid West Nederland, Goes, The Netherlands, Goes, Zeeland, Netherlands, ⁴Groene Hart Ziekenhuis, Gouda, The Netherlands, Gouda, Zuid-Holland, Netherlands, ⁵LUMC, Leiden, Zuid-Holland, Netherlands
Background/Purpose: A one-year methotrexate treatment in CSA has been shown to induce sustained reduction in subclinical inflammation during 2-years follow-up. We aim to study if…
Abstract Number: L07 • ACR Convergence 2023
3-year Results of Tapering TNFi to Withdrawal Compared to Stable TNFi Among Rheumatoid Arthritis Patients in Sustained Remission: A Multicenter Randomized Trial
Kaja Kjørholt¹, Nina Sundlisæter¹, Anna-Birgitte Aga¹, Joseph Sexton¹, Inge Christoffer Olsen², Åse Lexberg³, Tor Magne Madland⁴, Hallvard Fremstad⁵, Christian A. Høili⁶, Gunnstein Bakland⁷, Cristina Spada⁸, Hilde Haukeland⁹, Inger Myrnes Hansen¹⁰, Ellen Moholt¹, Karen Holten¹, Till Uhlig¹, Tore Kvien¹, Daniel Solomon¹¹, Désirée van der Heijde¹², Espen Haavardsholm¹ and Siri Lillegraven¹, ¹Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway, ²Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Nepal, ³Department of Rheumatology, Drammen Hospital, Vestre Viken HF, Drammen, Norway, ⁴Department of Rheumatology, Haukeland University Hospital, Bergen, Norway, ⁵Department of Rheumatology, Møre og Romsdal Hospital Trust, Ålesund, Norway, ⁶Department of Rheumatology, Østfold Hospital Trust, Moss, Norway, ⁷Department of Rheumatology, University Hospital of North Norway, Tromsø, Norway, ⁸Department of Rheumatology, Revmatismesykehuset AS, Lillehammer, Norway, ⁹Department of Rheumatology, Martina Hansens Hospital, Bærum, Norway, ¹⁰Deptartment of Rheumatology, Helgelandssykehuset, Mo i Rana, Norway, ¹¹Division of Rheumatology, Brigham and Women's Hospital, Newton, MA, ¹²Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands
Background/Purpose: Tapering of tumor necrosis factor inhibitor (TNFi) treatment in patients who have reached sustained remission is debated in current guidelines, and further data are…
Abstract Number: L14 • ACR Convergence 2023
Efficacy and Safety of Benralizumab Compared with Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Patients Receiving Standard of Care Therapy: Phase 3 MANDARA Study
Michael Wechsler¹, Parameswaran Nair², Benjamin Terrier³, Bastian Walz⁴, Arnaud Bourdin⁵, David Jayne⁶, David Jackson⁷, Florence Roufosse⁸, Lena Börjesson Sjö⁹, Ying Fan¹⁰, Maria Jison¹⁰, Christopher McCrae¹¹, Sofia Necander⁹, Anat Shavit¹², Claire Walton¹² and Peter Merkel¹³, ¹National Jewish Health, Denver, CO, ²McMaster University, Hamilton, ON, Canada, ³Cochin Hospital, Paris, France, ⁴University of Tübingen, Kirchheim-Teck, Germany, ⁵University of Montpellier, CHU Montpellier, INSERM, Montpellier, Montpellier, France, ⁶Addenbrooke's Hospital, Cambridge, United Kingdom, ⁷Guy's Severe Asthma Centre, School of Immunology & Microbial Sciences, King's College London,, London, United Kingdom, ⁸Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium, ⁹Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹⁰Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca,, Gaithersburg, MD, ¹¹Translational Science & Experimental Medicine, Early Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ¹²BioPharmaceutials Medical, AstraZeneca, Cambridge, United Kingdom, ¹³University of Pennsylvania, Philadelphia, PA
Background/Purpose: Eosinophilic inflammation is a key pathophysiological mechanism of eosinophilic granulomatosis with polyangiitis (EGPA). Oral glucocorticoids (OGCs) and immunosuppressants remain the basis for the standard…
Abstract Number: L10 • ACR Convergence 2023
Dazodalibep, a CD40L Antagonist, in a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial of Subjects with Sjögren’s Disease Having Unacceptable Symptomatic Burden but Limited Extraglandular Organ Involvement
E. William St. Clair¹, Liangwei Wang², Ilias Alevizos², William A. Rees², Alan N. Baer³, Wan-Fai Ng⁴, Ghaith Noaiseh⁵ and Chiara Baldini⁶, ¹Department of Medicine, Duke University Medical Center, Durham, NC, USA, Durham, NC, ²Horizon Therapeutics plc, Rockville, MD, ³Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA, Baltimore, MD, ⁴Translational and Clinical Research Institute, Newcastle University, Newcastle, United Kingdom, ⁵Division of Allergy, Clinical Immunology and Rheumatology, Department of Medicine, University of Kansas, Kansas City, KS, USA, Kansas CIty, KS, ⁶Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Pisa, Pisa, Italy
Background/Purpose: Dazodalibep (DAZ) is a non-antibody fusion protein that acts as a CD40L antagonist and blocks costimulatory signals between immune cells, including T cells, B…
Abstract Number: L15 • ACR Convergence 2023
AR882, an Efficacious and Selective URAT1 Inhibitor for Patients with Chronic Gouty Arthritis and Subcutaneous Tophi: Results from a Global, Prospective, Proof-of-Concept Trial Using Dual Energy Computed Tomography
Robert Keenan¹, James Cheng-Chung WEI², Sarah Morris³, Pamella Mundell³, Wen Wei³, Ke Shi³, Zancong Shen³, Vijay Hingorani⁴, Shunqi Yan³, Bahram Kiani⁵ and Litain Yeh³, ¹Arthrosi Therapeutics, Inc., Chapel Hill, NC, ²Chung Shan Medical University, Taichung, Taiwan (Republic of China), ³Arthrosi Therapeutics, Inc., San Diego, CA, ⁴Vanguard Healthsciences, Inc., San Diego, CA, ⁵Wake Forest University School of Medicine, Winston-Salem, NC
Background/Purpose: AR882 is a novel and selective URAT1 inhibitor currently in clinical stage development for the treatment of gout and tophaceous gout and has demonstrated…
Abstract Number: L12 • ACR Convergence 2023
Efficacy and Safety Outcomes of TAK-279, a Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, from a Randomized, Double-blind, Placebo-controlled Phase 2b Trial in Patients with Active Psoriatic Arthritis
Alan Kivitz¹, Elena Tomaselli Muensterman², Arthur Kavanaugh³, Désirée van der Heijde⁴, Piotr A. Klimiuk⁵, Guillermo Valenzuela⁶, Eva Dokoupilova⁷, Gabrielle Poirier⁸, Bhaskar Srivastava⁸, Sue Dasen⁸, Xinyan Zhang⁸, Mona Trivedi², Haoling Holly Weng⁹, Ting Hong¹⁰, Peter Pothula¹⁰ and Xenofon Baraliakos¹¹, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Takeda Development Center Americas, Inc., Cambridge, MA, ³Division of Rheumatology, Allergy & Immunology, University of California San Diego Medical School, San Diego, CA, ⁴Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, ⁵Department of Rheumatology and Internal Diseases, Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Białystok, Poland, ⁶Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁷Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University and MEDICAL PLUS, s.r.o., Brno and Uherské Hradiště, Czech Republic, ⁸Nimbus Discovery, Inc., Boston, MA, ⁹HW MedAdvice LLC, San Diego, CA, ¹⁰Takeda Development Center Americas, Inc., Boston, MA, ¹¹Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum, Germany
Background/Purpose: TYK2 mediates signaling by key cytokines involved in the pathogenesis of immune-mediated inflammatory diseases such as psoriatic arthritis (PsA) and psoriasis (PsO). TAK-279 is…
Abstract Number: L16 • ACR Convergence 2023
Withdrawal of Immunosuppressant and Low-dose Steroids in IgG4-RD Patients with Stable Disease (WInS IgG4-RD): An Investigator-initiated, Multi-center, Open-label, Randomized Controlled Trial
Linyi Peng¹, Yuxue nie¹, Jiaxin Zhou¹, Lijun Wu², Fang Wang³, Xiaomei Chen⁴, Jieqiong Li¹, Yu Peng¹, Hui Lu¹, Lidan Zhao¹, Mengtao Li¹, Yan Zhao¹, Xiaofeng Zeng⁵, Yunyun Fei¹ and Wen Zhang¹, ¹Peking Union Medical College Hospital，Department of Rheumatology and Clinical Immunology, National Clinical Research Center for Dermatologic and Immunologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Beijing, China, ²Xinjiang Uygur Autonomous Region People's Hospital, XinJiang, China, ³Beijing Hospital, Beijing, China, ⁴Xinjiang Uygur Autonomous Region People's Hospital, Wulumuqi, China, ⁵Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China
Background/Purpose: IgG4-related disease (IgG4-RD) is a fibroinflammatory disease. Remission induction treatment with glucocorticoid (GC) is usually effective, but its tendency of relapse makes the strategy…
Abstract Number: 0246 • ACR Convergence 2023
Safety & Efficacy of SEL-212 in Patients with Gout Refractory to Conventional Treatment: Primary Outcomes from Two Randomized, Double Blind, Placebo-Controlled, Multicenter Phase 3 Studies
Herbert Baraf¹, Alan Kivitz², Sheri Rhodes³, Sheldon Leung⁴, Olu Folarin⁴, Tania Gonzalez-Rivera⁵, Joanna Sobierska⁵, Jacquie Christie⁵, Anand Patel⁶, Wesley DeHaan⁴, Rehan Azeem⁴ and Peter Traber⁷, ¹The Center for Rheumatology and Bone Research, George Washington University, Rheumatology, Bethesda, MD, ²Altoona Center for Clinical Research, Duncansville, PA, ³Selecta Biosciences, Atlanta, GA, ⁴Selecta Biosciences, Inc., Watertown, MA, ⁵Swedish Orphan Biovitrum (Sobi), Stockholm, Sweden, ⁶Pioneer Research Solutions, Houston, TX, ⁷Selecta Biosciences, Gladwyne, PA
Background/Purpose: In patients with refractory gout, the inability to maintain serum uric acid (sUA) levels < 6 mg/dL leads to severe clinical manifestations for which…
Abstract Number: 0673 • ACR Convergence 2023
Reporting of Race, Ethnicity, Sex, Gender, Socioeconomic Status and Representativeness of Race and Ethnicity in ANCA-associated Vasculitis Randomized Trials
Michele Iudici¹, Juan C. Rueda² and Xavier Puéchal³, ¹Division of Rheumatology, Department of Internal Medicine Specialties, Geneva University Hospitals, Geneva, Switzerland, ²Universidad de La Sabana, Chía, Colombia, Chia, Colombia, ³National Referral Center for Rare Systemic Autoimmune Diseases, Paris, France
Background/Purpose: To assess how and to what extent race, ethnicity, sex, gender and socioeconomic status of participants are reported in ANCA-associated vasculitis (AAV) randomized controlled…
Abstract Number: 1610 • ACR Convergence 2023
Digital Acceptance and Commitment Therapy Improves Fibromyalgia Outcomes: Results from a Pivotal, Multi-center, Randomized Controlled Trial
Michael Gendreau¹, Andrea Chadwick², Lance McCracken³, David Williams⁴, Daniel Clauw⁵, Juan Luciano⁶, Yifei Dai⁷, Nicolette Vega⁸, Zunera Ghalib⁸, Kristen Guthrie⁸, Allison Kraus⁸, Michael Rosenbluth⁸, Jennifer Zomnir⁹, Dana Reddy¹⁰ and Lesley arnold¹¹, ¹Gendreau Consulting, LLC, Poway, CA, ²Department of Anesthesiology, Pain, and Perioperative Medicine, University of Kansas School of Medicine, Kansas City, KS, ³Department of Psychology, Uppsala University, Uppsala, Sweden, ⁴Chronic Pain and Fatigue Research Center, Department of Anesthesiology, University of Michigan, Ann Arbor, MI, ⁵Department of Anesthesiology, University of Michigan, Ann Arbor, MI, ⁶Department of Clinical and Health Psychology, Universitat Autónoma de Barcelona, Barcelona, Spain, ⁷Swing Therapeutics, Gainesville, FL, ⁸Swing Therapeutics, San Francisco, CA, ⁹DelRicht Resesarch, Mckinney, TX, ¹⁰Curavit, Scarsdale, NY, ¹¹Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati, Cincinnati, OH
Background/Purpose: Acceptance and Commitment Therapy (ACT), a form of guideline-recommended Cognitive Behavioral Therapy (CBT), has been empirically validated as a non-drug treatment for fibromyalgia (FM).…
Abstract Number: 2143 • ACR Convergence 2023
Efficacy of Filgotinib in Patients with Rheumatoid Arthritis: Week 156 Results from a Long-term Extension Study
Maya Buch¹, Daniel Aletaha², Roberto F. Caporali³, Bernard G. Combe⁴, Hendrik Schulze-Koops⁵, Jacques-Eric Gottenberg⁶, Yoshiya Tanaka⁷, Ricardo Blanco⁸, Tsutomu Takeuchi⁹, Edmund V. Ekoka Omoruyi¹⁰, Katrien Van Beneden¹¹, Vijay Rajendran¹², Chris Watson¹³, Francesco De Leonardis¹⁴ and Paul Emery¹⁵, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, Wien, Austria, ³Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milano, Italy, ⁴Department of Rheumatology, Montpellier University, Montpellier, France, ⁵Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig-Maximilians–University Munich, Munich, Germany, ⁶Rheumatology Department, Strasbourg University Hospital, Strasbourg, France, ⁷University of Occupational and Environmental Health, Kitakyushu, Japan, ⁸Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain, ⁹Keio University School of Medicine and Saitama Medical University, Tokyo, Japan, ¹⁰Biostatistics, Galapagos NV, Mechelen, Belgium, ¹¹Medical Safety, Galapagos NV, Mechelen, Belgium, ¹²Clinical Research, Galapagos NV, Mechelen, Belgium, ¹³Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹⁴Medical Affairs, Galapagos GmbH, Basel, Switzerland, ¹⁵Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Background/Purpose: In the treatment of RA, JAK inhibitors are a valuable option to meet remission or low disease activity (LDA) treatment targets following an inadequate…
Abstract Number: 0360 • ACR Convergence 2023
Increasing the Etanercept Dose in Juvenile Idiopathic Arthritis Patients: Does It Help Reaching the Treatment Target? A Post-hoc Analysis of the Best4Kids Randomised Clinical Trial
Bastiaan van Dijk¹, Sytske Anne Bergstra¹, Merlijn van den Berg², Dieneke Schonenberg-Meinema², Lisette van Suijlekom-Smit², Marion van Rossum³, Yvonne Koopman⁴, Rebecca Ten Cate¹, CF Allaart¹, Danielle Brinkman¹ and Petra Hissink Muller¹, ¹Leiden University Medical Center, Leiden, Netherlands, ²Emma Children's Hospital, Amsterdam University Medical Centers, Amsterdam, Netherlands, ³Amsterdam Rheumatology and Immunology Center | Reade, Amstelveen, Netherlands, ⁴HagaZiekenhuis Juliana Children's Hospital, The Hague, Netherlands
Background/Purpose: The relation between etanercept dose and clinical outcomes of juvenile idiopathic arthritis (JIA) is unclear. Most studies only evaluated doses up to 0.8 mg/kg/week…
Abstract Number: 0835 • ACR Convergence 2023
Abatacept in Individuals at Risk of Developing Rheumatoid Arthritis: Results from the Arthritis Prevention in the Pre-clinical Phase of RA with Abatacept (APIPPRA) Trial
Andrew Cope¹, Marianna Jasenecova², Joana Vasconcelos³, Andrew Filer⁴, Karim Raza⁵, Sumera Qureshi², Maria Antonietta D'Agostino⁶, Iain McInnes⁷, John Isaacs⁸, Arthur Pratt⁹, Benjamin A Fisher⁴, Christopher Buckley¹⁰, Paul Emery¹¹, Pauline Ho¹², Maya Buch¹³, Coziana Ciurtin¹⁴, René Toes¹⁵, Thomas Huizinga¹⁵, Dirkjan van Schaardenburg¹⁶, Caroline Caroline¹⁷ and Toby Prevost³, ¹King's College London, London, United Kingdom, ²Centre for Rheumatic Diseases, King's College London, London, United Kingdom, ³Nightingale-Saunders Clinical Trials & Epidemiology Unit, King's College London, London, United Kingdom, ⁴University of Birmingham, Birmingham, United Kingdom, ⁵Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom, ⁶Division of Rheumatology - Catholic University of the Sacred Heart, Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy, ⁷University of Glasgow, Glasgow, United Kingdom, ⁸Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom, ⁹Translational & Clinical Research Institute, University of Newcastle, Newcastle, United Kingdom, ¹⁰University of Oxford, Oxford, United Kingdom, ¹¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ¹²Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom, ¹³University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ¹⁴Centre for Rheumatology Research, University College London, London, United Kingdom, ¹⁵Leiden University Medical Center, Leiden, Netherlands, ¹⁶Reade, Amsterdam, Netherlands, ¹⁷King's Clinical Trials Unit, King's College London, London, United Kingdom
Background/Purpose: The definition of higher risk states for rheumatoid arthritis (RA) has been refined in more recent years through inclusion of serum autoantibodies and symptom…

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