ACR Meeting Abstracts

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Abstracts tagged "Randomized Trial"

  • 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…
  • Abstract Number: 1612 • ACR Convergence 2023

    Design and Validation of a Comparator for Randomized Controlled Trials of a Digital Cognitive Behavioral Therapy

    Michael Gendreau1, Yifei Dai2, Michael Rosenbluth3, David Williams4 and Daniel Clauw5, 1Gendreau Consulting, LLC, Poway, CA, 2Swing Therapeutics, Gainesville, FL, 3Swing Therapeutics, San Francisco, CA, 4Chronic Pain and Fatigue Research Center, Department of Anesthesiology, University of Michigan, Ann Arbor, MI, 5Department of Anesthesiology, University of Michigan, Ann Arbor, MI

    Background/Purpose: The use of a control arm (comparator) in randomized controlled trials (RCTs) is considered the gold standard for trial conduct and interpretation. Choosing an…
  • Abstract Number: 2144 • ACR Convergence 2023

    Pharmacodynamic Effects of Nipocalimab in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA): Results from the Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2A IRIS-RA Study

    Rohit Panchakshari1, Matthew Loza2, Thomas Huizinga3, Georg Schett4, Keying Ma2, Jocelyn H. Leu2, Sophia G. Liva2, Fowzia Ibrahim5, Bei Zhou6, Qingmin Wang2, Ricardo Rojo Cella2, Chetan S. Karyekar2, Kaiyin Fei2, Carolyn Cuff7 and Sheng Gao2, 1Janssen Research & Development, LLC, La Jolla, CA, 2Janssen Research & Development, LLC, Spring House, PA, 3Leiden University Medical Center, Leiden, Netherlands, 4Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, 5Janssen Research & Development, LLC, High Wycombe, United Kingdom, 6Janssen Research & Development, LLC, Chesterbrook, PA, 7Janssen Research & Development, LLC, Cambridge, MA

    Background/Purpose: Nipocalimab is a fully human, immunoglobulin G (IgG) 1 monoclonal antibody that blocks the neonatal crystallizable fragment receptor (FcRn), thereby lowering IgG levels. RA…
  • Abstract Number: 0406 • ACR Convergence 2023

    Obesity Is a Risk Factor for Poor Response to Treatment in Early Rheumatoid Arthritis – a NORD-STAR Spin-Off Study

    Violetta Dubovyk1, Gerdur Maria Grondal2, Bjorn Gudbjornsson3, Espen A Haavardsholm4, Marte Schrumpf Heiberg4, Merete Hetland5, Kim Hørslev-Petersen6, Meliha Kapetanovic7, Alf Kastbom8, John Lampa9, Kristina Lend10, Dan Nordstrom11, Michael Nurmohamed12, Milad Rizk13, Annika Söderbergh14, Till Uhlig15, Mikkel Østergaard16, Ronald van Vollenhoven12, Anna Rudin17 and Cristina Maglio18, 1University of Gothenburg, Gothenburg, Sweden, 2Department for Rheumatology, Landspitali University Hospital, Reykjavik, Iceland, 3Centre for Rheumatology Research, University Hospital, Reykjavik, Iceland, 4Diakonhjemmet Hospital, Oslo, Norway, 5Copenhagen Center for Arthritis Research, Rigshospitalet, Copenhagen, Denmark, 6University of Southern Denmark, Odense, Denmark, 7Lund University and Skåne University Hospital, Lund, Sweden, 8Linköping University, Linköping, Sweden, 9Stockholm County, Hãsselby, Sweden, 10Amsterdam UMC, Karolinska Institute, Stockholm, Sweden, 11Helsinki University Hospital, Helsinki, Finland, 12Amsterdam University Medical Centers, Amsterdam, Netherlands, 13Västmanlands Hospital Västerås, Västerås, Sweden, 14Örebro University Hospital, Örebro, Sweden, 15Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway, 16Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet; University of Copenhagen, Copenhagen, Denmark, 17Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, 18Institute of Medicine, University of Gothenburg, Gothenburg, Sweden

    Background/Purpose: Several therapeutic options are currently available to treat rheumatoid arthritis (RA); however, the response to treatment is highly variable, and not all patients achieve…
  • Abstract Number: 0839 • ACR Convergence 2023

    Efficacy and Safety of Nipocalimab in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA): The Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2a IRIS-RA Study

    Peter C. Taylor1, Georg Schett2, Fowzia Ibrahim3, Bei Zhou4, Jocelyn H. Leu5, Sophia G. Liva5, Qingmin Wang5, Ricardo Rojo Cella5, Chetan S. Karyekar5 and Kaiyin Fei5, 1Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, 2Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, 3Janssen Research & Development, LLC, High Wycombe, United Kingdom, 4Janssen Research & Development, LLC, Chesterbrook, PA, 5Janssen Research & Development, LLC, Spring House, PA

    Background/Purpose: RA is a chronic inflammatory disease associated with autoantibodies. Despite the use of targeted therapies, up to half of patients fail to achieve remission…
  • Abstract Number: 1634 • ACR Convergence 2023

    Iscalimab (CFZ533) in Patients with Sjögren’s Disease: Week 24 Efficacy and Safety Results of a Randomized, Placebo-controlled, Phase 2b Dose-ranging Study

    Benjamin A Fisher1, Xavier Mariette2, Athena S Papas3, Thomas Grader-Beck4, Hendrika Bootsma5, Wan-Fai Ng6, Paul Van Daele7, Stephanie Finzel8, Sergio Elgueta9, Josef Hermann10, Sara McCoy11, Arthur Bookman12, Monika Sopala13, Wen-Lin Luo14, Cornelia Scheurer13 and Wolfgang Hueber13, 1University of Birmingham, Birmingham, United Kingdom, 2Université Paris-Saclay, Le Kremlin-Bicêtre, France, 3Division of Oral Medicine, Tufts School of Dental Medicine, Boston, MA, 4Division of Rheumatology, Johns Hopkins School of Medicine, Baltimore, MD, 5Department of Rheumatology, University Medical Centre Groningen, Groningen, Netherlands, 6NIHR Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom, 7Department of internal medicine, Erasmus MC, Rotterdam, Netherlands, 8Department of Rheumatology and Clinical Immunology, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany, 9Clinical Research Chile SpA, Biomedical Research Centre, Valdivia, Chile, 10Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University Graz, Graz, Austria, 11University of Wisconsin School of Medicine and Public Health, Middleton, WI, 12Toronto Western Hospital, Toronto, ON, Canada, 13Novartis Pharma AG, Basel, Switzerland, 14Novartis Pharmaceuticals Corporation, East Hanover, NJ

    Background/Purpose: Sjögren's disease (SjD) is an autoimmune disease affecting secretory glands and other organs with no approved systemic treatments. Iscalimab (CFZ533) is a mAb directed…
  • Abstract Number: 2151 • ACR Convergence 2023

    Effects of Methotrexate on Blood Pressure in Rheumatoid Arthritis: A Randomized Controlled Trial

    Sara Tommasi1, Richard Woodman1, Michael Wiese2, Michael Shanahan1 and Arduino Mangoni1, 1Flinders University, Adelaide, Australia, 2University of South Australia, Adelaide, Australia

    Background/Purpose: Treatment with methotrexate (MTX) has been shown to be associated with lower cardiovascular risk and lower blood pressure (BP) compared with other disease modifying…
  • Abstract Number: 0439 • ACR Convergence 2023

    Humoral Immune Response to 13 Valent-conjugate and 23-valent Polysaccharide Pneumococcal Vaccines in RA Patients Treated with Abatacept: Results of the Open Randomized Controlled Trial VACINA (Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients)

    JACQUES MOREL1, Olivier Brocq2, Cécile Gaujoux Viala3, Arnaud Constantin4, Slim Lassoued5, Emanuelle Dernis6, Christophe Richez7, Cedric Lukas8, Claire Daien9 and Claire Duflos10, 1Protocole thérapeutique immuno-rhumatologie, Montpellier, France, 2Hospital of Princesse Grâce de Monaco, Monaco, Monaco, 3IDESP Univ Montpellier, INSERM, Rheumatology, CHU Nîmes, Montpellier, France, 4Teaching hospital Purpan, and University of Paul Sabatier, Toulouse, France, 5Hospital of Jean-Rougié, Cahors, France, 6CH Le Mans, Le Mans, France, 7Université de Bordeaux, Bordeaux, France, 8CHU Montpellier, Montpellier, France, 9University Hospital, Montpellier, France, 10CHU and University of Montpellier, Montpellier, France

    Background/Purpose: To prevent infections, EULAR recommends to vaccinate RA patients against streptococcal pneumoniae. PCV13 is a T- cell dependent vaccine whereas PPSV23 induces a T-independent…
  • Abstract Number: 0840 • ACR Convergence 2023

    Head-to-Head Comparison of TLL-018 and Tofacitinib in Patients with Active Rheumatoid Arthritis: Final Results from a Phase IIa Study

    Xiaofeng Zeng1, chanyuan wu2, Jiankang Hu3, SHENGYUN LIU4, Zhenyu Jiang5, Jingyang Li6, Xiaoxia Wang7, Ju Liu8, Chaofan Yuan9, Guang Yang10 and Chris Liang10, 1Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, 2Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, 3Pingxiang People’s Hospital, PingXiang, China, 4The First Affiliated Hospital Of Zhengzhou University, Zhengzhou, China, 5The First Hospital of Jilin University, Changchun, China, 6Zhuzhou Central Hospital, Zhuzhou, China, 7Second Hospital of Shanxi Medical University, Taiyuan, China, 8Jiujiang No. 1 People’s Hospital, JiuJiang, China, 9Hangzhou Highlightll Pharmaceutical Co., Ltd, Beijing, China, 10Hangzhou Highlightll Pharmaceutical Co., Ltd, HangZhou, China

    Background/Purpose: None of the currently approved treatments for rheumatoid arthritis (RA) can achieve ACR50 in >50% of the patients, and 5 – 20% of the…
  • Abstract Number: 1636 • ACR Convergence 2023

    Dazodalibep, a CD40L Antagonist, in Subjects with Sjögren’s Having Moderate-to-Severe Systemic Disease Activity: Full Crossover Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study

    E. William St. Clair1, Liangwei Wang2, Ilias Alevizos2, William A. Rees2, Alan Baer3, Wan-Fai Ng4, Ghaith Noaiseh5 and Chiara Baldini6, 1Duke University Medical Center, Durham, NC, 2Horizon Therapeutics, Rockville, MD, 3Johns Hopkins University School of Medicine, Baltimore, MD, 4NIHR Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom, 5University of Kansas Medical Center, Kansas City, KS, 6University 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…
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All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

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