ACR Meeting Abstracts

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Abstracts tagged "Randomized Trial"

  • Abstract Number: 0828 • ACR Convergence 2024

    Efficacy of Eosinophil-Targeting Therapies on Specific Disease Manifestations of Eosinophilic Granulomatosis with Polyangiitis in the Phase 3 MANDARA Trial

    Peter Merkel1, David Jayne2, Ulrich Specks3, Christian Pagnoux4, Benjamin Terrier5, Bernhard Hellmich6, Sofia Necander7, Anat Shavit8, Claire Walton9 and Michael Wechsler10, 1University of Pennsylvania, Philadelphia, PA, 2University of Cambridge, Cambridge, United Kingdom, 3Mayo Clinic, Rochester, MN, 4Mount Sinai Hospital, Toronto, ON, Canada, 5Service de Médecine interne, Hôpital Cochin, AP-HP, Paris, Ile-de-France, France, 6Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, 7Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, 8BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, 9Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, 10National Jewish Health, Denver, CO

    Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare inflammatory disorder characterized by small- to medium-vessel vasculitis, asthma and eosinophilia. In the head-to-head MANDARA trial…
  • Abstract Number: 1492 • ACR Convergence 2024

    Timing of SLEDAI-2K Item Improvements During the First Year of Intravenous Anifrolumab Treatment of Moderate to Severe SLE

    Edward Vital1, Richard Furie2, Eric Morand3, Ian Bruce4, Jacob Knagenhjelm5 and Catharina Lindholm6, 1Leeds Institute of Rheumatic and Musculoskeletal Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom, Leeds, England, United Kingdom, 2Northwell Health, Manhasset, NY, 3School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia, 4Centre for Musculoskeletal Research, The University of Manchester, Manchester, United Kingdom, 5BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden, 6BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden, Gothenburg, Sweden

    Background/Purpose: SLE is a chronic disease in which irreversible organ damage can accumulate over time; treatments associated with rapid responses in patients are therefore desirable.1…
  • Abstract Number: 1718 • ACR Convergence 2024

    Randomization to Holding versus Continuing (JAKi, IL17) and Autoimmune Patient Responses to COVID-19 Boosters: Results from the Covid-19 VaccinE Response in Rheumatology Patients (COVER) Study

    Amy Mudano1, Gary Cutter2, Emily Holladay3, Kevin Winthrop4, Ted Mikuls5, Geoffrey Thiele5, Mark Law5, Monique Bastidas6, Mike Zikry6, Kelly Chun6, Michael George7, Jayashree Sinha8, Naiara Alvarez9, John Tesser10 and Jeffrey Curtis11, and COVER Site Principal Investigator Group, 1Illumination Health, Hoover, AL, 2University of Alabama at Birmingham, Birmingham, AL, 3University of Alabama at Birmingham, Edmond, OK, 4School of Medicine, Oregon Health and Science University, Portland, OR, 5University of Nebraska Medical Center, Omaha, NE, 6Labcorp, Calabasas, CA, 7University of Pennsylvania, Philadelphia, PA, 8self employed, Clovis, NM, 9Integrative Rheumatology of South Texas, McAllen, TX, 10Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, 11University of Alabama at Birmingham, Hoover, AL

    Background/Purpose: Best practice for the use of immunosuppression to optimize vaccine response remains uncertain. We conducted the Covid VaccinE Response (COVER) trial, a multicenter, randomized…
  • Abstract Number: 2341 • ACR Convergence 2024

    Influence of Patient Baseline Characteristics on Zasocitinib (TAK-279) Efficacy, a Selective Oral Tyrosine Kinase 2 Inhibitor: A Randomized Phase 2b Trial in Psoriatic Arthritis

    Lihi Eder1, Elena Muensterman2, Desiree van der Heijde3, Alan Kivitz4, Mona Trivedi5, Ting Hong5, Muhammad Rehman5, Haoling Weng6, Jingjing Chen5 and Xenofon Baraliakos7, 1University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada, 2Takeda Development Center Americas, Cambridge, MA, 3Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, 4Altoona Center for Clinical Research, Duncansville, PA, 5Takeda Development Center Americas, Inc., Cambridge, MA, 6HW MedAdvice LLC, San Diego, CA, 7Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany

    Background/Purpose: Zasocitinib (TAK-279) is a potent, highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor. In a recent phase 2b trial in active psoriatic arthritis…
  • Abstract Number: 2672 • ACR Convergence 2024

    Prevention of the Development of Rheumatoid Arthritis by a 1-year Course of Methotrexate in ACPA-negative Arthralgia Patients at Increased Risk for Rheumatoid Arthritis: 4 Year Results of the TREAT EARLIER Trial

    Quirine Dumoulin1, Doortje Krijbolder2, Karen Visser3, Leroy Lard4 and Annette van der Helm-van Mil5, 1Leiden University Medical Centre, Leiden, Zuid-Holland, Netherlands, 2Leiden University Medical Centre, Leiden, Netherlands, 3Haga Hospital The Hague, Amsterdam, Netherlands, 4Haaglanden Medical Center The Hague, Leidschendam, Netherlands, 5LUMC, Leiden, Zuid-Holland, Netherlands

    Background/Purpose: Currently, prevention possibilities of developing ACPA-negative rheumatoid arthritis (RA) are unknown. Studying this is challenging because many ACPA-negative at-risk individuals have low risk of…
  • Abstract Number: 0858 • ACR Convergence 2024

    Baricitinib in Early Polymyalgia Rheumatica (BACHELOR Study)

    Alain SARAUX1, Guillermo CARVAJAL ALEGRIA2, Emmanuelle Dernis3, christian roux4, Christophe Richez5, Alice TISON6, Baptiste Quere7, Sandrine Jousse-Joulin8, Dewi Guellec7, Thierry Marhadou9, Patrice Kervarrec7, Divi Cornec10, Catherine Le Henaff7, Sandra Lesven7, nowak emmanuel7, Aghiles Souki7 and Valerie Devauchelle11, 1CHU Brest, Brest, France, 2CHRU de Tours, Tours, France, 3CH LE MANS, LE MANS, Pays de la Loire, France, 4rheumatology department, university Cote d'Azur, nice, France, 5Université de Bordeaux, Bordeaux, France, 6CHU de la Cavale Blanche, Brest, France, Brest, France, 7Centre Hospitalier Regional Universitaire (CHU) de Brest, Brest, France, 8cavale blanche hospital, brest, France, 9CHU Cavale Blanche, Brest, France, 10University of Brest, Brest, France, 11UBO, Brest, France

    Background/Purpose: Moderate glucocorticoids (GCs) improve nearly all cases of polymyalgia rheumatica (PMR) but related adverse events are common in senior patients.  The purpose of this…
  • Abstract Number: 1496 • ACR Convergence 2024

    Dysregulated Serum Cytokines in Association with Clinical Manifestations in Patients with Systemic Lupus Erythematosus

    Loqmane seridi1, Steven Leonardo2, Brittney Scott3, Robert Gordon1, cathye shu1, Kaiyin Fei1, Kim Lo3, Anne Stevens1 and Sheng Gao3, 1Janssen Research & Development, LLC, Spring House, PA, 2Janssen Research & Development, LLC, a Johnson & Johnson Company, Cambridge, MA, 3Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA

    Background/Purpose: SLE is a heterogeneous autoimmune disease affecting multiple organ systems, making clinical trial design challenging. Biomarkers that can identify patients with specific clinical manifestations…
  • 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…
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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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