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Abstracts tagged "Randomized Trial"

  • Abstract Number: 2368 • ACR Convergence 2025

    Inhibition of Structural Damage Progression with Guselkumab, a Selective IL-23i, in Participants with Active PsA: Results Through Week 24 of the Phase 3b, Randomized, Double-Blind, Placebo-Controlled APEX Study

    Philip J. Mease1, Christopher Ritchlin2, Laura Coates3, Alexa P. Kollmeier4, Bei Zhou5, Yusang Jiang5, Karen Bensley5, Koeun Im6, Rattandeep Batra7, Soumya Chakravarty8, Proton Rahman9 and Désirée Van Der Heijde10, 1Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, 2University of Rochester Medical Center, Canandaigua, NY, 3Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, 4Johnson & Johnson, San Diego, CA, USA, San Diego, CA, 5Johnson & Johnson, Spring House, PA, USA, Spring House, PA, 6Johnson & Johnson, Cambridge, MA, USA, Cambridge, MA, 7Johnson & Johnson, Toronto, ON, Canada, Toronto, ON, Canada, 8Johnson & Johnson, Horsham, PA, USA; Drexel University College of Medicine, Philadelphia, PA, USA, Villanova, PA, 9Division of Rheumatology, Craig L. Dobbin Genetics Research Centre, Discipline of Medicine, Memorial University of Newfoundland, St. John's, Canada, 10Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands

    Background/Purpose: Patients with active psoriatic arthritis (PsA) are at risk of irreversible joint damage that may significantly impact quality of life. Guselkumab (GUS), a fully…
  • Abstract Number: 1542 • ACR Convergence 2025

    Alternative Definitions of Moderate Flares That Simulate Clinical Practice in Systemic Lupus Erythematosus: Post Hoc Exploration of Moderate Flares in Patients Treated with Dapirolizumab Pegol in a 48-Week Phase 3 Trial

    Richard Furie1, George Bertsias2, Lucy Carter3, Eric Morand4, Marta Mosca5, Marilyn Pike6, Vanessa Taieb7, Annette Nelde8, Ed Vital9 and Christian Stach10, 1Division of Rheumatology, Northwell Health, Great Neck, NY, 2Rheumatology and Clinical Immunology, University Hospital of Heraklion and University of Crete Medical School and Foundation for Research and Technology-Hellas (FORTH), Infections and Immunity, Institute of Molecular Biology and Biotechnology, Heraklion, Greece, 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 4Centre for Inflammatory Diseases, Monash University and Monash Health, Melbourne, Victoria, Australia, 5University of Pisa, Pisa, Pisa, Italy, 6Rheumatology, MedPharm Consulting, Inc., Bethesda, MD, 7UCB, Colombes, France, 8Biogen, Baar, Switzerland, 9University of Leeds, Leeds, England, United Kingdom, 10UCB, Monheim am Rhein, Germany

    Background/Purpose: Despite the evolution of various flare definitions and their inclusion in SLE clinical trials, moderate flares tend to be underestimated in trials owing to…
  • Abstract Number: 0656 • ACR Convergence 2025

    Low-dose belimumab reduced disease flares in patients with systemic lupus erythematosus at low disease activity: a multicenter, randomized, double-blind, placebo-controlled trial

    Fangfang Sun1, Huijing Wang1, Danting Zhang1, Nan Shen1, Sheng Chen1, Tiing Li1, Weiguo Wan2, Shengming Dai3 and Shuang Ye4, 1Renji Hospital, Shanghai, China (People's Republic), 2Huashan Hospital, Shanghai, China (People's Republic), 3Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China (People's Republic), 4Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, Shanghai, Shanghai, China (People's Republic)

    Background/Purpose: B-lymphocyte stimulator was involved in the pathogenesis of SLE. The humanized monoclonal antibody belimumab with 10mg/kg was effective for active patients. The efficacy of…
  • Abstract Number: 0801 • ACR Convergence 2025

    Achieving Sustained Lupus Low Disease Activity State and Remission With Ianalumab (VAY736) in Patients with Systemic Lupus Erythematosus: A post hoc Analysis From a Phase II Study

    Eric Morand1, Corine Gaillez2, Stephen Oliver3, Swati Ghanshani4, Marilia Pozzobon5, Weibin Bao6 and Ed Vital7, 1Centre for Inflammatory Diseases, Monash University and Monash Health, Melbourne, Victoria, Australia, 2Novartis Pharma AG, Basel, Switzerland, Croissy Sur Seine, France, 3Novartis Pharma AG, Basel, Switzerland, 4Novartis Healthcare Private Limited, Hyderabad, India, Hyderabad, India, 5Novartis Pharma AG, Basel, Switzerland, Basel, Switzerland, 6Novartis Pharmaceuticals Corporation, Hanover, NJ, 7University of Leeds, Leeds, England, United Kingdom

    Background/Purpose: Ianalumab, a fully human monoclonal antibody against the B cell–activating factor receptor (BAFF-R), has a dual mechanism of action of B cell depletion through…
  • Abstract Number: 2356 • ACR Convergence 2025

    Clinical Efficacy in Male and Female Patients With Active Psoriatic Arthritis Treated With Deucravacitinib: A Pooled Analysis of Pivotal Phase 3 Studies

    Lihi Eder1, Philip J. Mease2, Joseph F Merola3, Alexis Ogdie4, Atul Deodhar5, Laura Coates6, Stefan Varga7, Navya Kalapala7, Ying-Ming Jou8, Eleni Vritzali9 and Laure Gossec10, 1University of Toronto, Toronto, ON, Canada, 2Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, 3Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, 4Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Wilmington, DE, 5Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, 6Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, 7Bristol Myers Squibb, Princeton, NJ, 8Bristol Myers Squibb, Princeton, 9Bristol Myers Squibb, Boudry, Switzerland, 10Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France

    Background/Purpose: PsA affects male and female patients equally; however, variations in clinical manifestations and treatment responses between sexes have been reported. Deucravacitinib is an oral,…
  • Abstract Number: 1531 • ACR Convergence 2025

    Achieving Remission and Low Disease Activity with Belimumab Versus Placebo in Patients with SLE Excluding the Glucocorticoid Component from Target Definitions: A Post Hoc Analysis of Five Phase 3 Trials

    Ioannis Parodis1, Julius Lindblom2, Roger A. Levy3, Alexander Tsoi1, Margherita Zen4, Dionysis Nikolopoulos5, Munther Khamashta6, Ryan Tomlinson7, Anca Askanase8, Ronald van Vollenhoven9 and Mandana Nikpour10, 1Karolinska Institutet and Karolinska University Hospital, Department of Medicine Solna, Division of Rheumatology, Stockholm, Sweden, 2Karolinska Institutet, Stockholm, Sweden, 3GSK, Specialty Care, Global Medical Affairs, Collegeville, PA, 4University of Padua, Department of Medicine, Division of Rheumatology, Padua, Italy, 5Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, 6GSK, Medical Affairs, Dubai, United Arab Emirates, 7GSK, Development – R&D, Collegeville, PA, 8Columbia University Medical Center, New York, NY, 9Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Department of Rheumatology, Amsterdam, Netherlands, 10University of Sydney School of Public Health and Department of Rheumatology, Royal Prince Alfred Hospital, Sydney, Victoria, Australia

    Background/Purpose: An integrated post hoc analysis of five Phase 3 trials in adults with SLE showed greater benefit of belimumab (BEL) than placebo (PBO), plus…
  • Abstract Number: 0654 • ACR Convergence 2025

    Obinutuzumab Shows Promise in Lupus Nephritis Regardless of Baseline Serological Markers: An Exploratory Post Hoc Analysis of a Phase II Trial

    Ed Vital1, Benni Vargas2, Julie Rae2, Tracey Wang3, Jason Hackney2, Cary Looney4, William Pendergraft2, Liz Lightstone5, Brad Rovin6, Richard Furie7 and Harini Raghu2, 1University of Leeds, Leeds, England, United Kingdom, 2Genentech, Inc., South San Francisco, CA, 3Hoffmann-La Roche Ltd, Missssauga, ON, Canada, 4F. Hoffmann-La Roche Ltd, Basel, Switzerland, 5Department of Immunology and Inflammation, Faculty of Medicine, Imperial College London, London, England, United Kingdom, 6The Ohio State University, Columbus, OH, 7Division of Rheumatology, Northwell Health, Great Neck, NY

    Background/Purpose: Lupus nephritis (LN) is characterized by kidney inflammation. B cells play a central role in LN pathogenesis and type I interferon (IFN-I) pathway activation…
  • Abstract Number: 0776 • ACR Convergence 2025

    Efficacy and Safety of Upadacitinib in Giant Cell Arteritis: 2-Year Results From the Re-Randomized, Double-Blind SELECT-GCA Phase 3 Trial

    Wolfgang Schmidt1, Arathi Setty2, Christian Dejaco3, Andrea Rubbert-Roth4, Maria Cid5, Tomonori Ishii6, Avani D. Joshi2, Nathaniel Zerad2, Aditi Kadakia7, Shaofei Zhao2, Weihan Zhao2, Ivan Lagunes2, Charles Phillips8, Daniel Blockmans9 and Peter Merkel10, 1Immanuel Krankenhaus Berlin, Medical Centre for Rheumatology Berlin-Buch; Waldfriede Hospital, Rheumatology, Berlin, Germany, 2AbbVie Inc, North Chicago, IL, 3Medical University of Graz, Department of Rheumatology, Graz, Austria; Department of Rheumatology, Hospital of Brunico (SABES-ASDAA), Brunico, Italy, 4Division of Rheumatology and Immunology, Cantonal Hospital St Gallen, St Gallen, Switzerland, 5Department of Autoimmune Diseases (member of European Reference Network RITA), Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain, 6Division of Hematology and Rheumatology, Tohoku Medical and Pharmaceutical University, Sendai, Japan, 7AbbVie Inc, Woburn, MA, 8AbbVie Inc, Princeton, NJ, 9Department of General Internal Medicine, University Hospitals Leuven; Department of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium, 10University of Pennsylvania, Philadelphia, PA

    Background/Purpose: In the SELECT-GCA phase 3 trial, treatment of patients with GCA with upadacitinib 15 mg (UPA15) demonstrated superior rates of disease remission, fewer disease…
  • Abstract Number: L08 • ACR Convergence 2024

    A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging and Parallel-group Study to Evaluate the Safety and Efficacy of XG005 in Subjects with Painful Osteoarthritis of the Knee

    Limin Ren1, Wenjie Zheng2, Zhenpeng Guan3, Yang Zhang4, Zeyu Huang5, Tong Li6, Yuwei Peng7, Qiuli Wu8, Wei Gou9, Wei Zhao10, Pengyan Qiao11, Xiaoli Pan12 and Guang-Liang Jiang13, 1Peking University, People’s Hospital, Rheumatology and Immunology Department, Beijing, China, 2Yantai Yuhuangding Hospital of Qingdao University, Department of Orthopedics, Yantai, China, 3Peking University, Shougang Hospital, Department of Orthopedics, Beijing, China, 4Division of Orthopaedic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China, 5West China Hospital of Sichuan University, Department of Orthopedics, Chengdu, China, 6Xiangya Hospital of Central South University, Rheumatology and Immunology Department, Changsha, China, 7PingXiang People’s Hospital, Rheumatology and Immunology Department, Pingxiang, China, 8Tianjin Medical University General Hospital, Department of Orthopedics, Tianjin, China, 9Hebei Petrochina Central Hospital, Rheumatology and Immunology Department, Langfang, China, 10Central Hospital Affiliated to Shenyang Medical College, Department of Orthopedics, Shenyang, China, 11Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Third Hospital of Shanxi Medical University, Tongji Shanxi Hospital, Rheumatology and Immunology Department, Taiyuan, China, 12Affiliated Hospital of Zunyi Medical University, Rheumatology and Immunology Department, Zunyi, China, 13Xgene Pharmaceutical, Lexington, MA

    Background/Purpose: Osteoarthritis (OA) affects 595 million people globally; cases are projected to increase 49-95% for various joints by 2050 as populations age (GBD 2023). OA…
  • Abstract Number: L14 • ACR Convergence 2024

    A Withdrawal Study of Colchicine in Behçet Syndrome

    Basak Sirin1, Sinem Nihal Esatoglu2, Hasan Yazıcı3 and Gulen Hatemi4, 1Istanbul University- Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Istanbul, Turkey, 2Istanbul University- Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul,Türkiye/Istanbul University- Cerrahpaşa, Behcet's Disease Research Center, Istanbul, Turkey, 3Academic Hospital, Istanbul, Turkey, 4Istanbul University- Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul,Türkiye/Istanbul University- Cerrahpaşa, Behcet's Disease Research Center, Istanbul,Türkiye, Istanbul, Turkey

    Background/Purpose: Previous randomized controlled studies reported conflicting results regarding the effectiveness of colchicine on oral ulcers in Behçet syndrome (BS). A randomized drug discontinuation design…
  • Abstract Number: L15 • ACR Convergence 2024

    LEVI-04, a Novel neurotrophin-3 Inhibitor, Substantially Improves Pain and Function Without Deleterious Effects on Joint Structure in People with Knee Osteoarthritis: A Randomized Controlled Phase II Trial

    Philip Conaghan1, Ali Guermazi2, Nathaniel Katz3, Asger Bihlet4, Dror Rom5, Michael Perkins6, Bernadette Hughes6, Claire Herholdt6, Iwona Bombelka6 and Simon Westbrook6, 1University of Leeds, Leeds, United Kingdom, 2Boston University, West Roxbury, MA, 3Rin Sof Innovation, Ltd, Boston, MA, 4NBCD A/S, Soeborg, Denmark, 5Prosoft Clinical, Chesterbrook, 6Levicept Ltd, Ramsgate, United Kingdom

    Background/Purpose: There is an urgent need for new therapies to treat OA. Excess neurotrophins (NT) are implicated in OA and other painful conditions. Previous OA…
  • Abstract Number: L16 • ACR Convergence 2024

    Dapirolizumab Pegol Demonstrated Significant Improvement in Systemic Lupus Erythematosus Disease Activity: Efficacy and Safety Results of a Phase 3 Trial

    Megan Clowse1, David Isenberg2, Joan Merrill3, Thomas Dörner4, Michelle Petri5, Edward Vital6, Eric Morand7, Teri Jimenez8, Stephen Brookes9, Janine Gaiha-Rohrbach10, Christophe Martin11, Annette Nelde12 and Christian Stach13, 1Division of Rheumatology and Immunology, Duke University, Durham, NC, 2Department of Ageing, Rheumatology and Regenerative Medicine, Division of Medicine, University College London, London, United Kingdom, 3Oklahoma Medical Research Foundation, Oklahoma City, OK, 4Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany, 5Johns Hopkins University School of Medicine, Baltimore, MD, 6Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, 7Centre for Inflammatory Diseases, Monash University, Melbourne, Australia, 8UCB, Raleigh, NC, 9Biogen, Maidenhead, United Kingdom, 10Biogen, Cambridge, MA, 11UCB, Slough, United Kingdom, 12Biogen, Baar, Switzerland, 13UCB, Monheim am Rhein, Germany

    Background/Purpose: Dapirolizumab pegol (DZP) is a novel, polyethylene glycol (PEG)-conjugated antigen-binding (Fab') fragment, lacking an Fc domain, that inhibits CD40L signaling. By binding to CD40L,…
  • Abstract Number: 0770 • ACR Convergence 2024

    Efficacy and Safety of Upadacitinib in Patients with Giant Cell Arteritis (SELECT-GCA): A Double-Blind, Randomized Controlled Phase 3 Trial

    Peter Merkel1, Sara Penn2, Arathi Setty2, Wolfgang Schmidt3, Andrea Rubbert-Roth4, Ellen Margrethe Hauge5, Helen Keen6, Tomonori Ishii7, Nader Khalidi8, Liu Meng2, weihan zhao2, Ivan Lagunes9, Ana B. Romero2, Peter Wung10 and daniel blockmans11, 1Division of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, 2AbbVie, North Chicago, IL, 3Immanuel Krankenhaus Berlin, Berlin, Germany, 4Cantonal Hospital St Gallen, St Gallen, Switzerland, 5Aarhus Universitetshospital, Aarhus, Denmark, 6University of Western Australia, Daglish, Western Australia, Australia, 7Tohoku Medical and Pharmaceutical University / Department of Hematology and Rheumatology, sendai, Japan, 8McMaster University, Hamilton, ON, Canada, 9Abbvie, Inc, North Chicago, IL, 10AbbVie Inc., North Chicago, IL, 11Department of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium; Department of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium, Leuven, Belgium

    Background/Purpose: The objective was to assess the efficacy and safety of UPA vs placebo (PBO), in combination with a GC taper regimen, in patients with…
  • Abstract Number: 1477 • ACR Convergence 2024

    Zasocitinib (TAK-279), a Highly Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, Elicits Early Skin Responses and Minimal Disease Activity in Patients with Active Psoriatic Arthritis: Results from a Randomized Phase 2b Study

    Alice Gottlieb1, Elena Muensterman2, Alan Kivitz3, Eva Dokoupilova4, Apinya Lertratanakul5, Ting Hong5, Jingjing Chen5 and Xenofon Baraliakos6, 1Icahn School of Medicine at Mount Sinai, Department of Dermatology, Seattle, WA, 2Takeda Development Center Americas, Cambridge, MA, 3Altoona Center for Clinical Research, Duncansville, PA, 4Medical Plus, s.r.o., Uherske Hradiste, and Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Prague, Czech Republic, 5Takeda Development Center Americas, Inc., Cambridge, MA, 6Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany

    Background/Purpose: Zasocitinib (TAK-279) is a highly selective, oral, allosteric tyrosine kinase 2 (TYK2) inhibitor. In a phase 2b trial in patients with active psoriatic arthritis…
  • Abstract Number: 1696 • ACR Convergence 2024

    Comparison of Mycophenolate Mofetil Plus Methotrexate versus Cyclophosphamide with Sequential Azathioprine for Active Takayasu’s Arteritis: An Open-Label, Randomized-Controlled Trial

    XIAOCHUAN SUN1, Jing Li1, Xinwang Duan2, Liyun Zhang3, Dongyun Yao4, Jing Xue5, zhenbiao wu6, Yi Zhao7, Lijun Wu8, HONGFENG ZHANG9, MENGTAO LI1, Xiaofeng Zeng10, Peter Merkel11 and Xinping Tian12, 1Peking Union Medical College Hospital, Beijing, China, 2The Second Affiliated Hospital of Nanchang University, Nanchang, China (People's Republic), 3Shanxi Bethune Hosptial, Taiyuan, China (People's Republic), 4Jiaozuo People's Hospital, Jiaozuo, Henan, China (People's Republic), 5Second Affiliated Hospital,Zhejiang University School of Medcine, Hangzhou, China (People's Republic), 6Xijing Hospital, Fourth Military Medical University, Xi'an, China (People's Republic), 7Xuanwu Hospital, Beijing, China, 8People's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang, China (People's Republic), 9The First Affiliated Hospital of Dalian Medical University, Dalian, 10Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China, 11University of Pennsylvania, Philadelphia, PA, 12Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China

    Background/Purpose: The management of Takayasu’s arteritis (TAK) is challenging for lack of large-scale, high-quality clinical trials. Cyclophosphamide (CYC) is a conventional first-line immunosuppressant but 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.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM CT on October 25. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

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