Abstracts tagged "clinical trial"

Abstract Number: 2013 • ACR Convergence 2025
Efficacy and Safety of Firsekibart in Acute Gouty Arthritis Patients with Limited Treatment Options: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Phase III Trial
Yu Xue¹, Tianshu Chu², Jiankang Hu³, Wei Gou⁴, Ning Zhang⁵, Juan Li⁶, Jing Yu⁷, Rongping Li⁸, Rongbin Li⁹, Long Qian¹⁰, Xinwang Duan¹¹, Lihua Duan¹² and Hejian Zou¹, ¹Department of Rheumatology,Huashan Hospital, Fudan University, Shanghai, China, shanghai, China (People's Republic), ²Department of Rheumatology, Henan Provincial People's Hospital, Zhengzhou, China, zhengzhou, China (People's Republic), ³Department of Rheumatology, Pingxiang People's Hospital, Pingxiang,China,, Pingxiang, China (People's Republic), ⁴Department of Rheumatology, Hebei Petro ChinaCentral Hospital, Langfang, China, Langfang, China (People's Republic), ⁵Department of Rheumatology, Shengjing Hospital of China Medical University, Shenyang, China, Shengjing, China (People's Republic), ⁶The First Affiliated Hospital of Hainan Medical University, Haikou, China (People's Republic), ⁷Department of Rheumatology, The FirstAffiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China, Shenyang, China (People's Republic), ⁸Department of Rheumatology, The First Affiliated Hospital of GannanMedical University, Ganzhou, China, Ganzhou, China (People's Republic), ⁹Department ofRheumatology, The First Hospital of Qiqihar, Qiqihar, China, Qiqihar, China (People's Republic), ¹⁰Department of Rheumatology, The Second Hopital of Anhui Medical University, Hefei, China, Hefei, China (People's Republic), ¹¹The Second Affiliated Hospital of Nanchang University, Nanchang, China (People's Republic), ¹²Department of Rheumatology, Jiangxi Provincial People's Hospital, Nanchang, China, Nanchang, China (People's Republic)
Background/Purpose: Acute gouty arthritis(GA) is a common and debilitating condition, especially for patients unsuitable for standard therapy. Firsekibart, previously called Genakumab, is a first-in-class fully…
Abstract Number: 2294 • ACR Convergence 2025
Comparative Analysis of Patients Included in Trials Utilizing Biologic Drugs in the Treatment of Primary Sjögren’s Syndrome
Carlota Navarro Joven¹, Silvia Piunno², Maryia Nikitsina³, CARMEN SAN JOSE MENDEZ⁴ and David A. Isenberg⁵, ¹Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain, ²Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy, ³University Hospital La Princesa, Madrid, Madrid, Madrid, Spain, ⁴Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain, ⁵University College London, London, United Kingdom
Background/Purpose: Sjögren’s syndrome is a heterogeneous autoimmune disease with no approved disease-modifying treatments. The aim of this systematic review was to evaluate primary Sjögren’s syndrome…
Abstract Number: 2445 • ACR Convergence 2025
Achievement of Treat to Target Measures With Upadacitinib in Patients With Systemic Lupus Erythematosus: Phase 2 Randomized SLEek Clinical Trial Results
Eric Morand¹, Joan Merrill², Martin Aringer³, Zahi Touma⁴, Richard Furie⁵, Karim Masri⁶, Christopher Saffore⁷, Ling Cheng⁸ and Ronald van Vollenhoven⁹, ¹Centre for Inflammatory Diseases, Monash University and Monash Health, Melbourne, Victoria, Australia, ²Oklahoma Medical Research Foundation, Oklahoma City ⁷³¹⁰⁴, OK, ³University Medical Center, Dresden, Germany, ⁴University of Toronto, Toronto, ON, Canada, ⁵Division of Rheumatology, Northwell Health, Great Neck, NY, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., waukegan, IL, ⁸AbbVie, North, IL, ⁹Department of Rheumatology, Amsterdam University Medical Centre, Amsterdam, Netherlands
Background/Purpose: Achievement of treat-to-target measures Lupus Low Disease Activity State (LLDAS) and Definition of Remission in SLE (DORIS) has been associated with improved outcomes and…
Abstract Number: 2671 • ACR Convergence 2025
Effect of Efgartigimod PH20 SC on Total Improvement Score, its Core Set Measures, and Patient/Clinician Impressions of Change: Results from the Phase 2 ALKIVIA Study of Adults with Active Idiopathic Inflammatory Myopathy
Rohit Aggarwal¹, Sebastian Rodriguez-Garcia², Agna Neto³, Despoina Papadopoulou⁴, Ben Van Baelen³, Paul Duncombe³, Leentje De Ceuninck⁵, Bas van der Woning⁶ and Hector Chinoy⁷, ¹University of Pittsburgh, Rheumatology and Clinical Immunology, Pittsburgh, United States of America, Pittsburgh, PA, ²Hospital Universitario de La Princesa, Madrid, Spain, ³argenx, Ghent, Belgium, ⁴argenx, Alimos Attikis, Greece, ⁵argenx, Issy-les-Moulineaux, France, ⁶argenx BV, Boston, MA, ⁷The University of Manchester, Manchester, United Kingdom
Background/Purpose: Idiopathic inflammatory myopathy (IIM) is a rare, systemic, autoimmune, rheumatic disease, with different subtypes, characterized by muscle weakness and extra-muscular involvement. There are no…
Abstract Number: 0470 • ACR Convergence 2025
Characterization of Patients With Rheumatoid Arthritis Based on Distinct Patterns of Pain Improvement Following Treatment With Filgotinib: A Post Hoc Analysis of FINCH 1
Peter Taylor¹, Yoshiya Tanaka², Louis Dron³, Katrien Van Beneden⁴, Gerd Burmester⁵ and Bruno Fautrel⁶, ¹University of Oxford, Oxford, United Kingdom, ²University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, ³Cytel, Toronto, Canada, ⁴Alfasigma S.p.A., Bologna, Italy, ⁵Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁶Sorbonne Université - APHP, Department of Rheumatology, Hôpital Pitié-Salpêtrière, Inserm UMRS ¹¹³⁶-⁵, PARIS, France, Paris, France
Background/Purpose: Janus kinase inhibitors have been shown to ameliorate pain as well as inflammation in patients with rheumatoid arthritis (RA). Pain response trajectories were modeled…
Abstract Number: 0816 • ACR Convergence 2025
Persistent Pain Despite Inflammatory Control in RA: A Pooled Analysis of 7 RCTs
Andreas Kerschbaumer¹, Marlene Steiner², William H. Robinson³, Josef Smolen⁴ and Daniel Aletaha⁵, ¹Stanford University / Medical University of Vienna, Stanford, CA, ²Medical University of Vienna, Vienna, Wien, Austria, ³Stanford University, Palo Alto, CA, ⁴Division of Rheumatology, Department of Medicine ³, Medical University of Vienna, Vienna, Austria, Vienna, Austria, ⁵Medical University Vienna, Wien, Austria
Background/Purpose: Joint swelling and tenderness are clinical hallmarks of rheumatoid arthritis (RA) and central to disease assessment. Regardless of treatment type, stringent remission based on…
Abstract Number: 0640 • ACR Convergence 2025
Impact of Clinically Important Improvements in Patient-Reported Outcomes on Disease Activity in Patients With Systemic Lupus Erythematosus Treated With Upadacitinib or Placebo: Results From the Phase 2 SLEek Study
Vibeke Strand¹, Zahi Touma², Anca Askanase³, Christopher Saffore⁴, Denise Kruzikas⁵, Karim Masri⁵, Siran Fang⁵, Yi Peng⁶, Patti Katz⁷ and Marta Mosca⁸, ¹Stanford University School of Medicine, Palo Alto CA, Portola Valley, CA, ²University of Toronto, Toronto, ON, Canada, ³Columbia University Medical Center, New York, NY, ⁴AbbVie Inc., waukegan, IL, ⁵AbbVie Inc., North Chicago, IL, ⁶AbbVie Inc., Maple Grove, MN, ⁷UCSF, San Rafael, CA, ⁸University of Pisa, Pisa, Pisa, Italy
Background/Purpose: This analysis evaluated associations between clinically important improvements in patient-reported outcomes (PROs) and reduced disease activity from the phase 2 SLEek trial evaluating upadacitinib…
Abstract Number: 1072 • ACR Convergence 2025
Inclusion of Older Adults in Pharmacologic Randomized Controlled Clinical Trials of Autoimmune Rheumatic Diseases: A Systematic Review
Manuel Carpio Tumba¹, Raisa Lomanto Silva², Lily Sung³, Laura C. Pedraza-Arévalo⁴, Sneha Gupta⁵, Jeenah Gwak⁶, Aida Mohamadi⁷, Diana Louden⁸, Rachael Stovall⁸, Namrata Singh⁹, Didem Saygin¹⁰, Sarah Lieber¹¹, Jiha Lee¹² and Sebastian E Sattui¹³, ¹University of Pittsburgh, Pittsburgh, PA, ²Massachusetts General Hospital, Boston, MA, ³Stanford University Hospital & Clinics, Hayward, CA, ⁴St. Barnabas Hospital, New York, NY, ⁵University of Pittsburgh Medical Center McKeesport, McKeesport, PA, ⁶Stanford University, Palo Alto, CA, ⁷Tehran University of Medical Sciences, Tehran, Iran, ⁸University of Washington, Seattle, WA, ⁹University of Washington, Bellevue, WA, ¹⁰Rush University Medical Center, Chicago, IL, ¹¹Hospital for Special Surgery, New York, NY, ¹²University of Michigan, Ann Arbor, MI, ¹³Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA
Background/Purpose: A growing number of older adults are living with autoimmune rheumatic diseases (AIRDs) as the global population is aging. And yet, they remain underrepresented…
Abstract Number: 1449 • ACR Convergence 2025
Bimekizumab Demonstrated Comparable One-Year Efficacy in Male and Female Patients with Axial Spondyloarthritis: Results from Two Phase 3 Studies
Lianne S. Gensler¹, Sofia Ramiro², Denis Poddubnyy³, Marina Magrey⁴, Irene E. van der Horst-Bruinsma⁵, Atul Deodhar⁶, Vanessa Taieb⁷, Diana Voiniciuc⁸, Natasha de Peyrecave⁹ and Martin Rudwaleit¹⁰, ¹Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ²Leiden University Medical Center, Bunde, Netherlands, ³Division of Rheumatology, Department of Medicine, University Health Network and University of Toronto, Toronto, Ontario, Canada, and Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany; Department of Epidemiology, German Rheumatism Research Centre, Berlin, Germany, ⁴Case Western Reserve University School of Medicine/University Hospitals Cleveland, Richfield, OH, ⁵Department of Rheumatology, Radboud University Medical Centre, Nijmegen, Netherlands, ⁶Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁷UCB, Colombes, France, ⁸UCB, Slough, United Kingdom, ⁹UCB, Brussels, Belgium, ¹⁰Bielefeld University, Medical School and University Medical Centre OWL, Klinikum Bielefeld, Department of Rheumatology, Bielefeld, Germany
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. BKZ has shown sustained efficacy to Week (Wk) 52…
Abstract Number: 1564 • ACR Convergence 2025
Validation of a Composite Endpoint for Systemic Sclerosis-Associated Interstitial Lung Disease
Elizabeth Volkmann¹, Holly Wilhalme², Samuel Good², Grace Kim², Jonathan Goldin², Michael Roth² and Donald Tashkin², ¹Division of Rheumatology, Department of Medicine, University of California, David Geffen School of Medicine, Los Angeles, CA, USA, Los Angeles, CA, ²UCLA, Los Angeles
Background/Purpose: The forced vital capacity (FVC) is the most commonly used endpoint in registrational trials for systemic sclerosis-associated interstitial lung disease (SSc-ILD). However, the FVC…
Abstract Number: 2014 • ACR Convergence 2025
Efficacy and Safety of Firsekibart in Acute Gouty Arthritis Patients with eGFR < 60ml/min/1.73m2:A Post-Hoc Analysis of 24-Week Data
Yu Xue¹, Tianshu Chu², Jiankang Hu³, Wei Gou⁴, Ning Zhang⁵, Juan Li⁶, Jing Yu⁷, Rongping Li⁸, Rongbin Li⁹, Long Qian¹⁰, Xinwang Duan¹¹, Lihua Duan¹² and Hejian Zou¹, ¹Department of Rheumatology,Huashan Hospital, Fudan University, Shanghai, China, shanghai, China (People's Republic), ²Department of Rheumatology, Henan Provincial People's Hospital, Zhengzhou, China, zhengzhou, China (People's Republic), ³Department of Rheumatology, Pingxiang People's Hospital, Pingxiang,China,, Pingxiang, China (People's Republic), ⁴Department of Rheumatology, Hebei Petro ChinaCentral Hospital, Langfang, China, Langfang, China (People's Republic), ⁵Department of Rheumatology, Shengjing Hospital of China Medical University, Shenyang, China, Shengjing, China (People's Republic), ⁶The First Affiliated Hospital of Hainan Medical University, Haikou, China (People's Republic), ⁷Department of Rheumatology, The FirstAffiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China, Shenyang, China (People's Republic), ⁸Department of Rheumatology, The First Affiliated Hospital of GannanMedical University, Ganzhou, China, Ganzhou, China (People's Republic), ⁹Department ofRheumatology, The First Hospital of Qiqihar, Qiqihar, China, Qiqihar, China (People's Republic), ¹⁰Department of Rheumatology, The Second Hopital of Anhui Medical University, Hefei, China, Hefei, China (People's Republic), ¹¹The Second Affiliated Hospital of Nanchang University, Nanchang, China (People's Republic), ¹²Department of Rheumatology, Jiangxi Provincial People's Hospital, Nanchang, China, Nanchang, China (People's Republic)
Background/Purpose: Approximately 70% of adults with gout have CKD (Chronic Kidney Disease) ≥stage 3 (i.e estimated glomerular filtration rate (eGFR) < 60ml/min/1.73m2), significantly restricts treatment…
Abstract Number: 2307 • ACR Convergence 2025
Peripheral Manifestations In Axial And Peripheral Spondyloarthritis: A Systematic Literature Review On Their Assessment In Clinical Trials
AUGUSTA ORTOLAN¹, Casper Webers², Elena Nikiphorou³, Alexandre Sepriano⁴, Louise Falzon⁵, Clementina López Medina⁶, Dafne capelusnik⁷, Désirée Van Der Heijde⁸, Anna Molto⁹ and Sofia Ramiro¹⁰, ¹Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy, ²Maastricht University Medical Centre, Maastricht, Netherlands, ³King's College London, London, United Kingdom, ⁴Department of Rheumatology, Leiden University Medical Centre, Portela Loures, Portugal, ⁵Sheffield Centre for Health and Related Research, University of Sheffield, Sheffield, United Kingdom, ⁶Department of Medicine, Hospital Universitario Reina Sofia, University of Cordoba, IMIBIC, Cordoba, Spain, ⁷Tel Aviv Sourasky Medical Center, Ramat Gan, Israel, ⁸Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁹Assistance Publique Hôpitauxde Paris, Paris, France, ¹⁰Leiden University Medical Center, Bunde, Netherlands
Background/Purpose: Peripheral manifestations (peripheral arthritis, enthesitis, dactylitis) of axial spondyloarthritis (axSpA) and peripheral spondyloarthritis (pSpA) represent a significant burden for patients, but are understudied. Our…
Abstract Number: 2452 • ACR Convergence 2025
Preliminary Safety, Efficacy, and Cellular Kinetics of CTA311, a CD19 Targeted Universal CAR-T Therapy, for Active Autoimmune Diseases
Sanbin Wang¹, Heng Mei², Dongmei Zhou³, Wei Xie², Songlou Yin³, Chunmei Liu³, Hanwei Wang⁴, Huan Zhou⁵, Yue Xie⁶, Lu Han⁷, Jiangtao Ren⁸, Yali Zhou⁸, Wengang Ge⁷ and Jan Davidson-Moncada⁸, ¹⁹²⁰th Hospital of Joint Logistic Support Force, Kunming, China (People's Republic), ²Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (People's Republic), ³The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China (People's Republic), ⁴The Third People’s Hospital of Bengbu, Beng bu, China (People's Republic), ⁵Clinical Research Hospital of the First Affiliated Hospital of Anhui Medical University, Hefei, China (People's Republic), ⁶Bioheng Therapeutics Limited, Nan Jing Shi, China (People's Republic), ⁷Bioheng Therapeutics Co., Limited, Nanjing, China (People's Republic), ⁸Bioheng Therapeutics Co., Limited, Nan Jing, China (People's Republic)
Background/Purpose: Systemic lupus erythematosus (SLE) and anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) are autoimmune conditions characterized by B cell activation, autoreactivity, and autoantibody production. CAR-T therapy…
Abstract Number: 2692 • ACR Convergence 2025
Individualized Strength, Mobility and Aerobic Rehabilitation Training in axial Spondyloarthritis (iSMART in axSpA)
Sophie De Mits¹, Tine Willems², Lieven Danneels², Patrick Calders², Gaëlle Varkas³, Filip Van den Bosch⁴, Dirk Elewaut⁵ and Philippe Carron⁶, ¹Ghent University Hospital, Gent, Belgium, ²Ghent University, Gent, Belgium, ³Department of Rheumatology, Ghent University Hospital, Ghent, Belgium, ⁴Department of Internal Medicine and Pediatrics, Ghent University and VIB Center for Inflammation Research, Ghent, Belgium, ⁵VIB Center for Inflammation Research, and Ghent University Hospital, Department of Rheumatology, Ghent, Belgium, ⁶Ghent University and VIB Center for Inflammation Research, Ghent, Belgium
Background/Purpose: AxSpA primarily affects the sacroiliac joints and spine, reducing trunk strength, mobility, and cardiorespiratory fitness. While exercise is a key treatment, few studies have…
Abstract Number: 0473 • ACR Convergence 2025
A Phase 2b Dose-Ranging Study of Peresolimab for Adults with RA
Jay Tuttle¹, Kirstin Griffing², Mark Genovese², Hyungmin Rha², So Young Park², Pia Yachi¹, Ajay Nirula¹, LANCE PFEIFER², Tami Jo Rayle², Jesus Abraham Simón-Campos³, Clifton Bingham⁴, Kevin Winthrop⁵, Daniel Aletaha⁶, Iain McInnes⁷, Yu Xue⁸, Yoshiya Tanaka⁹, Roy Fleischmann¹⁰, Paul Emery¹¹ and Michael Weinblatt¹², ¹Lilly Biotechnology Center, San Diego, CA, ²Eli Lilly and Company, Indianapolis, IN, ³Köhler & Milstein Research, UADY School of Medicine, Merida, Yucatan, Mexico, ⁴Johns Hopkins University, Baltimore, MD, ⁵Oregon Health & Science University, Portland, OR, ⁶Medical University Vienna, Wien, Austria, ⁷University of Glasgow, Glasgow, United Kingdom, ⁸Huashan Hospital, Fudan University, Shanghai, China (People's Republic), ⁹University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, ¹⁰Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ¹¹University of Leeds, Leeds, England, United Kingdom, ¹²Brigham and Women's Hospital, Boston, MA
Background/Purpose: Peresolimab, a humanized IgG1 mAb, activates programmed cell death protein 1. In a phase 2a study, peresolimab demonstrated efficacy in participants (pts) with RA…

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