ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: 2112 • ACR Convergence 2024

    Discontinuation and Non-Publication of Osteoporosis Studies: An Observational Analysis of 7,670,624 Patients

    Mohamed Abdelsalam1, Asmaa al-Najjar2, omnia Samy3, Rawan morse4, roaa Rafat5 and Mona Sajed6, 1Rheumatology, Rehabilitation and Physical medicine department - faculty of medicine -Misr University for science and technology, 6th of October, Al Jizah, Egypt, 2Faculty of medicine - Al-Azhar university in Gaza, Gaza, Palestinian Territories, 3Faculty of medicine - Zagazig university, Al Zagazig, Egypt, 4Medical Research Group of Egypt, Bur sa'id, Egypt, 5Faculty of medicine, Ahfad University for Women, Khartoum, Sudan, Cairo, Egypt, 6Faculty of Pharmacy - Al-Azhar university for girls, Mansoura, Ad Daqahliyah, Egypt

    Background/Purpose: Osteoporosis (OP) is one of the most common diseases, especially in old age, and as the population ages, the burden of osteoporosis is expected…
  • Abstract Number: 2425 • ACR Convergence 2024

    Ianalumab Induced Durable Depletion of Circulating B Cell Subsets and Associated Changes in B Cell and Neutrophil Transcriptomic and Proteomic Profiles in Patients with Systemic Lupus Erythematosus: 52-Week Treatment Results from a Phase 2 Trial

    Marianna Rowlands1, Thomas Dörner2, Diego Saldana Miranda3, Justin McMullen3, Aida Santos da Costa3, Ulrike Sommer3, Rainer Hillenbrand3, Andre Nogueira da Costa3, Claire Bonal3, Isabelle Isnardi3, Edward Khokhlovich1 and Stephen J Oliver3, 1Biomedical Research, Novartis, Cambridge, MA, 2Department of Medicine, Rheumatology and Clinical Immunology,Charite Universitätsmedizin Berlin, Germany and DRFZ, Berlin, Berlin, Germany, 3Novartis Pharma AG, Basel, Switzerland

    Background/Purpose: Ianalumab (VAY736), a B cell activating factor receptor (BAFFR) targeting mAb, depletes B cells via both antibody dependent cellular cytotoxicity and blockade of BAFF:BAFFR…
  • Abstract Number: 0278 • ACR Convergence 2024

    Efficacy and Safety of Genakumab versus Compound Betamethasone in Gout: The GUARD-1 Study

    Yu Xue1, Tianshu Chu2, Jiankang Hu3, Wei Gou4, Ning Zhang5, Juan Li6, Jing Yu7, Songping Li8, Songbin 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 China Central Hospital, Langfang, China, Langfang, China (People's Republic), 5Department of Rheumatology, Shengjing Hospital of China Medical University, Shenyang, China, Shenyang, China (People's Republic), 6Department of Rheumatology, The First Affiliated Hospital of Hainan Medical University, Haikou, China, Haikou, China (People's Republic), 7Department of Rheumatology, The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China, Shenyang, China (People's Republic), 8Department of Rheumatology, The First Affiliated Hospital of Ganna Medical University, Ganzhou, China, Ganzhou, China (People's Republic), 9Department of Rheumatology, 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), 11Department of Rheumatology, The Second Affiliated Hospital of Nanchang University, Nanchang, China, Nanchang, China (People's Republic), 12Department of Rheumatology, Jiangxi Provincial People's Hospital, Nanchang, China, Nanchang, China (People's Republic)

    Background/Purpose: The GUARD (Genakumab in high Uric Acid-induced Arthritis/goutfor Resolution and Delay study) program was designed to investigate the efficacy and safety of Genakumab, a…
  • Abstract Number: 0587 • ACR Convergence 2024

    Achieving Stringent Disease Control Criteria Was Associated with Greater Work Productivity Improvements in Patients with Active Psoriatic Arthritis: Results from Two Phase 3 Studies of Bimekizumab

    William Tillett1, Dafna Gladman2, Laure Gossec3, Jason Eells4, Patrick Healy5, Barbara Ink4, Nikos Lyris4 and Jessica A Walsh6, 1Royal National Hospital of Rheumatic Diseases; Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, 2University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, 3Sorbonne Université, Paris, France, 4UCB Pharma, Slough, United Kingdom, 5UCB Pharma, Morrisville, NC, 6Division of Rheumatology, Salt Lake City Veterans Affairs Health and University of Utah Health, Salt Lake City, UT

    Background/Purpose: Psoriatic arthritis (PsA) negatively impacts patients’ physical health and functional ability, which can contribute to reduced work productivity.1,2 We examined the association between achieving…
  • Abstract Number: 0682 • ACR Convergence 2024

    Results from Outcomes Selection and Development of a Patient-reported Outcome Measure for a Combined Response Index for Limited Cutaneous SSc: The CRISTAL Project

    Alain Lescoat1, Yen Chen2, Susan Murphy3, Nadia Vann2, Neda Kortam2, Rosemary Gedert2, Sue Farrington4, Yannick Allanore5, David Cella6, Lorinda Chung7, Philip Clements8, Christopher Denton9, Francesco Del Galdo10, Oliver Distler11, Monique Hinchcliff12, Michael Hughes13, Laura Hummers14, John Pauling15, Janet Pope16, Virginia Steen17, John Varga2, Peter Merkel18, Maya H. Buch19 and Dinesh Khanna2, and all CRISTAL collaborators, 1CHU Rennes - University Rennes 1, Rennes, France, 2University of Michigan, Ann Arbor, MI, 3University of Michigan, Plymouth, MI, 4Scleroderma & Raynaud UK, London, United Kingdom, 5Université Paris Cité, Paris, France, 6Northwestern University, Chicago, IL, 7Stanford University, Woodside, CA, 8United States, Los Angeles, CA, 9University College London, Northwood, United Kingdom, 10University of Leeds, Leeds, United Kingdom, 11Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland, Zurich, Switzerland, 12Yale School of Medicine, Westport, CT, 13Tameside and Glossop Integrated NHS Foundation Trust & The University of Manchester, Manchester, United Kingdom, 14Johns Hopkins University, Division of Rheumatology, Baltimore, MD, Ellicott City, MD, 15North Bristol NHS Trust, Bristol, United Kingdom, 16University of Western Ontario, London, ON, Canada, 17Georgetown University School of Medicine, Washington, DC, 18University of Pennsylvania, Philadelphia, PA, 19Division of Musculoskeletal & Dermatological Sciences, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom

    Background/Purpose: Limited cutaneous systemic sclerosis (lcSSc) is the most frequent subset of scleroderma, yet there is a paucity of outcome measures available to assess symptoms…
  • Abstract Number: 1134 • ACR Convergence 2024

    First-in-Human Evaluation of the Safety, Tolerability and Pharmacokinetics of the T Cell Receptor Signal Modulator AX-158

    Christopher VanDeusen1, Andres Gagete1, Annelize Koch2 and D Scott Batty Jr1, 1Artax Biopharma, Inc, Cambridge, MA, 2Simbec-Orion, Merthyr Tydfil, Wales, United Kingdom

    Background/Purpose: Nck is a cytosolic protein that binds a domain of the T cell receptor (TCR) following TCR interaction to amplify responses from low affinity…
  • Abstract Number: 1399 • ACR Convergence 2024

    A First-in-Human Clinical Trial Evaluating the Safety and Pharmacokinetics of SOL-116, a Novel Humanized Monoclonal Antibody Targeting Bile Salt-Stimulated Lipase for the Treatment of RA

    Karin Franck-Larsson1, Susanne Lindquist2, Agneta Wennerholm3, Johan Kolmert4, Maria Wanderoy3 and Olle Hernell2, 1Lipum AB, Uppsala, Sweden, 2Lipum AB; Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden, 3Lipum AB, Stockholm, Sweden, 4Lipum AB; Unit of Integrative Metabolomics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden

    Background/Purpose: Bile Salt-Stimulated Lipase (BSSL) is a lipolytic enzyme secreted by the lactating mammary gland and exocrine pancreas. Elevated plasma levels of BSSL have been…
  • Abstract Number: 1543 • ACR Convergence 2024

    Improvements in BILAG Musculoskeletal and Mucocutaneous Domains at Week 48 in a Phase 2 Double-Blind Placebo-Controlled Trial of ABBV-599 (Elsubrutinib + Upadacitinib Combination) and Upadacitinib Monotherapy for Treatment of Moderately to Severely Active Systemic Lupus Erythematosus

    Amit Saxena1, Zahi Touma2, Edward Vital3, Eric Morand4, Marta Mosca5, Kristin D'Silva6, Peter Wung6, Ling Cheng6, Melitza Iglesias-Rodriguez6, Shelly Kafka6 and Joan Merrill7, 1NYU Grossman School of Medicine, New York, NY, 2University of Toronto, Toronto, ON, Canada, 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom, Leeds, England, United Kingdom, 4School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia, 5University of Pisa, Pisa, Italy, 6AbbVie Inc., North Chicago, IL, 7Oklahoma Medical Research Foundation, Oklahoma City 73104, OK

    Background/Purpose: ABBV-599 is a novel combination of elsubrutinib (ELS; a selective Bruton’s tyrosine kinase inhibitor) and upadacitinib (UPA; a selective Janus kinase inhibitor), which targets…
  • Abstract Number: 1952 • ACR Convergence 2024

    Interest in Clinical Trial Participation Among People with Lupus: Results from the Research Accelerated by You (RAY) Registry

    Michael Fisher1, Mimi Kim2, Joan Merrill3, Safoah Agyemang1 and Joy Buie1, 1Lupus Foundation of America, Washington, DC, 2Albert Einstein College of Medicine, New York, NY, 3Oklahoma Medical Research Foundation, Oklahoma City 73104, OK

    Background/Purpose: With many treatments under study for SLE, a crisis in recruiting sufficient numbers of qualified patients for clinical trials has emerged. Willingness to consider…
  • Abstract Number: 2113 • ACR Convergence 2024

    Discontinuation and Non-publication of Postmenopausal Osteoporosis Clinical Studies: A Cross-sectional Analysis of 345,435 Patients

    Mohamed Abdelsalam1, yasmeen Alabdallat2, Yousef Hussein3, Mona Sajed4, Maryam Taha5, Rawan morse6, Wessam Selima7 and Ahmed Zabady8, 1Rheumatology, Rehabilitation and Physical medicine department - faculty of medicine -Misr University for science and technology, 6th of October, Al Jizah, Egypt, 2Faculty of medicine - Hashemite university, Zarqa, Jordan, 3Faculty of medicine - Benha university, Benha, Egypt, 4Faculty of Pharmacy - Al-Azhar university for girls, Mansoura, Ad Daqahliyah, Egypt, 5Faculty of medicine - Ain Shams university, Madinat Nasr, Al Qahirah, Egypt, 6Medical Research Group of Egypt, Bur sa'id, Egypt, 7Anaesethia & pain management department, Faculty of medicine, Ain Shams University, Cairo, Egypt, 8Faculty of science - Damanhour university, Cairo, Egypt

    Background/Purpose: Postmenopausal osteoporosis (PMOP) significantly contributes to global fracture rates annually, with its silent progression complicating early detection and intervention. Effective management strategies are crucial,…
  • Abstract Number: 2430 • ACR Convergence 2024

    Dapirolizumab Pegol Impacts Important Immunologic Pathways in Systemic Lupus Erythematosus: Pharmacodynamic Analysis of T Cell and Antigen Presenting Cell Pathways from a Phase 2b Trial

    Alex S. Powlesland1, Ioana Cutcutache1, Andrew Skelton1, Anthony Shock1, Matthew Page1, Eris Bame2, Janine Gaiha-Rohrbach2, George Stojan3, Ania Skowera1, Christian Stach4 and Thomas Dörner5, 1UCB Pharma, Slough, United Kingdom, 2Biogen Inc., Cambridge, MA, 3UCB Pharma, Atlanta, GA, 4UCB Pharma, Monheim am Rheim, Germany, 5Department of Medicine, Rheumatology and Clinical Immunology,Charite Universitätsmedizin Berlin, Germany and DRFZ, Berlin, Berlin, Germany

    Background/Purpose: CD40-CD40L interactions play a pivotal role in systemic lupus erythematosus (SLE) pathogenesis by orchestrating a range of immune and inflammatory responses involving B cells,…
  • Abstract Number: 0290 • ACR Convergence 2024

    Deucravacitinib Long-term Efficacy Through 4 Years in Week 16 Placebo Crossover Patients in the Phase 3 POETYK PSO-1, PSO-2, and LTE Program

    Mark Lebwohl1, Richard Warren2, Shinichi Imafuku3, Jerry Bagel4, April W. Armstrong5, Thierry Passeron6, Subhashis Banerjee7, Renata M. Kisa8, Matthew J. Colombo7, Thomas Scharnitz8, Kim Hoyt8, Diamant Thaçi9 and Andrew Blauvelt10, 1Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, 2Dermatology Centre, Northern Care Alliance NHS Foundation Trust and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, 3Fukuoka University Hospital Faculty of Medicine, Fukuoka, Japan, 4Psoriasis Treatment Center of New Jersey, East Windsor, 5University of California Los Angeles, Los Angeles, 6Université Côte d’Azur, University Hospital of Nice, Nice, France, 7Bristol Myers Squibb, Princeton, NJ, 8Bristol Myers Squibb, Princeton, 9Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, 10Oregon Medical Research Center, Portland, OR

    Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate…
  • Abstract Number: 0588 • ACR Convergence 2024

    Sex-Related Differences in Baseline Patient and Disease Characteristics: Post Hoc Analyses of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies in Patients with Active Psoriatic Arthritis

    Laura Coates1, Carlo Selmi2, Philip Mease3, Alexis Ogdie4, Francois Nantel5, Frederic Lavie6, Mohamed Sharaf7, Oyediran Adelakun8, Emmanouil Rampakakis9, Laura Pina Vegas10 and Lihi Eder11, 1University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, 2Department of Biomedical Sciences, Humanitas University, Rozzano, Italy, 3Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, 4Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, 5Nantel MedSci Consult, Montreal, QC, Canada, 6Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, 7Johnson & Johnson, Middle East FZ LLC, Dubai, UAE, Dubai, United Arab Emirates, 8Janssen Research & Development, LLC, Titusville, NJ, 9McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, 10Leiden University Medical Center, Leiden, Netherlands, 11University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada

    Background/Purpose: Although PsA occurs in males and females at similar rates, clinical manifestations and outcomes differ between sexes. Findings from real-world evidence (RWE) studies have…
  • Abstract Number: 0703 • ACR Convergence 2024

    Preliminary Results from the RECONNOITER Trial, a Phase 2 Study of AISA 021 in the Treatment of Secondary Raynaud’s, Primarily Due to Systemic Sclerosis

    Andrew Sternlicht1, Michael Shanahan2, Erin Morton2, Meredith Todd3, Ivana Hunt2, Zoey Reed2, amanda weragoda4, Lashika Weerakoon2 and Elizabeth Briggs2, 1Tufts University Medical Center and Aisa Pharma, Inc., Boston, MA, 2Flinders Medical Centre, Adelaide, Australia, 3Aisa Pharma Pty Ltd., East Lindfield, New South Wales, Australia, 4F, Adelaide, Australia

    Background/Purpose: While 95% of Systemic Sclerosis (SSc) patients have Raynaud’s phenomenon(RP) and many patients rate it as the most bothersome and severe symptom of their…
  • Abstract Number: 1135 • ACR Convergence 2024

    Deucravacitinib in Plaque Psoriasis: 4-Year Efficacy Results by Prior Biologic Treatment in the Phase 3 POETYK PSO-1, PSO-2, and Long-Term ExtensionTrials

    Richard Warren1, April W. Armstrong2, Shinichi Imafuku3, Akimichi Morita4, Carle Paul5, Matthias Augustin6, Thierry Passeron7, Leon Kircik8, Eleni Vritzali8, Thomas Scharnitz9, Georgene Schroeder9, Subhashis Banerjee10 and Bruce Strober11, 1Dermatology Centre, Northern Care Alliance NHS Foundation Trust and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, 2University of California Los Angeles, Los Angeles, 3Fukuoka University Hospital Faculty of Medicine, Fukuoka, Japan, 4Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, 5Toulouse University and CHU, Toulouse, France, 6Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, 7Université Côte d’Azur, University Hospital of Nice, Nice, France, 8Icahn School of Medicine at Mount Sinai, New York, NY, 9Bristol Myers Squibb, Princeton, 10Bristol Myers Squibb, Princeton, NJ, 11Department of Dermatology, Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell, CT

    Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate…
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