Abstracts tagged "clinical trial"

Abstract Number: 0775 • ACR Convergence 2024
A Phase 3, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Inebilizumab in IgG4-Related Disease (MITIGATE): Primary Efficacy and Safety Findings
John Stone¹, Emma Culver², Arezou Khosroshahi³, Wen Zhang⁴, Emanuel Della Torre⁵, Kazuichi Okazaki⁶, Yoshiya Tanaka⁷, Matthias Löhr⁸, Nicolas Schleinitz⁹, Lingli Dong¹⁰, Hisanori Umehara¹¹, Marco Lanzillotta¹², Zachary Wallace¹³, Mikael Ebbo¹⁴, George Webster¹⁵, Ferran Martinez Valle¹⁶, Manu Nayar¹⁷, Vinciane Rebours¹⁸, Cory Perugino¹⁹, Xinxin Dong²⁰, Yanping Wu²⁰, Nishi Rampal²⁰ and Daniel Cimbora²⁰, ¹Massachusetts General Hospital , Harvard Medical School, Concord, MA, ²John Radcliffe Hospital, and Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom, ³Emory University, Atlanta, GA, ⁴Peking Union Medical College Hospital, Dong Cheng Qu, China (People's Republic), ⁵Ospedale San Raffaele, Milan, Italy, ⁶University of Occupational and Environmental Health, Osaka, Japan, ⁷Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ⁸Karolinska Institutet, Stockholm, Sweden, ⁹Aix Marseille university, AP-HM, Marseille, France, ¹⁰Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (People's Republic), ¹¹Department of Rheumatology and Immunology, Nagahama City Hospital,, Nagahama, Shiga 526-0043, Japan, Japan, ¹²IRCCS Ospedale San Raffaele, Milano, Italy, ¹³Massachusetts General Hospital, Newton, MA, ¹⁴Aix-Marseille Université, Marseille, France, ¹⁵University College Hospital London, London, United Kingdom, ¹⁶Vall d’Hebron Hospital, Barcelona, Spain, ¹⁷Freeman Hospital, Newcastle Upon Tyne, United Kingdom, ¹⁸Beaujon Hospital, Université Paris-Cité, France, ¹⁹Massachusetts General Hospital, Boston, MA, ²⁰Amgen Inc., Thousand Oaks, CA
Background/Purpose: IgG4-related disease (IgG4-RD) is a rare, systemic, fibroinflammatory disease characterized by unpredictable and recurring flares, leading to organ damage and decreased quality of life.…
Abstract Number: 1211 • ACR Convergence 2024
An Evaluation of the Efficacy, Pharmacokinetics and Safety, of the Transient Receptor Potential Vanilloid 1 (TRPV1) Agonist RTX-GRT7039 – a Placebo-controlled Study in Patients with Osteoarthritis Knee Pain
Thor Ostenfeld¹, Stefan Ivanicius¹, Roman Stancik² and Philip G Conaghan³, ¹Grunenthal GmbH, Aachen, Germany, ²National Institute of Rheumatic Diseases, Piestany, Slovenia, ³Leeds 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: The transient receptor potential vanilloid 1 (TRPV1) is a critical driver of osteoarthritis (OA) pain. RTX-GRT7039 is an investigational medicinal product containing the active…
Abstract Number: 1468 • ACR Convergence 2024
Efficacy of bDMARDs in Early versus Established Disease in Axial Spondyloarthritis: A Meta-Analysis of Randomized Trials
Diego Benavent¹, Victoria Navarro Compán², Dafne Capelusnik³ and Sofia Ramiro⁴, ¹Rheumatology Department, Hospital Universitari de Bellvitge, Barcelona, Spain, CAMBRILS, Spain, ²La Paz University Hospital, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain, ³Tel Aviv Sourasky Medical Center, Ramat Gan, Israel, ⁴Leiden University Medical Center, Bunde, Netherlands
Background/Purpose: The ASAS consensus definition of ‘early axial spondyloarthritis (axSpA)’ (axial symptoms ≤ 2 years) was expert-based given the scarcity of evidence1. We conducted a…
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: 2020 • ACR Convergence 2024
Prediction of the Response of Patients with Chronic Uncontrolled Gout to Pegloticase
Peter Lipsky¹ and anthony yeo², ¹AMPEL BioSolutions, Charlottesville, VA, ²Independent consultant, Ann arbor, MI
Background/Purpose: Pegloticase is a pegylated recombinant uricase approved for treatment of chronic uncontrolled gout. Because of the development of anti-drug antibodies (ADA), persistent urate lowering…
Abstract Number: 2294 • ACR Convergence 2024
Pharmacodynamic Effects of Nipocalimab on Disease Biomarkers in Patients with Moderate-to-Severe Active Sjögren’s Disease: Results from a Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2 Study
Kathy Sivils¹, Steven Leonardo², He Li³, Keying Ma⁴, Matthew J. Loza⁵, Jonathan J. Hubbard⁴, Kim Campbell⁴ and Sheng Gao⁴, ¹Johnson & Johnson Innovative Medicine, Edmond, OK, ²Janssen Research & Development, LLC, a Johnson & Johnson Company, Cambridge, MA, ³Janssen Research & Development, LLC, Therapeutics Discovery, Spring House, PA, ⁴Janssen Research & Development, LLC, a Johnson & Johnson Company, Spring House, PA, ⁵Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, USA, Spring House, PA
Background/Purpose: Nipocalimab is a fully human, immunoglobulin G (IgG) 1 monoclonal antibody that selectively binds to the IgG-binding site of the neonatal crystallizable fragment receptor…
Abstract Number: 2577 • ACR Convergence 2024
Efficacy and Safety of ABBV-599 (Elsubrutinib and Upadacitinib Combination) and Upadacitinib Monotherapy for the Treatment of Systemic Lupus Erythematosus: Results Through 104 Weeks in a Long-Term Extension Study
Joan Merrill¹, Amit Saxena², Martin Aringer³, Yoshiya Tanaka⁴, Xiaofeng Zeng⁵, Peter Wung⁶, Ling Cheng⁶, Thao Doan⁶, Shelly Kafka⁶, David DCruz⁷ and Kristin D'Silva⁶, ¹Oklahoma Medical Research Foundation, Oklahoma City 73104, OK, ²NYU Grossman School of Medicine, New York, NY, ³University Medical Center and Faculty of Medicine, TU Dresden, Dresden, Germany, ⁴Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ⁵Department 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, ⁶AbbVie Inc., North Chicago, IL, ⁷The Louise Coote Lupus Unit, Guy's and St Thomas' Hospitals NHS Foundation Trust, London, United Kingdom
Background/Purpose: ABBV-599 (a combination of a selective Bruton’s tyrosine kinase inhibitor, elsubrutinib [ELS], and a selective Janus kinase inhibitor, upadacitinib [UPA]) targets a spectrum of…
Abstract Number: 0468 • ACR Convergence 2024
Plasma Calprotectin Assessed in Multiple Biological Treatment Strategies for Early Rheumatoid Arthritis over 48 Weeks
David Stevens¹, Lene Sundbakk², Amirhossein Kazemi², Marte Heiberg³, Tuulikki Sokka-Isler⁴, Bjorn Gudbjornsson⁵, Kristina Lend⁶, Anna Rudin⁷, Michael Nurmohamed⁸, Jon Lampa⁹, Merete Hetland¹⁰, Mikkel Ostergaard¹¹, Ronald Van Vollenhoven¹², Tillmann Uhlig², Espen Haavardsholm² and Hilde Hammer³, ¹St. Olavs hospital, Trondheim, Norway, ²Diakonhjemmet Hospital, Oslo, Norway, ³Diakonhjemmet Hospital, Oslo, Oslo, Norway, ⁴University of Eastern Finland, Faculty of Health Sciences, Jyvaskyla, Finland, ⁵Landspitali University Hospital and University of Iceland, Reykjavik, Iceland, ⁶Amsterdam UMC, Karolinska Institute, Stockholm, Sweden, ⁷Institute of Medicine, University of Gothenburg, Gothenburg, Sweden, ⁸Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁹Karolinska University Hospital, Hässelby, Sweden, ¹⁰Rigshospitalet Glostrup and University of Copenhagen, Glostrup, Denmark, ¹¹Department of Clinical Medicine, University of Copenhagen and Center for Rheumatology, Copenhagen Center for Arthritis Research, Glostrup, Denmark, ¹²Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands
Background/Purpose: Plasma calprotectin is a sensitive biomarker of inflammation in patients with rheumatoid arthritis (RA) and reflects activation of granulocytes and macrophages. Calprotectin has not…
Abstract Number: 0620 • ACR Convergence 2024
Clinical Efficacy and Patient-Reported Outcomes in Anti-Ro/Sjögren’s Syndrome–Related Antigen a Antibody–Positive Patients with Active SLE Treated WithDeucravacitinib in the Phase 2 PAISLEY Trial
Benjamin A. Fisher¹, Hendrika Bootsma², Vibeke Strand³, Wan-Fai Ng⁴, Thomas Wegman⁵, Brandon Becker⁶, Jiyoon Choi⁶, Antoine Sreih⁶, Leo Chen⁷, Antonia Christodoulou⁶ and Eric Morand⁸, ¹University of Birmingham, Birmingham, United Kingdom, ²Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, Groningen, Netherlands, ³Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, ⁴Institute of Cellular Medicine, Newcastle University, Gateshead, United Kingdom, ⁵Bristol Myers Squibb, Beaver Falls, PA, ⁶Bristol Myers Squibb, Princeton, NJ, ⁷Bristol Myers Squibb, Richmond, BC, Canada, ⁸School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia
Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved in multiple countries for the treatment of adults with moderate to…
Abstract Number: 0790 • ACR Convergence 2024
CoLchicine for Treatment of OsteoArthritis of the Knee: Clinical Outcomes from a 90-day Double-Blind, Placebo-Controlled Study
Jonathan Samuels¹, Katherine Tse², Wei David², maryfe Coronel², Fernando Bomfim², Renata La Rocca Vieira³, Nicole Leung⁴, Svetlana Krasnokutsky Samuels⁵, Michael Toprover⁶ and Michael Pillinger⁷, ¹NYU Langone, Rye Brook, NY, ²NYU Langone Health, new york, NY, ³NYU., New York, NY, ⁴New York University Langone Medical Center, New York, NY, ⁵Summit Health, Rye Brook, NY, ⁶New York University Langone Health, New York, NY, ⁷New York University Grossman School of Medicine, New York,, NY
Background/Purpose: Knee osteoarthritis (OA) leads to progressive disability, but approved pharmacologic treatments target analgesia without affecting disease course. Colchicine is well-tolerated and inhibits inflammation thought…
Abstract Number: 1221 • ACR Convergence 2024
Efficacy of Immersive Virtual Reality-based Biofeedback on Chronic Pain and Daily Life Impact in Fibromyalgia: A Pilot Randomized Controlled Trial
Luca Chittaro¹, Simone Longhino², Marta Serafini¹, Sofia Cacioppo² and Luca Quartuccio³, ¹Human-Computer Interaction Lab, Department of Mathematics, Computer Science and Physics, University of Udine, Udine, Italy, ²Division of Rheumatology, Department of Medicine, University of Udine, UDine, Italy, ³Division of Rheumatology, Department of Medicine (DMED), University of Udine, Udine, Italy, Udine, Italy
Background/Purpose: Fibromyalgia (FM) affects 2% of the global population, causing chronic musculoskeletal pain, fatigue, sleep and mood disorders, significantly impacting quality of life. Although many…
Abstract Number: 1471 • ACR Convergence 2024
Sex-related Differences in Efficacy and Safety Outcomes in Axial Spondyloarthritis Randomized Clinical Trials: A Systematic Literature Review and Meta-analysis
Angel Gao¹, Jordi Pardo Pardo², Steven Dang³, Lianne S Gensler⁴, Philip Mease⁵ and Lihi Eder⁶, ¹Queens University, Kingston, Canada, ²University of Ottawa, Ottawa, Canada, ³Women's College Hospital, Institute of Medical Science, University of Toronto, Toronto, ON, Canada, ⁴Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁵Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ⁶University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada
Background/Purpose: Limited information exists on sex-related differences in axial spondyloarthritis (axSpA) randomized controlled trials (RCTs). Through a systematic literature review and meta-analysis we aimed to assess…
Abstract Number: 1733 • ACR Convergence 2024
Safety and Efficacy of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-MyositisTM and RESET-SLETM Clinical Trials
Saira Sheikh¹, Tahseen Mozaffar², Vimal Derebail¹, Natalie Grover¹, Jonathan Hogan³, Courtney Little³, Yvonne White³, Claire Miller³, Rebecca Estremera³, Jenell Volkov³, Daniel Nunez³, Jason Stadanlick³, Mallorie Werner³, Zachary Vorndran³, Alexandra Ellis³, Jazmean Williams³, Justin Cicarelli³, Quynh Lam³, thomas Furmanak³, Chris Schmitt³, Fatemeh Nezhad³, Dan Thompson³, Samik Basu³ and David Chang³, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²University of California, Irvine, Irvine, CA, ³Cabaletta Bio, Philadelphia, PA
Background/Purpose: CD19 targeting chimeric antigen receptor (CAR) T cells have demonstrated durable drug-free responses and remission in patients with idiopathic inflammatory myopathies (IIM) and systemic…
Abstract Number: 2023 • ACR Convergence 2024
A PEGylated Mammalian Uricase Suitable for Intramuscular Administration to Patients with Refractory Chronic Gout
Frank Fan¹, Riyong Liu¹ and Yu Wang², ¹Chongqing PegBio Biopharm Co.,Ltd., Chongqing, China (People's Republic), ²Hangzhou Grand Biologic Pharmaceutical, Inc., Hangzhou, China (People's Republic)
Background/Purpose: For patients with refractory chronic gout, i.e., those who have frequent gout flares and/or persistent tophi despite treatment with the highest tolerable doses of…
Abstract Number: 2342 • ACR Convergence 2024
Guselkumab Shows Similar Domain-Specific Efficacy in Females and Males with Active Psoriatic Arthritis: Post Hoc Analyses of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies
Lihi Eder¹, Carlo Selmi², Philip Mease³, Alexis Ogdie⁴, Francois Nantel⁵, Frederic Lavie⁶, Mohamed Sharaf⁷, Oyediran Adelakun⁸, Emmanouil Rampakakis⁹, Laura PINA VEGAS¹⁰ and Laura Coates¹¹, ¹University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada, ²IRCCS Istituto Clinico Humanitas, 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 Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom
Background/Purpose: PsA occurs in males and females at similar rates. Females participating in randomized controlled trials (RCTs) have shown lower treatment efficacy based on composite…

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