Abstracts tagged "clinical trial"

Abstract Number: 2286 • ACR Convergence 2024
Certolizumab Inhibits Radiographic Progression Even in RA Patients with High Rheumatoid Factor Levels: A Pooled, Post-Hoc Analysis of Two Phase 3 Trials
Josef Smolen¹, Gerd Burmester², Yoshiya Tanaka³, Tsutomu Takeuchi⁴, Jeffrey Curtis⁵, Ted Mikuls⁶, Clementina López Medina⁷, Peter C. Taylor⁸, Nicola Tilt⁹, Bernard Lauwerys¹⁰, Baran Ufuktepe¹¹ and Thomas Huizinga¹², ¹Medical University of Vienna, Vienna, Austria, ²Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ³Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ⁴Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, ⁵The University of Alabama at Birmingham, Birmingham, AL, ⁶University of Nebraska Medical Center, Omaha, NE, ⁷Reina Sofia University Hospital, Cordoba, Spain, ⁸University of Oxford, Oxford, United Kingdom, ⁹UCB Pharma, Slough, United Kingdom, ¹⁰UCB Pharma, Brussels, Belgium, ¹¹UCB Pharma, Istanbul, Turkey, ¹²Department of Rheumatology, Leiden University, Leiden, Netherlands
Background/Purpose: In patients (pts) with rheumatoid arthritis (RA), including those treated with disease-modifying antirheumatic drugs, high rheumatoid factor (RF) levels are a poor prognostic factor,…
Abstract Number: 2527 • ACR Convergence 2024
Efficacy and Safety of Nipocalimab, an Anti-FcRn Monoclonal Antibody, in Primary Sjogren’s Disease: Results from a Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study (DAHLIAS)
Jacques-Eric Gottenberg¹, Kathy Sivils², Kim Campbell³, Jada Idokogi³, Kim Lo³, Sophia G. Liva³, Jonathan Shelton⁴, Harman Dhatt⁵, Jonathan J. Hubbard³ and Ghaith Noaiseh⁶, ¹Rheumatology Department, Strasbourg University Hospital,, Strasbourg, France, ²Johnson & Johnson Innovative Medicine, Edmond, OK, ³Janssen Research & Development, LLC, a Johnson & Johnson Company, Spring House, PA, ⁴Janssen Scientific Affairs, LLC, San Diego, CA, USA, San Diego, ⁵Janssen Global Services, LLC, a Johnson & Johnson Company, Raritan, NJ, USA, Raritan, NJ, ⁶University of Kansas Medical Center, Kansas City, KS
Background/Purpose: Sjögren’s disease (SjD) is a chronic, systemic autoimmune disease characterized by the presence of specific autoantibodies (AAb) and lymphocytic infiltration of exocrine glandular tissues.…
Abstract Number: 0405 • ACR Convergence 2024
Olokizumab, a Monoclonal Antibody Against IL-6, in Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA): Results of 24 Weeks of the Phase 2 Open-label Clinical Trial
Ekaterina Alexeeva¹, Tatiana Dvoryakovskaya², Elena Zholobova³, Elizaveta Krekhova⁴, Rinat Raupov⁵, Daria Bukhanova⁶, Alina Egorova⁶, Sofia Kuzkina⁶, Mikhail Samsonov⁶, Irina Nikishina⁷ and Mikhail Kostik⁵, ¹National Medical Research Center of Children's Health, Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia, ²National Medical Research Center of Children's Health, Moscow, Russia, ³Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia, ⁴National Medical Research Centre for Children's Health, Moscow, Russia, ⁵Saint-Petersburg State Pediatric Medical University, Saint Petersburg, Russia, ⁶R-Pharm, Moscow, Russia, ⁷V. A. Nasonova Research Institute of Rheumatology, Moscow, Russia
Background/Purpose: Olokizumab (OKZ) is a direct interleukin-6 inhibitor for treatment of rheumatoid arthritis and is being investigated in the open-label Phase 2 trial in adolescents…
Abstract Number: 0610 • ACR Convergence 2024
Clinical Evaluation on IFI44L Gene Methylation Detection for Diagnosis of Systemic Lupus Erythematosus by Methylation Sensitive High Resolution Melting (MS-HRM)
Xiaoping hong and liancheng lin, The Second Clinical Medical College of Jinan University, Shenzhen, China (People's Republic)
Background/Purpose: To evaluate the clinical effectiveness of IFI44L gene methylation detection for the diagnosis of Systemic Lupus Erythematosus (SLE) by MS-HRM, to determine the relative…
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…

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