Abstracts tagged "clinical trial"

Abstract Number: 0178 • ACR Convergence 2024
Are Participants in Gout Clinical Trials Representative of People with Gout in the General Population?
Jendy Liu, Gregory Gamble and Nicola Dalbeth, University of Auckland, Auckland, New Zealand
Background/Purpose: Ensuring study participants are representative of the general population is important to ensure that efficacy and safety findings of clinical trials are generalizable in…
Abstract Number: 0511 • ACR Convergence 2024
Do High Rheumatoid Factor Levels Impact Response to Certolizumab Pegol in Patients with Inadequately Controlled Rheumatoid Arthritis? A Post Hoc Analysis of a Phase 3b Trial
Josef Smolen¹, Ted Mikuls², James Galloway³, Ulf Müller-Ladner⁴, Jeffrey Curtis⁵, Motomu Hashimoto⁶, Tsutomu Takeuchi⁷, Ernest Choy⁸, Yoshiya Tanaka⁹, Carlos Cara¹⁰, Bernard Lauwerys¹¹, Nicola Tilt¹², Baran Ufuktepe¹³ and Peter C. Taylor¹⁴, ¹Medical University of Vienna, Vienna, Austria, ²University of Nebraska Medical Center, Omaha, NE, ³Centre for Rheumatic Diseases, King's College London, London, United Kingdom, ⁴Justus-Liebig University Giessen, Bad Nauheim, Germany, ⁵University of Alabama at Birmingham, Hoover, AL, ⁶Osaka Metropolitan University, Osaka, Japan, ⁷Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, ⁸Cardiff University School of Medicine, Cardiff, United Kingdom, ⁹Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ¹⁰UCB Pharma, Madrid, Spain, ¹¹UCB Pharma, Brussels, Belgium, ¹²UCB Pharma, Slough, United Kingdom, ¹³UCB Pharma, Istanbul, Turkey, ¹⁴University of Oxford, Oxford, United Kingdom
Background/Purpose: In pts with RA, high RF levels are associated with poor prognosis, higher disease activity, and decreased response to monoclonal antibodies targeting tumor necrosis…
Abstract Number: 0661 • ACR Convergence 2024
Validity, Reliability and Responsiveness of Lupus Impact Tracker and LupusPRO: AURORA Trial
Meenakshi Jolly¹, Matt Truman², Ronald Flauto³ and Kathryn Dao⁴, and AURORA, ¹Rush University Medical Center, Chicago, ²Aurinia Pharmaceuticals, Victoria, BC, Canada, ³Aurinia Pharmaceuticals, Rockville, MD, ⁴Aurinia Pharmaceuticals, Dallas
Background/Purpose: Voclosporin used in addition to Mycophenolate Mofetil and low dose oral steroids in patients with active Lupus Nephritis (LN) was found to be superior…
Abstract Number: 0827 • ACR Convergence 2024
Oral Corticosteroid-Sparing Effects of Mepolizumab in Eosinophilic Granulomatosis with Polyangiitis (EGPA): Results up to 7.4 Years from the Long-Term Access Programme
Paneez Khoury¹, Jared Silver², Gerhard Wolff³, Robert Price⁴, Rejina Verghis⁵, Emmeline Igboekwe² and Michael E Wechsler⁶, ¹National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, ²US Medical Affairs-Respiratory, GSK, Durham, ³Clinical Development-Respiratory, GSK, Collegeville, ⁴Biostatistics, GSK, Stevenage, United Kingdom, ⁵Biostatistics, Development Respiratory, GSK, Brentford, United Kingdom, ⁶Department of Medicine, National Jewish Health, Denver, CO
Background/Purpose: EGPA is a severe, rare, relapsing/remitting inflammatory disease, in which chronic or high oral corticosteroid (OCS) doses lead to adverse effects, adding to disease…
Abstract Number: 1380 • ACR Convergence 2024
Rapid, Clinically Meaningful Pain Improvements Are Associated with Improvements in Other Patient-Reported Outcomes in RA Patients Treated with Upadacitinib
Manish Jain¹, Arthur Kavanaugh², Angela Crowley³, Avani Joshi⁴, Patrick Zueger⁵, Diane Caballero⁶, Andrew Garrison⁶ and Peter C. Taylor⁷, ¹Endeavor Health Swedish Hospital and Captain James A, Chicago, IL, ²University of California San Diego, La Jolla, CA, ³Illinois Bone and Joint Institute, Hinsdale Orthopaedics, Hinsdale, IL, ⁴AbbVie, North Chicago, IL, ⁵AbbVie Inc, North Chicago, IL, ⁶AbbVie Inc., North Chicago, IL, ⁷University of Oxford, Oxford, United Kingdom
Background/Purpose: Pain is a crucial symptom for patients with RA; early and effective treatment can help alleviate it.1 In this post hoc analysis, we investigated…
Abstract Number: 1476 • ACR Convergence 2024
Individualizing NSAIDs in Axial Spondyloarthritis Through a Series of N-of-1 Clinical Trials with Bayesian Analysis
Mark Hwang¹, Seokhun Kim², Shervin Assassi³, Joyce Samuel⁴, Charles Green², Jon Tyson⁴ and John Reveille⁵, ¹Department of Internal Medicine, Division of Rheumatology, John P. and Katherine G. McGovern School of Medicine, UTHealth Houston, Houston, TX, ²UTHealth Houston, Houston, ³UTHealth Houston Division of Rheumatology, Houston, TX, ⁴UTHealth Houston, Houston, TX, ⁵UTHealth Houston Division of Rheumatology, Houston
Background/Purpose: Nonsteroidal anti-inflammatory drugs (NSAIDs) are first line pharmacological treatment for Axial Spondyloarthritis (axSpA), yet individual responses to different NSAIDs vary significantly. This study aims…
Abstract Number: 1757 • ACR Convergence 2024
Bimekizumab Treatment Resulted in Improvements in MRI Inflammatory and Structural Lesions in the Sacroiliac Joints of Patients with Axial Spondyloarthritis: 52-Week Results and Post Hoc Analyses from Two Phase 3 Studies
Walter Maksymowych¹, Sofia Ramiro², Denis Poddubnyy³, Xenofon Baraliakos⁴, Robert Lambert¹, Ute Massow⁵, Thomas Vaux⁶, Chetan Prajapati⁶, Alexander Marten⁵, Natasha de Peyrecave⁷ and Mikkel Ostergaard⁸, ¹University of Alberta, Edmonton, AB, Canada, ²Leiden University Medical Center, Bunde, Netherlands, ³Charite-Universitatsmedizin Berlin, Berlin, Germany, ⁴Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁵UCB Pharma, Monheim am Rhein, Germany, ⁶UCB Pharma, Slough, United Kingdom, ⁷UCB Pharma, Brussels, Belgium, ⁸Department of Clinical Medicine, University of Copenhagen and Center for Rheumatology, Copenhagen Center for Arthritis Research, Glostrup, Denmark
Background/Purpose: The impact of bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)‑17F in addition to IL-17A, on structural lesions in patients (pts)…
Abstract Number: 2085 • ACR Convergence 2024
The Effects of Pioglitazone on Metabolic Dysregulation in Inclusion Body Myositis: An Open-Label Pilot Study
Brittany Adler¹, Michael Bene¹, Cissy Zhang², Julie Paik¹, Christopher Mecoli¹, Thomas Lloyd³, Eleni Tiniakou⁴, Erika Darrah¹, Lisa Christopher-Stine¹, Albert Mears¹, Megan McGowan¹, Ruben Pagkatipunan¹, Anne Le² and Jemima Albayda⁵, ¹Johns Hopkins University, Baltimore, MD, ²Gigantest, Baltimore, MD, ³Baylor College of Medicine, Houston, TX, ⁴Johns Hopkins University, Lutherville Timonium, MD, ⁵Johns Hopkins School of Medicine, Baltimore, MD
Background/Purpose: Inclusion body myositis (IBM) is a progressive muscle disease for which there is no effective treatment. Mitochondrial dysregulation is a pathologic hallmark of IBM.…
Abstract Number: 2361 • ACR Convergence 2024
Assessment of Laboratory Parameter Changes in a Phase 2b Trial of Zasocitinib (TAK-279), an Oral, Highly Selective TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis
Arthur Kavanaugh¹, Elena Muensterman², Apinya Lertratanakul³, Ting Hong³, Jingjing Chen³, Peter Pothula⁴, Ejim Mark⁵ and Alan Kivitz⁶, ¹University of California San Diego, La Jolla, CA, ²Takeda Development Center Americas, Cambridge, MA, ³Takeda Development Center Americas, Inc., Cambridge, MA, ⁴Takeda Development Center Americas, Inc., Cambridge, ⁵Takeda Development Center Americas Inc., Cambridge, ⁶Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: Zasocitinib (TAK-279) is an oral, highly selective, allosteric tyrosine kinase 2 (TYK2) inhibitor that binds with high specificity to the Janus homology 2 domain…
Abstract Number: 2584 • ACR Convergence 2024
Zasocitinib (TAK-279), an Oral, Selective Tyrosine Kinase 2 Inhibitor: Achievement of Remission and Additional Improvements in Disease Activity in Patients with Psoriatic Arthritis Enrolled in a Phase 2b Trial
Philip Mease¹, Alan Kivitz², Elena Muensterman³, Apinya Lertratanakul⁴, Ting Hong⁴, Jingjing Chen⁴, Ejim Mark⁵ and Xenofon Baraliakos⁶, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²Altoona Center for Clinical Research, Duncansville, PA, ³Takeda Development Center Americas, Cambridge, MA, ⁴Takeda Development Center Americas, Inc., Cambridge, MA, ⁵Takeda Development Center Americas Inc., Cambridge, ⁶Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany
Background/Purpose: Zasocitinib (TAK-279) is an oral, selective TYK2 inhibitor under investigation for the treatment of immune-mediated inflammatory diseases including psoriatic arthritis (PsA). In a phase…
Abstract Number: 0179 • ACR Convergence 2024
Bridging the Gap: Enhancing Diversity in Lupus Clinical Trials Through Investigator and Research Staff Engagement
Tessa Englund¹, Katherine Holben¹, Simone Frank², Khadeejatul-Kubraa Lawal¹, Julie Hsieh³, Christine Lee³ and Saira Sheikh¹, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²North Carolina Translational and Clinical Sciences Institute, University of North Carolina at Chapel Hill, Chapel Hill, NC, ³U.S. Food and Drug Administration, Silver Spring, MD
Background/Purpose: Lupus disproportionately affects diverse racial and ethnic minority populations, yet there is a significant disparity between those affected and those enrolled in clinical trials.…
Abstract Number: 0518 • ACR Convergence 2024
Sustained Patient Meaningful Outcomes of Pain and Fatigue Relief and Improved Physical Functioning with Filgotinib in Rheumatoid Arthritis: A Post Hoc Analysis
Rieke Alten¹, Bruno Fautrel², Philip G Conaghan³, Dick de Vries⁴, Margaux Faes⁵, Mercedes Piovesan⁶, Katrien Van Beneden⁷, Chris Watson⁸, Angelique E.A.M. Weel-Koenders⁹, Eugen Feist¹⁰ and Kurt de Vlam¹¹, ¹Department of Internal Medicine and Rheumatology, Schlosspark Klinik, University Medicine Berlin, Berlin, Germany, ²INSERM, UMRS 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Sorbonne University – Assistance Publique-Hôpitaux de Paris, Département de Rhumatologie, Hôpital Pitié-Salpêtrière, Paris, Ile-de-France, France, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁴Clinical Development, Galapagos BV, Leiden, Netherlands, ⁵Biostatistics, Galapagos NV, Mechelen, Belgium, ⁶Medical Affairs, Galapagos Biopharma Spain SLU, Madrid, Spain, ⁷Medical Affairs, Galapagos NV, Mechelen, Belgium, ⁸Medical Affairs, Galapagos Biotech Ltd, Cambridge, United Kingdom, ⁹Erasmus School of Health Policy and Management, Erasmus University Rotterdam, and Department of Rheumatology and Clinical Immunology, Maasstad Hospital, Rotterdam, Netherlands, ¹⁰Department of Rheumatology, Helios Clinic Vogelsang-Gommern, cooperation partner of the Otto von Guericke University Magdeburg, Gommern, Germany, ¹¹Department of Rheumatology, UZ Leuven, and Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, KU Leuven, Leuven, Belgium
Background/Purpose: Quality of life for patients with RA can be severely impacted by pain, fatigue and impaired physical functioning.1 Filgotinib (FIL) has demonstrated early onset…
Abstract Number: 0662 • ACR Convergence 2024
Deucravacitinib, a First-in-Class, Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in SLE: Efficacy by Baseline Demographics and Disease Characteristics in the Phase 2 PAISLEY Trial
Eric Morand¹, Cristina Arriens², Laura Geraldino³, Ann E. Clarke⁴, Samantha Pomponi⁵, Coburn Hobar⁵, Thomas Wegman⁶, Ravi Koti⁵, Subhashis Banerjee⁵ and Ronald Van Vollenhoven⁷, ¹School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia, ²Department of Arthritis and Clinical Immunology, Rheumatology, Oklahoma Medical Research Foundation and Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, ³Division of Rheumatology, Department of Medicine, Columbia University, New York, NY, ⁴Division of Rheumatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada, ⁵Bristol Myers Squibb, Princeton, NJ, ⁶Bristol Myers Squibb, Beaver Falls, PA, ⁷Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands
Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase (TYK2) inhibitor approved in multiple countries for the treatment of adults with moderate to severe…
Abstract Number: 0828 • ACR Convergence 2024
Efficacy of Eosinophil-Targeting Therapies on Specific Disease Manifestations of Eosinophilic Granulomatosis with Polyangiitis in the Phase 3 MANDARA Trial
Peter Merkel¹, David Jayne², Ulrich Specks³, Christian Pagnoux⁴, Benjamin Terrier⁵, Bernhard Hellmich⁶, Sofia Necander⁷, Anat Shavit⁸, Claire Walton⁹ and Michael Wechsler¹⁰, ¹University of Pennsylvania, Philadelphia, PA, ²University of Cambridge, Cambridge, United Kingdom, ³Mayo Clinic, Rochester, MN, ⁴Mount Sinai Hospital, Toronto, ON, Canada, ⁵Service de Médecine interne, Hôpital Cochin, AP-HP, Paris, Ile-de-France, France, ⁶Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, ⁷Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁸BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ⁹Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ¹⁰National Jewish Health, Denver, CO
Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare inflammatory disorder characterized by small- to medium-vessel vasculitis, asthma and eosinophilia. In the head-to-head MANDARA trial…
Abstract Number: 1385 • ACR Convergence 2024
A Novel Oral 3D-Printed Delayed- and Extended-Release Tofacitinib (T19) for the Treatment of Rheumatoid Arthritis and Related Inflammatory Diseases
Yue Zhou, Meng Ji, luo wang, Feihuang Deng, Senping Cheng, Xiaoling Li and Yulian Zhang, Triastek, Inc., Nanjing, China (People's Republic)
Background/Purpose: Patients with inflammatory diseases, such as rheumatoid arthritis (RA), frequently continue to suffer from morning symptoms despite treatment with conventional therapies 1,2. Routine morning…

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