Abstracts tagged "Randomized Trial"

Abstract Number: 0298 • ACR Convergence 2024
RAY121, a Novel Recycling Monoclonal Antibody Against Complement C1s: Safety, Pharmacokinetic and Pharmacodynamic Data from a Phase 1a First in Human Clinical Trial in Healthy Adults
Miwa Haranaka¹, Akinori Yamada², Saki Takahashi², Keisuke Gotanda², Sonoko Nakano-Kanatani², Nana Uemura², Kensuke Ohnishi², Masanobu Nishidate², Ichio Ohnami² and Megumi Kai³, ¹Souseikai Hakata Clinic, Fukuoka, Japan, ²Chugai Pharmaceutical Co., Ltd., Tokyo, Japan, ³Oita University, Oita, Japan
Background/Purpose: Complement C1s is one of the major components of the classical complement pathway (CP), and the abnormal activation of CP is implicated in several…
Abstract Number: 1375 • ACR Convergence 2024
Effects of Training with Blood Flow Restriction on Muscle Strength in Women with Rheumatoid Arthritis: A Randomized Clinical Trial
Leonardo dos Santos¹, Rafaela Santo², Thiago Ramis¹, André Mallmann³, Daniel Moraes³, Lucas Dória⁴, Stephanie Pilotti³, Gabriel Grave³, Nicole Bueno³, Anderson Silveira³, Cristian Santos¹, Rafael Chakr¹, Odirlei Monticielo¹, Claiton Brenol¹ and Ricardo Xavier⁵, ¹Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil, ²Health Research and Innovation Science Centre, Klaipeda University, Klaipeda, Lithuania, Porto Alegre, Rio Grande do Sul, Brazil, ³Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil, ⁴Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil, ⁵Universidade Federal do Rio Grande do Sul, Porto Alegre/RS, Rio Grande do Sul, Brazil
Background/Purpose: Rheumatoid arthritis (RA) is an autoimmune inflammatory disease that often leads to decreased muscle strength and muscle mass. High intensity resistance training (HIRT), using…
Abstract Number: 1553 • ACR Convergence 2024
Safety, Pharmacokinetics, Clinical Efficacy and Exploratory Biomarker Results from a Randomized, Double-Blind, Placebo-Controlled Phase 1b Study of Enpatoran in Active Systemic and Cutaneous Lupus Erythematosus (SLE/CLE)
Torsten Witte¹, Ruth Fernandez Ruiz², Nadezda Abramova³, Dominika Weinelt³, Flavie Moreau⁴, Lena Klopp-Schulze⁵, Jamie Shaw⁶, Deborah Denis⁷ and Joerg Wenzel⁸, ¹Dept of Immunology and Rheumatology, Hannover, Germany, ²Global Clinical Development, EMD Serono, Billerica, MA, ³Global Patient Safety, the healthcare business of Merck KGaA, Darmstadt, Germany, ⁴Global Biostatistics, EMD Serono, Billerica, MA, ⁵Quantitative Pharmacology, the healthcare business of Merck KGaA, Darmstadt, Germany, ⁶Companion Diagnostics and Biomarker Strategy, EMD Serono, Billerica, MA, ⁷EMD Serono, Rockland, MA, ⁸Department of Dermatology and Allergy, University Hospital of Bonn, Bonn, Germany
Background/Purpose: Enpatoran, a highly selective, potent and reversible dual toll-like receptor 7/8 (TLR7/8) inhibitor, targets key innate and adaptive immune processes involved in the pathogenesis…
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: 2357 • ACR Convergence 2024
Longitudinal Evaluation of Neutrophil-to-Lymphocyte Ratio in Guselkumab-Treated Patients with Psoriatic Disease and Levels of Systemic Inflammation Associated with Elevated Cardiovascular Risk: Post-hoc Analysis of 4 Phase 3, Randomized, Controlled Studies
Joseph Merola¹, Alexis Ogdie², Arthur Kavanaugh³, Evan Leibowitz⁴, Emmanouil Rampakakis⁵, Ryan Funk⁶, Francois Nantel⁷, Frederic Lavie⁸, Katelyn Rowland⁹ and Enrique R. Soriano¹⁰, ¹UT Southwestern Medical Center, Newton, MA, ²Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ³University of California San Diego, La Jolla, CA, ⁴Janssen Scientific Affairs, LLC, Fair Lawn, NJ, ⁵McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, ⁶Johnson & Johnson Innovative Medicine, Long Grove, IL, ⁷Nantel MedSci Consult, Montreal, QC, Canada, ⁸Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁹Janssen Pharmaceuticals, Horsham, PA, ¹⁰Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
Background/Purpose: Psoriatic disease (PsD) is associated with an increased risk of cardiovascular (CV) disease. Neutrophil-to-lymphocyte ratio (NLR) is a biomarker of systemic inflammation; NLR ≥2.5…
Abstract Number: 0303 • ACR Convergence 2024
Phase 2b, Long-term Extension, Dose-ranging Study of Oral JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis: FRONTIER-2
Laura K. Ferris¹, Jerry Bagel², Yu-Huei Huang³, Andrew E. Pink⁴, Stephen K. Tyring⁵, Georgios Kokolakis⁶, Amy M. DeLozier⁷, Daniel Kakaley⁸, Shu Li⁹, Yaung-Kaung Shen¹⁰, Takayuki Ota⁷ and Robert Bissonnette¹¹, ¹University of Pittsburgh, Pittsburgh, PA, ²Psoriasis Treatment Center of Central NJ, East Windsor, NJ, ³Chang Gung Memorial Hospital and Chang Gung University, Linkou, Taoyuan City, Taiwan (Republic of China), ⁴NHS Foundation Trust Great Maze Pond, London, United Kingdom, ⁵Center for Clinical Studies, Webster, TX, ⁶Psoriasis Research and Treatment Center, Department of Dermatology, Venereology and Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ⁷Janssen Research & Development, LLC, San Diego, CA, ⁸Janssen Scientific Affairs, LLC, Horsham, PA, ⁹Janssen Research & Development, LLC, Spring House, PA/San Diego, CA, ¹⁰Janssen Research & Development, LLC, Spring House, PA, ¹¹Innovaderm Research, Montreal, QC, Canada
Background/Purpose: JNJ-77242113, a targeted oral peptide, inhibits IL-23 signaling by binding the IL-23 receptor. At all doses, JNJ-77242113 showed superior efficacy at Week 16 versus…
Abstract Number: 1392 • ACR Convergence 2024
Safety and Efficacy of Upadacitinib (UPA) in Japanese Patients with Rheumatoid Arthritis (RA) and Inadequate Response to Conventional Synthetic DMARDs: Results Through 5 Years from the SELECT-SUNRISE Study
Hideto Kameda¹, Tsutomu Takeuchi², Kunihiro Yamaoka³, Motohiro Oribe⁴, Mitsuhiro Kawano⁵, Masayuki Yokoyama⁶, Yuko Konishi⁶, Sumi Chonan⁶, Sara Penn⁷, Heidi S Camp⁷ and Yoshiya Tanaka⁸, ¹Toho University, Tokyo, Japan, ²Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, ³Kitasato University School of Medicine, Kanagawa, Japan, ⁴Oribe Clinic of Rheumatism and Medicine, Oita, Japan, ⁵Kanazawa Medical University, Ishikawa, Japan, ⁶AbbVie GK, Tokyo, Japan, ⁷AbbVie, North Chicago, IL, ⁸Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan
Background/Purpose: To evaluate the efficacy and safety of UPA in Japanese RA patients (pts) up to 5 yrs in a long term extension (LTE) of…
Abstract Number: 1554 • ACR Convergence 2024
Belimumab Increases SLE Responder Index-4 Response Rates versus Placebo in Early Active Systemic Lupus Erythematosus: A Large Integrated Analysis of Belimumab Trials
Karen Costenbader¹, Joan Merrill², Marta Mosca³, Holly Quasny⁴, Christine Henning⁵, Steven Bloom⁶, Julia Harris⁶, Ciara O’Shea⁷, Tatsuya Atsumi⁸ and Ronald van Vollenhoven⁹, ¹Brigham and Women’s Hospital, Division of Rheumatology, Inflammation and Immunity, Harvard Medical School, Boston, MA, ²Oklahoma Medical Research Foundation, Arthritis & Clinical Immunology Program, Oklahoma City, OK, ³University of Pisa, Department of Clinical and Experimental Medicine - Rheumatology Unit, Pisa, Italy, ⁴GSK, Clinical Sciences, Durham, NC, ⁵GSK, Global Medical Affairs, Durham, NC, ⁶GSK, Immunology Biostatistics, Brentford, United Kingdom, ⁷GSK, Rheumatology, Global Medical Affairs, Dublin, Ireland, ⁸Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan, Sapporo, Japan, ⁹Amsterdam Rheumatology and Immunology Center and Amsterdam University Medical Centers, Department of Rheumatology, Amsterdam, Netherlands

Background/Purpose: There are benefits of early treatment for autoimmune diseases; however, data are not available for patients (pts) with SLE as there is no definition…
Abstract Number: 2047 • ACR Convergence 2024
Safety in Patients with Latent Tuberculosis Who Received Concomitant Anti-Tuberculosis Medications: Analysis of 11 Studies of Guselkumab in Psoriatic Disease
Luis Puig¹, Tsen-Fang Tsai², Enrique R. Soriano³, Tina Bhutani⁴, Megan Miller⁵, Alexa P. Kollmeier⁵, Shu Li⁵, Yin You⁵, Melissa Petrick⁵, Hewei Li⁶, Hetal Patel⁷, Frederic Lavie⁸, Melinda Gooderham⁹, Angela Londoño¹⁰, Mark Lebwohl¹¹ and Peter Nash¹², ¹Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain, ²National Taiwan University Hospital, Taipei, Taiwan (Republic of China), ³Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁴University of California San Francisco Medical Center, San Francisco, CA, ⁵Janssen Research & Development, LLC, Spring House, PA/San Diego, CA, ⁶Janssen Pharmaceutical, Hopewell Township, NJ, ⁷Pharmaceutical Companies of Johnson & Johnson, Naperville, IL, ⁸Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁹SKiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada, ¹⁰CES University, Medellín, Colombia, ¹¹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ¹²School of Medicine, Griffith University, Sunshine Coast, Queensland, Australia
Background/Purpose: Certain psoriatic disease treatments, including TNF-α inhibitors (TNFi), increase risk of latent tuberculosis infection (LTBI) activation.1,2 Current treatment guidelines recommend TB screening before initiating…
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: L07 • ACR Convergence 2023
3-year Results of Tapering TNFi to Withdrawal Compared to Stable TNFi Among Rheumatoid Arthritis Patients in Sustained Remission: A Multicenter Randomized Trial
Kaja Kjørholt¹, Nina Sundlisæter¹, Anna-Birgitte Aga¹, Joseph Sexton¹, Inge Christoffer Olsen², Åse Lexberg³, Tor Magne Madland⁴, Hallvard Fremstad⁵, Christian A. Høili⁶, Gunnstein Bakland⁷, Cristina Spada⁸, Hilde Haukeland⁹, Inger Myrnes Hansen¹⁰, Ellen Moholt¹, Karen Holten¹, Till Uhlig¹, Tore Kvien¹, Daniel Solomon¹¹, Désirée van der Heijde¹², Espen Haavardsholm¹ and Siri Lillegraven¹, ¹Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway, ²Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Nepal, ³Department of Rheumatology, Drammen Hospital, Vestre Viken HF, Drammen, Norway, ⁴Department of Rheumatology, Haukeland University Hospital, Bergen, Norway, ⁵Department of Rheumatology, Møre og Romsdal Hospital Trust, Ålesund, Norway, ⁶Department of Rheumatology, Østfold Hospital Trust, Moss, Norway, ⁷Department of Rheumatology, University Hospital of North Norway, Tromsø, Norway, ⁸Department of Rheumatology, Revmatismesykehuset AS, Lillehammer, Norway, ⁹Department of Rheumatology, Martina Hansens Hospital, Bærum, Norway, ¹⁰Deptartment of Rheumatology, Helgelandssykehuset, Mo i Rana, Norway, ¹¹Division of Rheumatology, Brigham and Women's Hospital, Newton, MA, ¹²Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands
Background/Purpose: Tapering of tumor necrosis factor inhibitor (TNFi) treatment in patients who have reached sustained remission is debated in current guidelines, and further data are…
Abstract Number: L14 • ACR Convergence 2023
Efficacy and Safety of Benralizumab Compared with Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Patients Receiving Standard of Care Therapy: Phase 3 MANDARA Study
Michael Wechsler¹, Parameswaran Nair², Benjamin Terrier³, Bastian Walz⁴, Arnaud Bourdin⁵, David Jayne⁶, David Jackson⁷, Florence Roufosse⁸, Lena Börjesson Sjö⁹, Ying Fan¹⁰, Maria Jison¹⁰, Christopher McCrae¹¹, Sofia Necander⁹, Anat Shavit¹², Claire Walton¹² and Peter Merkel¹³, ¹National Jewish Health, Denver, CO, ²McMaster University, Hamilton, ON, Canada, ³Cochin Hospital, Paris, France, ⁴University of Tübingen, Kirchheim-Teck, Germany, ⁵University of Montpellier, CHU Montpellier, INSERM, Montpellier, Montpellier, France, ⁶Addenbrooke's Hospital, Cambridge, United Kingdom, ⁷Guy's Severe Asthma Centre, School of Immunology & Microbial Sciences, King's College London,, London, United Kingdom, ⁸Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium, ⁹Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹⁰Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca,, Gaithersburg, MD, ¹¹Translational Science & Experimental Medicine, Early Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ¹²BioPharmaceutials Medical, AstraZeneca, Cambridge, United Kingdom, ¹³University of Pennsylvania, Philadelphia, PA
Background/Purpose: Eosinophilic inflammation is a key pathophysiological mechanism of eosinophilic granulomatosis with polyangiitis (EGPA). Oral glucocorticoids (OGCs) and immunosuppressants remain the basis for the standard…
Abstract Number: L10 • ACR Convergence 2023
Dazodalibep, a CD40L Antagonist, in a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial of Subjects with Sjögren’s Disease Having Unacceptable Symptomatic Burden but Limited Extraglandular Organ Involvement
E. William St. Clair¹, Liangwei Wang², Ilias Alevizos², William A. Rees², Alan N. Baer³, Wan-Fai Ng⁴, Ghaith Noaiseh⁵ and Chiara Baldini⁶, ¹Department of Medicine, Duke University Medical Center, Durham, NC, USA, Durham, NC, ²Horizon Therapeutics plc, Rockville, MD, ³Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA, Baltimore, MD, ⁴Translational and Clinical Research Institute, Newcastle University, Newcastle, United Kingdom, ⁵Division of Allergy, Clinical Immunology and Rheumatology, Department of Medicine, University of Kansas, Kansas City, KS, USA, Kansas CIty, KS, ⁶Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Pisa, Pisa, Italy
Background/Purpose: Dazodalibep (DAZ) is a non-antibody fusion protein that acts as a CD40L antagonist and blocks costimulatory signals between immune cells, including T cells, B…
Abstract Number: L15 • ACR Convergence 2023
AR882, an Efficacious and Selective URAT1 Inhibitor for Patients with Chronic Gouty Arthritis and Subcutaneous Tophi: Results from a Global, Prospective, Proof-of-Concept Trial Using Dual Energy Computed Tomography
Robert Keenan¹, James Cheng-Chung WEI², Sarah Morris³, Pamella Mundell³, Wen Wei³, Ke Shi³, Zancong Shen³, Vijay Hingorani⁴, Shunqi Yan³, Bahram Kiani⁵ and Litain Yeh³, ¹Arthrosi Therapeutics, Inc., Chapel Hill, NC, ²Chung Shan Medical University, Taichung, Taiwan (Republic of China), ³Arthrosi Therapeutics, Inc., San Diego, CA, ⁴Vanguard Healthsciences, Inc., San Diego, CA, ⁵Wake Forest University School of Medicine, Winston-Salem, NC
Background/Purpose: AR882 is a novel and selective URAT1 inhibitor currently in clinical stage development for the treatment of gout and tophaceous gout and has demonstrated…
Abstract Number: L12 • ACR Convergence 2023
Efficacy and Safety Outcomes of TAK-279, a Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, from a Randomized, Double-blind, Placebo-controlled Phase 2b Trial in Patients with Active Psoriatic Arthritis
Alan Kivitz¹, Elena Tomaselli Muensterman², Arthur Kavanaugh³, Désirée van der Heijde⁴, Piotr A. Klimiuk⁵, Guillermo Valenzuela⁶, Eva Dokoupilova⁷, Gabrielle Poirier⁸, Bhaskar Srivastava⁸, Sue Dasen⁸, Xinyan Zhang⁸, Mona Trivedi², Haoling Holly Weng⁹, Ting Hong¹⁰, Peter Pothula¹⁰ and Xenofon Baraliakos¹¹, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Takeda Development Center Americas, Inc., Cambridge, MA, ³Division of Rheumatology, Allergy & Immunology, University of California San Diego Medical School, San Diego, CA, ⁴Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, ⁵Department of Rheumatology and Internal Diseases, Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Białystok, Poland, ⁶Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁷Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University and MEDICAL PLUS, s.r.o., Brno and Uherské Hradiště, Czech Republic, ⁸Nimbus Discovery, Inc., Boston, MA, ⁹HW MedAdvice LLC, San Diego, CA, ¹⁰Takeda Development Center Americas, Inc., Boston, MA, ¹¹Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum, Germany
Background/Purpose: TYK2 mediates signaling by key cytokines involved in the pathogenesis of immune-mediated inflammatory diseases such as psoriatic arthritis (PsA) and psoriasis (PsO). TAK-279 is…

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