Abstracts tagged "Randomized Trial"

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: 1472 • ACR Convergence 2024
Achievement of Low Disease Activity/Remission in Guselkumab-Treated Patients with Moderately-Highly Active Psoriatic Arthritis Regardless of Baseline Characteristics: Pooled Post-Hoc Analysis of Two Phase 3/Randomized Studies
Philip Mease¹, Alice Gottlieb², Iain McInnes³, Natalie J. Shiff⁴, Anthony Todd⁵, Emmanouil Rampakakis⁶, Francois Nantel⁷, Jenna Parrett⁵, Frederic Lavie⁸ and Proton Rahman⁹, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²Icahn School of Medicine at Mount Sinai, Department of Dermatology, Seattle, WA, ³University of Glasgow, College of Medical Veterinary and Life Sciences, Glasgow, United Kingdom, ⁴Janssen Scientific Affairs, LLC / University of Saskatchewan, Adjunct, Community Health and Epidemiology, Horsham, PA, ⁵Janssen Scientific Affairs, LLC, Horsham, PA, ⁶McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, ⁷Nantel Medsci Consult, Montreal, QC, Canada, ⁸Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁹Memorial University of Newfoundland, Faculty of Medicine, Division of Rheumatology, St. John's, Canada
Background/Purpose: Guselkumab (GUS), a fully human IL-23p19-subunit inhibitor, has demonstrated multidomain efficacy (swollen/tender joints, psoriasis, enthesitis and dactylitis) in patients (pts) with active PsA in…
Abstract Number: 1680 • ACR Convergence 2024
Reporting Quality of Non-inferiority and Equivalence Rheumatoid Arthritis Randomized Clinical Trials: A Systematic Review
Osama Alalwan¹ and Majeed Haider², ¹Salmaniya Medical Complex, Bahrain, Bahrain, ²Salmaniya Medical Complex, Manama, Bahrain
Background/Purpose: The number of non-inferiority/equivalence randomized clinical trials (NI/EQ-RCTs) in the rheumatoid arthritis (RA) field has recently increased for various reasons. These designs require special…
Abstract Number: 2274 • ACR Convergence 2024
Efficacy and Safety of the Biased Melanocortin Receptor Agonist AP1189/resomelagon in Combination with Methotrexate in DMARD-naïve Rheumatoid Arthritis Patients: The EXPAND Trial
Asger Reinstrup Bihlet¹, Philip G Conaghan², Thomas Boesen³, Mette Arnum Jensen³, Alejandro Castillo Mondragón⁴, Ema Erkocevic Petersen⁴, Cathrine Borgsted Bak⁴ and Thomas EN Jonassen³, ¹NBCD A/S, Soeborg, Denmark, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ³Synact Pharma ApS, Holte, Denmark, ⁴NBCD A/S, Soborg, Denmark
Background/Purpose: AP1189 is a novel, first-in-class, oral, biased melanocortin (MC)1 and MC3 receptor agonist in development for Rheumatoid Arthritis (RA) treatment. Through multiple actions including…
Abstract Number: 2582 • ACR Convergence 2024
Efficacy and Safety of Sonelokimab, a Novel IL-17A- and IL-17F-Inhibiting Nanobody, in Patients with Active PsA: 24-Week Results from a Global, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
Iain McInnes¹, Laura Coates², Philip Mease³, Alexis Ogdie⁴, Arthur Kavanaugh⁵, Lihi Eder⁶, Georg Schett⁷, Alan Kivitz⁸, Nuala Brennan⁹, Alex Godwood⁹, Eva Cullen⁹, Kristian Reich⁹, Christopher Ritchlin¹⁰ and Joseph F. Merola¹¹, ¹University of Glasgow, College of Medical Veterinary and Life Sciences, Glasgow, United Kingdom, ²University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, 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, ⁵University of California San Diego, La Jolla, CA, ⁶University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada, ⁷Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, ⁸Altoona Center for Clinical Research, Duncansville, PA, ⁹MoonLake Immunotherapeutics AG, Zug, Switzerland, ¹⁰Department of Medicine, Allergy, Immunology, and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, ¹¹UT Southwestern Medical Center, Dallas, TX
Background/Purpose: Sonelokimab is a novel humanized Nanobody designed to inhibit IL-17A and IL-17F and penetrate clinically relevant sites of inflammation. The 24-week Phase 2 ARGO…
Abstract Number: 0670 • ACR Convergence 2024
A Randomized, Open-Label, Phase III Trial Comparing Efficacy and Safety of Intravenous Cyclophosphamide, Mycophenolate Mofetil, or Tacrolimus as Induction Therapy in Lupus Nephritis
Alekhya Amudalapalli, Ashlesha Shukla, Abhichandra Maddineni, Sandeep Nagar, Sudhish Gadde, Harish BV, Rashmi Ranjan Sahoo and Pradeepta Sekhar Patro, IMS and SUM Hospital, Bhubaneswar, India
Background/Purpose: The optimal treatment for lupus nephritis is challenging due to its heterogeneity and the lack of prognostic factors favoring one immunosuppressive drug over another.…
Abstract Number: 1474 • ACR Convergence 2024
Efficacy of Guselkumab in Bionaive Psoriatic Arthritis Patients with Severe Disease Activity: Post-hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
Christopher Ritchlin¹, Ennio Lubrano², Maria Sole Chimenti³, Evan Leibowitz⁴, Mohamed Sharaf⁵, Oyediran Adelakun⁶, Emmanouil Rampakakis⁷, Francois Nantel⁸, Frederic Lavie⁹ and Atul Deodhar¹⁰, ¹Department of Medicine, Allergy, Immunology, and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, ²Vincenzo Tiberio Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy, ³Rheumatology, Allergology and Clinical Immunology, System Medicine Department, University of Rome Tor Vergata, Rome, Italy, ⁴Immunology, Janssen Scientific Affairs, LLC, Horsham, PA, ⁵Johnson & Johnson, Middle East FZ LLC, Dubai, UAE, Dubai, United Arab Emirates, ⁶Janssen Research & Development, LLC, Titusville, NJ, ⁷McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, ⁸Nantel Medsci Consult, Montreal, QC, Canada, ⁹Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ¹⁰Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR
Background/Purpose: In previous DISCOVER (D)1 and 2 analyses, the fully human IL-23p19-subunit inhibitor guselkumab (GUS) was associated with robust and sustained improvement in PsA signs/symptoms…
Abstract Number: 1695 • ACR Convergence 2024
Efficacy of Upadacitinib in Patients with Giant Cell Arteritis: Subgroup Analysis of the SELECT-GCA Phase 3 Trial
Peter Merkel¹, Arathi Setty², Ricardo Blanco-Alonso³, Ravi Suppiah⁴, Thomas Daikeler⁵, Valerie Devauchelle⁶, Elisabeth Brouwer⁷, Hiromichi Tamaki⁸, Liu Meng², Yang Yang², Avani Joshi², Charles Phillips², Peter K. Wung² and Cristina Ponte⁹, ¹Division of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, ²AbbVie, North Chicago, IL, ³Division of Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL, Immunopathology group, Santander, Spain, ⁴Health New Zealand, Te Toka Tumai Auckland, Auckland, New Zealand, ⁵university hospital, Basel, Switzerland, ⁶UBO, Brest, France, ⁷University Medical Center Groningen, Groningen, Netherlands, ⁸St. Luke's International Hospital, Tokyo, Japan, ⁹Unidade Local de Saúde Santa Maria, Serviço de Reumatologia e Doenças Ósseas Metabólicas, Lisboa, Portugal., Lisbon, Portugal
Background/Purpose: Giant cell arteritis (GCA) is a chronic systemic vasculitis with limited targeted therapeutic options. The recent SELECT-GCA phase 3 trial demonstrated a favorable benefit-risk…
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: 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: 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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