Abstracts tagged "clinical trial"

Abstract Number: 1498 • ACR Convergence 2023
First-in-Human Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of DS-7011a, an Anti-TLR7 Antagonistic Monoclonal Antibody for the Treatment of Systemic Lupus Erythematosus
Giorgio Senaldi¹, Aparna Mohan¹, Li Zhang¹, Jun Tanaka², Grishma Pandya³, Sindee Grossman³, Sarah Urbina⁴, Steven Reynolds⁵ and Alan Hand⁴, ¹Daiichi Sankyo, Basking Ridge, NJ, ²Daiichi Sankyo, Inc., Basking Ridge, NJ, ³Daiichi Sankyo Inc., Basking Ridge, NJ, ⁴Worldwide Clinical Trials, San Antonio, TX, ⁵Cenexel, Los Alamitos, CA
Background/Purpose: Toll-like receptor (TLR)7 is a pattern recognition receptor, whose ligands include nucleic acids and whose activation is part of the pathogenesis of systemic lupus…
Abstract Number: 1922 • ACR Convergence 2023
Use of Plasma with High Titer Neutralizing Autoantibodies to Type I Interferons in Patients with Severe Refractory Flare-up of Hidradenitis Suppurativa as Novel Passive Immunotherapy Approach: Trial Protocol
Charline Vauchy¹, Maxime Desmarets¹, Paul Bastard², Anne Puel², Pascale Richard³, Jean Laurent Casanova², Pierre Tiberghien³, Eric Toussirot⁴ and Francois Aubin⁵, ¹INSERM CIC-1431, Besançon, France, ²IHU Imagine, AP-HP Necker, Paris, France, ³Etablissement Français du Sang, St. Denis, France, ⁴University Hospital of Besancon, Besançon, France, ⁵Dermatology, University Hospital of Besancon, Besançon, France
Background/Purpose: Hidradenitis suppurativa (HS) is a multifactorial auto-inflammatory disorder with a prevalence of 1% in North American and European populations. HS may be associated with…
Abstract Number: 2229 • ACR Convergence 2023
Individual Entheseal Points Have Differential Frequency of Involvement and Impact on Patient Reported Outcomes in Patients with Active Psoriatic Arthritis: Pooled Analysis of Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Studies
Laura Coates¹, Iain McInnes², Sibel Aydin³, Mitsumasa Kishimoto⁴, Philip J. Mease⁵, May Shawi⁶, Miriam Zimmermann⁷, Emmanouil Rampakakis⁸, Frederic Lavie⁹ and Dennis McGonagle¹⁰, ¹University of Oxford, Oxford, United Kingdom, ²University of Glasgow, Glasgow, United Kingdom, ³Department of Medicine, Ottawa Hospital Riverside Campus, Ottawa, ON, Canada, ⁴Kyorin University School of Medicine, Yokohoma, Japan, ⁵Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁶Immunology, Janssen Research & Development, LLC, Titusville, NJ, ⁷Immunology, Janssen Medical Affairs, LLC, Zug, Switzerland, ⁸McGill University, Department of Pediatrics / JSS Medical Research, Scientific Affairs, Montreal, QC, Canada, ⁹The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France, ¹⁰Leeds Biomedical Research Centre, University of Leeds, Leeds, United Kingdom
Background/Purpose: In patients with mono/oligoarticular psoriatic arthritis (PsA), swelling or tenderness of specific joints can be associated with poorer patient-reported outcomes (PROs) and physician global…
Abstract Number: 2342 • ACR Convergence 2023
Modulation of B Cell and Interferon Pathways by Ianalumab in Patients with Systemic Lupus Erythematosus: Findings from a Phase 2 Clinical Trial
Aida Santos da Costa¹, Thomas Dörner², Andrea Grioni¹, Alexandre Avrameas¹, Ulrike Sommer¹, Rainer Hillenbrand¹, Valeria De Luca¹, Enrico Ferrero¹, Andre Nogueira da Costa¹, Isabelle Isnardi¹ and Stephen J Oliver¹, ¹Novartis Pharma AG, Basel, Switzerland, ²Department of Medicine, Rheumatology and Clinical Immunology, Charité Universitätsmedizin and Deutsches Rheumaforschungszentrum, Berlin, Germany
Background/Purpose: Ianalumab (VAY736) is an afucosylated monoclonal antibody targeting the B cell activating factor receptor (BAFFR) that depletes B cells via enhanced antibody dependent cellular…
Abstract Number: 0360 • ACR Convergence 2023
Increasing the Etanercept Dose in Juvenile Idiopathic Arthritis Patients: Does It Help Reaching the Treatment Target? A Post-hoc Analysis of the Best4Kids Randomised Clinical Trial
Bastiaan van Dijk¹, Sytske Anne Bergstra¹, Merlijn van den Berg², Dieneke Schonenberg-Meinema², Lisette van Suijlekom-Smit², Marion van Rossum³, Yvonne Koopman⁴, Rebecca Ten Cate¹, CF Allaart¹, Danielle Brinkman¹ and Petra Hissink Muller¹, ¹Leiden University Medical Center, Leiden, Netherlands, ²Emma Children's Hospital, Amsterdam University Medical Centers, Amsterdam, Netherlands, ³Amsterdam Rheumatology and Immunology Center | Reade, Amstelveen, Netherlands, ⁴HagaZiekenhuis Juliana Children's Hospital, The Hague, Netherlands
Background/Purpose: The relation between etanercept dose and clinical outcomes of juvenile idiopathic arthritis (JIA) is unclear. Most studies only evaluated doses up to 0.8 mg/kg/week…
Abstract Number: 0598 • ACR Convergence 2023
Litifilimab Modulates Type I IFN Biomarkers in Patients with SLE or CLE in the Phase 2 LILAC Study
Richard Furie¹, Victoria Werth², Eric Milliman³, Kyle Ferber³, Fergal Casey³, Roland Brown³, Denitza Raitcheva³, Jad Zoghbi³, Danielle Graham³, George Kong³, Youmna Lahoud³, Nathalie Franchimont⁴ and Catherine Barbey⁵, ¹Northwell Health, Manhasset, NY, ²University of Pennsylvania and Corporal Michael J. Crescenz VAMC, Philadelphia, PA, ³Biogen, Cambridge, MA, ⁴Former employee of Biogen, Cambridge, MA, ⁵Biogen, Baar, Switzerland
Background/Purpose: Litifilimab is a humanized IgG1 mAb targeting BDCA2, a receptor expressed on plasmacytoid dendritic cells (pDCs), that negatively regulates the production of Type I…
Abstract Number: 0840 • ACR Convergence 2023
Head-to-Head Comparison of TLL-018 and Tofacitinib in Patients with Active Rheumatoid Arthritis: Final Results from a Phase IIa Study
Xiaofeng Zeng¹, chanyuan wu², Jiankang Hu³, SHENGYUN LIU⁴, Zhenyu Jiang⁵, Jingyang Li⁶, Xiaoxia Wang⁷, Ju Liu⁸, Chaofan Yuan⁹, Guang Yang¹⁰ and Chris Liang¹⁰, ¹Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, ²Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, ³Pingxiang People’s Hospital, PingXiang, China, ⁴The First Affiliated Hospital Of Zhengzhou University, Zhengzhou, China, ⁵The First Hospital of Jilin University, Changchun, China, ⁶Zhuzhou Central Hospital, Zhuzhou, China, ⁷Second Hospital of Shanxi Medical University, Taiyuan, China, ⁸Jiujiang No. 1 People’s Hospital, JiuJiang, China, ⁹Hangzhou Highlightll Pharmaceutical Co., Ltd, Beijing, China, ¹⁰Hangzhou Highlightll Pharmaceutical Co., Ltd, HangZhou, China
Background/Purpose: None of the currently approved treatments for rheumatoid arthritis (RA) can achieve ACR50 in >50% of the patients, and 5 – 20% of the…
Abstract Number: 1343 • ACR Convergence 2023
Cardiovascular (CV) and Malignancy Events in the Filgotinib Rheumatoid Arthritis (RA) Clinical Development Program up to 8.3 Years
Xavier Mariette¹, Sven Borchmann², Sandrine Aspeslagh³, Jaime Calvo- Alén⁴, Richard Moriggl⁵, Zoltan Szekanecz⁶, Francesco De Leonardis⁷, Nadia Verbruggen⁸, Paul Van Hoek⁹, Marc Schmalzing¹⁰, Andreas Stallmach¹¹, Christina Charles-Schoeman¹², Vijay Rajendran¹³, Christine Rudolph⁹, Chris Watson¹⁴, Yoshiya Tanaka¹⁵ and Ernest Choy¹⁶, ¹Université Paris-Saclay, Le Kremlin-Bicêtre, France, ²Department of Internal Medicine, University of Cologne, Cologne, Germany, ³Department of Medical Oncology, UZ Brussel, Brussels, Belgium, ⁴Rheumatology, Bioaraba Research Unit, Hospital Universitario Araba, Vitoria, Spain, ⁵Institute of Animal Breeding and Genetics, University of Veterinary Medicine, Vienna, Austria, ⁶Division of Rheumatology, University of Debrecen, Debrecen, Hungary, ⁷Medical Affairs, Galapagos GmbH, Basel, Switzerland, ⁸Biostatistics, Galapagos NV, Mechelen, Belgium, ⁹Medical Safety, Galapagos NV, Mechelen, Belgium, ¹⁰University Hospital, Rheumatology/Clinical Immunology, Department of Internal Medicine II, Würzburg, Germany, ¹¹Department of Internal Medicine, Jena University Hospital, Jena, Germany, ¹²UCLA Medical Center, Santa Monica, CA, ¹³Clinical Research, Galapagos NV, Mechelen, Belgium, ¹⁴Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹⁵University of Occupational and Environmental Health, Kitakyushu, Japan, ¹⁶Section of Rheumatology, Cardiff University, Cardiff, United Kingdom
Background/Purpose: Filgotinib (FIL) is a Janus kinase (JAK) 1 preferential inhibitor for the treatment of RA. Data from the ORAL Surveillance post-marketing study (NCT02092467) suggest…
Abstract Number: 1503 • ACR Convergence 2023
Disease Course and Complement as Predictors of Response to Standard of Care Plus Placebo in Patients with SLE: A Post Hoc Analysis of Dapirolizumab Pegol and Epratuzumab Clinical Trial Data
Christian Stach¹, Caroline Gordon², Vanessa Taieb³, George Stojan⁴ and Joan Merrill⁵, ¹UCB Pharma, Monheim am Rheim, Germany, ²Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom, ³UCB Pharma, Colombes, France, ⁴UCB, Baltimore, MD, ⁵Oklahoma Medical Research Foundation, Oklahoma City, OK
Background/Purpose: High placebo responses pose challenges to systemic lupus erythematosus (SLE) clinical trials.1This analysis aims to identify predictors of standard of care plus placebo (SOC+PBO)…
Abstract Number: 1946 • ACR Convergence 2023
Zetomipzomib Demonstrates Favorable Long-term Safety and Tolerability Profile Without Signs of Immunosuppression: Results from the PRESIDIO Study and Its Open-label Extension Study in Patients with Dermatomyositis and Polymyositis
Rohit Aggarwal¹, Namita Goyal², Diana Lam³, Allen Ng³, Richard Leff⁴, Kathryn Ray³, Eunmi Park³ and Noreen Henig³, ¹University of Pittsburgh, Pittsburgh, PA, ²UCI Health, Orange, CA, ³Kezar Life Sciences, South San Francisco, CA, ⁴Kezar Life Sciences, Chadds Ford, PA
Background/Purpose: Polymyositis (PM) and dermatomyositis (DM) are chronic autoimmune diseases characterized by muscle inflammation and weakness. In a collagen-induced myositis mouse model, immunoproteasome inhibition has…
Abstract Number: 2233 • ACR Convergence 2023
Neutrophil Levels Associate with Early Improvement in Spinal Pain and Week 24 Multi-Domain Disease Control During Guselkumab Treatment in Active Psoriatic Arthritis: Post Hoc Pooled Analyses of Two Phase 3 Randomized Controlled Trials
Thomas Macleod¹, Xenofon Baraliakos², Emmanouil Rampakakis³, Warner Chen⁴, Antonius Pieter J Van Den Heuvel⁴, Loqmane Seridi⁴, May Shawi⁵, Frederic Lavie⁶, Joseph F. Merola⁷, Proton Rahman⁸ and Dennis McGonagle⁹, ¹University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, ²Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ³McGill University, Department of Pediatrics / JSS Medical Research, Scientific Affairs, Montreal, QC, Canada, ⁴Translational Sciences, Janssen Research & Development, LLC, Spring House, PA, ⁵Immunology, Janssen Research & Development, LLC, Titusville, NJ, ⁶The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France, ⁷Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ⁸Craig Dobbin Research Institute, Memorial University, St. John's, NL, Canada, ⁹Leeds Biomedical Research Centre, University of Leeds, Leeds, United Kingdom
Background/Purpose: Neutrophils have potential pathogenic roles in chronic inflammatory diseases (e.g., neutrophilic cutaneous microabscesses in psoriasis, and neutrophils in the synovial fluid/tissue in PsA and…
Abstract Number: 2345 • ACR Convergence 2023
Paired Kidney Biopsies from the AURORA 2 Study of Voclosporin in Active Lupus Nephritis
Samir Parikh¹, Salem Almaani², Arnon Arazi³, Huijuan Song¹, Pearlly Yan¹, Estela Puchulu-Campanella¹, Clint Abner⁴, Ernie Yap⁴, Krista Piper⁴, Robert B. Huizinga⁵ and Henry Leher⁴, ¹Ohio State University, Columbus, OH, ²Ohio State University Medical Center, Columbus, OH, ³Broad Institute of MIT and Harvard, Melrose, MA, ⁴Aurinia Pharmaceuticals Inc., Edmonton, AB, Canada, ⁵Reformation Consulting Services, North Saanich, BC, Canada
Background/Purpose: Voclosporin is approved for the treatment of adults with active lupus nephritis. Addition of voclosporin to mycophenolate mofetil (MMF) and low-dose glucocorticoids in the…
Abstract Number: 0372 • ACR Convergence 2023
Efficacy and Safety of Secukinumab in Juvenile Idiopathic Arthritis: Interim Results from the Extension of the JUNIPERA Trial
Hermine Brunner¹, Ivan Foeldvari², Ekaterina Alexeeva³, Nuray Aktay Ayaz⁴, Grant Schulert⁵, Seza Ozen⁶, Artem Popov⁷, Athimalaipet V Ramanan⁸, Christiaan Scott⁹, Betul Sozeri¹⁰, Elena Zholobova¹¹, Sudhanshu Chakraborty¹², Xuan Zhu¹³, Ruvie Martin¹³, Sarah Whelan¹⁴, Sharonjeet Kaur¹⁵, Luminita Pricop¹³, Daniel J Lovell¹⁶, Alberto Martini¹⁷ and Nicolino Ruperto¹⁸, ¹Cincinnati Children's Hospital Medical Center, Division of Rheumatology, Cincinnati, OH, ²Hamburger Zentrum fuer Kinder und Jugendrheumatologie, Rheumatology, Hamburg, Germany, ³National Scientific and Practical Center of Children's Health, Rheumatology, Moscow, Russia, ⁴Department of Pediatric Rheumatology, Faculty of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey, ⁵Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ⁶Hacettepe University Medical Faculty, Ankara, Turkey, ⁷Ural State Medical University Ekaterinburg, Sverdlovsk, Russia, ⁸Bristol Royal Hospital for Children & Translational Health Sciences, University of Bristol, Bristol, United Kingdom, ⁹Department of Paediatric Rheumatology, Red Cross War Memorial Children’s Hospital, University of Cape Town, Cape Town, South Africa, ¹⁰Division of Pediatric Rheumatology, University of Health Sciences, Ümraniye Training and Research Hospital, Istanbul, Turkey, ¹¹First Moscow State Medical University, n.a. I.M.Sechenov, Moscow, Russia, ¹²IQVIA, Durrham, NC, ¹³Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁴Novartis Ireland Ltd, Dublin, Ireland, ¹⁵Novartis Pharma AG, Basel, Switzerland, ¹⁶UC Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, OH, ¹⁷Università di Genova, Genova, Italy, ¹⁸IRCCS Istituto Giannina Gaslini, UOSID Centro Trial, Genova, Italy
Background/Purpose: Secukinumab has demonstrated efficacy and safety in patients with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) categories of juvenile idiopathic arthritis (JIA) for…
Abstract Number: 0600 • ACR Convergence 2023
Identification of Subsets of SLE Patients Responsive to Baricitinib by Transcriptomic Analysis at Baseline
Prathyusha Bachali¹, Amrie Grammer² and Peter Lipsky², ¹AMPEL BioSolutions, Redmond, WA, ²AMPEL BioSolutions, Charlottesville, VA
Background/Purpose: Baricitinib is an inhibitor of Jak1 approved for treatment of rheumatoid arthritis, atopic dermatitis, alopecia areata and Covid-19. A phase 2 trial showed success…
Abstract Number: 1104 • ACR Convergence 2023
Dotinurad, a Potent and Selective Uricosuric Agent, Exhibited Promising Pharmacokinetics and Pharmacodynamic Profiles to Significantly Reduce Serum Urate Levels Following Once Daily Dosing in Healthy U.S. Subjects in a Phase 1 Clinical Trial
Scott Baumgartner, Raymond Zheng, Mark Harnett and Jay Kranzler, Urica Therapeutics Inc., New York, NY
Background/Purpose: Dotinurad is a potent and selective URAT1 inhibitor that has been approved as a once-daily drug for the treatment of hyperuricemia with or without…

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].