Abstracts tagged "clinical trial"

Abstract Number: 2340 • ACR Convergence 2023
Multi-targeted Therapy Better in Achieving Complete Response in Lupus Nephritis: A Systematic Review and Meta-analysis
Omer Pamuk¹, Bisma Shaikh², Saif Khan³, Ali Abbas⁴, Sarah Abi Doumeth⁵ and sarfaraz Hasni⁶, ¹University Hospitals Cleveland Medical Center, Cleveland, OH, ²Jinnah Sindh Medical University, Karachi, Pakistan, ³College of Medical and Dental Sciences, Birmingham, United Kingdom, ⁴Alabama College of Osteopathic Medicine, Dothan, AL, ⁵Case Western Reserve University/University Hospitals Cleveland Medical Center, Cleveland, OH, ⁶Lupus Clinical Trials Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health (NIH), Bethesda, MD
Background/Purpose: The overall management of SLE and Lupus Nephritis (LN) has significantly improved over the last four decades.Recently great therapeutic strides have been made in…
Abstract Number: 0354 • ACR Convergence 2023
Open-label Phase 3 Study of Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis: Pharmacokinetics, Effectiveness, Safety, and Immunogenicity over 252 Weeks
Nicolino Ruperto¹, Daniel J Lovell², Sarah Ringold³, Xie L. Xu⁴, Jocelyn H. Leu³, Edwin Lam³, Yuhua Wang³, Alberto Martini⁵ and Hermine Brunner⁶, ¹IRCCS Istituto Giannina Gaslini, UOSID Centro Trial, Genova, Italy, ²UC Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, OH, ³Janssen Research & Development, LLC, Spring House, PA, ⁴Janssen Research & Development, LLC, San Diego, CA, ⁵Universita degli Studi di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Genova, Italy, ⁶Cincinnati Children's Hospital Medical Center, Division of Rheumatology, Cincinnati, OH
Background/Purpose: The phase 3, Intravenous Golimumab in Pediatric Participants with Active Polyarticular-Course JIA Despite MTX (GO-VIVA) study demonstrated that golimumab (GLM) 80 mg/m2 at Week…
Abstract Number: 0596 • ACR Convergence 2023
Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in a Phase 2 Trial in Systemic Lupus Erythematosus (SLE): Achievement of Sustained SRI(4), BICLA and Dual Responses over 48 Weeks
Richard Furie¹, Cristina Arriens², Kenneth Kalunian³, Marilyn Pike⁴, Ronald van Vollenhoven⁵, Coburn Hobar⁶, Ayanbola Elegbe⁶, Samantha Pomponi⁶, Subhashis Banerjee⁶, Shalabh Singhal⁶, Thomas Wegman⁷ and Eric Morand⁸, ¹Northwell Health, Manhasset, NY, ²Oklahoma Medical Research Foundation and University of Oklahoma Health Sciences Center, Department of Arthritis & Clinical Immunology, Oklahoma City, OK, ³University of California San Diego, La Jolla, CA, ⁴MedPharm consulting, Inc., Raleigh, NC, ⁵Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁶Bristol Myers Squibb, Princeton, NJ, ⁷Bristol Myers Squibb, Beaver Falls, PA, ⁸Monash University, Centre for Inflammatory Diseases, Melbourne, Australia
Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor approved in multiple countries for the treatment of adults with plaque psoriasis. In…
Abstract Number: 0839 • ACR Convergence 2023
Efficacy and Safety of Nipocalimab in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA): The Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2a IRIS-RA Study
Peter C. Taylor¹, Georg Schett², Fowzia Ibrahim³, Bei Zhou⁴, Jocelyn H. Leu⁵, Sophia G. Liva⁵, Qingmin Wang⁵, Ricardo Rojo Cella⁵, Chetan S. Karyekar⁵ and Kaiyin Fei⁵, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, ³Janssen Research & Development, LLC, High Wycombe, United Kingdom, ⁴Janssen Research & Development, LLC, Chesterbrook, PA, ⁵Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: RA is a chronic inflammatory disease associated with autoantibodies. Despite the use of targeted therapies, up to half of patients fail to achieve remission…
Abstract Number: 1339 • ACR Convergence 2023
Neutrophil Activation and Formation of Neutrophil Extracellular Traps Are Associated with Response to Abatacept in Patients with Moderate to Severe Rheumatoid Arthritis
Ting Wang¹, Natalia V. Giltiay², Christian Lood² and Bobby Kwanghoon Han², ¹University of Washington, Seattle, WA, ²Division of Rheumatology, University of Washington, Seattle, WA
Background/Purpose: Neutrophil activation and formation of neutrophil extracellular traps (NETs) have been implicated in the pathogenesis of rheumatoid arthritis (RA). Calprotectin, a neutrophil activation marker,…
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…

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