Abstracts tagged "clinical trial"

Abstract Number: 1327 • ACR Convergence 2023
Effects of Long-Term Low Dose Glucocorticoid Treatment for Rheumatoid Arthritis on Body Weight and Blood Pressure: A Pooled Analysis of Individual Patient Data from Five Randomised Trials
Andriko Palmowski¹, Sabrina Mai Nielsen², Zhivana Boyadzhieva³, Linda Hartman⁴, Judith Oldenkott⁵, Björn Svensson⁶, Ingiäld Hafström⁷, Siegfried Wassenberg⁸, Ernest Choy⁹, John Kirwan¹⁰, Robin Christensen¹¹, Maarten Boers¹² and Frank Buttgereit¹³, ¹Charité - Universitätsmedizin Berlin, Berlin, Germany, ²The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, ³Charité Universitatsmedizine - Berlin, Berlin, Germany, ⁴Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁵Charite - University Medicine Berlin, Berlin, Germany, ⁶Lund University, Lund, Sweden, ⁷Karolinska Institutet, Stockholm, Sweden, ⁸Rheumazentrum Ratingen, Ratingen, Germany, ⁹Section of Rheumatology, Cardiff University, Cardiff, United Kingdom, ¹⁰University of Bristol, Bristol, United Kingdom, ¹¹Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Denmark, ¹²Amsterdam UMC, Vrije Universiteit, Amersfoort, Netherlands, ¹³Charité Universitätsmedizin, Dept. Rheumatology, Berlin, Germany
Background/Purpose: High-dose glucocorticoids (GCs) can cause weight gain and hypertension. It is unclear whether GCs at ≤7.5mg/day prednisone equivalent ("low dose"), administered for rheumatoid arthritis…
Abstract Number: 1496 • ACR Convergence 2023
Clinical Safety and Efficacy Results from EQUALISE Type B: A Phase 1b Open-label Clinical Study of Itolizumab, a Novel anti-CD6 Therapy, in Subjects with Active Proliferative Lupus Nephritis
Kenneth Kalunian¹, Robert Levin², Sreejith Parameswaran³, nelson kopyt⁴, Stephen Connelly⁵, Eugene Sun⁵, Katie Kim⁵, maple fung⁵ and Manish Rathi⁶, ¹University of California San Diego, La Jolla, CA, ²South Florida University, Tampa, FL, ³JIPMER, New Delhi, India, ⁴LeHigh University, LeHigh, PA, ⁵Equillium, La Jolla, CA, ⁶Postgraduate Institute of Medical education and Research, Chandigarh, India
Background/Purpose: Itolizumab is a first-in-class, non-depleting, monoclonal antibody against the co-stimulatory receptor CD6 that blocks its interaction with ALCAM, to inhibit Teff cell activity and…
Abstract Number: 1883 • ACR Convergence 2023
Thalamocortical Mechanisms of a Remote Mind-body Intervention for Knee Osteoarthritis Pain
Jian Kong¹, Valeria Sacca¹ and Chenchen Wang², ¹Massachusetts General Hospital, Boston, MA, ²Center of Integrative Medicine and Division of Rheumatology, Tufts Medical Center, Boston, MA
Background/Purpose: Studies found that individuals with pain exhibit altered thalamocortical rhythm, abnormal function, and structural connectivity within the network. Effective treatment may relieve pain by…
Abstract Number: 2176 • ACR Convergence 2023
Cellular and Proteomic Changes Following Administration of Peresolimab, in a Phase 2a Trial in Rheumatoid Arthritis
Robert J. Benschop¹, Jay Tuttle¹, Paul Emery², Christoph Preuss¹, Mark Daniels¹, Veavi Ching-Yun Chan¹, Pia Yachi¹ and Ajay Nirula¹, ¹Eli Lilly and Company, Indianapolis, IN, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Background/Purpose: Peresolimab is a humanized immunoglobulin G1 monoclonal antibody that stimulates human programmed cell death protein 1 (PD-1). Peresolimab demonstrated superiority to placebo in Disease…
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…

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