Abstracts tagged "clinical trial"

Abstract Number: 2005 • ACR Convergence 2024
Impact of Anti-drug Antibodies on the Efficacy of SEL-212 in Patients with Chronic Gout Refractory to Conventional Therapy
Puja Khanna¹, Vibeke Strand², Atul Singhal³, Herbert Baraf⁴, Rehan Azeem⁵, Wesley DeHaan⁶, Sheldon Leung⁵, Hugues Santin-Janin⁷, Aletta Falk⁸ and Alan Kivitz⁹, ¹University of Michigan, Ann Arbor, MI, ²Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, ³Southwest Arthritis Research Group, Mesquite, TX, ⁴Center for Rheumatology and Bone Research, Wheaton, MD, ⁵Sobi Inc., Waltham, MA, ⁶Sobi, Inc, Waltham, MA, ⁷Sobi, BETTENDORF (68560), France, ⁸Sobi, Stockholm, Sweden, ⁹Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: SEL-212 is a once-monthly, investigational, two-component infusion therapy consisting of pegadricase (SEL-037, a pegylated uricase) and immune-tolerizing nanoparticles containing sirolimus (SEL-110), for the treatment…
Abstract Number: 2252 • ACR Convergence 2024
Long-term Efficacy of Filgotinib Monotherapy and Combination Therapy: Interim Results from a Post Hoc Analysis of the FINCH 4 Study
Maya H. Buch¹, Patrick Verschueren², Roberto Caporali³, Thomas Huizinga⁴, Edmund V. Ekoka Omoruyi⁵, Dick de Vries⁶, Jeffrey Ritsema⁷, Francesco De Leonardis⁸ and Daniel Aletaha⁹, ¹Division of Musculoskeletal & Dermatological Sciences, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Department of Rheumatology, University Hospital Leuven and KU Leuven, Leuven, Belgium, ³Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milan, Italy, ⁴Department of Rheumatology, Leiden University, Leiden, Netherlands, ⁵Biostatistics, Galapagos NV, Mechelen, Belgium, ⁶Clinical Development, Galapagos BV, Leiden, Netherlands, ⁷Medical Affairs, Galapagos BV, Leiden, Netherlands, ⁸Medical Affairs, Galapagos GmbH, Basel, Switzerland, ⁹Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Wien, Austria
Background/Purpose: Filgotinib (FIL) is a preferential Janus kinase 1 inhibitor for the treatment of moderate to severe RA. FINCH 4 (NCT03025308) is an ongoing, open-label,…
Abstract Number: 2478 • ACR Convergence 2024
Avacopan versus a Prednisone Taper in Patients with ANCA-Associated Vasculitis Without Kidney Involvement in a Phase 3 Trial
Christian Pagnoux¹, Antoine Neel², Sarah Bray³, Rachel E. Gurlin⁴, Darcy Trimpe⁵, David Jayne⁶ and Peter Merkel⁷, and ADVOCATE Study Group, ¹Mount Sinai Hospital, Toronto, ON, Canada, ²Department of Internal Medicine, CHU Nantes, Nantes, France, ³Amgen Ltd, Cambridge, United Kingdom, ⁴Amgen Inc., Mountain View, CA, ⁵Amgen Inc., Thousand Oaks, CA, ⁶University of Cambridge, Cambridge, United Kingdom, ⁷University of Pennsylvania, Philadelphia, PA
Background/Purpose: Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are subtypes of ANCA-associated vasculitis that frequently involve the kidneys. However, a subset of patients with…
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: 0593 • ACR Convergence 2024
Value of the Routine Assessment of Patient Index Data 3 in Assessing Disease Severity and Treatment Effect in Patients with Early Oligoarticular Psoriatic Arthritis Treated with Apremilast
Alvin F. Wells¹, Arthur Kavanaugh², William Tillett³, Philip S. Helliwell⁴, Marijn Vis⁵, Yuri Klyachkin⁶, Cynthia Deignan⁷, Lichen Teng⁷, Rebecca Wang⁷ and Alexis Ogdie⁸, ¹Rheumatology and Immunotherapy Center, Franklin, WI, ²University of California San Diego, La Jolla, CA, ³Royal National Hospital of Rheumatic Diseases; Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, ⁴Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK, Leeds, United Kingdom, ⁵Erasmus MC, Rotterdam, Netherlands, ⁶Amgen, Lexington, KY, ⁷Amgen Inc., Thousand Oaks, CA, ⁸Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: The Routine Assessment of Patient Index Data 3 (RAPID3) score is a composite of 3 patient-reported outcomes (PROs): Health Assessment Questionnaire (HAQ), pain visual…
Abstract Number: 0747 • ACR Convergence 2024
Clofutriben to Improve the Benefit-Risk Profile of Prednisolone in Patients with Polymyalgia Rheumatica
FRANK HARTMUT DR. BUTTGEREIT¹, Andrea Everding², Ioana Andreica³, Herbert Kellner⁴, Florian Schuch⁵, Tonya K Marmon⁶, Frank S Czerwiec⁷, Ketan Desai⁸ and David A Katz⁹, ¹Charité University Medicine Berlin, Berlin, Germany, ²Hamburger Rheuma Forschungszentrum II, Hamburg, Germany, ³Rheumazentrum Ruhrgebiet, Bochum, Germany, ⁴Schwerpunktpraxis f�r Rheumatologie und Gastroenterologie, Munich, Germany, ⁵PGRN, Erlangen, Germany, ⁶Marmon Biostatistics, Seattle, WA, ⁷Sparrow Pharmaceuticals, Portand, OR, ⁸IMC, Easton, PA, ⁹Sparrow Pharmaceuticals, Portland, OR
Background/Purpose: 11β-hydroxysteroid dehydrogenase type 1 (HSD-1) differentially regulates intracellular glucocorticoid levels in the immune system and glucocorticoid toxicity target organs. Clofutriben is a potent HSD-1…
Abstract Number: 1169 • ACR Convergence 2024
Efficacy of Intravenous Immunoglobulin (Octagam 10%) on Pulmonary Manifestations in Patients with Dermatomyositis: Results from the ProDERM Study
Rohit Aggarwal¹, christina Charles-Schoeman² and Joachim Schessl³, and the ProDERM Investigators, ¹Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, USA, Pittsburgh, PA, ²UCLA Medical Center, Santa Monica, CA, ³Friedrch-Baur-Institut; Ludwig-Maximilians University of Munich, Munich, Germany
Background/Purpose: Interstitial lung disease (ILD) and other pulmonary manifestations are a major cause of mortality and morbidity in patients with dermatomyositis (DM). The ProDERM study…
Abstract Number: 1427 • ACR Convergence 2024
Observed and Simulated Pharmacokinetics and Pharmacodynamics of Nipocalimab, a Fully Human FcRn Blocking Monoclonal Antibody, in Adults with Sjögren’s Disease: Results from a Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study
Sophia G. Liva¹, fudan Zheng¹, Jocelyn H. Leu², Kathy Sivils³, Keying Ma¹, He Li⁴, Steven Leonardo⁵, Kim Lo¹, Jada Idokogi¹, Kim Campbell¹ and Jonathan J. Hubbard¹, ¹Janssen Research & Development, LLC, a Johnson & Johnson Company, Spring House, PA, ²Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, PA, ³Johnson & Johnson Innovative Medicine, Edmond, OK, ⁴Janssen Research & Development, LLC, Therapeutics Discovery, Spring House, PA, ⁵Janssen Research & Development, LLC, a Johnson & Johnson Company, Cambridge, MA
Background/Purpose: Sjögren’s disease (SjD) is a chronic, progressive autoimmune disease characterized by aberrant B lymphocyte activity, elevated IgG production, and the presence of IgG autoantibodies…
Abstract Number: 1596 • ACR Convergence 2024
Efficacy of Eosinophil-Targeting Therapies According to Disease Severity in Patients with Eosinophilic Granulomatosis with Polyangiitis
Bernhard Hellmich¹, Peter Merkel², David Jayne³, Benjamin Terrier⁴, Florence Roufosse⁵, Parameswaran Nair⁶, Nader Khalidi⁶, David J. Jackson⁷, Shunsuke Furuta⁸, Lena Börjesson Sjö⁹, Sofia Necander⁹, Anat Shavit¹⁰, Claire Walton¹¹ and Michael Wechsler¹², ¹Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, ²University of Pennsylvania, Philadelphia, PA, ³University of Cambridge, Cambridge, United Kingdom, ⁴Service de Médecine interne, Hôpital Cochin, AP-HP, Paris, Ile-de-France, France, ⁵Department of Internal Medicine, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium, ⁶McMaster University and St Joseph’s Healthcare, Hamilton, ON, Canada, ⁷Guy’s Severe Asthma Centre, Guy’s and St Thomas’ NHS Trust; School of Immunology and Microbial Sciences, King’s College London, London, United Kingdom, ⁸Department of Allergy and Clinical Immunology, Chiba University Hospital, Chiba, Japan, ⁹Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹⁰BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ¹¹Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ¹²National Jewish Health, Denver, CO
Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare inflammatory disorder characterized by asthma, eosinophilia, and small-to-medium size vessel vasculitis, with individual manifestations widely ranging…
Abstract Number: 2008 • ACR Convergence 2024
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Dose of ABP-671 in Participants with Chronic Kidney Disease (CKD)
ullrich schwertschlag¹, william dongfang Shi², rOBERT PERRY³, Kwabena Ayesu⁴, rOY WU⁵, jerry liu⁶, JinSying Lin⁷ and Adam Jin⁸, ¹Atombio Science, PALO ALTO, CA, ²Jiangsu Atom Bioscience,, Suzhou, Jiangsu, China (People's Republic), ³Panax Clin Res, Miami Lakes, FL, ⁴OMEGARLLC, ORLANDO, FL, ⁵Atom Bioscience, SAN FRANCISCO, CA, ⁶atombio, San Diego, CA, ⁷Biostatconsulting, Wuzhong, Suzhou, Jiangsu, China (People's Republic), ⁸atom biosciences, Wuzhong, Suzhou, Jiangsu, China (People's Republic)
Background/Purpose: In this open-label Phase 1 study, 22 participants were enrolled in 3 cohorts, 10 participants with normal kidney function (eGFR ≥90 ml/min/1.73m2 and no…
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: 2480 • ACR Convergence 2024
Avacopan versus a Prednisone Taper in Patients with ANCA-Associated Vasculitis and Ear, Nose, or Throat Involvement in a Phase 3 Trial
Robert Spiera¹, Robert Lebovics², Sarah Bray³, Rachel E. Gurlin⁴, David Jayne⁵ and Peter Merkel⁶, and ADVOCATE Study Group, ¹Scleroderma, Vasculitis, and Myositis Center, Hospital for Special Surgery, Weill Cornell Medical College, New York, NY, ²Hackensack Meridian University Health System, Hackensack, NJ, ³Amgen Ltd, Cambridge, United Kingdom, ⁴Amgen Inc., Mountain View, CA, ⁵University of Cambridge, Cambridge, United Kingdom, ⁶University of Pennsylvania, Philadelphia, PA
Background/Purpose: In the phase 3 ADVOCATE trial, 45.2% and 42.1% of patients in the avacopan and prednisone taper groups, respectively, had active ear, nose, or…
Abstract Number: 0349 • ACR Convergence 2024
Impact of the Stanford University Chronic Pain Self-Management Education Program on Pain Severity, Pain Self-Efficacy, and Pain Disability in a Population with a High Prevalence of Arthritis
Dina Jones¹, Louise Murphy², Ranjita Misra¹, Teresa Brady³, Sijin Wen¹, Dana Guglielmo⁴, Maura Robinson¹, Samantha Shawley-Brzoska¹, Chong Li¹, Alison Vargovich⁵, Megan Burkart⁶ and Richard Vaglienti¹, ¹West Virginia University, Morgantown, WV, ²Consultant, Halifax, NS, Canada, ³Clarity Consulting and Communications, Atlanta, GA, ⁴Consultant, Los Angeles, CA, ⁵Private Practice, Buffalo, NY, ⁶West Virginia Unviverstiy, Morgantown, WV
Background/Purpose: In 2021, 51.6 million (20.9%) US adults reported chronic pain (CP). Arthritis is a leading cause of CP. The Stanford Chronic Pain Self-Management Program…
Abstract Number: 0600 • ACR Convergence 2024
Bimekizumab-Treated Patients with Active Psoriatic Arthritis Showed Sustained Reductions in Disease Impact Assessed by the Psoriatic Arthritis Impact of Disease (PsAID)-12 Questionnaire: Up to 2‑Year Results from Two Phase 3 Studies
Laure Gossec¹, Dafna Gladman², Laura Coates³, Maarten de Wit⁴, Barbara Ink⁵, Rajan Bajracharya⁵, Jason Coarse⁶, Jérémy Lambert⁷ and Ana-Maria Orbai⁸, ¹Sorbonne Université, Paris, France, ²University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ³University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, ⁴Stichting Tools, Patient Research Partner, Amsterdam, Netherlands, ⁵UCB Pharma, Slough, United Kingdom, ⁶UCB Pharma, Morrisville, NC, ⁷UCB Pharma, Colombes, France, ⁸Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD
Background/Purpose: Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits IL‑17F in addition to IL‑17A, has demonstrated sustained reductions in disease impact of PsA, assessed…
Abstract Number: 0750 • ACR Convergence 2024
Corticosteroid Withdrawal Using Tocilizumab and Its Association with Autoantibody Profile in Takayasu Arteritis: A Multicenter, Single-arm, Prospective Study
Tsuyoshi Shirai¹, Tomonori Ishii², Soshi Okazaki¹, Yuko Shirota³, Yusho Ishii⁴, Hiroko Sato¹ and Hiroshi Fujii¹, ¹Tohoku University, Sendai, Japan, ²Tohoku Medical and Pharmaceutical University / Department of Hematology and Rheumatology, sendai, Japan, ³Tohoku University Hospital / Department of Hematology and Rheumatology, Sendai, Japan, ⁴Tohoku university, Sendai, Miyagi, Japan
Background/Purpose: The application of molecular targeted drugs has been expanding in vasculitides. Takayasu arteritis (TAK) frequently relapses and tocilizumab (TCZ) and tumor necrosis factor inhibitors…

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