Abstracts tagged "clinical trial"

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…
Abstract Number: 1175 • ACR Convergence 2024
Physical Activity and Symmetry Following Total Knee Arthroplasty:Results of an Exploratory Trial
Kelli Allen¹, Liubov Arbeeva², Daniel Bracey³, Derek Hales³, Carla Hill⁴, Katie Huffman⁵, Todd Schwartz⁶ and Robin Queen⁷, ¹University of North Carolina, Durham, NC, ²University of North Carolina, Chapel Hill, Carrboro, NC, ³University of North Carolina at Chapel HIll, Chapel Hill, NC, ⁴UNC Health, Raleigh, NC, ⁵UNC Thurston Arthritis Research Center, Chapel Hill, NC, ⁶University of North Carolina-Chapel Hill, Chapel Hill, NC, ⁷Virginia Tech, Blacksburg, VA
Background/Purpose: Studies have identified two key deficits in individuals’ activity-related trajectories following total knee arthroplasty (TKA). First, overall physical activity (PA) levels remain very low.…
Abstract Number: 1453 • ACR Convergence 2024
Efficacy and Safety of the Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection (XKH004) in Patients with Active Ankylosing Spondylitis: Findings from a 24-Week, Phase 2 Multicenter, Randomized, Placebo-Controlled Study
Ling Zhou¹, Juan Zhao¹, Lingyun Sun², Xuan Zhang³, Xiaomei Li⁴, Jiankang Hu⁵, Lijun Wu⁶, Zhenyu Jiang⁷, Min Yang⁸, Xiaoxia Wang⁹, Yongjun Mei¹⁰, Qingchun Huang¹¹, Yongtao Chen¹², Yang Li¹³, Lingli Dong¹⁴, Hui Luo¹⁵, Li Guo¹⁶, Jianguo You¹⁶, Yunpeng Zhang¹⁶, Ke Ren¹⁶ and Huji Xu¹, ¹Shanghai Changzheng Hospital, Shanghai, China (People's Republic), ²Nanjing Drum Tower Hospital, Nanjing, China (People's Republic), ³Beijing Hospital, Beijing, China, ⁴The First Affiliated Hospital of University of Science and Technology of China, Anhui, China (People's Republic), ⁵Department of Rheumatology, Pingxiang People's Hospital, Pingxiang, China, Pingxiang, China (People's Republic), ⁶People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China (People's Republic), ⁷The First Hospital of Jilin University, Changchun, China (People's Republic), ⁸Nanfang Hospital, Guangzhou, China (People's Republic), ⁹Second Hospital of Shanxi Medical University, Taiyuan, China (People's Republic), ¹⁰The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, ¹¹The Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China (People's Republic), ¹²West China Hospital, Sichuan University, Chengdu, China (People's Republic), ¹³Guangdong Provincial People's Hospital, Guangzhou, China (People's Republic), ¹⁴Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (People's Republic), ¹⁵Xiangya Hospital, Central South University, Changsha, China (People's Republic), ¹⁶Kanova Biopharma, Zhejiang, China (People's Republic)
Background/Purpose: XKH004, the first recombinant anti-human IL-17A/F humanized monoclonal antibody in China (also known as XKH004), shares the same therapeutic target as Bimekizumab from UCB…
Abstract Number: 1603 • ACR Convergence 2024
Antineutrophil Cytoplasmic Autoantibody Levels in Patients in the Avacopan Phase 3 Trial
Frank B. Cortazar¹, Duvuru Geetha², Salem Almaani³, Christina Song⁴, Tomasz M. Wilmanski⁴, Alana M. Bozeman⁴, Peter Merkel⁵ and David Jayne⁶, and ADVOCATE Study Group, ¹New York Nephrology Vasculitis and Glomerular Center, Saint Peter’s Hospital-Albany, Albany, NY, ²Johns Hopkins University, Baltimore, MD, ³The Ohio State University Medical Center, Columbus, OH, ⁴Amgen Inc., Thousand Oaks, CA, ⁵University of Pennsylvania, Philadelphia, PA, ⁶University of Cambridge, Cambridge, United Kingdom
Background/Purpose: The utility of measuring serial antineutrophil cytoplasmic autoantibody (ANCA) levels to guide treatment in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) is controversial.…
Abstract Number: 2012 • ACR Convergence 2024
Safety, Tolerability and Efficacy of Pegloticase Administered with a Shorter Infusion Duration in Subjects with Uncontrolled Gout Receiving Methotrexate: Primary Findings of the AGILE Open-label Trial
Orrin Troum¹, John Botson², Fang Fang³, Katie Obermeyer³, Supra Verma³ and Brian LaMoreaux⁴, ¹Providence Health Care/Doctor's of St John's (MDSJ) Santa Monica, CA, Santa Monica, CA, ²Orthopedic Physicians Alaska, Anchorage, AK, ³Amgen, Inc., Thousand Oaks, CA, ⁴Amgen, Inc., Deerfield, IL
Background/Purpose: Pegloticase, infused every 2 weeks over ≥2 hrs, lowers serum urate (SU) in patients with refractory gout. Decreasing infusion time is expected to improve…
Abstract Number: 2281 • ACR Convergence 2024
Assessment of Comparative Efficacy Between Candidate Biosimilar AVT05 and Reference Golimumab
Monica Luque¹, Kristina Zhelyazkova¹, Laxmikant Vashishta², Masna Rai³, Abid Sattar⁴, Richard Bucknall⁴, Steffen Leutz³ and FAUSTO BERTI¹, ¹Alvotech, Zürich, Switzerland, ²Alvotech, Bangalore, India, ³Alvotech, Jülich, Germany, ⁴Alvotech, London, United Kingdom
Background/Purpose: Golimumab is a safe and effective treatment for RA. Biosimilars to the reference product (RP) may make treatment more accessible. We assessed comparable efficacy…
Abstract Number: 2482 • ACR Convergence 2024
Long-Term Safety of Mepolizumab in Eosinophilic Granulomatosis with Polyangiitis (EGPA): Pooled Results from Two Open-Label Extension Studies
Gerhard Wolff¹, Michael E Wechsler², Jared Silver³, Robert Price⁴, Rejina Verghis⁵, Peter Weller⁶, Peter Merkel⁷, Thomas Corbridge⁸ and Paneez Khoury⁹, ¹Clinical Development-Respiratory, GSK, Collegeville, ²Department of Medicine, National Jewish Health, Denver, CO, ³US Medical Affairs-Respiratory, GSK, Durham, ⁴Biostatistics, GSK, Stevenage, United Kingdom, ⁵Biostatistics, Development Respiratory, GSK, Brentford, United Kingdom, ⁶Beth Israel Deaconess Medical Center, Department of Medicine, Division of Allergy and Inflammation, Harvard Medical School, Boston, MA, ⁷Division of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, ⁸US Value Evidence and Outcomes, GSK, Durham, NC, ⁹National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD
Background/Purpose: The 52-week Phase III MIRRA trial demonstrated the safety and efficacy of anti-IL-5 mepolizumab in patients with EGPA. However, longer-term safety data are limited.…

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