Abstracts tagged "clinical trial"

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.…
Abstract Number: 0357 • ACR Convergence 2024
Evaluating Meaningful Within-Person Change Thresholds in PROMIS-Fatigue Scores from Three Phase 3 Clinical Trials of Sarilumab for Rheumatoid Arthritis Using Empirical Cumulative Distribution Function (eCDF) Curves
Clifton Bingham¹, Emily Molina², Amy Praestgaard³, Stefano Fiore³ and David Cella⁴, ¹Johns Hopkins University, Baltimore, MD, ²Johns Hopkins, Baltimore, MD, ³Sanofi, Bridgewater, NJ, ⁴Northwestern University, Chicago, IL
Background/Purpose: To evaluate changes over time in fatigue measured by Patient Reported Outcome Measures Information System (PROMIS)-Fatigue scores in rheumatoid arthritis (RA) patients treated with…
Abstract Number: 0601 • ACR Convergence 2024
Early Improvement of Pain, Long-Term Disease Control, and Quality of Life Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib
Peter C. Taylor¹, Lihi Eder², Yael Klionsky³, Fabian Proft⁴, Thomas Iyile⁵, Erin Mancl⁶, Priscila Magalhaes Reis Nakasato⁷, Xiaolan Ye⁸, Limei Zhou⁶ and Philip Mease⁹, ¹University of Oxford, Oxford, United Kingdom, ²University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada, ³Division of Rheumatology, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, NC, ⁴Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ⁵AbbVie Inc., hyattsville, MD, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., Randolph, NJ, ⁸AbbVie Inc., Mettawa, IL, ⁹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA

Background/Purpose: Severe musculoskeletal manifestations of PsA, particularly joint pain, can result in reduced physical function, decreased quality of life, and progressive and irreversible joint damage.1,2…
Abstract Number: 0770 • ACR Convergence 2024
Efficacy and Safety of Upadacitinib in Patients with Giant Cell Arteritis (SELECT-GCA): A Double-Blind, Randomized Controlled Phase 3 Trial
Peter Merkel¹, Sara Penn², Arathi Setty², Wolfgang Schmidt³, Andrea Rubbert-Roth⁴, Ellen Margrethe Hauge⁵, Helen Keen⁶, Tomonori Ishii⁷, Nader Khalidi⁸, Liu Meng², weihan zhao², Ivan Lagunes⁹, Ana B. Romero², Peter Wung¹⁰ and daniel blockmans¹¹, ¹Division of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, ²AbbVie, North Chicago, IL, ³Immanuel Krankenhaus Berlin, Berlin, Germany, ⁴Cantonal Hospital St Gallen, St Gallen, Switzerland, ⁵Aarhus Universitetshospital, Aarhus, Denmark, ⁶University of Western Australia, Daglish, Western Australia, Australia, ⁷Tohoku Medical and Pharmaceutical University / Department of Hematology and Rheumatology, sendai, Japan, ⁸McMaster University, Hamilton, ON, Canada, ⁹Abbvie, Inc, North Chicago, IL, ¹⁰AbbVie Inc., North Chicago, IL, ¹¹Department of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium; Department of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium, Leuven, Belgium
Background/Purpose: The objective was to assess the efficacy and safety of UPA vs placebo (PBO), in combination with a GC taper regimen, in patients with…
Abstract Number: 1184 • ACR Convergence 2024
Sustained Clinical Effects After a Single Intra-articular Injection of PCRX-201 for Moderate-to-Severe Osteoarthritis of the Knee
Stanley Cohen¹, Philip G Conaghan², Marc Hochberg³, Alan Kivitz⁴, Nino Joy⁵, Derek Jackson⁵, Masato Nakazawa⁵, Mary DiGiorgi⁵ and Jonathan Slonin⁵, ¹Metroplex Clinical Research Center, dallas, TX, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ³University of Maryland School of Medicine, Baltimore, MD, ⁴Altoona Center for Clinical Research, Duncansville, PA, ⁵Pacira BioSciences, Inc., Tampa, FL
Background/Purpose: Osteoarthritis of the knee (OAK) is a common and severe disease. Current treatments provide temporary pain relief, demonstrating unmet need. PCRX-201 is a high…

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