Abstracts tagged "clinical trial"

Abstract Number: L05 • ACR Convergence 2024
Prolonged Plasma Urate-Lowering After a Single Intravenous Administration of PRX-115, a Novel PEGylated Uricase, in Participants with Elevated Urate Levels
Christian Schwabe¹, Orit Cohen Barak², Alexandra Cole³, Hadar Reuveni², Liron Shelev², Liora Blinder-Haddad² and Nicola Dalbeth⁴, ¹NZCR, Auckland, New Zealand, ²Protalix Ltd, Karmiel, Israel, ³NZCR, Christchurch, New Zealand, ⁴University of Auckland, Auckland, New Zealand
Background/Purpose: PEGylated uricases have already demonstrated therapeutic modality in the treatment of refractory gout patients. PRX-115 is a recombinant homotetrameric uricase enzyme, produced from Candida…
Abstract Number: L09 • ACR Convergence 2024
Efficacy and Safety of Tofacitinib in Patients with Active Systemic Juvenile Idiopathic Arthritis
Hermine Brunner¹, Caifeng Li², Kogie Chinniah³, Yosef Uziel⁴, Olga Synoverska⁵, Sujata Sawhney⁶, Inmaculada Calvo Penades⁷, Ingrid Clara Louw⁸, Meiping Lu⁹, Pooja Nikunj Patel¹⁰, Pamela F. Weiss¹¹, Cheng Chang¹², Ivana Vranic¹³, Shixue Liu¹⁴, Annette Diehl¹⁵, Jose L. Rivas¹⁶, Carol A. Connell¹⁷, Gary G. Koch¹⁸, Alberto Martini¹⁹, Daniel J. Lovell¹, Nicolino Ruperto²⁰ and the PRINTO and PRCSG investigators, ¹Cincinnati Children’s Hospital Medical Center, and University of Cincinnati, Cincinnati, OH, ²Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, Bejing, China, ³Department of Paediatrics and Child Health, University of Kwa-Zulu, and Enhancing Care Foundation, Durban, South Africa, ⁴Pedriatric Rheumatology Unit, Department of Pediatrics, Meir Medical Center and Israel Tel Aviv University School of Medicine, Kfar Saba, Israel, ⁵Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine, ⁶Sir Ganga Ram Hospital, New Delhi, India, ⁷Hospital Universitario y Politécnico La Fe, Valencia, Spain, ⁸Panorama Medical Centre, Cape Town, South Africa, ⁹Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China, ¹⁰Ann & Robert H. Lurie Children’s Hospital of Chicago; Northwestern University School of Medicine, Chicago, IL, ¹¹Division of Rheumatology, Children's Hospital of Philadelphia, and University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, ¹²Pfizer Inc, New York, NY, ¹³Pfizer Ltd, Tadworth, United Kingdom, ¹⁴Pfizer Inc, Shanghai, China, ¹⁵Pfizer Inc, Collegeville, PA, ¹⁶Pfizer SLU, Madrid, Spain, ¹⁷Pfizer Inc, Groton, CT, ¹⁸University of North Carolina at Chapel Hill, Chapel Hill, NC, ¹⁹University of Genoa, Genoa, Italy, ²⁰Università Milano Bicocca, Milano, and IRCCS Fondazione San Gerardo dei Tintori, Monza, Italy
Background/Purpose: Tofacitinib (TOF) has been shown to be efficacious in the treatment of polyarticular course JIA, including systemic JIA (sJIA) without active systemic features. Here…
Abstract Number: L10 • ACR Convergence 2024
Neuroimmune Modulation in Adults with Rheumatoid Arthritis and Inadequate Response or Intolerance to Biological or Targeted Synthetic DMARDs: Results at 12 and 24 Weeks from a Randomized, Sham-Controlled, Double-Blind Pivotal Study
John Tesser¹, Joshua June², Pendleton Wickersham³, Jane Box⁴, Guillermo Valenzuela⁵, Angela Crowley⁶, Nikila Kumar⁷, Norman Gaylis⁸, Gordan Lam⁹, David Ridley¹⁰, Gineth Paola Pinto-Patarroyo¹¹ and David Chernoff¹², ¹Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ²Great Lakes Center of Rheumatology, Lansing, MI, ³Arthritis Associates PA, San Antonio, TX, ⁴DJL Clinical Research, PLLC, Charlotte, NC, ⁵Guillermo Valenzuela MD PA/ IRIS Rheumatology, Plantation, FL, ⁶Illinois Bone and Joint Institute - Hinsdale Orthopaedics, Hinsdale, IL, ⁷Arizona Arthritis & Rheumatology Associates, Scottsdale, AZ, ⁸Arthritis & Rheumatic Disease Specialties, Aventura, FL, ⁹Arthritis & Osteoporosis Consults of the Carolinas, Charlotte, NC, ¹⁰St. Paul Rheumatology, Eagan, MN, ¹¹Annapolis Rheumatology, Fairfax, VA, ¹²SetPoint Medical, Sausalito, CA
Background/Purpose: In this study, we evaluated the safety and efficacy of an implantable, cervical vagus nerve stimulation device for treatment of RA. Methods: This randomized,…
Abstract Number: L16 • ACR Convergence 2024
Dapirolizumab Pegol Demonstrated Significant Improvement in Systemic Lupus Erythematosus Disease Activity: Efficacy and Safety Results of a Phase 3 Trial
Megan Clowse¹, David Isenberg², Joan Merrill³, Thomas Dörner⁴, Michelle Petri⁵, Edward Vital⁶, Eric Morand⁷, Teri Jimenez⁸, Stephen Brookes⁹, Janine Gaiha-Rohrbach¹⁰, Christophe Martin¹¹, Annette Nelde¹² and Christian Stach¹³, ¹Division of Rheumatology and Immunology, Duke University, Durham, NC, ²Department of Ageing, Rheumatology and Regenerative Medicine, Division of Medicine, University College London, London, United Kingdom, ³Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁴Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany, ⁵Johns Hopkins University School of Medicine, Baltimore, MD, ⁶Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁷Centre for Inflammatory Diseases, Monash University, Melbourne, Australia, ⁸UCB, Raleigh, NC, ⁹Biogen, Maidenhead, United Kingdom, ¹⁰Biogen, Cambridge, MA, ¹¹UCB, Slough, United Kingdom, ¹²Biogen, Baar, Switzerland, ¹³UCB, Monheim am Rhein, Germany
Background/Purpose: Dapirolizumab pegol (DZP) is a novel, polyethylene glycol (PEG)-conjugated antigen-binding (Fab') fragment, lacking an Fc domain, that inhibits CD40L signaling. By binding to CD40L,…
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…
Abstract Number: 1457 • ACR Convergence 2024
Treat-to-Target Approaches in Early Psoriatic Arthritis: Early Secukinumab versus Standard Care – 12- and 24-Week Results from a Multicenter, Open-Label, Randomized Controlled Trial
Gonul Hazal Koc¹, Marc R. Kok², Fazira R. Kasiem³, Jolanda Luime³, Ilja Tchetverikov⁴, Kim Wilhelm - de Jong³, Lindy A. Korswagen⁵, Jessica Bijsterbosch⁶, Yvonne P. M. Goekoop-Ruiterman⁷, Paul Baudoin⁸, Petra Kok⁹, Reinhard Bos¹⁰, radboud J.e.m. Dolhain¹¹ and Marijn Vis³, ¹Erasmus MC, Rotterdam, Zuid-Holland, Netherlands, ²Maasstad Hospital, Rotterdam, Netherlands, ³Erasmus MC, Rotterdam, Netherlands, ⁴Albert Schweitzer Hospital, Dordrecht, Netherlands, ⁵Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands, ⁶Amphia Hospital, North Brabant, Netherlands, ⁷Haga Hospital, Den Haag, Netherlands, ⁸Reumazorg Zuid West Nederland, Roosendaal, Netherlands, ⁹Reinier de Graaf Gasthuis, Delft, Netherlands, ¹⁰Medical Center Leeuwarden, Leeuwarden, Netherlands, ¹¹Department of Rheumatology, Erasmus University Medical Center, Rotterdam, Netherlands
Background/Purpose: The Strategy Treatments aiming at Minimal Disease Activity in PsA (STAMP) is a one-year randomized controlled trial designed to investigate the efficacy of two…
Abstract Number: 1669 • ACR Convergence 2024
Will Investigators Enroll? A Vignette Study to Gauge Investigator Equipoise in a Trial of Surgery vs. Nonoperative Therapy in Subjects with Meniscal Tear and Persistent Pain Following Physical Therapy
Jeffrey Katz¹, Faith Selzer², Katharine Fox³, Jon Dhani³, Kyna Long³, Andrea Carland⁴, Tiffany Thavison⁴, Leslie Bisson⁴, Morgan Jones³, Katherine Krupa³ and Nomi Weiss-laxer⁵, ¹Brigham and Women's Hospital, Brookline, MA, ²Brigham and Women's Hospital, Amesbury, MA, ³Brigham and Women's Hospital, Boston, MA, ⁴University at Buffalo, Buffalo, NY, ⁵U, Buffalo, NY
Background/Purpose: Clinician investigators may be unwilling to enroll all eligible subjects into randomized controlled trials (RCTs) because they feel certain subjects would benefit more from…
Abstract Number: 2016 • ACR Convergence 2024
Treat to Target in Gout Yields Superior Outcomes Compared to Treat to Avoid Symptoms Approach (results from the Gout TrEatment Strategy Overture Trial)
Anusha Moses¹, Martijn Oude Voshaar¹, Tim L.Th. Jansen² and Mart Van De Laar¹, ¹University of Twente, Enschede, The Netherlands, Enschede, Overijssel, Netherlands, ²1VieCuri Medisch Centrum, Venlo, Netherlands
Background/Purpose: Both the European League Against Rheumatism (EULAR) and the American College for Rheumatology (ACR) state that gout can be effectively managed by reducing sUA…
Abstract Number: 2285 • ACR Convergence 2024
Safety and Tolerability of a Combination of Curcumin, Omega-3 and Vitamin-D: Results from the PASCOD Study, an RA Prevention Protocol
Halle Cochrane, Caitlin Mcfadyen, Kale Mayor, Rhonda Silva, Kristin James, Xiaobo Meng, Dylan Mackay, Hani El-Gabalawy and Liam O'Neil, University of Manitoba, Winnipeg, MB, Canada
Background/Purpose: Rheumatoid Arthritis (RA) is a progressive inflammatory autoimmune disease affecting 1% of the global population for which there is currently no cure. Recent research…
Abstract Number: 2515 • ACR Convergence 2024
Upadacitinib for Refractory Behçet’s Syndrome: A Multi-center, Prospective, Open-label, Pilot Study
Weiyi Xia¹, Jiachen Li¹, Tian Liu¹ and Yuhui Li², ¹Peking University People’s Hospital, Beijing, China, ²Peking University, BeiJing, China
Background/Purpose: The aim of this prospective cohort study is to evaluate the efficacy and safety of Janus kinase (JAK) inhibitor upadacitinib in refractory Behçet’s Syndrome…
Abstract Number: 0376 • ACR Convergence 2024
Preliminary Results of the Ondansetron Pre-medication Trial in Juvenile Idiopathic Arthritis: A Pragmatic Randomized Controlled Trial Nested in the CAPRI Registry
Gaelle Chedeville¹, Heinrike Schmeling², Jean-Philippe Proulx-Gauthier³, Michelle Batthish⁴, Jean Jacques De Bruycker⁵, Brian Feldman⁶, Roberta A Berard⁷, Roxana Bolaria⁸, Amieleena Chhabra⁹, Lily Lim¹⁰, Adam Huber¹¹, Matthew Berkowitz¹², Thomas Loughin¹² and Jaime Guzman¹³, and CAPRI Registry Investigators, ¹The Montreal Children's Hospital, Montreal, QC, Canada, ²University of Calgary, Calgary, AB, Canada, ³CHU de Quebec - Universite Laval, Quebec, QC, Canada, ⁴McMaster Children's Hospital, Hamilton, ON, Canada, ⁵UNIVERSITY OF MONTREAL, Montreal, QC, Montreal, QC, Canada, ⁶Division of Rheumatology, The Hospital for Sick Children; Departments of Pediatrics and Medicine, Faculty of Medicine; The Institute for Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada, ⁷London Health Sciences Centre, London, ON, Canada, ⁸Victoria Arthritis Center, Victoria, BC, Canada, ⁹University of British Columbia, Penticton, BC, Canada, ¹⁰University of Manitoba, Winnipeg, MB, Canada, ¹¹IWK Health Centre, Halifax, NS, Canada, ¹²Simon Fraser University, Burnaby, BC, Canada, ¹³University of British Columbia and BC Children's Hospital, Vancouver, BC, Canada
Background/Purpose: About 50% of children with Juvenile Idiopathic Arthritis (JIA) receiving methotrexate (MTX) develop MTX intolerance with severe anticipatory nausea/vomiting and avoidance behaviors. Intolerance often…
Abstract Number: 0602 • ACR Convergence 2024
Bimekizumab Impact on Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Core Domains for Patients with Psoriatic Arthritis: Results up to 2 Years of Treatment Duration
Joseph F. Merola¹, Philip Mease², Atul Deodhar³, Alice Gottlieb⁴, Barbara Ink⁵, Dirk de Cuyper⁶, Rajan Bajracharya⁵, Jérémy Lambert⁷, Jason Coarse⁸ and Laura Coates⁹, ¹UT Southwestern Medical Center, Dallas, TX, ²Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ³Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁴Icahn School of Medicine at Mount Sinai, Department of Dermatology, Seattle, WA, ⁵UCB Pharma, Slough, United Kingdom, ⁶UCB Pharma, Brussels, Belgium, ⁷UCB Pharma, Colombes, France, ⁸UCB Pharma, Morrisville, NC, ⁹University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom
Background/Purpose: The Group for Research and Assessment of Psoriasis and PsA (GRAPPA) domain‑based treatment recommendations for PsA focus on six key domains: peripheral arthritis, axial…

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