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: 0290 • ACR Convergence 2024
Deucravacitinib Long-term Efficacy Through 4 Years in Week 16 Placebo Crossover Patients in the Phase 3 POETYK PSO-1, PSO-2, and LTE Program
Mark Lebwohl¹, Richard Warren², Shinichi Imafuku³, Jerry Bagel⁴, April W. Armstrong⁵, Thierry Passeron⁶, Subhashis Banerjee⁷, Renata M. Kisa⁸, Matthew J. Colombo⁷, Thomas Scharnitz⁸, Kim Hoyt⁸, Diamant Thaçi⁹ and Andrew Blauvelt¹⁰, ¹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ²Dermatology Centre, Northern Care Alliance NHS Foundation Trust and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ³Fukuoka University Hospital Faculty of Medicine, Fukuoka, Japan, ⁴Psoriasis Treatment Center of New Jersey, East Windsor, ⁵University of California Los Angeles, Los Angeles, ⁶Université Côte d’Azur, University Hospital of Nice, Nice, France, ⁷Bristol Myers Squibb, Princeton, NJ, ⁸Bristol Myers Squibb, Princeton, ⁹Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ¹⁰Oregon Medical Research Center, Portland, OR
Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate…
Abstract Number: 0588 • ACR Convergence 2024
Sex-Related Differences in Baseline Patient and Disease Characteristics: Post Hoc Analyses of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies in Patients with Active Psoriatic Arthritis
Laura Coates¹, Carlo Selmi², Philip Mease³, Alexis Ogdie⁴, Francois Nantel⁵, Frederic Lavie⁶, Mohamed Sharaf⁷, Oyediran Adelakun⁸, Emmanouil Rampakakis⁹, Laura Pina Vegas¹⁰ and Lihi Eder¹¹, ¹University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, ²Department of Biomedical Sciences, Humanitas University, Rozzano, Italy, ³Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ⁴Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁵Nantel MedSci Consult, Montreal, QC, Canada, ⁶Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁷Johnson & Johnson, Middle East FZ LLC, Dubai, UAE, Dubai, United Arab Emirates, ⁸Janssen Research & Development, LLC, Titusville, NJ, ⁹McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, ¹⁰Leiden University Medical Center, Leiden, Netherlands, ¹¹University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada
Background/Purpose: Although PsA occurs in males and females at similar rates, clinical manifestations and outcomes differ between sexes. Findings from real-world evidence (RWE) studies have…
Abstract Number: 0703 • ACR Convergence 2024
Preliminary Results from the RECONNOITER Trial, a Phase 2 Study of AISA 021 in the Treatment of Secondary Raynaud’s, Primarily Due to Systemic Sclerosis
Andrew Sternlicht¹, Michael Shanahan², Erin Morton², Meredith Todd³, Ivana Hunt², Zoey Reed², amanda weragoda⁴, Lashika Weerakoon² and Elizabeth Briggs², ¹Tufts University Medical Center and Aisa Pharma, Inc., Boston, MA, ²Flinders Medical Centre, Adelaide, Australia, ³Aisa Pharma Pty Ltd., East Lindfield, New South Wales, Australia, ⁴F, Adelaide, Australia
Background/Purpose: While 95% of Systemic Sclerosis (SSc) patients have Raynaud’s phenomenon(RP) and many patients rate it as the most bothersome and severe symptom of their…
Abstract Number: 1135 • ACR Convergence 2024
Deucravacitinib in Plaque Psoriasis: 4-Year Efficacy Results by Prior Biologic Treatment in the Phase 3 POETYK PSO-1, PSO-2, and Long-Term ExtensionTrials
Richard Warren¹, April W. Armstrong², Shinichi Imafuku³, Akimichi Morita⁴, Carle Paul⁵, Matthias Augustin⁶, Thierry Passeron⁷, Leon Kircik⁸, Eleni Vritzali⁸, Thomas Scharnitz⁹, Georgene Schroeder⁹, Subhashis Banerjee¹⁰ and Bruce Strober¹¹, ¹Dermatology Centre, Northern Care Alliance NHS Foundation Trust and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ²University of California Los Angeles, Los Angeles, ³Fukuoka University Hospital Faculty of Medicine, Fukuoka, Japan, ⁴Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, ⁵Toulouse University and CHU, Toulouse, France, ⁶Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, ⁷Université Côte d’Azur, University Hospital of Nice, Nice, France, ⁸Icahn School of Medicine at Mount Sinai, New York, NY, ⁹Bristol Myers Squibb, Princeton, ¹⁰Bristol Myers Squibb, Princeton, NJ, ¹¹Department of Dermatology, Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell, CT
Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate…
Abstract Number: 1404 • ACR Convergence 2024
Modeling Diversity in Systemic Lupus Erythematosus (SLE) Clinical Trials Using Real-world Data (RWD) Sources
Andrew Bevan¹ and Nora Carroll², ¹Integrated Project Solutions, PPD, part of Thermo Fisher Scientific, Cambridge, United Kingdom, ²Cardiovascular and General Medicine, Thermo Fisher Scientific, Athlone, Ireland
Background/Purpose: The FDA places emphasis on studying clinically relevant trial populations but does not address how these might be defined. SLE disproportionately affects women and…
Abstract Number: 1545 • ACR Convergence 2024
Rates of Sustained Complete Renal Response with Long-term Use of Voclosporin in AURORA 2
Ernie Yap¹, Matt Truman², Cynthia Auguste¹, Vanessa Birardi³ and Greg Keenan¹, ¹Aurinia Pharmaceuticals Inc., Edmonton, Canada, ²Aurinia Pharmaceuticals, Victoria, BC, Canada, ³Aurinia Pharmaceuticals Inc., Rockville, MD
Background/Purpose: Unlike in many other disease states, there is no accepted definition for clinical response in lupus nephritis (LN). The Phase 3 AURORA 1 study…
Abstract Number: 1978.5 • ACR Convergence 2024
Post-Hoc Analysis of Clinically Relevant Anti-Vaccine Antibodies in Participants with Rheumatoid Arthritis Treated with Nipocalimab
Faye Yu¹, Eugene Myshkin², Carolina Bobadilla Mendez³, Marta Cossu⁴, Kaiyin Fei⁵, Qingmin Wang⁶, Matthew J. Loza⁶, Dessislava Dimitrova³ and Sheng Gao³, ¹Janssen Research & Development, LLC, a Johnson & Johnson company, Cambridge, MA, USA, MA, MA, ²Janssen Research & Development, LLC, a Johnson & Johnson company, Cambridge, MA, ³Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, ⁴Janssen Pharmaceutical Research and Development, a Johnson & Johnson company, Leiden, Netherlands, ⁵Janssen Research & Development, LLC, Spring House, PA, ⁶Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, USA, Spring House, PA

Background/Purpose: Nipocalimab is a fully human, high affinity, aglycosylated, effectorless IgG1 monoclonal antibody designed to selectively block neonatal fragment crystallizable receptor (FcRn), thereby lowering IgG…
Abstract Number: 2144 • ACR Convergence 2024
Impact of Immunogenicity on Clinical Outcomes in Postmenopausal Women with Osteoporosis: Results from a Randomized Controlled Phase 3 Study to Compare CT-P41 (Proposed Denosumab Biosimilar) and Reference Denosumab
Jean-Yves Reginster¹, Stuart L. Silverman², Edward Czerwinski³, Przemyslaw Borowy⁴, Tomasz Budlewski⁵, Joanna Kwiatek⁶, Svitlana Postol⁷, Airi Põder⁸, Jerzy Supronik⁹, SungHyun Kim¹⁰, JeeHye Suh¹⁰, GoEun Yang¹⁰, NooRi Han¹⁰, NaHyun Kim¹⁰ and SeoHee Bae¹⁰, ¹Biochemistry Dept, College of Science, King Saud University, Riyadh, Kingdom of Saudi Arabia, CLARENS, Switzerland, ²OMC clinical research center and Cedars Sinai Medical Center, Beverly Hills, CA, ³Krakowskie Centrum Medyczne, Kraków, Poland, ⁴Krakowskie Centrum Medyczne, Krakow, Poland, ⁵Department of Rheumatology, Medical University of Lodz, Lodz, Poland, ⁶Centrum Medyczne Poznan - PRATIA, Skorzewo, Poland, ⁷Medical Center of Medbud - Clinic LLC, Kyiv, Ukraine, ⁸Clinical Research Centre Ltd, Tartu, Estonia, ⁹Osteo-Medic s.c., Białystok, Poland, ¹⁰Celltrion, Inc., Incheon, Republic of Korea

Background/Purpose: CT-P41 has been developed as a proposed biosimilar of the reference denosumab (DEN), a fully human monoclonal antibody that binds the cytokine receptor activator…
Abstract Number: 2462 • ACR Convergence 2024
A Potent Inhibitor of PAI-1, MDI-2517, Mitigates Disease Severity in Preclinical Models of Systemic Sclerosis
Enming Su¹, Pei-Suen Tsou¹, Mark Warnock², Natalya Subbotina¹, Kris Mann¹, Sirapa Vichaikul¹, Xianying Xing¹, Enze Xing¹, Olesya Plazyo¹, Rachael Wasikowski¹, Lam C. Tsoi³, Mark Weinberg⁴, Cory D. Emal⁵, Dinesh Khanna¹, John Varga¹, Thomas H. Sisson¹, Johann Gudjonsson¹ and Daniel Lawrence², ¹University of Michigan, Ann Arbor, MI, ²Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, ³Michigan, Dept. of Dermatology, Ann Arbor, MI, ⁴MDI, Ann Arbor, MI, ⁵EMU, Ann Arbor, MI
Background/Purpose: Systemic sclerosis (SSc) is a complex and heterogeneous condition characterized by progressive fibrosis in multiple organs. Currently, there is no known cure for SSc,…
Abstract Number: 0298 • ACR Convergence 2024
RAY121, a Novel Recycling Monoclonal Antibody Against Complement C1s: Safety, Pharmacokinetic and Pharmacodynamic Data from a Phase 1a First in Human Clinical Trial in Healthy Adults
Miwa Haranaka¹, Akinori Yamada², Saki Takahashi², Keisuke Gotanda², Sonoko Nakano-Kanatani², Nana Uemura², Kensuke Ohnishi², Masanobu Nishidate², Ichio Ohnami² and Megumi Kai³, ¹Souseikai Hakata Clinic, Fukuoka, Japan, ²Chugai Pharmaceutical Co., Ltd., Tokyo, Japan, ³Oita University, Oita, Japan
Background/Purpose: Complement C1s is one of the major components of the classical complement pathway (CP), and the abnormal activation of CP is implicated in several…
Abstract Number: 0591 • ACR Convergence 2024
Bimekizumab Maintained Efficacy Responses in Patients with Active Psoriatic Arthritis: Up to 2-Year Results from Two Phase 3 Studies
Jessica A Walsh¹, Joseph F. Merola², Christopher T Ritchlin³, Yoshiya Tanaka⁴, Ennio Giulio Favalli⁵, Dennis McGonagle⁶, Diamant Thaçi⁷, Barbara Ink⁸, Rajan Bajracharya⁸, Jason Coarse⁹ and William Tillett¹⁰, ¹Division of Rheumatology, Salt Lake City Veterans Affairs Health and University of Utah Health, Salt Lake City, UT, ²UT Southwestern Medical Center, Dallas, TX, ³Allergy, Immunology & Rheumatology Division, University of Rochester Medical School, Rochester, NY, ⁴Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ⁵ASST Gaetano Pini-CTO, Milan, Lombardia, Italy, ⁶National Institute for Health Research (NIHR) Leeds Biomedical Research Centre (BRC), Leeds Teaching Hospitals, Leeds, UK, Leeds, England, United Kingdom, ⁷Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ⁸UCB Pharma, Slough, United Kingdom, ⁹UCB Pharma, Morrisville, NC, ¹⁰Royal National Hospital of Rheumatic Diseases; Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom
Background/Purpose: PsA is a chronic disease, and patients (pts) can experience loss of response with sustained therapy; therefore, assessing long-term maintenance of response in pts…

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