Abstracts tagged "clinical trial"

Abstract Number: 0644 • ACR Convergence 2025
Improvement of Fatigue, Musculoskeletal Pain, and Morning Stiffness in Patients with Systemic Lupus Erythematosus Treated with Dapirolizumab Pegol: 48-Week Results from a Phase 3 Trial
Ioannis Parodis¹, Caroline Gordon², Joan Merrill³, Matthias Schneider⁴, Zahi Touma⁵, Teri Jimenez⁶, Thomas Morel⁷, Mina Nejati⁸, Christian Stach⁹, Christine de La Loge¹⁰ and Laurent arnaud¹¹, ¹Karolinska Institutet and Karolinska University Hospital, Department of Medicine Solna, Division of Rheumatology, Stockholm, Sweden, ²Department of Inflammation and Ageing, College of Medicine and Health, University of Birmingham, Birmingham, United Kingdom, ³Oklahoma Medical Research Foundation, Oklahoma City ⁷³¹⁰⁴, OK, ⁴Clinic of Rheumatology and Hiller Research Unit, Heinrich-Heine-University, Düsseldorf, Germany, ⁵University of Toronto, Toronto, ON, Canada, ⁶UCB, Raleigh, NC, ⁷UCB, Basel, Switzerland, ⁸Biogen, Cambridge, MA, ⁹UCB, Monheim am Rhein, Germany, ¹⁰UCB, Brussels, Belgium, ¹¹Service de rhumatologie, Hôpitaux Universitaires de Strasbourg, INSERM UMR-S ¹¹⁰⁹, Strasbourg, France, Strasbourg, France
Background/Purpose: Fatigue, musculoskeletal pain, and joint stiffness are common manifestations of SLE, presenting considerable treatment challenges, particularly in addressing chronic fatigue. Dapirolizumab pegol (DZP) is…
Abstract Number: 0852 • ACR Convergence 2025
LEVI-04 Significantly Reduces Bone Marrow Lesions and Symptoms in Knee Osteoarthritis: Results from a Phase II RCT
Simon Westbrook¹, Ali Guermazi² and Philip Conaghan³, ¹Levicept Ltd, Sandwich, United Kingdom, ²Boston University, West Roxbury, MA, ³University of Leeds, Leeds, United Kingdom
Background/Purpose: Bone marrow lesions (BMLs), detectable on MRI as areas of ill-defined high signal intensity on fluid-sensitive sequences, are a common feature of osteoarthritis (OA),…
Abstract Number: 0482 • ACR Convergence 2025
R-2487, a Synthetic Biology-Based Oral Immunotherapy, Promotes Treg-Mediated Immune Rebalancing and Reduces Disease Activity in Rheumatoid Arthritis Patients
Christian Furlan Freguia¹, Janet Stephens¹, Sathya Janardhanan¹, Chuck Bourne¹, Kaitlyn Skeie¹, Hudson Lowe¹, David Pascual² and Gary Fanger¹, ¹Rise Therapeutics, Rockville, MD, ²University of Wyoming, Laramie, WY
Background/Purpose: R-2487 is a novel, orally delivered, synthetic biology-based immunotherapy that utilizes Lactococcus lactis as a carrier vehicle to deliver Colonization Factor Antigen I (CFA/I)…
Abstract Number: 1506 • ACR Convergence 2025
Perspectives on Clinical Trial Participation for Novel Advanced Therapies: A Focus Group Study in Systemic Lupus Erythematosus (SLE)
Olivia A. Stein¹, Jennifer Lee¹, Evelyne Vinet², Arielle Mendel³, Christian Pineau⁴, Leanne Mielczarek⁵ and Sasha Bernatsky², ¹Research Institute of the McGill University Health Centre, Montreal, Canada, ²Research Institute of the McGill University Health Centre, Montreal, QC, Canada, ³McGill University Health Centre, Montreal, Canada, ⁴McGill University, Montréal, QC, Canada, ⁵Lupus Canada, Newmarket, Canada
Background/Purpose: Our objective is to identify barriers and facilitators perceived by people with systemic lupus erythematosus (SLE) regarding participation in clinical trials for novel/advanced agents,…
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…

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