Abstracts tagged "clinical trial"

Abstract Number: 0645 • ACR Convergence 2025
Achievement of Low Disease Activity and Remission in Patients with Systemic Lupus Erythematosus Treated with Dapirolizumab Pegol: 48-Week Results from a Phase 3 Trial
Eric Morand¹, Lucy Carter², Maria Dall'Era³, Michelle Petri⁴, Ed Vital⁵, Teri Jimenez⁶, Janine Gaiha-Rohrbach⁷, Bernard Lauwerys⁸, Annette Nelde⁹, Christian Stach¹⁰ and Ronald van Vollenhoven¹¹, ¹Centre for Inflammatory Diseases, Monash University and Monash Health, Melbourne, Victoria, Australia, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³Division of Rheumatology, University of California, San Francisco, CA, ⁴Johns Hopkins University School of Medicine, Timonium, MD, ⁵University of Leeds, Leeds, England, United Kingdom, ⁶UCB, Raleigh, NC, ⁷Biogen, Cambridge, MA, ⁸Systemic and Inflammatory Rheumatic Diseases Section, Institute of Experimental and Clinical Research (IREC), UCLouvain, Brussels, Belgium, ⁹Biogen, Baar, Switzerland, ¹⁰UCB, Monheim am Rhein, Germany, ¹¹Department of Rheumatology, Amsterdam University Medical Centre, Amsterdam, Netherlands
Background/Purpose: Dapirolizumab pegol (DZP) is a novel CD40L inhibitor with broad modulatory effects on SLE immunopathology;1,2 it consists of a polyethylene glycol (PEG)-conjugated antigen-binding fragment…
Abstract Number: 0855 • ACR Convergence 2025
Certolizumab Pegol to Prevent Adverse Pregnancy Outcomes in Patients with Antiphospholipid Syndrome and Lupus Anticoagulant (IMPACT): Results from Ongoing Recruitment of a Prospective, Single-Arm, Open-Label, Phase 2 Trial
Jane Salmon¹, Mimi Kim², Marta Guerra¹, Joseph Worden³, Carl Laskin⁴, Maria DeSancho⁵, Inna Landres⁵, Jason S. Knight⁶, Haley Slosberg¹, Margaret Minett¹ and Ware Branch⁷, ¹Hospital for Special Surgery, New York, NY, ²Albert Einstein College of Medicine, Bronx, NY, ³University of Utah School of Medicine, Salt Lake City, ⁴University of Toronto, Toronto, ON, Canada, ⁵Weill Cornell Medicine, New York, ⁶University of Michigan, Ann Arbor, MI, ⁷University of Utah Health Sciences Center, Salt Lake City, UT
Background/Purpose: The IMPACT trial (NCT03152058) showed that certolizumab appears effective in preventing placenta-mediated adverse pregnancy outcome (APO) in high-risk antiphospholipid syndrome (APS) patients. We have…
Abstract Number: 0484 • ACR Convergence 2025
Comparable Efficacy of FK-Tocilizumab and Reference Tocilizumab in Rheumatoid Arthritis Patients With and Without Prior Biologic Exposure
Ernest Choy¹, Marco Gattorno², Kamila Klama³, Andras Illes⁴, Peter Baker⁵, Maria Romanova Michailidi⁶ and Anna Zubrzycka-Sienkiewicz⁷, ¹Division of Infection and Immunity, CREATE Centre, Cardiff University, Cardiff, United Kingdom, ²IRCCS G. Gaslini, Genova, Genoa, Italy, ³Solumed Clinical Research Center, Poznan, Poland, ⁴Fresenius Kabi SwissBioSim, Eysin, Switzerland, ⁵Fresenius Kabi Biopharma, Eysins, Switzerland, ⁶University of Geneva, Eysins, Switzerland, ⁷Reumatika - Centrum Reumatologii, Warszawa, Poland
Background/Purpose: Biosimilars offer comparable efficacy and safety to their originators, thereby improving patient access to affordable treatments. FK-Tocilizumab (FK-toci) is the first tocilizumab biosimilar approved…
Abstract Number: 0257 • ACR Convergence 2025
Safety of Guselkumab in Inflammatory Bowel Disease Up to 1 Year: Integrated Safety Analysis of Phase 2 and 3 Studies in Crohn’s Disease and Ulcerative Colitis
Bruce E. Sands¹, Remo Panaccione², Silvio Danese³, Julián Panés⁴, Tadakazu Hisamatsu⁵, Geert D’Haens⁶, Rian Van Rampelbergh⁷, Mobolaji Olurinde⁸, Jacqueline Yee⁸, Karissa Lozenski⁹, Thomas Baker⁸, Shadi Yarandi⁸, Matthew Germinaro⁸, Marion L. Vetter⁸, Hewei Li⁸, Mauricio Rosas Ballina¹⁰, Jessica R. Allegretti¹¹, Anita Afzali¹² and David T. Rubin¹³, ¹Icahn School of Medicine at Mount Sinai, New York, NY, USA, NY, ²University of Calgary, Calgary, AB, Canada, AB, Canada, ³Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy, Milano, Italy, ⁴Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain, Barcelona, Spain, ⁵Kyorin University School of Medicine, Tokyo, Japan, Tokyo, Japan, ⁶Amsterdam University Medical Centers, Amsterdam, The Netherlands, D’Haens, Swaziland, ⁷Johnson & Johnson, Antwerp, Belgium, Antwerp, Belgium, ⁸Johnson & Johnson, Spring House, PA, USA, PA, ⁹Johnson & Johnson, Horsham, PA, ¹⁰Actelion Research & Development, Allschwil, Switzerland, Allschwil, Switzerland, ¹¹Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA, MA, ¹²University of Cincinnati, College of Medicine, Cincinnati, OH, USA, OH, ¹³University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA, IL
Background/Purpose: Guselkumab (GUS), a dual-acting interleukin (IL)-23 inhibitor that potently neutralizes IL-23 and binds to CD64 (a receptor on cells that produce IL-23), is currently…
Abstract Number: 2463 • ACR Convergence 2025
Allogenic anti- CD19 CAR-T cells induce remission in refractory systemic lupus erythematosus
Chunnei Yang¹, Chuanyin Sun², Binghe Tan³, Chao Hu¹, Liyan Wan², Changling Xie³, Qian Tan³, Mingyao Liu³, Jin Lin², Bing Du³ and Hongyan Tong¹, ¹Department of Hematology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China (People's Republic), ²Department of Rheumatology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China (People's Republic), ³BRL Medicine Inc., Shanghai, Shanghai, China (People's Republic)
Background/Purpose: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease associated with significant morbidity and mortality. The treatment approach for SLE primarily involves immunomodulation and…
Abstract Number: 2345 • ACR Convergence 2025
Biological Sex-Related Differences in Radiographic Progression and Relationship with Early Clinical Response: Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo‑Controlled Study in Biologic-Naive Participants with Active Psoriatic Arthritis Treated with Guselkumab
Dafna D. Gladman¹, Lihi Eder², Carlo Selmi³, Philip J. Mease⁴, Alexis Ogdie⁵, Karissa Lozenski⁶, Mohamed Sharaf⁷, Emmanouil Rampakakis⁸, Laura Pina Vegas⁹ and Laura Coates¹⁰, ¹Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Division of Rheumatology, Toronto, ON, Canada, ²University of Toronto, Toronto, ON, Canada, ³Humanitas University, Milan, Italy, ⁴Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁵University of Pennsylvania, Philadelphia, PA, ⁶Johnson & Johnson, Horsham, PA, ⁷Janssen - Johnson & Johnson, Dubai, United Arab Emirates, ⁸JSS Medical Research, Montréal, QC, Canada, ⁹Epidemiology in Dermatology and Evaluation of Therapeutics (EpiDermE), University Paris-Est Créteil Val de Marne, Créteil, France; Rheumatology, Hospital Henri Mondor, AP-HP, Créteil, France, Creteil, France, ¹⁰Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom
Background/Purpose: Previous research has shown that women with psoriatic arthritis (PsA) often have lower rates of clinical response to medication but less severe radiographic joint…
Abstract Number: 2081 • ACR Convergence 2025
Radiologic surveillance in the Phase II RCT of LEVI-04, a novel neurotrophin-3 inhibitor, in people with knee osteoarthritis: exclusions at screening
Ali Guermazi¹, Philip Conaghan², C Michael Perkins³, Claire Herholdt⁴, Iwona Bombelka⁵ and Simon Westbrook⁶, ¹Boston University, West Roxbury, MA, ²University of Leeds, Leeds, United Kingdom, ³Levicept, Sandwich, United Kingdom, ⁴Levicept Ltd, Ashtead, United Kingdom, ⁵Levicept, Sandwich, Kent, United Kingdom, ⁶Levicept Ltd, Sandwich, United Kingdom
Background/Purpose: LEVI-04 is a first-in-class fusion protein (p75NTR-Fc) that supplements the endogenous p75NTR binding protein, providing analgesia via inhibition of NT-3 activity. Like p75NTR, LEVI-04…
Abstract Number: 1608 • ACR Convergence 2025
Efficacy of Anti-IL-5/R Therapies on Specific Disease Manifestations of Eosinophilic Granulomatosis with Polyangiitis
Peter Merkel¹, Arnaud Bourdin², Bernhard Hellmich³, Nader Khalidi⁴, David Jackson⁵, David Jayne⁶, Parameswaran Nair⁷, Christian Pagnoux⁸, Ulrich Specks⁹, Benjamin Terrier¹⁰, Lena Börjesson Sjö¹¹, Priya Jain¹², Aadarsh Lal¹³, Sofia Necander¹⁴, Claire Walton¹⁵ and Michael Wechsler¹⁶, ¹University of Pennsylvania, Philadelphia, PA, ²Department of Respiratory Diseases, Montpellier University Hospitals, Arnaud de Villeneuve Hospital, Montpellier, France, ³Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, ⁴Department of Medicine, McMaster University and St. Joseph’s Healthcare, Hamilton, Canada, ⁵Guy’s Severe Asthma Centre, Guy's and St Thomas’ NHS Trust, London, and School of Immunology and Microbial Sciences, King's College London, London, United Kingdom, ⁶University of Cambridge, Cambridge, United Kingdom, ⁷Department of Medicine, McMaster University and St. Joseph’s Healthcare, Hamilton, ON, Canada, ⁸Mount Sinai Hospital, University Health Network, Toronto, and Canadian Vasculitis Research Network (CanVasc), Toronto, ON, Canada, ⁹Mayo Clinic, Rochester, MN, ¹⁰Cochin Hospital, Paris, France, ¹¹Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca,, Gothenburg, Sweden, ¹²BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ¹³Respiratory & Immunology, AstraZeneca, Bengaluru, Karnataka, India, ¹⁴Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹⁵Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ¹⁶Department of Medicine, National Jewish Health, Denver
Background/Purpose: Results from the 1-year double-blind period and first year of the open-label extension (OLE) of the MANDARA trial (NCT04157348) demonstrated that over 60% of…
Abstract Number: 1454 • ACR Convergence 2025
Long-Term Safety and Tolerability of Bimekizumab Treatment Across Phase 2b and Phase 3 Studies in Patients with Axial Spondyloarthritis or Psoriatic Arthritis: 3-Year Update from the Phase 3 Studies
Philip J. Mease¹, Denis Poddubnyy², Rajan Bajracharya³, Barbara Ink³, Myriam Manente⁴, Luke Peterson⁵, Katy White⁶, Peter Nash⁷ and Lianne S. Gensler⁸, ¹Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ²Division of Rheumatology, Department of Medicine, University Health Network and University of Toronto, Toronto, Ontario, Canada, and Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany; Department of Epidemiology, German Rheumatism Research Centre, Berlin, Germany, ³UCB, Slough, England, United Kingdom, ⁴UCB, Braine-L'Alleud, Belgium, ⁵UCB, Morrisville, NC, ⁶UCB, Slough, United Kingdom, ⁷School of Medicine, Griffith University, Brisbane, Australia, ⁸Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA

Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. Previous analyses of phase (Ph)2b/3 safety data (data…
Abstract Number: 1157 • ACR Convergence 2025
Safety and Tolerability of a Recombinant Zoster Vaccine in Patients with Inflammatory Rheumatic Musculoskeletal Diseases: A Prospective Longitudinal Study over 12 Months
Ella Steiner¹, Ioana Andreica², Stefanie Reale³, Gianna Chierego⁴, Philipp Köhler⁵, Sonja Zapke⁴, Benjamin Wilde⁶, David Kiefer⁷, Philipp Sewerin², Hilal Kavruk⁵, Dimitra Karagkiozidou⁵, Panagiotis Ermeidis⁵, Barbara Guminski⁵, Andreas Kribben⁶, Jürgen Braun⁸, Xenofon Baraliakos⁹ and Uta Kiltz⁹, ¹Rheumazentrum Ruhrgebiet Herne, Herne, Nordrhein-Westfalen, Germany, ²Rheumazentrum Ruhrgebiet Herne; Ruhr-Universität Bochum, Germany, Herne, Germany, ³Rheumazentrum Ruhrgebiet, Herne, Nordrhein-Westfalen, Germany, ⁴Rheumazentrum Ruhrgebiet, Herne, Germany, ⁵Rheumazentrum Ruhrgebiet Herne, Herne, Germany, ⁶University Hospital, Nephrology, Essen, Essen, Germany, ⁷Private practice of rheumatology, Hattingen, Germany, ⁸Ruhr-University, Bochum, Germany; and Rheumatologische Versorgungszentrum (RVZ) Steglitz, Berlin, Germany, ⁹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Herpes zoster (HZ) is common among older adults, with a lifetime risk of 25%. The risk is particularly increased in individuals with immunosuppression such…
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: 2697 • ACR Convergence 2025
A Prospective Randomized Controlled 96-week Study to Evaluate the Efficacy and Safety of Tacrolimus and Glucocorticoid as Continuous Induction-Maintenance Treatment for Class III/IV±V Lupus Nephritis
Sandra Navarra¹, Desmond Yat-Hin Yap², Zhaohui Ni³, Yingyos Avihingsanon⁴, Soo Kun Lim⁵, Na Jiang³, Wei Chen⁶, Chao Li⁷, Helen Zhi⁸, Chenzhu Zhang⁹, Catherine Chan², Susan Yung², Tsutomu Takeuchi¹⁰ and Tak Mao Daniel Chan², ¹University of Santo Tomas, Manila, Philippines, ²Department of Medicine, The University of Hong Kong, Hong Kong SAR, Hong Kong, ³Renji Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China (People's Republic), ⁴King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand, ⁵Department of Medicine, University Malaya Medical Centre, Kuala Lumpur, Malaysia, ⁶Department of Nephrology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China (People's Republic), ⁷Department of Nephrology, Peking Union Medical College Hospital, Beijing, China (People's Republic), ⁸School of Public Health, The University of Hong Kong, Hong Kong SAR, Hong Kong, ⁹Department of Medicine, University of Hong Kong-Shenzhen Hospital, Shenzhen, China (People's Republic), ¹⁰Saitama Medical University and Keio University, Tokyo, Japan
Background/Purpose: Tacrolimus (TAC) and glucocorticoid as continuous induction-maintenance therapy for lupus nephritis (LN) has never been investigated. We conducted a prospective randomized open-label multicenter study…

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