Abstracts tagged "clinical trial"

Abstract Number: 2425 • ACR Convergence 2024
Ianalumab Induced Durable Depletion of Circulating B Cell Subsets and Associated Changes in B Cell and Neutrophil Transcriptomic and Proteomic Profiles in Patients with Systemic Lupus Erythematosus: 52-Week Treatment Results from a Phase 2 Trial
Marianna Rowlands¹, Thomas Dörner², Diego Saldana Miranda³, Justin McMullen³, Aida Santos da Costa³, Ulrike Sommer³, Rainer Hillenbrand³, Andre Nogueira da Costa³, Claire Bonal³, Isabelle Isnardi³, Edward Khokhlovich¹ and Stephen J Oliver³, ¹Biomedical Research, Novartis, Cambridge, MA, ²Department of Medicine, Rheumatology and Clinical Immunology,Charite Universitätsmedizin Berlin, Germany and DRFZ, Berlin, Berlin, Germany, ³Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Ianalumab (VAY736), a B cell activating factor receptor (BAFFR) targeting mAb, depletes B cells via both antibody dependent cellular cytotoxicity and blockade of BAFF:BAFFR…
Abstract Number: 0278 • ACR Convergence 2024
Efficacy and Safety of Genakumab versus Compound Betamethasone in Gout: The GUARD-1 Study
Yu Xue¹, Tianshu Chu², Jiankang Hu³, Wei Gou⁴, Ning Zhang⁵, Juan Li⁶, Jing Yu⁷, Songping Li⁸, Songbin Li⁹, Long Qian¹⁰, Xinwang Duan¹¹, Lihua Duan¹² and Hejian Zou¹, ¹Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China, Shanghai, China (People's Republic), ²Department of Rheumatology, Henan Provincial People's Hospital, Zhengzhou, China, Zhengzhou, China (People's Republic), ³Department of Rheumatology, Pingxiang People's Hospital, Pingxiang, China, Pingxiang, China (People's Republic), ⁴Department of Rheumatology, Hebei Petro China Central Hospital, Langfang, China, Langfang, China (People's Republic), ⁵Department of Rheumatology, Shengjing Hospital of China Medical University, Shenyang, China, Shenyang, China (People's Republic), ⁶Department of Rheumatology, The First Affiliated Hospital of Hainan Medical University, Haikou, China, Haikou, China (People's Republic), ⁷Department of Rheumatology, The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China, Shenyang, China (People's Republic), ⁸Department of Rheumatology, The First Affiliated Hospital of Ganna Medical University, Ganzhou, China, Ganzhou, China (People's Republic), ⁹Department of Rheumatology, The First Hospital of Qiqihar, Qiqihar, China, Qiqihar, China (People's Republic), ¹⁰Department of Rheumatology, The Second Hopital of Anhui Medical University, Hefei, China, Hefei, China (People's Republic), ¹¹Department of Rheumatology, The Second Affiliated Hospital of Nanchang University, Nanchang, China, Nanchang, China (People's Republic), ¹²Department of Rheumatology, Jiangxi Provincial People's Hospital, Nanchang, China, Nanchang, China (People's Republic)
Background/Purpose: The GUARD (Genakumab in high Uric Acid-induced Arthritis/goutfor Resolution and Delay study) program was designed to investigate the efficacy and safety of Genakumab, a…
Abstract Number: 0587 • ACR Convergence 2024
Achieving Stringent Disease Control Criteria Was Associated with Greater Work Productivity Improvements in Patients with Active Psoriatic Arthritis: Results from Two Phase 3 Studies of Bimekizumab
William Tillett¹, Dafna Gladman², Laure Gossec³, Jason Eells⁴, Patrick Healy⁵, Barbara Ink⁴, Nikos Lyris⁴ and Jessica A Walsh⁶, ¹Royal National Hospital of Rheumatic Diseases; Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, ²University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ³Sorbonne Université, Paris, France, ⁴UCB Pharma, Slough, United Kingdom, ⁵UCB Pharma, Morrisville, NC, ⁶Division of Rheumatology, Salt Lake City Veterans Affairs Health and University of Utah Health, Salt Lake City, UT
Background/Purpose: Psoriatic arthritis (PsA) negatively impacts patients’ physical health and functional ability, which can contribute to reduced work productivity.1,2 We examined the association between achieving…
Abstract Number: 0682 • ACR Convergence 2024
Results from Outcomes Selection and Development of a Patient-reported Outcome Measure for a Combined Response Index for Limited Cutaneous SSc: The CRISTAL Project
Alain Lescoat¹, Yen Chen², Susan Murphy³, Nadia Vann², Neda Kortam², Rosemary Gedert², Sue Farrington⁴, Yannick Allanore⁵, David Cella⁶, Lorinda Chung⁷, Philip Clements⁸, Christopher Denton⁹, Francesco Del Galdo¹⁰, Oliver Distler¹¹, Monique Hinchcliff¹², Michael Hughes¹³, Laura Hummers¹⁴, John Pauling¹⁵, Janet Pope¹⁶, Virginia Steen¹⁷, John Varga², Peter Merkel¹⁸, Maya H. Buch¹⁹ and Dinesh Khanna², and all CRISTAL collaborators, ¹CHU Rennes - University Rennes 1, Rennes, France, ²University of Michigan, Ann Arbor, MI, ³University of Michigan, Plymouth, MI, ⁴Scleroderma & Raynaud UK, London, United Kingdom, ⁵Université Paris Cité, Paris, France, ⁶Northwestern University, Chicago, IL, ⁷Stanford University, Woodside, CA, ⁸United States, Los Angeles, CA, ⁹University College London, Northwood, United Kingdom, ¹⁰University of Leeds, Leeds, United Kingdom, ¹¹Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland, Zurich, Switzerland, ¹²Yale School of Medicine, Westport, CT, ¹³Tameside and Glossop Integrated NHS Foundation Trust & The University of Manchester, Manchester, United Kingdom, ¹⁴Johns Hopkins University, Division of Rheumatology, Baltimore, MD, Ellicott City, MD, ¹⁵North Bristol NHS Trust, Bristol, United Kingdom, ¹⁶University of Western Ontario, London, ON, Canada, ¹⁷Georgetown University School of Medicine, Washington, DC, ¹⁸University of Pennsylvania, Philadelphia, PA, ¹⁹Division of Musculoskeletal & Dermatological Sciences, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom
Background/Purpose: Limited cutaneous systemic sclerosis (lcSSc) is the most frequent subset of scleroderma, yet there is a paucity of outcome measures available to assess symptoms…
Abstract Number: 1134 • ACR Convergence 2024
First-in-Human Evaluation of the Safety, Tolerability and Pharmacokinetics of the T Cell Receptor Signal Modulator AX-158
Christopher VanDeusen¹, Andres Gagete¹, Annelize Koch² and D Scott Batty Jr¹, ¹Artax Biopharma, Inc, Cambridge, MA, ²Simbec-Orion, Merthyr Tydfil, Wales, United Kingdom
Background/Purpose: Nck is a cytosolic protein that binds a domain of the T cell receptor (TCR) following TCR interaction to amplify responses from low affinity…
Abstract Number: 1399 • ACR Convergence 2024
A First-in-Human Clinical Trial Evaluating the Safety and Pharmacokinetics of SOL-116, a Novel Humanized Monoclonal Antibody Targeting Bile Salt-Stimulated Lipase for the Treatment of RA
Karin Franck-Larsson¹, Susanne Lindquist², Agneta Wennerholm³, Johan Kolmert⁴, Maria Wanderoy³ and Olle Hernell², ¹Lipum AB, Uppsala, Sweden, ²Lipum AB; Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden, ³Lipum AB, Stockholm, Sweden, ⁴Lipum AB; Unit of Integrative Metabolomics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
Background/Purpose: Bile Salt-Stimulated Lipase (BSSL) is a lipolytic enzyme secreted by the lactating mammary gland and exocrine pancreas. Elevated plasma levels of BSSL have been…
Abstract Number: 1543 • ACR Convergence 2024
Improvements in BILAG Musculoskeletal and Mucocutaneous Domains at Week 48 in a Phase 2 Double-Blind Placebo-Controlled Trial of ABBV-599 (Elsubrutinib + Upadacitinib Combination) and Upadacitinib Monotherapy for Treatment of Moderately to Severely Active Systemic Lupus Erythematosus
Amit Saxena¹, Zahi Touma², Edward Vital³, Eric Morand⁴, Marta Mosca⁵, Kristin D'Silva⁶, Peter Wung⁶, Ling Cheng⁶, Melitza Iglesias-Rodriguez⁶, Shelly Kafka⁶ and Joan Merrill⁷, ¹NYU Grossman School of Medicine, New York, NY, ²University of Toronto, Toronto, ON, Canada, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom, Leeds, England, United Kingdom, ⁴School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia, ⁵University of Pisa, Pisa, Italy, ⁶AbbVie Inc., North Chicago, IL, ⁷Oklahoma Medical Research Foundation, Oklahoma City 73104, OK
Background/Purpose: ABBV-599 is a novel combination of elsubrutinib (ELS; a selective Bruton’s tyrosine kinase inhibitor) and upadacitinib (UPA; a selective Janus kinase inhibitor), which targets…
Abstract Number: 1952 • ACR Convergence 2024
Interest in Clinical Trial Participation Among People with Lupus: Results from the Research Accelerated by You (RAY) Registry
Michael Fisher¹, Mimi Kim², Joan Merrill³, Safoah Agyemang¹ and Joy Buie¹, ¹Lupus Foundation of America, Washington, DC, ²Albert Einstein College of Medicine, New York, NY, ³Oklahoma Medical Research Foundation, Oklahoma City 73104, OK
Background/Purpose: With many treatments under study for SLE, a crisis in recruiting sufficient numbers of qualified patients for clinical trials has emerged. Willingness to consider…
Abstract Number: 2113 • ACR Convergence 2024
Discontinuation and Non-publication of Postmenopausal Osteoporosis Clinical Studies: A Cross-sectional Analysis of 345,435 Patients
Mohamed Abdelsalam¹, yasmeen Alabdallat², Yousef Hussein³, Mona Sajed⁴, Maryam Taha⁵, Rawan morse⁶, Wessam Selima⁷ and Ahmed Zabady⁸, ¹Rheumatology, Rehabilitation and Physical medicine department - faculty of medicine -Misr University for science and technology, 6th of October, Al Jizah, Egypt, ²Faculty of medicine - Hashemite university, Zarqa, Jordan, ³Faculty of medicine - Benha university, Benha, Egypt, ⁴Faculty of Pharmacy - Al-Azhar university for girls, Mansoura, Ad Daqahliyah, Egypt, ⁵Faculty of medicine - Ain Shams university, Madinat Nasr, Al Qahirah, Egypt, ⁶Medical Research Group of Egypt, Bur sa'id, Egypt, ⁷Anaesethia & pain management department, Faculty of medicine, Ain Shams University, Cairo, Egypt, ⁸Faculty of science - Damanhour university, Cairo, Egypt
Background/Purpose: Postmenopausal osteoporosis (PMOP) significantly contributes to global fracture rates annually, with its silent progression complicating early detection and intervention. Effective management strategies are crucial,…
Abstract Number: 2430 • ACR Convergence 2024
Dapirolizumab Pegol Impacts Important Immunologic Pathways in Systemic Lupus Erythematosus: Pharmacodynamic Analysis of T Cell and Antigen Presenting Cell Pathways from a Phase 2b Trial
Alex S. Powlesland¹, Ioana Cutcutache¹, Andrew Skelton¹, Anthony Shock¹, Matthew Page¹, Eris Bame², Janine Gaiha-Rohrbach², George Stojan³, Ania Skowera¹, Christian Stach⁴ and Thomas Dörner⁵, ¹UCB Pharma, Slough, United Kingdom, ²Biogen Inc., Cambridge, MA, ³UCB Pharma, Atlanta, GA, ⁴UCB Pharma, Monheim am Rheim, Germany, ⁵Department of Medicine, Rheumatology and Clinical Immunology,Charite Universitätsmedizin Berlin, Germany and DRFZ, Berlin, Berlin, Germany
Background/Purpose: CD40-CD40L interactions play a pivotal role in systemic lupus erythematosus (SLE) pathogenesis by orchestrating a range of immune and inflammatory responses involving B cells,…
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…

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].