Abstracts tagged "clinical trial"

Abstract Number: 2356 • ACR Convergence 2025
Clinical Efficacy in Male and Female Patients With Active Psoriatic Arthritis Treated With Deucravacitinib: A Pooled Analysis of Pivotal Phase 3 Studies
Lihi Eder¹, Philip J. Mease², Joseph F Merola³, Alexis Ogdie⁴, Atul Deodhar⁵, Laura Coates⁶, Stefan Varga⁷, Navya Kalapala⁷, Ying-Ming Jou⁸, Eleni Vritzali⁹ and Laure Gossec¹⁰, ¹University of Toronto, Toronto, ON, Canada, ²Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ³Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ⁴Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Wilmington, DE, ⁵Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁶Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ⁷Bristol Myers Squibb, Princeton, NJ, ⁸Bristol Myers Squibb, Princeton, ⁹Bristol Myers Squibb, Boudry, Switzerland, ¹⁰Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France
Background/Purpose: PsA affects male and female patients equally; however, variations in clinical manifestations and treatment responses between sexes have been reported. Deucravacitinib is an oral,…
Abstract Number: 2086 • ACR Convergence 2025
WOMAC Physical Function and 3D MRI Bone Shape: Advancing a “Virtual” Total Knee Replacement Endpoint for Knee Osteoarthritis Clinical Trials
Dawn McGuire¹, Alan Brett², Neil Segal³, Meghan Miller⁴, David Rosen¹ and Yoshi Kumagai⁵, ¹OrthoTrophix, Inc, Foster City, CA, ²Imorphics, Manchester M²⁰ ²HJ, England, United Kingdom, ³KUMC, Kansa City, KS, ⁴OrthoTrophics, Foster City, CA, ⁵OrthoTrophix, Foster City, CA
Background/Purpose: TPX-100, a peptide derived from matrix extracellular phosphoglycoprotein (MEPE), is in development as a potential disease-modifying osteoarthritis drug (DMOAD) for mild to severe knee…
Abstract Number: 1674 • ACR Convergence 2025
A Phase 2, Randomized, Placebo-Controlled Trial of Hydroxychloroquine in Individuals At-Risk for Future Rheumatoid Arthritis
Kevin Deane¹, Christopher Striebich², Marie Feser³, James O'Dell⁴, Judith James⁵, Jeffrey Sparks⁶, John Davis⁷, Jonathan Graf⁸, Maureen McMahon⁹, Elizabeth Solow¹⁰, Lindsy Forbess¹¹, Athan Tiliakos¹², Elena Schiopu¹³, David Fox¹⁴, Maria I. ("Maio") Danila¹⁵, Diane Horowitz¹⁶, Jonathan Kay¹⁷, Colin Strickland³, Joel Guthridge⁵, Cristina Arriens⁵, Jennifer Grossman¹⁸, Kristen Demoruelle¹⁹, Elizabeth Bemis³, Ashley Frazer-Abel³, Chelsie Fleischer²⁰, Ted Mikuls⁴, Melissa Greenleaf²¹, Kate York²², Sarah Walker²³, Lynette Keyes-Elstein²³, Margie Byron²³, Janel Fedler²⁴, Ellen Goldmuntz²⁵ and V. Michael Holers²⁶, ¹University of Colorado Denver Anschutz Medical Campus, Aurora, CO, ²University of Colorado, Aurora, CO, ³University of Colorado Anschutz Medical Campus, Aurora, CO, ⁴University of Nebraska Medical Center, Omaha, NE, ⁵Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁶Brigham and Women's Hospital, Boston, MA, ⁷Mayo Clinic, Rochester, MN, ⁸UCSF, San Francisco, CA, ⁹UCLA David Geffen School of Medicine, Los Angeles, CA, ¹⁰UT Southwestern Medical Center, Dallas, TX, ¹¹Cedars-Sinai Medical Center, Los Angeles, CA, ¹²Emory University, Roswell, GA, ¹³Medical College of Georgia at Augusta University, Martinez, GA, ¹⁴University of Michigan, Dexter, MI, ¹⁵University of Alabama at Birmingham (UAB), Birmingham VA Medical Center, Birmingham, AL, ¹⁶Northwell Health, Jericho, NY, ¹⁷UMass Chan Medical School, Worcester, MA, ¹⁸UCLA, Sherman Oaks, CA, ¹⁹University of Colorado Anschutz Medical Campus, Golden, CO, ²⁰University of Colorado Denver, Aurora, CO, ²¹National Institutes of Health, Rockville, MD, ²²Rho, Inc, Durham, NC, ²³Rho, Inc., Durham, NC, ²⁴Rho, Inc., Salem, IA, ²⁵NIAID/ NIH, Washington, DC, ²⁶University of Colorado, Denver, CO
Background/Purpose: Individuals with elevations of serum anti-cyclic citrullinated peptide (anti-CCP) antibodies are at-risk for rheumatoid arthritis (RA). Identification of interventions to prevent RA in anti-CCP-positive…
Abstract Number: 1461 • ACR Convergence 2025
Digital Behavioral Therapy Improves Outcome in Patients With Axial Spondyloarthritis And Persistent Pain: Results From a Randomized Controlled Trial
David Kiefer¹, Yade Sonkaya², Dietmar Krause³, Markus Voglau⁴, Bernhard Mintrop⁵, Imke Redeker⁶, Xenofon Baraliakos⁷ and Uta Kiltz⁷, ¹Ruhr-Universität Bochum; Private practice of rheumatology, Hattingen, Germany, Herne, Germany, ²Ruhr-Universität Bochum, Herne, Germany, ³Elisabeth-Gruppe, Herne, Germany, Essen, Germany, ⁴myself, Oldenburg, Germany, ⁵Private rheumatology practice, Hattingen, Germany, ⁶Ruhr University Bochum, Bochum, Germany, ⁷Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Axial spondyloarthritis (axSpA) is often associated with persistent pain despite effective anti-inflammatory treatment, substantially impacting patients' quality of life. Digital health applications (DiGAs) provide…
Abstract Number: 1270 • ACR Convergence 2025
Increasing Participation in the FT819 Cell Therapy Trial Amongst People Living with Lupus: A Focus Group Study
Joy Buie¹, Safoah Agyemang¹, Andrew Henry², Andrew BitMansour³, Vaneet Sandhu⁴, Debra Zack⁵ and Michael Fisher¹, ¹Lupus Foundation of America, Washington, DC, ²Fate Therapeutics, Inc., San Diego, CA, ³Fate Therapeutics, Inc., San Carlos, CA, ⁴Fate Therapeutics, Inc., San Diego, ⁵Fate Therapeutics, San Diego
Background/Purpose: Clinical trials exploring the safety and efficacy of chimeric antigen receptor (CAR) T-cell therapy for lupus are growing. Challenges linked to recruitment for CAR…
Abstract Number: 0656 • ACR Convergence 2025
Low-dose belimumab reduced disease flares in patients with systemic lupus erythematosus at low disease activity: a multicenter, randomized, double-blind, placebo-controlled trial
Fangfang Sun¹, Huijing Wang¹, Danting Zhang¹, Nan Shen¹, Sheng Chen¹, Tiing Li¹, Weiguo Wan², Shengming Dai³ and Shuang Ye⁴, ¹Renji Hospital, Shanghai, China (People's Republic), ²Huashan Hospital, Shanghai, China (People's Republic), ³Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China (People's Republic), ⁴Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, Shanghai, Shanghai, China (People's Republic)
Background/Purpose: B-lymphocyte stimulator was involved in the pathogenesis of SLE. The humanized monoclonal antibody belimumab with 10mg/kg was effective for active patients. The efficacy of…
Abstract Number: 0874 • ACR Convergence 2025
Impact of Deucravacitinib on Disease Activity in Patients With Psoriatic Arthritis (PsA): Results From the Pivotal Phase 3 PsA Studies
Atul Deodhar¹, Ricardo Blanco², Arthur Kavanaugh³, Alice Gottlieb⁴, Laura Coates⁵, Christopher Ritchlin⁶, Alan Kivitz⁷, Xiaofeng Zeng⁸, Akimichi Morita⁹, Diamant Thaçi¹⁰, Stefan Varga¹¹, Kexuan Li¹¹, Ying-Ming Jou¹², Eleni Vritzali¹³ and Philip J. Mease¹⁴, ¹Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ²Rheumatology Division, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Santander, Spain, Santander, Cantabria, Spain, ³University of California, San Diego, School of Medicine, San Diego, CA, ⁴Department of Dermatology, UT Southwestern Medical Center, Dallas, TX, ⁵Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ⁶University of Rochester Medical Center, Canandaigua, NY, ⁷Altoona Center for Clinical Research, Duncansville, PA, ⁸Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China (People's Republic), ⁹Department of Geriatric and Environmental Dermatology, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan, ¹⁰Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, ¹¹Bristol Myers Squibb, Princeton, NJ, ¹²Bristol Myers Squibb, Princeton, ¹³Bristol Myers Squibb, Boudry, Switzerland, ¹⁴Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA
Background/Purpose: The first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor deucravacitinib has an established clinical profile in moderate to severe plaque psoriasis with over…
Abstract Number: 0487 • ACR Convergence 2025
Efficacy of sarilumab in patients with rheumatoid arthritis of different disease activity at treatment initiation: a post-hoc analysis of a Phase 3 trial of sarilumab in Japan
Hideto Kameda¹, Toshiya Takahashi², Naoki Soeda² and Yoshiya Tanaka³, ¹Department of Internal Medicine, Toho University, Tokyo, Japan, ²Medical Affairs, Asahi Kasei Pharma Corporation, Tokyo, Japan, ³University of Occupational and Environmental Health, Japan, Kitakyushu, Japan
Background/Purpose: The efficacy and safety of sarilumab (SAR) and methotrexate (MTX) in patients (pts) in Japan with moderate-to-severely active rheumatoid arthritis (RA) and inadequate response…
Abstract Number: 0261 • ACR Convergence 2025
Randomized Confirmatory Basket Trial: Performance Evaluation of a Simulated Application Example in Rare Disease Using Real World Data
Daphne Guinn¹, Linchen He², Yuru Ren¹, Valeriy Korostyshevskiy¹ and Robert Beckman¹, ¹Georgetown University, Washington, ²Novartis, East Hanover
Background/Purpose: Basket trials group together participants who share a common biomarker or disease pathway across several diseases or phenotypes in a single clinical study. Such…
Abstract Number: 2465 • ACR Convergence 2025
CD19/BCMA Dual-Targeting FasTCAR-T Cells GC012F (AZD0120) in patients with refractory Systemic Lupus Erythematosusm: an open-label, single-center Phase I study
chunmei Wu¹, Yakai Fu², Jia Liu³, Yan Ye⁴, Ran Wang⁵, Xintong Feng³, Lianjun Shen⁶, Peiying Li⁵, Shuang Ye⁵ and Qiong Fu⁷, ¹Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, Shanghai, China (People's Republic), ²Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, Shanghai, China (People's Republic), ³Astrazeneca, Shanghai, China (People's Republic), ⁴Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China (People's Republic), ⁵Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, Shanghai, Shanghai, China (People's Republic), ⁶Astrazeneca, Shanghai, Shanghai, China (People's Republic), ⁷Renji Hospital, Shanghai, Shanghai, China
Background/Purpose: GC012F (AZD0120) is a CD19/B cell maturation antigen (BCMA) dual-targeting chimeric antigen receptor T-cell (CAR-T) developed on the novel FasTCAR-T platform with next-day manufacturing,…
Abstract Number: 2352 • ACR Convergence 2025
Long-Term Uveitis Rates with Bimekizumab Treatment Across Pooled Phase 2b and Phase 3 Studies in Patients with Axial Spondyloarthritis or Psoriatic Arthritis: 3-Year Update
Martin Rudwaleit¹, Irene E. van der Horst-Bruinsma², Floris A. van Gaalen³, Nigil Haroon⁴, Lianne S. Gensler⁵, Myriam Manente⁶, Chetan Prajapati⁷, Katy White⁷, Atul Deodhar⁸ and Matthew A. Brown⁹, ¹Bielefeld University, Medical School and University Medical Centre OWL, Klinikum Bielefeld, Department of Rheumatology, Bielefeld, Germany, ²Department of Rheumatology, Radboud University Medical Centre, Nijmegen, Netherlands, ³Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁴Department of Medicine/Rheumatology, University Health Network, Schroeder Arthritis Institute, University of Toronto, Toronto, ON, Canada, ⁵Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁶UCB, Braine-L'Alleud, Belgium, ⁷UCB, Slough, United Kingdom, ⁸Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁹Genomics England, London, United Kingdom
Background/Purpose: Uveitis is a common extra-musculoskeletal manifestation in patients (pts) with spondyloarthritis (SpA); incidence varies with SpA type and disease duration.1–3 IL-17 has been implicated…
Abstract Number: 2083 • ACR Convergence 2025
Evaluation of a Parent-Trial as a Run-In Period: Efficacy and Safety of Repeat Injections of Lorecivivint over Three Years
Christopher Swearingen¹ and Yusuf Yazici², ¹Biosplice Therapeutics, Inc, San Diego, CA, ²NYU Grossman School of Medicine, La Jolla, CA
Background/Purpose: Lorecivivint (LOR) is an intra-articular CLK/DYRK inhibitor in clinical development for the treatment of knee OA. A Phase 3 Trial, OA-11 (NCT03928184), assessed clinical…
Abstract Number: 1671 • ACR Convergence 2025
Emapalumab Treatment for Patients with Differing Presentations of Macrophage Activation Syndrome (MAS) Secondary to Still’s Disease: Results from a Pooled Analysis of Two Prospective Trials
Alexiei GROM¹, Sebastiaan Vastert², Jordi anton³, Pierre Quartier⁴, Bruno Fautrel⁵, Paul Brogan⁶, Edward Behrens⁷, Melissa Elder⁸, Francesca Minoia⁹, Pavla Dolezalova¹⁰, Robert Biesen¹¹, Masaki Shimizu¹², Uwe Ullmann¹³, Adnan Mahmood¹⁴, Andrew Danquah¹³, Elena Burillo¹³, Marco Petrimpol¹³, Steve Mallett¹⁵, Brian Jamieson¹⁶ and Fabrizio De Benedetti¹⁷, ¹Cincinnati Children’s Hospital Medical Center, Division of Rheumatology, Cincinnati, OH, ²University Medical Center Utrecht, Utrecht, Utrecht, Netherlands, ³Hospital Sant Joan de Düu. Universitat de Barcelona, Barcelona, Spain, ⁴Hôpital Necker-Enfants Malades, Paris, France, ⁵Sorbonne Université - APHP, Department of Rheumatology, Hôpital Pitié-Salpêtrière, Inserm UMRS ¹¹³⁶-⁵, PARIS, France, Paris, France, ⁶Great Ormond Street Hospital for Children NHS Foundation Trust and University College London Great Ormond Street Institute of Child Health, London, United Kingdom, ⁷CHOP, West Chester, PA, ⁸College of Medicine and Division of Pediatric Allergy, Immunology, and Rheumatology, Department of Pediatrics, University of Florida, GAINESVILLE, FL, ⁹Pediatric Immuno-Rheumatology Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy, ¹⁰Paediatric Rheumatology and Autoinflammatory Diseases Unit, General University Hospital, Prague, Czech Republic, ¹¹Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany, Berlin, Germany, ¹²Department of Pediatrics and Developmental Biology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan, ¹³Sobi, Basel, Switzerland, ¹⁴Sobi, Stockholm, Sweden, ¹⁵Sobi, Stock, Sweden, ¹⁶Sobi Inc., Morrisville, NC, ¹⁷Bambino Gesu Children's Hospital, Rome, Rome, Italy
Background/Purpose: MAS is a life-threatening complication of Still’s disease characterized by systemic IFNg-driven hyperinflammation. Patients with Still’s disease may present with MAS at any disease…
Abstract Number: 1458 • ACR Convergence 2025
Clinical Efficacy of Bimekizumab Treatment up to 2 Years Across Patients with Psoriatic Arthritis and Varying Baseline Joint Involvement: Results from a Post Hoc Analysis of Two Pooled Phase 3 Studies
Philip J. Mease¹, Laure Gossec², Hideto Kameda³, David Nicholls⁴, Proton Rahman⁵, Barbara Ink⁶, Rajan Bajracharya⁶, Patrick Healy⁷ and Laura Coates⁸, ¹Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ²Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France, ³Department of Internal Medicine, Toho University, Tokyo, Japan, ⁴Clinical Trials Unit, University of the Sunshine Coast, Queensland, Australia, ⁵Division of Rheumatology, Craig L. Dobbin Genetics Research Centre, Discipline of Medicine, Memorial University of Newfoundland, St. John's, Canada, ⁶UCB, Slough, England, United Kingdom, ⁷UCB, Morrisville, NC, ⁸Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom
Background/Purpose: Patients (pts) in PsA clinical trials often have greater joint involvement than in the clinical setting due to trial inclusion criteria,1 thus it is…
Abstract Number: 1175 • ACR Convergence 2025
Secukinumab In Patients with Giant Cell Arteritis with Polymyalgia Rheumatica Symptoms: A Post Hoc Analysis of the Phase 2 TitAIN Study
Nils Venhoff¹, Wolfgang Schmidt², Raoul Bergner³, Juergen Rech⁴, Leonore Unger⁵, Stephanie Finzel⁶, Ioana Andreica⁷, David Kofler⁸, Stefan Weiner⁹, Prof. Dr. med. Peter Lamprecht¹⁰, Hendrik Schulze-Koops¹¹, Meryl Mendelson¹², Weibin Bao¹³, Monica Keyport¹⁴, Meron Maricos¹⁵, Valeria Jordan M.¹⁶ and Jens Thiel¹⁷, ¹University of Freiburg, Freiburg, Germany, ²Immanuel Krankenhaus Berlin, Medical Centre for Rheumatology Berlin-Buch; Waldfriede Hospital, Rheumatology, Berlin, Germany, ³Department of Internal Medicine A, Nephrology and Rheumatology, Municipal Hospital Ludwigshafen, Ludwigshafen, Germany, ⁴Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, Erlangen, Germany, ⁵Städtisches Klinikum Dresden, Dresden, Germany, ⁶Universitétsklinikum Freiburg, Freiburg im Breisgau, Germany, ⁷Rheumazentrum Ruhrgebiet Herne; Ruhr-Universität Bochum, Germany, Herne, Germany, ⁸University of Cologne, Cologne, Germany, ⁹Brüderkrankenhaus Trier, Trier, Germany, ¹⁰University of Lübeck, Lübeck, Germany, ¹¹LMU Hospital, Division for Rheumatology and Clinical Immunology, Munich, Bayern, Germany, ¹²Novartis Pharmaceuticals, Larchmont, NY, ¹³Novartis Pharmaceuticals Corporation, Hanover, NJ, ¹⁴Novartis Pharmaceuticals, Stillwater, MN, ¹⁵Novartis, Nürnberg, Germany, ¹⁶Novartis Pharmaceuticals Corporation, Tenafly, NJ, ¹⁷University Hospital Freiburg, Medical University Graz, Freiburg, Germany
Background/Purpose: GCA and PMR are closely related, immune-mediated chronic inflammatory diseases often occurring concurrently in individuals over 50.1,2 While glucocorticoids (GC) are the mainstay of…

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