Abstracts tagged "clinical trial"

Abstract Number: 2464 • ACR Convergence 2025
IMC-002 (IMM0306), a First-in-Class Bi-specific Fusion Protein, Demonstrates Improvements in Systemic Lupus Erythematosus (SLE) Disease Activity Measures and Biomarkers in Patients with Moderate to Severe Active SLE in the Open-label Phase 1b/2 Study
Haihong Yao¹, Wenzhi Tian², Qian Zheng², Min Chen², Guoping Jiang³, Zhichun Liu⁴, Yingkun Nie⁵, Rui Wu⁶, Zhaohui Zheng⁷ and Zhanguo Li¹, ¹Peking University People's Hospital, Beijing, China (People's Republic), ²ImmuneCare Biopharmaceuticals (Shanghai) Co.,Ltd, Shanghai, China (People's Republic), ³Jilin Province People's Hospital, Changchun, China (People's Republic), ⁴The Second Affiliated Hospital of Soochow, Suzhou, China (People's Republic), ⁵The Second Affiliated Hospital of Harbin Medical University, Haerbin, China (People's Republic), ⁶The First Affiliated Hospital of Nanchang University, Nanchang, China (People's Republic), ⁷The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China (People's Republic)
Background/Purpose: Deep B cell depletion has been confirmed to be the main mechanism for complete clinical response of SLE patients. We analyzed the peripheral blood…
Abstract Number: 0259 • ACR Convergence 2025
Inhaled pirfenidone as an innovative therapeutic approach to treat autoimmune ILD and other forms of Progressive Pulmonary Fibrosis: Phase 2b Study Design
Kristin Highland¹, Colin Reisner², Allison Trucillo³, Deepthi Nair⁴, Felix Woodhead⁴, Howard Lazarus⁴, Craig Conoscenti⁴ and Martin Kolb⁵, ¹Cleveland Clinic, Shaker Heights, OH, ²DevPro Biopharma, Basking Ridge, NJ, ³Avalyn Pharma, Austin, TX, ⁴Avalyn Pharma, Cambridge, MA, ⁵McMaster University, Hamilton, ON, Canada
Background/Purpose: Progressive Pulmonary Fibrosis (PPF) is an increasingly recognized condition, defined in 2022 to address the progression of pulmonary fibrosis in patients with interstitial lung…
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: 0873 • ACR Convergence 2025
Sex Differences in Proteomic Profiles and the Impact of Deucravacitinib Treatment in Patients with Active Psoriatic Arthritis: A Pooled Phase 3 Analysis
Lihi Eder¹, Shangzhong Li², Philip J. Mease³, Christopher Ritchlin⁴, Walter P Maksymowych⁵, Hendrik Schulze-Koops⁶, Josef Smolen⁷, Oliver FitzGerald⁸, Vinod Chandran⁹, Chun Wu¹⁰ and Jinqi Liu², ¹University of Toronto, Toronto, ON, Canada, ²Bristol Myers Squibb, Princeton, NJ, ³Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁴University of Rochester Medical Center, Canandaigua, NY, ⁵Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁶LMU Hospital, Division for Rheumatology and Clinical Immunology, Munich, Bayern, Germany, ⁷Division of Rheumatology, Department of Medicine ³, Medical University of Vienna, Vienna, Austria, Vienna, Austria, ⁸UCD, Dublin ⁶, Dublin, Ireland, ⁹Division of Rheumatology, Departments of Medicine and Laboratory Medicine and Pathobiology, University of Toronto, and Gladman Krembil Psoriatic Arthritis Research Program, Krembil Research Institute, University Health Network, Toronto, Canada, ¹⁰Bristol Myers Squibb, Princeton
Background/Purpose: PsA affects male and female patients equally; however, variations in manifestations and treatment response exist between sexes. Deucravacitinib is an oral, selective, allosteric tyrosine…
Abstract Number: 0650 • ACR Convergence 2025
Obinutuzumab Demonstrates Steroid-Sparing Effects and Consistent Benefit In Patients with Lupus Nephritis When Using Multiple Primary Endpoint Definitions: A Secondary Analysis of Phase III Trial Results
Brad Rovin¹, Jay Garg², Richard Furie³, Rachel Jones⁴, Amit Saxena⁵, Pasquale Esposito⁶, Elsa Martins⁷, Claire Petry⁷, Nicolas Frey⁷, Bongin Yoo², Imran Hassan⁸, Thomas Schindler⁷, Theodore Omachi⁹, William Pendergraft², Mittermayer Santiago¹⁰, Gustavo Aroca Martínez¹¹ and Ana Malvar¹², ¹The Ohio State University, Columbus, OH, ²Genentech, Inc., South San Francisco, CA, ³Division of Rheumatology, Northwell Health, Great Neck, NY, ⁴Renal Medicine, Cambridge University Hospitals, Cambridge, England, United Kingdom, ⁵Division of Rheumatology, Department of Medicine, NYU Grossman School of Medicine, New York, NY, ⁶Clinica Nefrologica, Dialisi, Trapianto, Department of Internal Medicine, University of Genoa and IRCCS Ospedale Policlinico San Martino, Genova, Italy, ⁷F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁸Hoffmann-La Roche Ltd, Mississauga, ON, Canada, ⁹Genentech, Inc., South San Francisco, ¹⁰Bahiana School of Medicine and Public Health and UFBA, Federal University of Bahia, and Clínica SER da Bahia, Salvador, Bahia, Brazil, ¹¹Universidad Simón Bolívar, Barranquilla, Colombia y Clínica de la Costa, Barranquilla, Colombia, ¹²Organización Médica de Investigación, Buenos Aires, Argentina
Background/Purpose: The Phase III REGENCY study (NCT04221477) demonstrated superiority of obinutuzumab (OBI) over placebo (PBO) in achieving complete renal response (CRR) at Week 76 when…
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…
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: 1662 • ACR Convergence 2025
Efficacy and Safety of Nerandomilast in Patients with Autoimmune Disease-Related Progressive Pulmonary Fibrosis: Subgroup Analysis of the FIBRONEER-ILD trial
Anna-Maria Hoffmann-Vold¹, Shervin Assassi², Vincent Cottin³, Michael Kreuter⁴, Claudia Valenzuela⁵, Marlies S Wijsenbeek⁶, Hui Gu⁷, Ivana Ritter⁸, Susanne Stowasser⁸, Gerrit Weimann⁸ and Toby M Maher⁹, ¹Oslo University Hospital, Oslo, Norway, ²Division of Rheumatology, UTHealth Houston, Houston, Texas, USA, Houston, TX, ³National Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, Claude Bernard University Lyon ¹, UMR ⁷⁵⁴, ERN-LUNG, Lyon, France, Lyon, France, ⁴Center for Pulmonary Medicine, Department of Pneumology, Mainz University Medical Center and Pulmonary, Critical Care & Sleep Medicine, Marienhaus Clinic Mainz, Mainz, Germany, Heidelberg, Germany, ⁵Pulmonology Department, Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Madrid, Spain, Madrid, Spain, ⁶Center of Expertise for Interstitial Lung Diseases, Department of Respiratory Medicine, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands, Rotterdam, Netherlands, ⁷Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA, Ridgefield, ⁸Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, Ingelheim am Rhein, Germany, ⁹Department of Pulmonary, Critical Care and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA and Section of Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College London, London, UK, Los Angeles
Background/Purpose: Nerandomilast is a preferential inhibitor of phosphodiesterase 4B with antifibrotic and immunomodulatory properties. The Phase III FIBRONEER-ILD trial in patients with progressive pulmonary fibrosis…
Abstract Number: 2082 • ACR Convergence 2025
Pharmacokinetic Profile of MM-II Following a Single Intra-Articular Injection in Patients with Knee Osteoarthritis in a Phase 2b Randomized, Controlled, Dose-Ranging Trial
Thomas Schnitzer¹, Xavier Chevalier², Helene Rovsing³, Edith Lau⁴, Sidsel Boll⁵, Ballari Brahmachari⁶, Richard Chou⁷, Tarini Joshi⁸, Roni Wechsler⁹, Sveta Weiner¹⁰, Mudgal Kothekar¹¹, Asger Bihlet¹² and Philip Conaghan¹³, ¹Northwestern University Feinberg School of Medicine, Chicago, IL, ²Henri Mondor Hospital, University Paris XII UPEC, Créteil, France, ³Sanos Clinic, Gandrup, Denmark, ⁴Hong Kong Center for Clinical Research, Hong Kong, Hong Kong, ⁵Sanos Clinic, Vejle, Denmark, ⁶Sun Pharmaceuticals Industries Ltd., mumbai, Maharashtra, India, ⁷Sun Pharmaceutical Industries, Inc., Princeton, NJ, ⁸Sun Pharmaceutical Industries Limited, Mumbai, India, ⁹Moebius Medical, Tel Aviv, Israel, ¹⁰Sun Pharma Advanced Research Company Limited, Princeton, NJ, ¹¹Sun Pharma Advanced Research Company Limited, Andheri (E), Princeton, NJ, ¹²NBCD A/S, Herlev, Denmark, ¹³University of Leeds, Leeds, United Kingdom
Background/Purpose: MM-II is a first-in-class investigational treatment for knee OA pain that consists of a one-time IA injection of empty liposomes comprised of phospholipids dipalmitoylphosphatidylcholine…
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: 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: 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: 0488 • ACR Convergence 2025
Early and Sustained Improvements in Disease Activity and Patient-Reported Outcomes in Patients Treated with Filgotinib for Rheumatoid Arthritis: Up to 2-Year Interim Real-World Data From FILOSOPHY and PARROTFISH
Jérôme Avouac¹, Neil Betteridge², Karen Bevers³, Gerd Burmester⁴, Roberto Caporali⁵, Ouafia Bouzid⁶, Thomas Debray⁶, Carole Van der Donckt⁶, James Galloway⁷, Susana Romero-Yuste⁸ and Patrick Verschueren⁹, ¹Hôpital Cochin, AP-HP Centre - Université Paris Cité, Paris, France, ²Neil Betteridge Associates, London, United Kingdom, ³Sint Maartenskliniek, Nijmegen, Netherlands, ⁴Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁵University of Milan and ASST Gaetano Pini-CTO, Milano, Italy, ⁶Alfasigma S.p.A., Bologna, Italy, ⁷King's College London, London, United Kingdom, ⁸University Hospital Complex of Pontevedra, Pontevedra, Spain, ⁹Rheumatology, University Hospital Leuven and Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium
Background/Purpose: FILOSOPHY (NCT04871919) and PARROTFISH (NCT05323591) are ongoing, prospective, observational Phase 4 studies of filgotinib in patients (pts) with rheumatoid arthritis (RA) in Europe. In…
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: 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…

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