Abstracts tagged "clinical trial"

Abstract Number: 0664 • ACR Convergence 2025
Pharmacodynamic Effects of Obinutuzumab on B cells and Serological Markers in Patients With Active Lupus Nephritis: Results From a Phase III Trial
Richard Furie¹, Ioannis Parodis², Rachel Jones³, Liz Lightstone⁴, Olivia Hwang⁵, Amelia Au-Yeung⁵, Imran Hassan⁶, Huiyan Mao⁶, William Pendergraft⁵, Jay Garg⁵, Harini Raghu⁵ and Brad Rovin⁷, ¹Division of Rheumatology, Northwell Health, Great Neck, NY, ²Karolinska Institutet and Karolinska University Hospital, Department of Medicine Solna, Division of Rheumatology, Stockholm, Sweden, ³Renal Medicine, Cambridge University Hospitals, Cambridge, England, United Kingdom, ⁴Department of Immunology and Inflammation, Faculty of Medicine, Imperial College London, London, England, United Kingdom, ⁵Genentech, Inc., South San Francisco, CA, ⁶Hoffmann-La Roche Ltd, Mississauga, ON, Canada, ⁷The Ohio State University, Columbus, OH
Background/Purpose: Lupus nephritis (LN) is a severe manifestation of systemic lupus erythematosus, marked by kidney inflammation and damage. Obinutuzumab, a glycoengineered, type II CD20 antibody…
Abstract Number: 0562 • ACR Convergence 2025
Icotrokinra (ICO), a Novel Targeted Oral Peptide, in Patients (Pts) With Psoriatic Disease: Exploratory Assessments From a Phase 2 Psoriasis (PsO) Study Informing a Phase 3 Clinical Program in Psoriatic Arthritis (PsA)
Joseph F Merola¹, Philip J. Mease², Laura Coates³, Iain McInnes⁴, Peter Nash⁵, Alexis Ogdie⁶, Lihi Eder⁷, mitsumasa kishimoto⁸, Anna Beutler⁹, Konstantina Psachoulia⁹, Shihong Sheng¹⁰, Bei Zhou¹¹, Mehrdad Javidi¹², Chandni Valiathan¹², Charles Iaconangelo¹⁰, Ya-Wen Yang¹³, Arun Kannan¹³, Chetan S. Karyekar⁹ and Tasneam Shagroni⁹, ¹Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ²Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ³Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ⁴University of Glasgow, Glasgow, United Kingdom, ⁵Griffith University and U of Queensland, Maroochydore, Queensland, Australia, Queensland, Australia, ⁶University of Pennsylvania, Philadelphia, PA, ⁷University of Toronto, Toronto, ON, Canada, ⁸Kyorin University School of Medicine, Tokyo, Japan, ⁹Johnson & Johnson, Spring House, PA, USA, Spring House, ¹⁰Johnson & Johnson, Chesterbrook, PA, USA, Chesterbrook, ¹¹Johnson & Johnson, Spring House, PA, USA, Spring House, PA, ¹²Johnson & Johnson, San Diego, CA, USA, San Diego, ¹³Johnson & Johnson, San Diego, CA, USA, San Diego, CA
Background/Purpose: PsA affects ~20-30% of pts with PsO, causing articular inflammation/damage, and impaired health-related quality of life (HRQoL). ICO, a novel targeted oral peptide that…
Abstract Number: 0504 • ACR Convergence 2025
Spatial profiling of gene signatures in synovial tissue informs treatment strategy for Rheumatoid Arthritis
Vincent Wong¹, Katie Lowe², Annabelle Small³, Christopher Altmann³, Susanna Proudman⁴, Malcolm Smith², Wittaya Suwakulsiri⁵, Ranjeny Thomas⁵, Chung Hoow Kok⁶ and Mihir Wechalekar⁷, ¹College of Medicine and Public Health, Bedford Park, South Australia, Australia, ²Flinders University, Adelaide, South Australia, Australia, ³Flinders University, Bedford Park, South Australia, Australia, ⁴The University of Adelaide, Adelaide, Victoria, Australia, ⁵Frazer Institute, University of Queensland, Brisbane, Queensland, Australia, ⁶Centre for Cancer Biology, and Clinical Health Sciences, University of South Australia, Adelaide, South Australia, Australia, ⁷Flinders Medical Centre and Flinders University, Bedford Park, South Australia, Australia
Background/Purpose: Rheumatoid arthritis (RA) shows heterogeneous therapeutic responses that may reflect diversity within synovial tissue (ST). We aimed to identify gene signatures that predict Adalimumab…
Abstract Number: 0335 • ACR Convergence 2025
Discontinuation and Non-Publication of Osteoarthritis Clinical Studies: A Cross-Sectional Analysis of 10,686,413 Patients
Mohamed Abdelsalam¹, Hadeer Hafez², Maryam Lasheen³, Bassant Elaraby Elsayed Badwy⁴, Omar Sameh Nabil El Sedafy¹, Abdelrahman M Hafez⁵, Omnia Samy El-Sayed⁴, Menat Alla Ayman Ali Mahdy⁴, Ali Tarek Hassanin³, Mohamed Reda Awad⁶ and Mohammed Safwat Kamal Hamza⁷, ¹Misr University For Science and Technology, ⁶ october, Al Jizah, Egypt, ²⁶th October University, ⁶ october, Al Jizah, Egypt, ³Misr University For Science and Technology, Helwan, Al Qahirah, Egypt, ⁴Misr University For Science and Technology, Nasr City, Al Qahirah, Egypt, ⁵Faculty of medecine, Damietta university, Mansoura, Ad Daqahliyah, Egypt, ⁶Al Azhar University, Cairo, Egypt, Giza, Al Jizah, Egypt, ⁷Faculty of Medicine, Misr University for Science and Technology, ⁶ october, Al Jizah, Egypt
Background/Purpose: Osteoarthritis (OA) is rising at an alarming rate, affecting millions worldwide and threatening mobility, independence, and quality of life. High-quality evidence is essential to…
Abstract Number: 2587 • ACR Convergence 2025
Nanoencapsulated Sirolimus Plus Pegadricase Reduced Disease Burden in Patients With Uncontrolled Gout: Results From the Phase 3 DISSOLVE Trials
Puja Khanna¹, Amar Majjhoo², Rehan Azeem³, Ben Peace⁴, Bhavisha Desai⁵ and Vibeke Strand⁶, ¹Division of Rheumatology, University of Michigan, Ann Arbor, MI, ²Shores Rheumatology, St. Clair Shores, MI, ³Global MACD, Sobi Inc., Waltham, MA, ⁴Statistical Science, Sobi, Stockholm, Sweden, ⁵Sobi, Glastonbury, CT, ⁶Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA
Background/Purpose: Patients (pts) with uncontrolled gout (UG; persistent elevation in serum uric acid [sUA] levels and clinical manifestations despite oral urate-lowering therapy) have poor health-related…
Abstract Number: 2361 • ACR Convergence 2025
Secondary Outcomes from a Series of N-of-1 NSAID Trials in Axial Spondyloarthritis: Functional, Quality-of-Life, and Safety Results from a Bayesian Analysis
Mark Hwang¹, Seokhun Kim², Shervin Assassi³, Joyce Samuel¹, Charles Green¹, Jon Tyson² and John Reveille⁴, ¹UTHealth Houston, Houston, TX, ²UTHealth Houston, Houston, ³Division of Rheumatology, UTHealth Houston, Houston, Texas, USA, Houston, TX, ⁴Department of Medicine, University of Texas Medical Center, Houston, TX
Background/Purpose: We previously reported primary outcomes from a Bayesian series of N-of-1 trials comparing celecoxib, meloxicam, and naproxen in axial spondyloarthritis (axSpA), demonstrating improved ASDAS…
Abstract Number: 2103 • ACR Convergence 2025
PCRX-201 High-Capacity Adenovirus Serotype 5 Gene Therapy Demonstrates Sustained Clinical Efficacy and Safety in Patients With Knee Osteoarthritis
Stanley Cohen¹, Philip Conaghan², Marc C. Hochberg³, Alan Kivitz⁴, MiJeong Kim⁵, Nino Joy⁶, Shoshanna Jiang⁶, Mary DiGiorgi⁷, Jonathan Slonin⁶ and Derek Slonin⁶, ¹Metroplex Clinical Research Center, dallas, TX, ²University of Leeds, Leeds, United Kingdom, ³Marc C. Hochberg University of Maryland School of Medicine, Baltimore, MD, ⁴Altoona Center for Clinical Research, Duncansville, PA, ⁵Pacira BioSciences, Inc., Brisbane, ⁶Pacira BioSciences, Inc., Brisbane, CA, ⁷Pacira BioSciences, Inc, Brisbane, CA
Background/Purpose: Knee OA is a common disease affecting ~15 million people in the United States. There is an urgent unmet need for additional OA treatments…
Abstract Number: 1925 • ACR Convergence 2025
Associations between Representation and Quality in Clinical Trials for Systemic Lupus Erythematosus
Joshua Skydel¹, Anna Leland², Reshma Ramachandran³, Fotios Koumpouras³ and Joshua Wallach², ¹Yale-New Haven Hospital, New Haven, CT, ²Rollins School of Public Health, Atlanta, GA, ³Yale School of Medicine, New Haven, CT
Background/Purpose: Drug development in SLE is informed by US Food and Drug Administration recommendations for study design, enrollment, and efficacy endpoints. However, persistent challenges to…
Abstract Number: 1519 • ACR Convergence 2025
Post-hoc Analysis of Sustained Response Over Time in Systemic Lupus Erythematosus Patients Treated with Cenerimod in CARE (Phase 2 B) Study
Anca Askanase¹, Bruno Flamion², Ouali Berkani² and Cecile Dubois², ¹Columbia University Medical Center, New York, NY, ²Viatris Innovation, Allschwil, Switzerland
Background/Purpose: Cenerimod is a highly selective S1P1 receptor modulator which is undergoing trials for potential therapeutic benefits in autoimmune disease, including Systemic Lupus Erythematous (SLE).…
Abstract Number: 1356 • ACR Convergence 2025
Use of (MSB11456), the first tocilizumab biosimilar approved for rheumatoid arthritis: 6-month data from an international observational study
Jonathan Kay¹, Eugen feist², Ernest Choy³, Joerg Kaufmann⁴, Ernest Wong⁵, Hector Corominas⁶, René-Marc Flipo⁷, Jérôme Avouac⁸, María América López Lasanta⁹, Joelle Monnet¹⁰, Peter Baker¹¹, Maria Romanova Michailidi¹², Fabrizio Dolfi¹¹ and Graziella Pourcel¹³, ¹UMass Chan Medical School, Worcester, MA, ²Helios Department of Rheumatology, Vogelsang-Gommern, Germany, ³Division of Infection and Immunity, CREATE Centre, Cardiff University, Cardiff, United Kingdom, ⁴NA, Ludwigsfelde, Germany, ⁵Portsmouth Hospitals University NHS Trust, Portsmouth, United Kingdom, ⁶Hospital de Sant Pau, Barcelona, Spain, ⁷Université de Lille, CHU Lille, Service de rhumatologie, Lille, France, Lille, France, ⁸Hôpital Cochin, AP-HP Centre - Université Paris Cité, Paris, France, ⁹Hospital Universitario Vall d´Hebron, Barcelona, Spain, ¹⁰Fresenius Kabi SwissBioSim, Eysins, Switzerland, ¹¹Fresenius Kabi Biopharma, Eysins, Switzerland, ¹²University of Geneva, Eysins, Switzerland, ¹³Fresenius Kabi Biopharma, Eyzins, France
Background/Purpose: Although most healthcare professionals are convinced of the quality, safety, and favorable economic impact of biosimilars, their routine use is not yet widespread. MSB11456…
Abstract Number: 0663 • ACR Convergence 2025
iPSC-Derived Off-the-Shelf anti-CD19 CAR T cells Deliver Improved Clinical Outcomes in Lupus with Reduced or No Conditioning Chemotherapy
Parastoo Fazeli¹, Jennifer Medlin², Andrew BitMansour³, Debra Zack⁴, Rebecca Elstrom⁵, Bertha Villa⁵, Lilly Wong⁶, John Goulding⁷, Nicholas Brookhouser⁵, Trever Greene⁵, Cara Bickers⁵, Carol Wong⁵, Beatrice Ferguson⁵, Tom Lee⁵, Jode Goodridge⁵, Marie Hu⁸, Veronika Bachanova⁸, Jeffrey Miller⁹, Bahram Valamehr⁶, Matthew Lunning¹⁰ and Vaneet Sandhu⁵, ¹UMN, ST PAUL, MN, ²University of Nebraska Medical Center, Omaha, NE, ³Fate Therapeutics, Inc., San Carlos, CA, ⁴Fate Therapeutics, Inc., Solana Beach, CA, ⁵Fate Therapeutics, Inc., San Diego, ⁶Fate Therapeutics, Inc., San Diego, CA, ⁷Fate Therapeutics, San Diego, ⁸University of Minnesota, Minneapolis, ⁹University of Minnesota, Minneaspolis, MN, ¹⁰University of Nebraska, Omaha
Background/Purpose: Anti-CD19 chimeric antigen receptor (CAR) T cell therapy shows promise in autoimmune disease. However, autologous CAR T-cell therapy is limited by prolonged pre- and…
Abstract Number: 0891 • ACR Convergence 2025
MEthotrexate versus TOcilizumab for treatment of Giant cell Arteritis (METOGiA trial): a multicenter, randomized, controlled trial.
Maxime Samson¹, Abderrahmane Bourredjem², Rodérau Outh³, Vincent Grobost⁴, François Lifermann⁵, Guillaume DIREZ⁶, Emmanuel Ribeiro⁷, Eric Oziol⁸, Valerie Devauchelle⁹, Mikael Ebbo¹⁰, Nicolas Limal¹¹, Romain Paule¹², Boris Bienvenu¹³, Antoine Poulet¹³, Sébastien Miranda¹⁴, Ygal Benhamou¹⁴, Thomas Quemeneur¹⁵, Claire Dingremont¹⁶, Andre Ramon¹⁷, Bernard Simorre⁸, Quitterie Reynaud¹⁸, Christian AGARD¹⁹, Olivier Espitia²⁰, Arsène Mekinian²¹, Jean-François Alexandra²², Emilie Berthoux²³, Laurent Perard²³, Antoine Baudet²⁴, Rafik Mesbah²⁵, David Lacôte-Delarbre²⁶, Julien Stievenart²⁷, Marc André²⁷, Jean Sébastien Allain²⁸, Rolland Jaussaud²⁹, Julie Magnant³⁰, Amélie Servettaz³¹, Hubert De Boysson³², Marc Ruivard⁴, Benjamin Terrier³³, Alexis REGENT³⁴, Amélie Cransac³⁵, Isabelle Fournel³⁶, Hervé Devilliers³⁶ and Bernard Bonnotte³⁷, ¹CHU Dijon Bourgogne, Dijon, France, ²Centre d'Investigation Clinique, CHU Dijon, Dijon, France ; INSERM, CIC ¹⁴³², Module Epidémiologie Clinique, Dijon, France, ³Department of Internal Medicine, Centre Hospitalier de Perpignan, Perpignan, France., Clermont-Ferrand, France, ⁴Internal medicine, CHU Clermont Ferrand Estaing, Clermont Ferrand, France, ⁵Internal Medicine, CH de Dax, Dax, France, ⁶Rheumatology, CH Le Mans, Le Mans, France, ⁷Internal medicine and clinical immunology, CHU Bordeaux, Hôpital Saint-André, Bordeaux, France, ⁸Internal Medicine, CH Bézier, Bézier, France, ⁹UBO, Brest, France, ¹⁰Internal Medicine, Marseille-APHM, hôpital La Timone, Marseille, France, ¹¹Internal Medicine, CHU Henri Mondor, Créteil, France, ¹²Hospital Foch, Service de medicine interne, Suresnes, Paris, Suresnes, France, ¹³Internal Medicine, Hôpital Saint Joseph, Marseille, France, ¹⁴Internal Medicine, CHU Rouen, Rouen, France, ¹⁵Nephrology and Internal Medicine, CH Valenciennes, Valenciennes, France, ¹⁶Internal Medicine, Groupement hospitalier Tarbes-Lourdes, Tarbes, France, ¹⁷Rheumatology, Université Bourgogne Europe, CHU Dijon Bourgogne, Dijon, France, ¹⁸Internal medicine and vascular diseases, Hospices Civils de Lyon, Lyon, France, ¹⁹Internal medicine, Nantes University Hospital, Nantes, France, ²⁰CHU de Nantes, Nantes, France, ²¹Department of Internal Medicine, Inflammation-Immunopathology-Biotherapy Department (DMU i³), Saint-Antoine University Hospital, ⁷⁵⁰¹² Paris, France, Paris, France, ²²Internal Medicine, Hôpital Bichat, APHP, Paris, France, ²³Internal Medicine, Saint Luc Saint Joseph Hospital, Lyon, France, ²⁴Internal Medicine, CH Annecy, Annecy, France, ²⁵Nephrology, CH Boulogne sur Mer, Boulogne sur Mer, France, ²⁶Internal Medicine, Hôpital d’instruction des armées Saint Anne, Toulon, France, ²⁷Internal Medicine, CHU Clermont Ferrand Gabriel Montpied, Clermont Ferrand, France, ²⁸Internal Medicine and Clinical Immunology, CH Saint Malo, Saint Malo, France, ²⁹Internal Medicine and Clinical Immunology, CHU Nancy, Nancy, France, ³⁰Internal Medicine, CHU Tours, Tours, France, ³¹Internal Medicine, CHU Reims, Reims, France, ³²Internal Medicine, CHU Caean, Caen, France, ³³Cochin Hospital, Paris, France, ³⁴Hopital Cochin, Paris, France, ³⁵Pharmacy, CHU Dijon Bourgogne, Dijon, France, ³⁶Centre d'Investigation Clinique, CHU Dijon, Dijon, France ; INSERM, CIC ¹⁴³², Module Epidémiologie Clinique, Dijon, France, ³⁷Internal medicine and clinical immunology, Université Bourgogne Europe , CHU Dijon Bourgogne, Dijon, France
Background/Purpose: This trial aimed to compare the efficacy and safety of methotrexate (MTX) vs. tocilizumab (TCZ), in combination with glucocorticoid (GC), in patients with giant…
Abstract Number: 0501 • ACR Convergence 2025
Phase 1b Study of SBT777101, an Engineered CAR-T-Regulatory Cell Product, in Patients With Rheumatoid Arthritis: Interim Demographics and Safety
Sarah Baxter¹, Ari Bitton², Victor Yuan², Fawad Aslam³, Gregory Challener⁴, Jonathan Graf⁵, Melissa Griffith⁶, Tamiko Katsumoto⁷, Minna Kohler⁸, Elena Massarotti⁹, Larry Moreland¹⁰, Allison Rosenthal¹¹, Jeffrey Sparks⁹, Steven Vlad¹², Janeth Yinh¹³, Andrew Clauw¹⁴, Sally Arai¹⁵, Alexander Carvidi⁵, Angela Chavez¹⁶, Olivia Gabriel¹⁷, Rita Gyurko¹⁷, Megan Hall¹⁸, Jennifer Seifert¹⁹, Emma Stainton¹⁵, Michelle Blake¹, Sabrina Fox-Bosetti², Mark Fromhold¹, Mindy Jensen²⁰, Herve Lebrec², Sean O'Bryan², Amanda Pace²¹, Mei-Lun Wang², Yuanyuan Xiao², Joseph Arron² and Jeffrey Bluestone²², ¹Sonoma Biotherapeutics, Seattle, WA, ²Sonoma Biotherapeutics, San Francisco, CA, ³Mayo Clinic, Arizona, Scottsdale, AZ, ⁴MGH, Boston, MA, ⁵UCSF, San Francisco, CA, ⁶University of Colorado, Aurora, CO, ⁷Division of Immunology and Rheumatology, Stanford University, Millbrae, CA, ⁸Massachusetts General Hospital, Harvard Medical School, Boston, MA, ⁹Brigham and Women's Hospital, Boston, MA, ¹⁰University of Colorado, Denver, CO, ¹¹Mayo Clinic, Phoenix, ¹²Tufts Medicine, Boston, MA, ¹³Massachusetts General Hospital, Boston, MA, ¹⁴Univ of Colorado, Aurora, CO, ¹⁵Stanford, Palo Alto, CA, ¹⁶Tufts, Boston, MA, ¹⁷BWH, Boston, MA, ¹⁸Mayo, Scottsdale, AZ, ¹⁹University of Colorado and Oklahoma Medical Research Foundation, Aurora, CO, ²⁰Sonoma Bio, Seattle, ²¹Sonoma Bio, Seattle, WA, ²²Sonoma Biotherapeutics, South San Francisco, CA
Background/Purpose: Regulatory T cells (Tregs) modulate inflammation, maintain self-tolerance, and promote tissue repair, and thus hold promise as a versatile therapeutic tool. Autologous polyclonal Tregs…
Abstract Number: 0310 • ACR Convergence 2025
Evaluate Safety, Tolerability, and Pharmacodynamics of a Single Intra-Articular Injection of GNSC-001 Gene Therapy in Subjects with Knee Osteoarthritis: 12-month Results from DONATELLO
Annahita Keravala¹, Philip Conaghan², shanna jackson¹, sharmila Vijay¹, Thomas Chalberg³, Jeyanesh Tambiah⁴ and Laurie Halligan¹, ¹Genascence, Palo Alto, CA, ²University of Leeds, Leeds, United Kingdom, ³Genascence Corp, Palo Alto, CA, ⁴Genascence, San Diego, CA
Background/Purpose: IL-1 contributes significantly to osteoarthritis (OA) pathology, driving inflammation and cartilage degradation. Prior therapies targeting IL-1 have shown limited success due to inadequate drug…
Abstract Number: 2576 • ACR Convergence 2025
Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH) Study: Anti-inflammatory cytokine signals related to decreased arthritis disease activity over time
Alfonso Sucerquia¹, Jose Forero², Juan Alzate¹, Adrienne Poon³, Gary Firestein⁴, Larry Moreland⁵, Andres Cadena⁶, Jose Lara⁶, Octavio pizarro⁶, Jesus Godoy⁶, Liliana Encinales⁷, David Boyle⁸, Evelyn Mendoza⁹, Carlos Herrera¹⁰ and Aileen Chang³, ¹The George Washington University, Arlington, ²The George Washington University, Arlington, VA, ³The George Washington University, Washington, ⁴University of California, San Diego, San Diego, CA, ⁵University of Colorado, Denver, CO, ⁶Clinica de la Costa, Barranquilla, Colombia, ⁷Allied Research Society, Barranquilla, Colombia, ⁸University of California, San Diego, San Diego, ⁹Universidad Libre de Barranquilla, Barranquilla, Colombia, ¹⁰The George Washington University, Alexandria
Background/Purpose: The MARCH study evaluates the efficacy of methotrexate monotherapy in patients with chikungunya-associated arthritis and aims to elucidate its pathologic mechanism via cytokine analysis.…

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