Abstracts tagged "clinical trial"

Abstract Number: 2588 • ACR Convergence 2025
Nanoencapsulated Sirolimus plus Pegadricase (NASP) Demonstrates a Reduction in Gout Flares: Results from the Phase 3 DISSOLVE Studies
Angelo Gaffo¹, Herbert Baraf², Anand Patel³, Tuhina Neogi⁴, Rehan Azeem⁵, Wesley DeHaan⁶, Ben Peace⁷, Hugues Santin-Janin⁸, Bhavisha Desai⁹ and Naomi Schlesinger¹⁰, ¹Division of Rheumatology and Clinical Immunology, University of Alabama, Birmingham, AL, USA; Birmingham VA Medical Center, Birmingham, AL, USA, Birmingham, AL, ²The Center for Rheumatology and Bone Research, Rheumatology, Wheaton, Maryland, USA; Division of Rheumatology, The George Washington University, Washington, DC, ³Conquest Research, Winter Park, FL, USA, Winter Park, FL, ⁴Boston University School of Medicine, Boston, MA, ⁵Global MACD, Sobi Inc., Waltham, MA, ⁶Sobi, Inc, Waltham, MA, ⁷Statistical Science, Sobi, Stockholm, Sweden, ⁸Sobi, BASEL, Switzerland, ⁹Sobi, Glastonbury, CT, ¹⁰Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, UT, USA, Salt Lake City, UT
Background/Purpose: Urate-lowering therapy is recommended to lower serum urate (sUA) and for long-term prevention of gout flares (FitzGerald et al. Arthritis Care Res (Hoboken) 2020;…
Abstract Number: 2365 • ACR Convergence 2025
Sustained Efficacy up to 3 Years with Bimekizumab Treatment Across GRAPPA Core Domains in Patients with Psoriatic Arthritis: Long-Term Results from Two Phase 3 Trials
Joseph F Merola¹, Laura Coates², Atul Deodhar³, Alice B. Gottlieb⁴, Enrique R. Soriano⁵, Barbara Ink⁶, Rajan Bajracharya⁶, Jason Coarse⁷ and Philip J. Mease⁸, ¹Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ³Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁴Department of Dermatology, UT Southwestern Medical Center, Dallas, TX, ⁵Rheumatology Section, Internal Medicine Service, Hospital Italiano de Buenos Aires and University Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁶UCB, Slough, England, United Kingdom, ⁷UCB, Morrisville, NC, ⁸Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA
Background/Purpose: Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)‑17F in addition to IL‑17A, has demonstrated sustained efficacy to 3 years (yrs) in…
Abstract Number: 2278 • ACR Convergence 2025
Neuroimmune modulation for the Treatment of Rheumatoid Arthritis: Results at 12 months from a Randomized, Sham-Controlled, Double-Blind Study
John Tesser¹, Angela Crowley², Jane Box³, Joshua June⁴, Pendleton Wickersham⁵, Guillermo Valenzuela⁶, Norman Gaylis⁷, Gordon Lam⁸, Leroy Pacheco⁹, David Ridley¹⁰, Gineth Pinto-Patarroyo¹¹, Stuart Novack¹², Melvin Churchill¹³, Minna Kohler¹⁴, Eric Lee¹⁵, Jose A Pando¹⁶, Glenn R. Parris¹⁷, Jeff Peterson¹⁸, Tina Shah¹⁹, Atul Singhal²⁰, Victoria Vuong²¹, Jeffrey Curtis²² and David Chernoff²³, ¹Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ²Illinois Bone and Joint Institute - Hinsdale Orthopaedics, Hinsdale, IL, ³DJL Clinical Research, PLLC, Charlotte, NC, ⁴Great Lakes Center of Rheumatology, Lansing, MI, ⁵Arthritis Associates PA, San Antonio, TX, ⁶Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁷Arthritis & Rheumatic Disease Specialties, Aventura, FL, ⁸Arthritis and Osteoporosis Consultants of the Carolinas, Cornelius, NC, ⁹Albuquerque Ctr for Rheumatology, Albuquerque, NM, ¹⁰Saint Paul Rheumatology, Eagan, MN, ¹¹Annapolis Rheumatology, Herndon, VA, ¹²Nuvance Health network, NORWALK, CT, ¹³Arthritis Center of Nebraska, Lincoln, NE, ¹⁴Massachusetts General Hospital, Harvard Medical School, Boston, MA, ¹⁵Inland Rheumatology and Osteoporosis Medical Group, Upland, CA, ¹⁶Delaware Arthritis, Lewes, DE, ¹⁷PARRIS & ASSOCIATES, Lilburn, GA, ¹⁸Western Washington Arthritis Clinic, Seattle, WA, ¹⁹Kansas City Physician Partners, Kansas City, MO, ²⁰SouthWest Arthritis Research Group, Mesquite, TX, ²¹Long Island Regional Arthritis & Osteoporosis Care, Hicksville, NY, ²²University of Alabama at Birmingham, Birmingham, AL, ²³SetPoint Medical, Sausalito, CA
Background/Purpose: Neuroimmune modulation by electrical stimulation of the left cervical vagus nerve represents a novel treatment option for rheumatoid arthritis (RA). We present 12-month efficacy…
Abstract Number: 1992 • ACR Convergence 2025
Tolerance of Methotrexate Coadministered with Pegloticase in Patients with Uncontrolled Gout: Findings from MIRROR RCT
Vinicius Domingues¹, Alexis Woods², Xiaoqing Yang³, Brian Lamoreaux⁴ and Michael Weinblatt⁵, ¹Rheumatology, Allergy, Asthma & Arthritis Center, Daytona beach, FL, ²Amgen, Detroit, MI, ³Amgen, Seattle, WA, ⁴Amgen, Inc., Deerfield, IL, ⁵Brigham and Women's Hospital/ Harvard Medical School, Waban, MA
Background/Purpose: Methotrexate (MTX) coadministered with pegloticase attenuates anti-drug antibody formation, leading to higher response rates and markedly reduced infusion reaction risk compared with pegloticase +…
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: 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: 1466 • ACR Convergence 2025
Impact of Bimekizumab on Spinal MRI Inflammation and Structural Lesions in Patients with Radiographic Axial Spondyloarthritis: 2-Year CANDEN Scoring Results from a Phase 3 Study and Its Open-Label Extension
Walter P. Maksymowych¹, Robert G. W. Lambert², Victoria Navarro-Compan³, Xenofon Baraliakos⁴, Jason Coarse⁵, Natasha de Peyrecave⁶ and Mikkel Ostergaard⁷, ¹Department of Medicine, University of Alberta, ⁵⁶⁸ Heritage Building, Edmonton, AB, Canada, ²University of Alberta, Department of Radiology & Diagnostic Imaging, Edmonton, AB, Canada, ³Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ⁴Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁵UCB, Morrisville, NC, ⁶UCB, Brussels, Belgium, ⁷Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark, and Copenhagen Center for Arthritis Research, Center for Rheumatology, Rigshospitalet, Glostrup, Denmark
Background/Purpose: Spinal inflammation and structural progression are key features of radiographic axial spondyloarthritis (r-axSpA).1 Canada-Denmark (CANDEN) scoring enables anatomical-based assessments of MRI inflammatory and structural…

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