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: 1521 • ACR Convergence 2025
Kidney-Related Outcomes With Obinutuzumab in Patients With Active Lupus Nephritis: A Pre-Specified Exploratory Analysis of the Clinical Trial Data
Brad Rovin¹, William Pendergraft², Liz Lightstone³, Eric Daugas⁴, Richard Furie⁵, Theodore Omachi², Imran Hassan⁶, Elsa Martins⁷, Thomas Schindler⁷, Jay Garg², Luis Quintana⁸, Piotr Leszczyński⁹ and Ana Malvar¹⁰, ¹The Ohio State University, Columbus, OH, ²Genentech, Inc., South San Francisco, CA, ³Department of Immunology and Inflammation, Faculty of Medicine, Imperial College London, London, England, United Kingdom, ⁴Department of Nephrology, Hospital Bichat - Claude-Bernard, Paris, France, ⁵Division of Rheumatology, Northwell Health, Great Neck, NY, ⁶Hoffmann-La Roche Ltd, Mississauga, ON, Canada, ⁷F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁸Department of Nephrology, Hospital Clinic, Barcelona, Spain, ⁹Department of Internal Medicine and Metabolic Diseases, Poznan University of Medical Sciences, Poznan, Poland, ¹⁰Organización Médica de Investigación, Buenos Aires, Argentina
Background/Purpose: Lupus nephritis (LN) is the most common, severe, organ-threatening manifestation of systemic lupus erythematosus (SLE). The randomized, double-blind, placebo-controlled, Phase III REGENCY trial (NCT04221477)…
Abstract Number: 1363 • ACR Convergence 2025
Evaluation of the Clinical Outcome of Baricitinib in Patients with Rheumatoid Arthritis from Multi-center Collaborative Study in Japan: Sub-analysis for Difficult-to-treat RA.
Naoki Kondo and Nariaki Hao, Division of Orthopedic Surgery, Niigata University Medical and Dental General Hospital, Niigata, Japan
Background/Purpose: The aim is to examine the efficacy and safety of baricitinib (BARI) in Japanese rheumatoid arthritis (RA) patients in real clinical practice and is…
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).…

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