Abstracts tagged "clinical trial"

Abstract Number: 0377 • ACR Convergence 2025
New efforts to incorporate patient-reported outcomes into clinical trials for lupus therapeutics
Patti Katz¹, Anca Askanase², Nandan Baruah³, Wen-Hung Chen⁴, Nicole Cooper⁵, Anna Fisch³, Lili Garrard⁶, Meenakshi Jolly⁷, Veronica Vargas Lupo⁸, Carla Menezes⁹, Judith Mills³, Hoang Nguyen¹⁰, Teodora Staeva⁵, Josephine Park¹¹ and Zahi Touma¹², ¹UCSF, San Rafael, CA, ²Columbia University Medical Center, New York, NY, ³Lupus Voices Council, Lupus Accelerating Breakthroughs Consortium, New York, ⁴GlaxoSmithKline, Philadelphia, PA, ⁵Lupus Research Alliance, New York, ⁶FDA, CDER, SIlver Spring, MD, ⁷Rush University, Chicago, ⁸Lupus Voices Council, Lupus Research Alliance, New York, NY, ⁹Lupus Therapeutics, New York, NY, ¹⁰Lupus Research Alliance, New York, NY, ¹¹EMDSerono, Boston, MA, ¹²University of Toronto, Toronto, ON, Canada
Background/Purpose: Lupus Accelerating Breakthroughs Consortium (Lupus ABC) was formed by the Lupus Research Alliance as a public private partnership of people living with lupus, investigators,…
Abstract Number: 2624 • ACR Convergence 2025
Results of Large Multi-Site Pragmatic Clinical Trial Comparing Corticosteroids or Blinded Lidocaine-only Injections in Treating Osteoarthritis of the Knee
Joshua Baker¹, Katherine Wysham², Mercedes Quinones³, Bryant England⁴, Kaitian Jin¹, Marianna Olave⁵, Sarah Wetzel⁶, Rachel Gillcrist⁷, Criswell Lavery¹, Natalie Keller⁸, Kimberly Hayes⁹, Bridget Kramer⁴, Hannah Brubeck¹⁰, Bibiana Ateh¹¹, Daniel K. White¹², Alexis Ogdie¹³, Rui Xiao¹, Tuhina Neogi¹⁴ and Carla Scanzello¹, ¹University of Pennsylvania, Philadelphia, PA, ²VA PUGET SOUND/UNIVERSITY OF WASHINGTON, Seattle, WA, ³Washington DC VA Medical Center, Bethesda, MD, ⁴University of Nebraska Medical Center, Omaha, NE, ⁵Brown University, Philadelphia, PA, ⁶Drexel University, Pittsburgh, PA, ⁷Dartmouth College, Lebanon, NH, ⁸University of Oklahoma, Philadelphia, PA, ⁹Teachers College, Columbia University, Philadelphia, PA, ¹⁰VA Puget Sound Health Care System, Seattle, WA, ¹¹Washington VA Medical Center, Washington, District of Columbia, ¹²University of Delaware, Newark, DE, ¹³Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Wilmington, DE, ¹⁴Boston University School of Medicine, Boston, MA
Background/Purpose: Intra-articular corticosteroids are widely used for routine management of chronic pain from knee osteoarthritis (KOA), though estimates of their benefit vary widely. We aimed…
Abstract Number: 2393 • ACR Convergence 2025
Improving Clinical Outcomes In SLE Arthritis Trials: Post-Hoc Analysis Of A Prospective Intervention Study
Samuel Wood¹, Khaled Mahmoud², Md Yuzaiful Md Yusof², Philip Conaghan², Elizabeth Hensor² and Ed Vital³, ¹University of Leeds, Leeds Institute for Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, ²University of Leeds, Leeds, United Kingdom, ³University of Leeds, Leeds, England, United Kingdom
Background/Purpose: Musculoskeletal (MSK) manifestations of SLE are the most frequently assessed domain in clinical trials. Optimal MSK assessment is contested; candidates include the binary or…
Abstract Number: 2281 • ACR Convergence 2025
Effectiveness of Upadacitinib in Patients with Rheumatoid Arthritis in Canadian Real-World Practice: Final Results from the CLOSE-UP Post-Marketing Observational Study
Louis Bessette¹, Andrew Chow², Raman Rai³, Hugues Allard-Chamard⁴, Pauline Boulos⁵, Guylaine Roy⁶ and Dalinda Liazoghli⁶, ¹Centre de l'Ostéoporose et de Rhumatologie de Québec, Quebec, QC, Canada, ²Credit Valley Rheumatology, Mississauga, McMaster University, Hamilton, University of Toronto, Toronto, ON, Canada, ³Drs. Rai & Sekhon Medicine Professional Corporation, Brampton, ON, Canada, ⁴Université de Sherbrooke, Sherbrooke, Canada, ⁵McMaster University, Hamilton, ON, Canada, ⁶AbbVie Corporation, Saint-Laurent, QC, Canada
Background/Purpose: Upadacitinib (UPA) is an oral, selective Janus kinase (JAK)-inhibitor proven effective and well-tolerated in patients with rheumatoid arthritis (RA) in 6 randomized clinical trials.…
Abstract Number: 1998 • ACR Convergence 2025
Reduction in Tophi Observed in Patients with Uncontrolled Gout Treated with NASP: Results from Phase 3 DISSOLVE Studies
Herbert Baraf¹, Puja Khanna², Frédéric Lioté³, Rehan Azeem⁴, Wesley DeHaan⁵, Ben Peace⁶, Hugues Santin-Janin⁷, Bhavisha Desai⁸ and Alan Kivitz⁹, ¹The Center for Rheumatology and Bone Research, Rheumatology, Wheaton, Maryland, USA; Division of Rheumatology, The George Washington University, Washington, DC, ²Division of Rheumatology, University of Michigan, Ann Arbor, MI, ³Université Paris Cité-Inserm UMR¹¹³² & Rheumatology Department, GH Paris Saint Joseph & Institut Arthur Vernes, Paris, France, ⁴Global MACD, Sobi Inc., Waltham, MA, ⁵Sobi, Inc, Waltham, MA, ⁶Statistical Science, Sobi, Stockholm, Sweden, ⁷Sobi, BASEL, Switzerland, ⁸Sobi, Glastonbury, CT, ⁹Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: Patients (pts) with uncontrolled gout (UG) and tophi experience joint pain, impaired function and poor quality of life (Schlesinger et al. Semin Arthritis Rheum…
Abstract Number: 1538 • ACR Convergence 2025
Safety, Pharmacodynamics, and Efficacy of a Novel Plasmacytoid Dendritic Cells Targeting Antibody in Healthy Adults and Patients with SLE or Cutaneous Lupus Erythematosus with Active Skin Lesions: A First-In-Human Study of KK4277
Minoru Hasegawa¹, Jun Kinoshita², Shigeki Otsubo³, Kana Yamada³ and Ehsanollah Esfandiari⁴, ¹Division of Medicine, University of Fukui, Yoshida-gun, Fukui, Japan, ²Kyowa Kirin Co., Ltd., Chiyoda-ku, Tokyo, Japan, ³Kyowa Kirin Co., Ltd., Tokyo, Japan, ⁴Kyowa kirin International plc, London, United Kingdom
Background/Purpose: Plasmacytoid dendritic cells (pDCs) are known to be the main source of type 1 interferon (IFN), which is the cause of various autoimmune diseases.…
Abstract Number: 1374 • ACR Convergence 2025
AZD1163, a Novel Bispecific Human Antibody Targeting PAD2/4 Enzymes Responsible for Generating Citrullinated Protein Auto-antigens in Rheumatoid Arthritis, Demonstrates Dose-dependent Inhibition of Systemic PAD Activity in Healthy Volunteers
Susanne Prothon¹, Jacob Leander¹, Ulla Seppälä¹, Eduard Molins², Mia Collins¹, Nicholas White³, Ivonne Puente¹, Andre Santa Maria¹, Gary Sims⁴, David Han⁵, Obada Al Hamdan⁶, Ronald Goldwater⁷, Emon Khan⁸ and David Close⁹, ¹AstraZeneca, Gothenburg, Sweden, ²AstraZeneca, Barcelona, Spain, ³AstraZeneca, Cambridge, United Kingdom, ⁴AstraZeneca, Gaithersburg, ⁵Parexel, Los Angeles, ⁶Parexel, Berlin, Germany, ⁷Parexel, Baltimore, ⁸BioPharmaceuticals R&D, Late Respiratory and Immunology, AstraZeneca, Academy House, Cambridge, United Kingdom, ⁹AstraZeneca, Royston, United Kingdom
Background/Purpose: AZD1163 is a novel bispecific antibody that inhibits the activity of extracellular Peptidyl Arginine Deiminases (PADs) 2 and 4, enzymes responsible for protein citrullination…
Abstract Number: 0692 • ACR Convergence 2025
A Randomised Open Label Pilot Trial Comparing Mycophenolate Mofetil with no Immunosuppression in Limited Cutaneous Systemic Sclerosis (MINIMISE-Pilot)
Christopher Denton¹, Philip Yee², medha kanitkar³, Charlotte Clarke⁴, Saiam Ahmed⁴, Voon H. Ong³, Francesco Del Galdo⁵, John Pauling⁶, Marina Anderson⁷, Muditha Samaranayaka⁸, Michael Hughes⁹, Smita Bhat¹⁰, Bridget Griffiths¹¹, MAYA BUCH¹², David D'Cruz¹³, Ariane Herrick¹⁴, Madelon Vonk¹⁵, Nicholas Feemantle⁴ and Dehbi Hakim-Moulay⁴, ¹University College London, UK, London, United Kingdom, ²Division of Medicine, Centre for Rheumatology, University College London, London, England, United Kingdom, ³Division of Medicine, Centre for Rheumatology, University College London, London, United Kingdom, ⁴University College London, London, United Kingdom, ⁵University of Leeds, Leeds, United Kingdom, ⁶North Bristol NHS Trust, Bristol, United Kingdom, ⁷Lancaster University and NHS University Hospitals of Liverpool Group, Liverpool, United Kingdom, ⁸Salford Royal Hospital, Salford, United Kingdom, ⁹Division of Musculoskeletal and Dermatological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK, Manchester, England, United Kingdom, ¹⁰Ninewells Hospital Dundee, Dundee, Scotland, United Kingdom, ¹¹Ninewells Hospital Dundee, Newcastle, England, United Kingdom, ¹²UNIVERSITY OF MANCHESTER, MANCHESTER, United Kingdom, ¹³Kings College London, London, United Kingdom, ¹⁴The University of Manchester, UK, Aberdeen, United Kingdom, ¹⁵Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands
Background/Purpose: Mycophenolate mofetil (MMF) is recommended for skin in diffuse cutaneous (dc)SSc, and for lung fibrosis in SSc, but patients with limited cutaneous (lc)SSc are…
Abstract Number: 0563 • ACR Convergence 2025
Efficacy and Safety of Guselkumab in Patients with Active Psoriatic Arthritis and Inadequate Response and/or Intolerance to One Prior Tumor Necrosis Factor Inhibitor
Alexis Ogdie¹, Joseph F Merola², Philip J. Mease³, Christopher Ritchlin⁴, Jose U. Scher⁵, Kimberly Parnell Lafferty⁶, Daphne Chan⁷, Soumya Chakravarty⁸, Wayne Langholff⁹, Yanli Wang⁹, Olivia Choi, MD, PhD, FAAD⁷, Yevgeniy Krol¹⁰ and Alice Gottlieb¹¹, ¹Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Wilmington, DE, ²Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ³Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁴University of Rochester Medical Center, Canandaigua, NY, ⁵New York University School of Medicine, New York, NY, ⁶Johnson & Johnson, Dermatology, Horsham, PA, ⁷Johnson & Johnson, Horsham, PA, USA, Horsham, PA, ⁸Johnson & Johnson, Horsham, PA, USA; Drexel University College of Medicine, Philadelphia, PA, USA, Villanova, PA, ⁹Johnson & Johnson, Biostatistics, Spring House, PA, ¹⁰Johnson & Johnson, Horsham, PA, ¹¹Department of Dermatology, UT Southwestern Medical Center, Dallas, TX
Background/Purpose: Guselkumab (GUS), a fully human IL-23p19-subunit inhibitor, has demonstrated efficacy in significantly improving psoriatic arthritis (PsA) signs and symptoms with two dosing regimens: 100…
Abstract Number: 0523 • ACR Convergence 2025
SPECTREM: Guselkumab Significantly Improves Patient Reported Outcomes at Week 16 in Participants with Low Body Surface Area, Moderate Psoriasis with Special Sites Involvement
Jennifer Soung¹, Virginie Kelly², Marni Wiseman³, Adrian Rodriguez⁴, Theodore Alkousakis⁵, Olivia Choi⁵, Daphne Chan⁵, Katelyn Rowland⁵, Linda Hou⁶, Jenny Jeyarajah⁷, Nastaran Abbarin⁸, Elizabeth Skobelev⁵, Sancharitha Ramji⁵, James Krell⁹, Max Sauder¹⁰ and David Adam¹¹, ¹Southern California Dermatology, Inc, Santa Ana, CA, USA, Santa Ana, ²Saint-Louis Medical Clinic, Quebec, Canada, Quebec, Canada, ³SkinWise Dermatology, Manitoba, Canada, Manitoba, Canada, ⁴Nashville Skin Comprehensive Dermatology Center, Nashville, TN, USA, Nashville, TN, ⁵Johnson & Johnson, Horsham, PA, USA, Horsham, PA, ⁶Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Horsham, ⁷Johnson & Johnson, Horsham, PA, USA, Horsham, ⁸Janssen Inc, Toronto, ON, Canada, Toronto, Canada, ⁹Total Skin & Beauty Dermatology Center, Birmingham, AL, USA, Birmingham, ¹⁰Probity Medical Research, ON, Canada; University of Toronto, ON, Canada, Toronto, Canada, ¹¹CCA Medical Research, ON, Canada, Toronto, Canada
Background/Purpose: Even low body surface area (BSA) psoriasis can be extremely bothersome to patients and can have a significant impact on their lives just as…
Abstract Number: 0364 • ACR Convergence 2025
Group-Based Medical Mistrust and Logistical Factors Influencing Rheumatology Clinical Trial Enrollment: A Single-Center Cross-Sectional Survey
Andreina Martinez Paulino¹, Miles King², Danny Arias Diaz¹, Asma Cheema³ and Muznay Khawaja⁴, ¹Jersey City Medical Center, Jersey City, NJ, ²Albert Einstein College of Medicine, New York, NY, ³Montefiore Einstein , Wakefield Campus, Woodbridge Township, NJ, ⁴Jersey City Medical Center, Hoboken, NJ

Background/Purpose: Clinical trials are the cornerstone of evidence-based rheumatology, yet enrolling and retaining a representative patient cohort remains challenging. While underrepresentation of underserved minorities is…
Abstract Number: 2614 • ACR Convergence 2025
Impact of Vagus Nerve-Mediated Neuroimmune Modulation on structural joint damage using Gd-MRI RAMRIS imaging in Biologic-Experienced Patients with Rheumatoid Arthritis
Charles Peterfy, MD, PhD¹, John Tesser², Yaakov Levine³, Melissa Evangelista⁴, Vibeke Strand⁵, Michael Weinblatt⁶ and David Chernoff⁷, ¹Spire Sciences, Inc., Boca Raton, FL, ²Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ³SetPoint Medical, Valencia, CA, ⁴SetPoint Medical Corporation, Valencia, CA, ⁵Stanford University School of Medicine, Palo Alto CA, Portola Valley, CA, ⁶Brigham and Women's Hospital/ Harvard Medical School, Waban, MA, ⁷SetPoint Medical, Sausalito, CA
Background/Purpose: Previously reported results from RESET-RA (ClinicalTrials.gov, NCT04539964) showed neuroimmune modulation via electrical stimulation of the left vagus nerve using an implantable device to treat…
Abstract Number: 2374 • ACR Convergence 2025
Bimekizumab Efficacy And Safety Through 5 Years In Patients With Moderate To Severe Plaque Psoriasis In The US And Canada
Andrew Blauvelt¹, Saakshi Khattri², Phoebe Rich³, Ronald Vender⁴, Kenneth B. Gordon⁵, Balint Szilagyi⁶, Heather Herr⁷, Bertram Knapp⁶, Delphine Deherder⁸, Sarah Kavanagh⁹ and Kim Papp¹⁰, ¹Blauvelt Consulting, LLC, Portland, OR, ²The Mount Sinai Hospital, New York, NY, ³Oregon Dermatology and Research Center, Portland, OR, ⁴Dermatrials Research Inc., Hamilton, ON, Canada, ⁵Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, ⁶UCB, Monheim am Rhein, Germany, ⁷UCB, Smyrna, GA, ⁸UCB, Braine-l'Alleud, Belgium, ⁹UCB, Morrisville, NC, ¹⁰Probity Medical Research and Alliance Clinical Trials, Waterloo, and Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada
Background/Purpose: Given the chronic nature of psoriasis, and the loss of response observed with biologic therapies over time, it is crucial to establish the long-term…
Abstract Number: 2279 • ACR Convergence 2025
Long-Term Prevention of RA in high-risk individuals after a 6-Month Placebo-Controlled Intervention with Abatacept -The ARIAA Trial
Koray Tascilar¹, Mikkel Ostergaard², Verena Schoenau³, Uta Kiltz⁴, Xenofon Baraliakos⁴, David Kofler⁵, Martin Feuchtenberger⁶, Ulrike Steffen⁷, Mario Zaiss⁸, Michael Zaenker⁹, Reinhard Voll¹⁰, Cornelia. Glaser¹¹, Holger Bang¹², Eugen feist¹³, Gerd Burmester¹⁴, Kirsten Karberg¹⁵, Joachim Strunk¹⁶, Juan Cañete¹⁷, Esperanza Naredo¹⁸, Mária Filková¹⁹, Ladislav Šenolt¹⁹, Georg Schett²⁰ and Juergen Rech⁷, ¹Department of Medicine ³ - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and University Hospital Erlangen, Erlangen, Germany, ²Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark, and Copenhagen Center for Arthritis Research, Center for Rheumatology, Rigshospitalet, Glostrup, Denmark, ³- Department of Medicine ³ - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, Germany., Erlangen, Germany, ⁴Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁵University of Cologne, Cologne, Germany, ⁶MED | BAYERN OST GmbH, Fachbereich Rheumatologie, Burghausen, Germany, Burghausen, Bayern, Germany, ⁷Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Department of Internal Medicine ³ - Rheumatology and Immunology, Erlangen, Germany, Erlangen, Bayern, Germany, ⁸¹Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Department of Internal Medicine ³ - Rheumatology and Immunology, Erlangen, Germany, Erlangen, Bayern, Germany, ⁹Immanuel Klinikum Bernau , Herzzentrum Brandenburg, Abteilung Innere Medizin, Bernau, Germany, Berlin, Germany, ¹⁰University Medical Center Freiburg, Freiburg, Germany, ¹¹Department of Rheumatology and Clinical Immunology, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany, Freiburg, Baden-Wurttemberg, Germany, ¹²Orgentec, Mainz, Germany, ¹³Helios Department of Rheumatology, Vogelsang-Gommern, Germany, ¹⁴Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ¹⁵Praxis für Rheumatologie und Innere Medizin, Rheumatologie, Berlin, Germany, Berlin, Germany, ¹⁶Krankenhaus Porz am Rhein GmbH, Rheumaklinik, Köln (Porz), Germany, Köln-Porz, Germany, ¹⁷Rheumatology Department, Hospital Clínic and IDIBAPS, Barcelona, Spain, Barcelona, Spain, ¹⁸Department of Rheumatology and Joint and Bone Research Unit. Fundación Jiménez Díaz University Hospital and Health Research Institute FJD-UAM, Madrid, Spain, MADRID, Spain, ¹⁹Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ²⁰Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, Erlangen, Germany
Background/Purpose: A 6-month intervention with abatacept in the ARIAA trial (EUDRA-CT 2014–000555–93) significantly retarded the development of RA compared to placebo in ACPA-positive individuals with…
Abstract Number: 1994 • ACR Convergence 2025
Pharmacokinetics of Ready-to-Use Pegloticase Formulation Compared to Standard Pegloticase Dosing: Data from the AGILE Study
Orrin Troum¹, John Botson², Afroz S. Mohammad³, Xiaoqing Yang⁴, Nathan Roe⁵, Supra Verma⁶ and Brian Lamoreaux⁷, ¹Providence Health Care/Doctor's of St John's (MDSJ) Santa Monica, CA, Santa Monica, CA, ²Orthopedic Physicians Alaska, Anchorage, AK, ³Amgen Inc, Deerfield, ⁴Amgen, Seattle, WA, ⁵Horizon Therapeutics, Boise, ID, ⁶Horizon Therapeutics, Newport Beach, CA, ⁷Amgen, Inc., Deerfield, IL
Background/Purpose: Pegloticase is approved for uncontrolled gout as 8-mg infusions admixed in 250 cc of normal saline over 120 minutes or more administered every 2…

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