Abstracts tagged "clinical trial"

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: 0545 • ACR Convergence 2025
Temporal trends in the phenotype and treatment outcomes in axial spondyloarthritis patients included in randomized clinical trials over 25 years: a systematic literature review and meta-regression analysis
Omar-Javier Calixto¹, Uta Kiltz², Brikena Lalazi³, Franziska Neinert³, Philipp Sewerin⁴ and Xenofon Baraliakos², ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Cellular and Molecular Immunology Group (InmuBo), Universidad El Bosque, Herne, Nordrhein-Westfalen, Germany, ²Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ³Rheumazentrum Ruhrgebiet, Herne, Germany, ⁴Rheumazentrum Ruhrgebiet Herne; Ruhr-Universität Bochum, Germany, Herne, Germany
Background/Purpose: The phenotypes of axial spondyloarthritis (axSpA) and clinical responses to placebo and study drugs in randomized controlled trials (RCTs) have changed over time. We…
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: 0665 • ACR Convergence 2025
Infusion-Related Reactions (IRRs) and Hematologic Events Associated With Obinutuzumab in Lupus Nephritis: A Secondary Analysis of a Phase III Trial
Richard Furie¹, Teresa Baczkowska², Amit Saxena³, Imran Hassan⁴, Bongin Yoo⁵, Ben Lanza⁶, Himanshi Sehgal⁷, Frederic Boissard⁷, Jay Garg⁵, Thomas Schindler⁷, Elsa Martins⁷, William Pendergraft⁵ and Brad Rovin⁸, ¹Division of Rheumatology, Northwell Health, Great Neck, NY, ²Department of Transplantation Medicine, Nephrology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland, ³Division of Rheumatology, Department of Medicine, NYU Grossman School of Medicine, New York, NY, ⁴Hoffmann-La Roche Ltd, Mississauga, ON, Canada, ⁵Genentech, Inc., South San Francisco, CA, ⁶Roche Products Ltd, Welwyn Garden City, United Kingdom, ⁷F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁸The Ohio State University, Columbus, OH
Background/Purpose: The REGENCY (NCT04221477) trial demonstrated superior efficacy of obinutuzumab and standard therapy (OBI+ST) over placebo and ST (PBO+ST) in patients (pts) with active lupus…
Abstract Number: 0564 • ACR Convergence 2025
Improvements in Patient Reported Outcomes Through 24 Weeks of Guselkumab Treatment in Participants with Active Psoriatic Arthritis and Inadequate Response and/or Intolerance to One Prior Tumor Necrosis Factor Inhibitor
Alice Gottlieb¹, 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 Alexis Ogdie¹¹, ¹Department of Dermatology, UT Southwestern Medical Center, Dallas, TX, 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, ¹¹University of Pennsylvania School of Medicine, Philadelphia, PA
Background/Purpose: Guselkumab (GUS), a fully human IL-23p19-subunit inhibitor, has demonstrated efficacy in significantly improving psoriatic arthritis (PsA) signs and symptoms in participants (pts) with active…
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…

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