Abstracts tagged "clinical trial"

Abstract Number: 0989 • ACR Convergence 2022
Regulatory T Cell Defects in SLE and Therapy with a Novel IL-2 Mutein: Phase 1 Clinical Results with Efavaleukin Alfa
Nandita Sarkar¹, Xuguang Hu¹, Nadia Tchao¹, Richard Furie², Alan Kivitz³, Stanley B Cohen⁴ and Kevin Gorski⁵, ¹Amgen Inc., South San Francisco, CA, ²Northwell Health, Great Neck, NY, ³Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, ⁴Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ⁵Amgen, Inc., Thousand Oaks, CA
Background/Purpose: Regulatory T cells (Treg) are critical for maintaining self-tolerance and preventing autoimmunity, and IL-2 is essential for their development, survival and suppressive function. Defects…
Abstract Number: 1431 • ACR Convergence 2022
Impact of Tofacitinib on Fracture Risk in Rheumatoid Arthritis
Karen E Hansen¹, Mahta Mortezavi², Edward Nagy³, Cunshan Wang⁴, Carol A Connell⁴, Zaher Radi⁵, Heather J Litman⁶, Giovanni Adami⁷ and Maurizio Rossini⁷, ¹Rheumatology Division, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, ²Pfizer Inc, New York, NY, ³Pfizer Ltd, Tadworth, United Kingdom, ⁴Pfizer Inc, Groton, CT, ⁵Pfizer Inc., Cambridge, MA, ⁶CorEvitas, LLC, Waltham, MA, ⁷Rheumatology Unit, Department of Medicine, University of Verona, Verona, Italy
Background/Purpose: Preclinical data suggest that tofacitinib stimulates osteoblast function and would have a protective effect on bone health and fracture risk in RA.1 We report…
Abstract Number: 1639 • ACR Convergence 2022
A Phase 3, 56-Week, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial (OA-11) to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint Injected in the Target Knee Joint of Moderate to Severe Osteoarthritis Participants
Yusuf Yazici¹, Christopher Swearingen², Heli Ghandehari³, Jon Britt⁴, ismail simsek⁵, Mark Fineman⁶, Sarah Kennedy², Jeyanesh Tambiah⁷ and Timothy McAlindon⁸, ¹New York University School of Medicine, La Jolla, CA, ²Biosplice Therapeutics, Inc, San Diego, CA, ³Biosplice Therapeutics, Inc., San Diego, CA, ⁴Biosplice Therapeutics, Inc., Los Angeles, CA, ⁵Alpine Immunesciences, San Diego, CA, ⁶Biosplice Therapeutics, San Diego, CA, ⁷Biosplice Ther Inc., San Diego, CA, ⁸Tufts Medical Center, Arlington, MA
Background/Purpose: Knee osteoarthritis (OA) is a common joint disorder associated with pain, disability, and joint damage. There remains a large unmet need for treatments that…
Abstract Number: 1900 • ACR Convergence 2022
CoLchicine for Treatment of OsteoArthritis of the Knee (CLOAK)-A Double-blind, Placebo-controlled Trial
Jonathan Samuels¹, Michael Pillinger², Michael Toprover³, Svetlana Krasnokutsky Samuels⁴, Apoorva Patil⁵, Fernando Bomfim⁶, Renata La Rocca Vieira⁶, David Wei⁵, Sydney Catron⁵, Maryfe coronel⁵, Annie Kim⁵ and Sarah Moussavi⁵, ¹NYU Langone, Rye Brook, NY, ²NYU Grossman School of Medicine, New York, NY, ³Division of Rheumatology, New York University Grossman School of Medicine and Rheumatology Section, New York Harbor Health Care System, New York Campus of the U.S. Department of Veterans Affairs, New York, NY, ⁴Westmed, Rye Brook, NY, ⁵NYU Langone Health, New York, NY, ⁶NYU Langone, New York, NY
Background/Purpose: Knee osteoarthritis (OA) is an inflammatory disease, with a probable role for IL-1b. Calcium and urate crystals may promote OA by activating the NLRP3…
Abstract Number: 2109 • ACR Convergence 2022
Domains Contributing to Minimal Disease Activity Non-Achievement in Patients with Psoriatic Arthritis Receiving Golimumab: Post Hoc Analysis of a Phase 3, Randomized, Double-blind, Placebo-controlled Study
Arthur Kavanaugh¹, Gordon Lam², Lai-shan Tam³, Natalie Shiff⁴, Youngja Lee⁵, Ana-Maria Bravo Perdomo⁶, May Shawi⁷, Elizabeth Hsia⁸, Emmanouil Rampakakis⁹ and Carlos Enrique Toro Gutiérrez¹⁰, ¹University of California San Diego, La Jolla, CA, ²Arthritis and Osteoporosis Consultants of the Carolinas; Clinical Affiliate, Atrium Health and the Wake Forest School of Medicine, Cornelius, NC, ³The Chinese University of Hong Kong, Hong Kong, China, ⁴Janssen Scientific Affairs, LLC, Horsham, PA, USA/ Department of Community Health and Epidemiology, College of Medicine, University of Saskatchewan, Saskatoon, Canada, Philadelphia, PA, ⁵Immunology Medical Affairs, Janssen Asia Pacific, Yongsan-gu, Seoul, Republic of Korea, ⁶Immunology Medical Affairs, Janssen Latin America, Columbia, Colombia, ⁷Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁸Janssen Research and Development, LLC; University of Pennsylvania School of Medicine, Kennett Square, PA, ⁹McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, ¹⁰Internal Medicine and Rheumatology, Reference Center for Osteoporosis, Rheumatology & Dermatology. Pontificia Javeriana University, Calí, Colombia
Background/Purpose: Sustained minimal disease activity (MDA) is only achieved by a small portion of PsA patients (pts). Levels of disease activity consistent with MDA may…
Abstract Number: 2245 • ACR Convergence 2022
Feasibility and Efficacy of a Peer Education Program to Improve Patient Engagement in Lupus Clinical Trials
Saira Sheikh¹, Caroline Donovan², Carla Menezes², Albert T. Roy², Andrew Simkus³, Diane Gross⁴, Anca Askanase⁵, Rosalind Ramsey-Goldman⁶, Vikas Majithia⁷, Nicole Wanty³, Annie McNeill³, Kristen Holtz³ and S. Sam Lim⁸, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²Lupus Therapeutics, LLC, New York, NY, ³KDH Research & Communication, Atlanta, GA, ⁴Lupus Research Alliance, New York, NY, ⁵Columbia University Medical Center, New York, NY, ⁶Northwestern University Feinberg School of Medicine, Chicago, USA, Chicago, IL, ⁷University of Mississippi Medical Center, Ridgeland, MS, ⁸Emory University, Atlanta, GA
Background/Purpose: To assess outcomes related to Lupus Therapeutics' Patient Advocates for Lupus Studies (LT-PALS) a peer-to-peer clinical trial (CT) education program designed to improve CT…
Abstract Number: 0280 • ACR Convergence 2022
Safety of Filgotinib in Patients with RA: Laboratory Analysis Results from a Long-Term Extension Study
Maya Buch¹, James Galloway², Ennio Giulio Favalli³, Arnaud Constantin⁴, Patrick Durez⁵, Paul Van Hoek⁶, Christopher Watson⁷, Pieter-Jan Stiers⁶, Vijay Rajendran⁸, Katrien Van Beneden⁶, Tsutomu Takeuchi⁹ and BERNARD COMBE¹⁰, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²King's College London, London, United Kingdom, ³University of Milan, ASST Gaetano Pini-CTO Institute, Milano, Italy, ⁴Toulouse University Hospital and University Toulouse III Paul Sabatier, Toulouse, France, ⁵Rheumatology, Cliniques Universitaires Saint-Luc – Université catholique de Louvain (UCLouvain) – Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium, ⁶Galapagos NV, Mechelen, Belgium, ⁷Galapagos Biotech Ltd, Cambridge, United Kingdom, ⁸Galapagos NV, Gent, Belgium, ⁹Keio University and Saitama Medical University, Tokyo, Japan, ¹⁰Montpellier University, Montpellier, France
Background/Purpose: Filgotinib (FIL) is a Janus kinase (JAK) 1 preferential inhibitor, approved for treatment of moderate to severe active RA in Europe, the UK, and…
Abstract Number: 0358 • ACR Convergence 2022
Long-term Safety and Efficacy of Voclosporin in Hispanic and Latino Patients with Lupus Nephritis
Ellen M. Ginzler¹, Amit Saxena², Victoria Bal³, Vanessa Birardi⁴ and Henry Leher⁴, ¹SUNY Downstate Health Sciences University, Department of Medicine, Brooklyn, NY, ²NYU School of Medicine, New York, NY, ³Aurinia Pharmaceuticals, Inc., Victoria, BC, Canada, ⁴Aurinia Pharmaceuticals Inc, Rockville, MD
Background/Purpose: The AURORA 1 study demonstrated that addition of voclosporin to MMF and low-dose steroids significantly increased complete renal response rates at 52 weeks, with…
Abstract Number: 0524 • ACR Convergence 2022
A Randomized, Double-Blind, Phase II Study of Glucocorticoid Replacement by Vilobelimab, an Anti-C5a Monoclonal Antibody, in ANCA-Associated Vasculitis
Peter Merkel¹, Bernhard Hellmich², Anja Pfaff³, Carina Müller⁴, Elena Startseva³ and David Jayne⁵, ¹University of Pennsylvania, Philadelphia, PA, ²Klinik für Innere Medizin, Rheumatologie & Immunologie, Medius Kliniken, Universität Tübingen, Plochingen, Germany, ³InflaRx, Jena, Germany, ⁴Metronomia Clinical Research, Munich, Germany, ⁵University of Cambridge, Cambridge, United Kingdom
Background/Purpose: Induction of remission for severe ANCA-associated vasculitis [granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)] utilizes rituximab (RTX) or cyclophosphamide (CYC) and tapering doses…
Abstract Number: 0990 • ACR Convergence 2022
KPG-818, a Novel Cereblon (CRBN) Modulator, in Patients with SLE: Results of a Phase Ib Multiple Ascending Dose Study
RAMESH C. GUPTA¹, Paul Lunseth², Robert Levin³, Philip Waller⁴, Amber Khan⁵, Lester Hernandez⁵, Kai Wei⁶, Baisong Liao⁶, Tao Wang⁷, Kaiyue Hao⁷, Yanjiao Yin⁷ and Yong Guo⁷, ¹Shelby Research LLC, Memphis, TN, ²Clinical Research of West Florida, Tampa, FL, ³Clinical Research of West Florida. Inc., Clearwater, FL, ⁴Accurate Clinical Research, Houston, TX, ⁵Accurate Clinical Management, LLC., Houston, TX, ⁶Kangpu Biopharmaceuticals, Ltd., Shanghai, China, ⁷Kangpu Biopharmaceuticals, Ltd, Shanghai, China
Background/Purpose: KPG-818 is a novel CRL4-CRBN E3 ubiquitin ligase modulator that binds to CRBN with high affinity and leads to rapid and effective degradation of…
Abstract Number: 1432 • ACR Convergence 2022
Pharmacokinetic Evaluation of a Proposed Adalimumab Biosimilar MSB11022 versus the US-Licensed Reference Product: Results of a Randomized, Double-Blind, 3-Arm Parallel-Group, Single-Dose Trial in Healthy Subjects
Anna Dryja¹, Anna Lucia Buccarello², Isabelle Gaillard² and Joëlle Monnet², ¹MTZ Clinical Research Sp. z o.o.,, Warsaw, Poland, ²Fresenius Kabi Swiss BioSim, Eysins, Switzerland
Background/Purpose: Adalimumab, a recombinant fully human monoclonal immunoglobulin G1 antibody, is a biologic directed against tumor necrosis factor-alpha indicated for use in a range of…
Abstract Number: 1652 • ACR Convergence 2022
Long-term Safety and Efficacy of Anifrolumab in Adult Patients with Systemic Lupus Erythematosus: A Multicenter, Randomized, Double-blind, Placebo-controlled 3-year TULIP Extension Study
Kenneth C. Kalunian¹, Richard A. Furie², Eric F. Morand³, Ian N. Bruce⁴, Susan Manzi⁵, Yoshiya Tanaka⁶, Kevin Winthrop⁷, Gabriel Abreu⁸, Ihor Hupka⁹, Lijin Zhang¹⁰, Shanti Werther¹¹, Micki Hultquist¹², Raj Tummala¹⁰ and Catharina Lindholm¹¹, ¹UC San Diego, La Jolla, CA, ²Northwell Health, Great Neck, NY, ³Monash University, Melbourne, Australia, ⁴The University of Manchester, Manchester, United Kingdom, ⁵Allegheny Health Network, Pittsburgh, PA, ⁶University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, ⁷Oregon Health & Science University, Portland, OR, ⁸AstraZeneca, Mölndal, Sweden, ⁹AstraZeneca, Warsaw, Poland, ¹⁰AstraZeneca, Gaithersburg, MD, ¹¹AstraZeneca, Gothenburg, Sweden, ¹²AstraZeneca, Bethesda, MD
Background/Purpose: Anifrolumab is a fully human IgG1 κ monoclonal antibody that binds to the type I IFN receptor and inhibits type I IFN signaling.1 In…
Abstract Number: 1901 • ACR Convergence 2022
What Does Radiographic Minimum JSW Actually Measure? Comparison of Radiographic and MRI Measures Using Data from the OAI
Alan Brett¹, Michael Bowes² and Philip G Conaghan³, ¹Stryker, Austin, TX, ²Stryker, Manchester, United Kingdom, ³University of Leeds, Leeds, United Kingdom
Background/Purpose: Change in radiographic joint space width (JSW) is used as a surrogate for cartilage loss and recognized by regulatory bodies as a measure of…
Abstract Number: 2110 • ACR Convergence 2022
Guselkumab Efficacy in Psoriatic Arthritis Assessed by Multi-domain Composite Indices: Data from the Phase 3b COSMOS Trial in a TNFi-IR Population
Laure Gossec¹, Mohamed Sharaf², Elke Theander³, Marlies Neuhold⁴, Paul Bergmans⁵, May Shawi⁶, Michelle Perate⁷, Christine Contré⁸ and Laura Coates⁹, ¹Sorbonne Université, Paris, France, ²Johnson & Johnson, Middle East FZ LLC, Dubai, United Arab Emirates, ³Formerly at Janssen Scientific Affairs, LLC, Solna, Sweden, ⁴Takeda Europe & Canada Business Unit (EUCAN) Medical Affairs, Zurich, Switzerland; formerly at Janssen Scientific Affairs, LLC, Zug, Switzerland, ⁵Formerly at Janssen, Breda, Netherlands, ⁶Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁷Janssen Scientific Affairs, LLC, Horsham, PA, ⁸Formerly at Janssen Scientific Affairs, LLC, Issy-les-Moulineaux, France, Issy-les-Moulineaux, France, ⁹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom
Background/Purpose: The Phase 3b COSMOS study (NCT03796858) demonstrated the efficacy and safety of guselkumab (GUS), an IL-23 p19 subunit inhibitor, in patients (pts) with psoriatic…
Abstract Number: L07 • ACR Convergence 2021
Depletion of KLRG1+ T Cells in a First-in-human Clinical Trial of ABC008 in Inclusion Body Myositis (IBM)
Niti Goel¹, Dulce Soler-Ferran², Monette Coutreau², Jorge Escobar³, Kate Courtemanche², Merrilee Needham⁴ and Steven Greenberg⁵, ¹Abcuro, Inc.; Duke University, Durham, NC, ²Abcuro, Inc., Newton, MA, ³Abcuro, Inc., Hayward, CA, ⁴Perron Institute, Murdoch University, Perth, Australia, ⁵Brigham and Women's Hospital, Harvard Medical School, Boston, MA
Background/Purpose: Inclusion body myositis (IBM), a relentlessly progressive autoimmune skeletal muscle disease, has no effective available pharmacological therapy. A prominent feature of IBM on microscopy…

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