Abstracts tagged "clinical trial"

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: 0281 • ACR Convergence 2022
Clinical Outcomes of Filgotinib in Patients with RA Aged ≥65 Years: A Post Hoc Subgroup Analysis of Phase 2 and 3 Clinical Trials and Ongoing Long-Term Extensions
Maya Buch¹, BERNARD COMBE², Jose A Gomez-Puerta³, Roberto Felice Caporali⁴, jacques-eric gottenberg⁵, Paul Van Hoek⁶, Vijay Rajendran⁷, Pieter-Jan Stiers⁶, Katrien Van Beneden⁶, Daniel Aletaha⁸, Gerd Burmester⁹, Rene Westhovens¹⁰ and Yoshiya Tanaka¹¹, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Montpellier University, Montpellier, France, ³Hospital Clínic de Barcelona, Barcelona, Spain, ⁴University of Milan, Milano, Italy, ⁵Strasbourg University Hospital, Strasbourg, France, ⁶Galapagos NV, Mechelen, Belgium, ⁷Galapagos NV, Gent, Belgium, ⁸Medical University Vienna, Wien, Austria, ⁹Charité University Medicine Berlin, Berlin, Germany, ¹⁰University Hospitals Leuven, Leuven, Belgium, ¹¹University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan
Background/Purpose: Filgotinib (FIL) is a Janus kinase 1 preferential inhibitor approved for the treatment of moderate to severe active RA.1 It was previously reported that…
Abstract Number: 0359 • ACR Convergence 2022
Attainment of Remission with Anifrolumab: A Post Hoc Analysis of Pooled TULIP-1 and TULIP-2 Datasets
Ronald Van Vollenhoven¹, Eric F. Morand², Richard A. Furie³, Ian N. Bruce⁴, Gabriel Abreu⁵, Raj Tummala⁶, Hussein Al-Mossawi⁷ and Catharina Lindholm⁸, ¹Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, University of Amsterdam, Amsterdam, Netherlands, ²Monash University, Melbourne, Australia, ³Northwell Health, Great Neck, NY, ⁴The University of Manchester, Manchester, United Kingdom, ⁵AstraZeneca, Mölndal, Sweden, ⁶AstraZeneca, Gaithersburg, MD, ⁷AstraZeneca, Cambridge, United Kingdom, ⁸AstraZeneca, Gothenburg, Sweden
Background/Purpose: In patients with SLE, achieving remission is a treat-to-target goal. Remission is associated with lower rates of hospitalization and damage accrual and better quality…
Abstract Number: 0525 • ACR Convergence 2022
Recovery of Renal Function Among ANCA-Associated Vasculitis Patients with Baseline eGFR ≤20 in the Avacopan ADVOCATE Trial
David Jayne¹, Peter Merkel², Frank Cortazar³, John Niles⁴ and Pirow Bekker⁵, ¹University of Cambridge, Cambridge, United Kingdom, ²U of Pennsylvania, Philadelphia, PA, ³St. Peter's Hospital, Albany, NY, ⁴Harvard, Boston, MA, ⁵ChemoCentryx, San Juan Capistrano, CA
Background/Purpose: In the 330-patient ADVOCATE trial of avacopan for the treatment of ANCA-associated vasculitis, in which 81% of patients with ANCA-associated vasculitis had renal involvement,…
Abstract Number: 0992 • ACR Convergence 2022
Interim Results from the Phase 2 MISSION Study Evaluating Zetomipzomib (KZR-616), a First-in-Class Selective Immunoproteasome Inhibitor for the Treatment of Lupus Nephritis
Amit Saxena¹, Samir Parikh², Richard Furie³, Richard Leff⁴, Steven Hua⁴, Li Long⁵ and Noreen Henig⁴, ¹NYU School of Medicine, New York, NY, ²The Ohio State University, Columbus, OH, ³Northwell Health, Great Neck, NY, ⁴Kezar Life Sciences, South San Francisco, CA, ⁵Kezar Life Sciences, Inc., South San Francisco, CA
Background/Purpose: Zetomipzomib is a first-in-class selective inhibitor of the immunoproteasome that is active in multiple autoimmune disease models, including murine models of SLE and LN.…
Abstract Number: 1439 • ACR Convergence 2022
Lymphatic Delivery of Etanercept Achieves Significant Improvements in Rheumatoid Arthritis Disease Measures at 50% of the Standard Dose for Patients with an Inadequate Response to Subcutaneous Injections
Alan Smith¹, Pei-Ling Roerig¹, Jacob Cason², David Fancis², Brian Cooley², Mike Royal³, Vibeke Strand⁴, John Goldman⁵, Roel Querubin⁶ and Russell Ross², ¹4P Therapeutics, Peachtree Corners, GA, ²Sorrento Therapeutics, Atlanta, GA, ³Sorrento Therapeutics, San Diego, CA, ⁴Stanford University School of Medicine, Stanford, CA, ⁵Northside Hospital, Atlanta, GA, ⁶Atlanta Research Center for Rheumatology, Marietta, GA
Background/Purpose: The lymphatic system plays an integral role in the pathology of rheumatoid arthritis (RA)1 and mediates local RA flares2, yet most biologic therapies are…
Abstract Number: 1653 • ACR Convergence 2022
Voclosporin for Lupus Nephritis: Assessment of Long-Term Safety and Efficacy Including Renal Outcome over Three Years of Treatment in the Phase 3 AURORA 1 and AURORA 2 Studies
Cristina Arriens¹, Samir Parikh², Lucy Hodge³, Chris Mela⁴ and Henry Leher⁵, ¹Oklahoma Medical Research Foundation, Oklahoma City, OK, ²The Ohio State University, Columbus, OH, ³Aurinia Pharmaceuticals, Seattle, WA, ⁴Aurinia Pharmaceuticals, Inc., Victoria, BC, Canada, ⁵Aurinia Pharmaceuticals Inc, Rockville, MD
Background/Purpose: In the Phase 3 AURORA 1 study, the addition of voclosporin to mycophenolate mofetil (MMF) and low-dose steroids led to significant reductions in proteinuria…
Abstract Number: 1902 • ACR Convergence 2022
Structural Severity in Knee Osteoarthritis Impacts Treatment Response: A Post Hoc Pooled Analysis of Lorecivivint Clinical Trials
Yusuf Yazici¹, Christopher Swearingen², Heli Ghandehari³, ismail simsek⁴, Sarah Kennedy⁵, Jeyanesh Tambiah⁶ and Timothy McAlindon⁷, ¹New York University School of Medicine, La Jolla, CA, ²Samumed LLC, San Diego, CA, ³Biosplice Therapeutics, Inc., San Diego, CA, ⁴Alpine Immunesciences, San Diego, CA, ⁵Biosplice Therapeutics, Inc, San Diego, CA, ⁶Biosplice Ther Inc., San Diego, CA, ⁷Tufts Medical Center, Arlington, MA
Background/Purpose: Osteoarthritis (OA) is a leading cause of disability globally, and its disease burden is expected to increase as risk factors such as aging and…

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