Abstracts tagged "clinical trial"

Abstract Number: 0228 • ACR Convergence 2020
Impact of Upadacitinib or Adalimumab as Initial Therapy on the Achievement of 48-Week Treatment Goals in Patients with Rheumatoid Arthritis and Inadequate Response to Methotrexate: Post Hoc Analysis of a Phase 3 Study
Eduardo Mysler¹, Yoshiya Tanaka², Arthur Kavanaugh³, Daniel Aletaha⁴, Peter Taylor⁵, In-Ho Song⁶, Tim Shaw⁶, Yanna Song⁷, Ryan DeMasi⁶, Mira Ali⁶ and Roy Fleischmann⁸, ¹Organización Medica de Investigación, Buenos Aires, Argentina, ²The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ³Division of Rheumatology, Allergy, & Immunology, University of California San Diego Medical School, San Diego, CA, ⁴Division of Rheumatology, Department of Medicine III, Medical University of Vienna,, Vienna, Austria, ⁵Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., North Chicago,, IL, ⁸Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: In the randomized, double-blinded, Phase 3 SELECT-COMPARE study, upadacitinib (UPA) + MTX demonstrated greater clinical and functional responses vs adalimumab (ADA) + MTX in…
Abstract Number: 0428 • ACR Convergence 2020
Enrichment of Clinical Trial Recruitment Using Advanced Molecular Imaging in Takayasu’s Arteritis
Kaitlin Quinn¹, Mark Ahlman², Emily Rose³, Peter Merkel⁴ and Peter C. Grayson⁵, ¹Systemic Autoimmunity Branch, National Institutes of Health, NIAMS, Bethesda, ²National Institutes of Health, Clinical Center, Radiology and Imaging Sciences, Bethesda, MD, ³Systemic Autoimmunity Branch, Vasculitis Translational Research Program, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD, ⁴University of Pennsylvania, Philadelphia, PA, ⁵Systemic Autoimmunity Branch, National Institutes of Health, NIAMS, Bethesda, MD
Background/Purpose: Definitions of disease activity are not standardized in Takayasu’s arteritis (TAK), which can lead to difficulty in determining whether a patient should be enrolled…
Abstract Number: 0826 • ACR Convergence 2020
Clinical Responses and Patient Flow over 2 Years of Treatment with Abatacept, Including Dose De-Escalation, in Patients with Early, MTX-Naïve, ACPA+ RA: Results from a Phase IIIb Study
Paul Emery¹, Yoshiya Tanaka², Vivian Bykerk³, Clifton Bingham III⁴, Thomas Huizinga⁵, Gustavo Citera⁶, Kuan-Hsiang Gary Huang⁷, Sean Connolly⁸, Yedid Elbez⁹, Robert Wong⁸, Karissa Lozenski⁸ and Roy Fleischmann¹⁰, ¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK, Leeds, United Kingdom, ²The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ³Hospital for Special Surgery, New York, NY, ⁴Johns Hopkins University, Baltimore, MD, ⁵Leiden University Medical Center, Leiden, Netherlands, ⁶Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, ⁷Bristol-Myers Squibb Company (at time of analysis), Princeton, NJ, ⁸Bristol-Myers Squibb Company, Princeton, NJ, ⁹Excelya, Boulogne-Billancourt, France, ¹⁰Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: In the 56-week (wk) induction period (IP) of the Phase IIIb Assessing Very Early RA Treatment (AVERT)-2 trial (NCT02504268), a greater proportion of patients…
Abstract Number: 0988 • ACR Convergence 2020
Two-Year Results from a Randomized, Controlled Study of Obinutuzumab for Proliferative Lupus Nephritis
Richard Furie¹, Gustavo Aroca², Analia Alvarez³, Hilda Fragoso-Loyo⁴, Elizabeth Zuta Santillan⁵, Brad Rovin⁶, Paul Brunetta⁷, Thomas Schindler⁸, Imran Hassan⁹, Matthew Cascino¹⁰, Jay Garg¹⁰ and Ana Malvar¹¹, ¹Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ²Simon Bolivar University y Clinica de la Costa, Barranquilla, Colombia, ³CEMIC, Buenos Aires, Argentina, ⁴Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico, ⁵Instituto de Ginecología y Reproducción, Lima, Peru, ⁶The Ohio State University, Columbus, ⁷Genentech, Inc., South San Francisco, ⁸F. Hoffmann-La Roche Ltd., Basel, Switzerland, ⁹Hoffmann-La Roche Ltd, Mississauga, Canada, ¹⁰Genentech, Inc., South San Francisco, CA, ¹¹Organizacion Medica de Investigacion, Buenos Aires, Argentina
Background/Purpose: NOBILITY demonstrated improved renal responses and complete B-cell depletion with the humanized type II anti-CD20 monoclonal antibody obinutuzumab (OBI) compared with placebo (PBO) through…
Abstract Number: 1351 • ACR Convergence 2020
Efficacy of Ixekizumab versus Adalimumab in Psoriatic Arthritis (PsA) Patients with and Without Moderate-to-severe Psoriasis: 52-week Results from a Multicentre, Randomised Open-label Study
Lars Erik Kristensen¹, Masato Okada², William Tillett³, Soyi Liu-Leage⁴, Celine El Baou⁵, Andrew Bradley⁵, Gabriella Meszaros⁴ and Kurt de Vlam⁶, ¹The Parker Institute Copenhagen Denmark, Copenhagen, Denmark, Bispebjerg and Frederiksberg, Denmark, ²St. Luke's International University, Tokyo, Japan, Chuo-ku, Tokyo, Japan, ³Royal National Hospital for Rheumatic Diseases, Bath, UK; Department of Pharmacy and Pharmacology, University of Bath, Bath, UK, Bath, United Kingdom, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Eli Lilly and Company, Indianapolis, IN, USA, Indianapolis, IN, ⁶Department of Rheumatology, University of Leuven, Belgium, Leuven, Belgium
Background/Purpose: Ixekizumab (IXE), a selective interleukin-17A antagonist, is approved for the treatment of active PsA, moderate-to-severe psoriasis (PsO), and radiographic/non-radiographic axial SpA in adults. The…
Abstract Number: 1828 • ACR Convergence 2020
Comprehensive Efficacy of Anifrolumab Across Organ Domains in Patients with Active SLE: Pooled Data from 2 Phase 3 Trials
Eric Morand¹, Richard Furie², Ian Bruce³, Ed Vital⁴, Maria Dall'Era⁵, Emmanuelle Maho⁶, Lilia Pineda⁷ and Raj Tummala⁷, ¹Monash University, Melbourne, Australia, ²Zucker School of Medicine at Hofstra/Northwell, Great Neck, ³Centre for Epidemiology Versus Arthritis, The University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ⁴University of Leeds; NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁵Division of Rheumatology, University of California, San Francisco, CA, ⁶BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ⁷BioPharmaceuticals R&D, AstraZeneca, Gaithersburg
Background/Purpose: SLE is a heterogeneous autoimmune disease with clinical manifestations across multiple organ systems. In the phase 3 TULIP-1 and TULIP-2 trials, anifrolumab treatment resulted…
Abstract Number: 0143 • ACR Convergence 2020
Filgotinib Improved Work Productivity and Activity Impairment in Patients with Rheumatoid Arthritis Who Are Methotrexate-naïve: Results from the FINCH-3 Study
Zobair Younossi¹, Maria Stepanova², Lynn Gerber¹, Susan Lee³, Ken Hasegawa³, Thijs Hendrikx⁴, Annelies Boonen⁵, Bernard Combe⁶, David Walker⁷ and Rieke Alten⁸, ¹Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, ²Center for Outcomes Research in Liver Disease, Washington, DC, ³Gilead Sciences, Inc., Foster City, CA, ⁴Galapagos BV, Leiden, Netherlands, ⁵Maastricht University Medical Center, Maastricht, Netherlands, ⁶University of Montpellier, Montpellier, France, ⁷Northumbria Healthcare Trust, North Shields, United Kingdom, ⁸Schlosspark-Klinik, Universitätsmedizin, Berlin, Germany
Background/Purpose: Filgotinib (FIL) is a potent oral selective janus kinase 1 inhibitor currently being investigated as an agent to treat rheumatoid arthritis (RA). In the…
Abstract Number: 0234 • ACR Convergence 2020
Characterization of Serious Infections with Upadacitinib in Patients with Rheumatoid Arthritis
Kevin Winthrop¹, Leonard Calabrese², Filip Van den Bosch³, Kunihiro Yamaoka⁴, Carlo Selmi⁵, Yanna Song⁶, Barbara Hendrickson⁷, Ivan Lagunes-Galindo⁸ and Iain McInnes⁹, ¹Oregon Health & Science University, Portland, OR, ²Cleveland Clinic, Cleveland, OH, ³Ghent University Hospital, Ghent, Belgium, ⁴Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan, ⁵Humanitas Research Hospital and Humanitas University, MIlan, Italy, ⁶AbbVie Inc., North Chicago,, IL, ⁷AbbVie, Inc, North Chicago, IL, ⁸AbbVie Inc., North Chicago, IL, ⁹Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom
Background/Purpose: Upadacitinib (UPA) is a selective and reversible Janus kinase (JAK) inhibitor with an approved dose of 15 mg once daily (QD) for the treatment…
Abstract Number: 0432 • ACR Convergence 2020
The Effect on Renal Function of the Complement C5a Receptor Inhibitor Avacopan in ANCA-Associated Vasculitis
Peter Merkel¹, Pirow Bekker², Huibin Yue², Catherine Kelleher², Thomas Schall² and David Jayne³, ¹University of Pennsylvania, Philadelphia, PA, ²ChemoCentryx, Mountain View, CA, ³Department of Medicine, Vasculitis and Lupus Research Group, University of Cambridge, Cambridge, UK, Cambridge, United Kingdom
Background/Purpose: Avacopan, a novel, orally-administered selective antagonist of C5aR, was recently evaluated in a pivotal Phase 3 randomized clinical trial where its use in patients…
Abstract Number: 0849 • ACR Convergence 2020
Herpes Zoster Events with Anifrolumab in Patients with Active SLE: An Integrated Analysis of Phase 2 and Phase 3 Trials
Joan Merrill¹, Kenneth Kalunian², Richard Furie³, Kevin Winthrop⁴, Patricia Primakov⁵, Lilia Pineda⁶, Gabriel Abreu⁷ and Raj Tummala⁶, ¹Oklahoma Medical Research Foundation, Oklahoma City, ²School of Health Sciences, University of California, La Jolla, ³Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ⁴Oregon Health & Science University, Portland, OR, ⁵BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁶BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, ⁷BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
Background/Purpose: In the phase 2 MUSE and phase 3 TULIP-1 and TULIP-2 trials, treatment with anifrolumab, a monoclonal antibody to the type I interferon receptor,…
Abstract Number: 0989 • ACR Convergence 2020
Withdrawal of MMF Is Safe in Quiescent Renal and Non-Renal SLE: Results from a Multi-Center Randomized Trial
Eliza Chakravarty¹, Tammy Utset², Diane Kamen³, Gabriel Contreras⁴, W. Joseph McCune⁵, Kenneth Kalunian⁶, Cynthia Aranow⁷, Megan Clowse⁸, Elena Massarotti⁹, Ellen Goldmuntz¹⁰, Jessica Springer¹⁰, Lynette Keyes-Elstein¹¹, Bill Barry¹¹, Ashley Pinckney¹¹ and Judith James¹², ¹Oklahoma Medical Research Foundation, Oklahoma City, OK, ²University of Chicago, Chicago, IN, ³Medical University of South Carolina, Charleston, SC, ⁴University of Miami Miller School of Medicine, Miami, ⁵University of Michigan, Ann Arbor, MI, ⁶University of California San Diego, La Jolla, CA, ⁷Feinstein Institutes for Medical Research, Manhasset, NY, ⁸Duke University, Chapel Hill, NC, ⁹Brigham and Women's hospital, Boston, MA, ¹⁰NIH/NIAID, Rockville, MD, ¹¹Rho, Durham, NC, ¹²Oklahoma Medical Research Foundation, Oklahoma City
Background/Purpose: Mycophenolate Mofetil (MMF) is standard of care therapy for long term treatment of lupus nephritis and other manifestations of SLE. However, it is associated…
Abstract Number: 1368 • ACR Convergence 2020
Proportions of Patients Achieving a Minimal Disease Activity State upon Treatment with Tildrakizumab in a Psoriatic Arthritis Phase 2b Study
Peter Nash¹, Michael Luggen², Ferran J. García Fructuoso³, Richard Chou⁴, Alan Mendelsohn⁵, Stephen Rozzo⁵ and Iain McInnes⁶, ¹School of Medicine Griffith University, Brisbane, Queensland, Australia, ²University Hospital/University of Cincinnati College of Medicine, Cincinnati Rheumatic Disease Study Group, Inc, Cincinnati, OH, ³Hospital CIMA Sanitas, Barcelona, Spain, ⁴University at Buffalo, School of Medicine and Biomedical Sciences, Amherst, NY, ⁵Sun Pharmaceutical Industries, Inc., Princeton, NJ, ⁶Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom
Background/Purpose: Tildrakizumab (TIL) is a high-affinity anti–interleukin-23p19 monoclonal antibody approved in the US, EU, and Australia to treat moderate to severe plaque psoriasis.1 A randomized,…
Abstract Number: 1829 • ACR Convergence 2020
Lupus Disease Activity After Cessation of Anifrolumab Treatment During the Phase 2b MUSE Trial Follow-up Period
Richard Furie¹, Kenneth Kalunian², Joan Merrill³, Gabriel Abreu⁴ and Raj Tummala⁵, ¹Zucker School of Medicine at Hofstra/Northwell, Great Neck, ²School of Health Sciences, University of California, La Jolla, ³Oklahoma Medical Research Foundation, Oklahoma City, ⁴BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁵BioPharmaceuticals R&D, AstraZeneca, Gaithersburg
Background/Purpose: In the randomized, double-blind, phase 2b MUSE trial, anifrolumab reduced disease activity vs placebo across multiple endpoints in patients with moderately to severely active…
Abstract Number: 0199 • ACR Convergence 2020
A Phase 1, Randomized, Open-label, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17, a Proposed, Higher Concentration Biosimilar (100 mg/mL) Adalimumab, in Healthy Subjects
Edward C Keystone¹, Daniel Furst*², Jonathan Kay³, EunJin Choi⁴, Antonia Davidson⁵, YunJu Bae⁴, Darin Brimhall⁶, SangJoon Lee⁴, SungHyun Kim⁴ and DaHye Kwak⁴, ¹Mount Sinai Hospital, Toronto, ON, Canada, ²Department of Medicine, Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA, Los Angeles, CA, ³University of Massachusetts Medical School, Worcester, MA, ⁴Celltrion, Inc., Incheon, Republic of Korea, ⁵PPD Development, Austin, TX, ⁶PPD Development, Las Vegas, NV
Background/Purpose: CT-P17 is a recombinant human monoclonal antibody that was developed as the first biosimilar adalimumab with high concentration (100 mg/mL) and citrate-free formulation. The…
Abstract Number: 0235 • ACR Convergence 2020
Safety and Biological Activity of Rozibafusp Alfa in Subjects with Rheumatoid Arthritis: Final Results of a Phase 1b Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study
Lubna Abuqayyas¹, Laurence Cheng¹, Kyong Park¹, Marcia Teixeira dos Santos¹, Barbara Sullivan¹, Hui Wang¹, Yanchen Zhou¹, Vishala Chindalore², Stanley Cohen³, Alan Kivitz⁴, Maximilian Posch⁵ and Jane Parnes¹, ¹Amgen Inc., Thousand Oaks, CA, ²Pinnacle Research Group, Anniston, AL, ³Metroplex Clinical Research Center, Dallas, TX, ⁴Altoona Center for Clinical Research/Altoona Arthritis and Osteoporosis Center, Duncansville, PA, ⁵Charité Research Organisation, Berlin, Germany
Background/Purpose: B-cell activating factor (BAFF) and inducible costimulator ligand (ICOSL) are implicated in autoimmune disease pathogenesis, and clinical findings support their utility as drug targets…

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