ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • 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…
  • Abstract Number: 0504 • ACR Convergence 2020

    Efficacy and Safety of Upadacitinib in Patients with Active Psoriatic Arthritis and Inadequate Response to Biologic Disease-Modifying Anti-Rheumatic Drugs: A Double-Blind, Randomized Controlled Phase 3 Trial

    Mark Genovese1, Apinya Lertratanakul2, Jaclyn K Anderson2, Kim Papp3, William Tillett4, Filip Van den Bosch5, Shigeyoshi Tsuji6, Eva Dokoupilova7, Mauro Keiserman8, Xin Wang2, Sheng Zhong2, Patrick Zueger2, Aileen Pangan9 and Philip Mease10, 1Stanford University Medical Center, Palo Alto, CA, 2AbbVie Inc., North Chicago, IL, 3Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada, 4Royal National Hospital for Rheumatic Diseases, Bath, UK; Department of Pharmacy and Pharmacology, University of Bath, Bath, UK, Bath, United Kingdom, 5Ghent University Hospital, Ghent, Belgium, 6Department of Orthopaedics/Rheumatology, National Hospital Organization, Osaka Minami Medical Center, Osaka, Japan, 7Uherske Hradiste and University of Veterinary and Pharmaceutical Sciences,, Brno, Czech Republic, 8Pontificial Catholic University, Porto Alegre, Brazil, 9Abbvie Inc., La Grange, IL, 10Seattle Rheumatology Associates, P.L.L.C., Seattle, WA

    Background/Purpose: Upadacitinib (UPA) is an oral, reversible, JAK inhibitor approved for treatment of moderate to severe rheumatoid arthritis (RA) and currently under evaluation for treatment…
  • Abstract Number: 0855 • ACR Convergence 2020

    Treatment of SLE with or Without Nephritis with the Immunoproteasome Inhibitor KZR-616: Updated Results of the MISSION Study

    Richard Furie1, Samir Parikh2, Kenneth Harvey3, Christopher Kirk4, Darrin Bomba4 and MK Farmer5, 1Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, 2The Ohio State University, Columbus, OH, 3Kezar Life Sciences, South San Francisco, CA, 4Kezar Life Sciences, Inc, San Francisco, CA, 5Kezar, Raleigh, NC

    Background/Purpose: Immunoproteasome inhibition has demonstrated meaningful therapeutic potential in preclinical models of systemic lupus erythematosus (SLE) and lupus nephritis (LN). KZR-616 is a first-in-class selective…
  • Abstract Number: 1039 • ACR Convergence 2020

    Tofacitinib as a Steroid-sparing Therapy in Pulmonary Sarcoidosis: Two Prospective Cases and Molecular Analysis

    Marcia Friedman1, Stevens Janelle2, Julianna Desmarais3, Daniel Seifer3, Brian Le3, Kimberly Ogle3, Christina Harrington3, Peter Jackson4, Dongseok Choi3 and James Rosenbaum3, 1Oregon Health and Science University, Portland, OR, 2Tuality Healthcare, Hillsboro, OR, 3Oregon Health & Science University, Portland, OR, 4Johns Hopkins University, Baltimore, MD

    Background/Purpose: Patients with pulmonary sarcoidosis often require prolonged corticosteroids to treat their disease. There are currently no FDA approved steroid-sparing therapies for sarcoidosis. We report…
  • Abstract Number: 1369 • ACR Convergence 2020

    Efficacy of Tildrakizumab in PsA: DAPSA Remission and Low Disease Activity in PASDAS Through Week 52

    Saima Chohan1, Arthur Kavanaugh2, Vibeke Strand3, Richard Chou4, Alan Mendelsohn5, Stephen Rozzo5 and Philip Mease6, 1Arizona Arthritis and Rheumatology Research, PLLC, Pheonix, AZ, 2UC San Diego Health System, San Diego, CA, 3Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, 4University at Buffalo, School of Medicine and Biomedical Sciences, Amherst, NY, 5Sun Pharmaceutical Industries, Inc., Princeton, NJ, 6Seattle Rheumatology Associates, P.L.L.C., Seattle, WA

    Background/Purpose: Tildrakizumab (TIL), an anti–interleukin-23p19 monoclonal antibody, is approved in the US, EU, and Australia for treatment of moderate to severe plaque psoriasis. A randomized,…
  • Abstract Number: 1842 • ACR Convergence 2020

    Repository Corticotropin Injection (Acthar® Gel) for Persistently Active Systemic Lupus Erythematosus: Post Hoc Analyses of Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-blind, Placebo-Controlled Trial

    Anca Askanase1, George Wan2, Mary Panaccio2, Enxu Zhao2, Julie Zhu2, Roman Bilyk2 and Richard Furie3, 1Columbia University College of Physicians and Surgeons, New York, NY, 2Mallinckrodt Pharmaceuticals, Bedminster, NJ, 3Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY

    Background/Purpose: Repository corticotropin injection (RCI, Mallinckrodt Pharmaceuticals) is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides approved for the treatment…
  • Abstract Number: L05 • 2019 ACR/ARP Annual Meeting

    Safety, Tolerability, Pharmacokinetics, and Clinical Outcomes Following Single-Dose IA Administration of UBX0101, a Senolytic MDM2/p53 Interaction Inhibitor, in Patients with Knee OA

    Benjamin Hsu1, Jennifer Visich 2, Mark Genovese 3, Kimberly Walter 2, Mahru An 4, Remi-Martin Laberge 4 and Jamie Dananberg 4, 1Unity Biotechnology, Brisbane, 2Unity Biotechnology, Brisbane, California, 3Stanford University, Stanford, CA, 4Unity Biotechnology, Brisbane, CA

    Background/Purpose: A non-drug biomarker study showed senescent cell (SnC) burden in OA synovial tissue to correlate with disease severity, inflammation, and knee pain (C. Yohn,…
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