Abstracts tagged "clinical trial"

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…
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: 0201 • ACR Convergence 2020
A Multicenter, Randomized, Placebo-controlled, Double-blind Phase 2 Study of SHR0302 versus Placebo in Chinese Subjects with Moderate to Severe Active Rheumatoid Arthritis (RA)
Xiaofeng Zeng¹, Ying Jiang², Ying Yang³ and Hanying Li⁴, ¹Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China (People's Republic), ²Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Beijing, China (People's Republic), ³Jiangsu Hengrui Medicine Co., Ltd, Guangzhou, China (People's Republic), ⁴Jiangsu Hengrui Medicine Co., Ltd, Shanghai, China (People's Republic)
Background/Purpose: Proinflammatory cytokine activation of JAK/STAT signal pathway is critical in the pathogenesis and progression of RA. SHR0302, a potent and selective inhibitor of JAK1,…

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