Abstracts tagged "clinical trial"

Abstract Number: 1751 • ACR Convergence 2021
Voclosporin Is Effective in Achieving Complete Renal Response Across Lupus Nephritis Biopsy Classes: Pooled Data from the AURA-LV and AURORA 1 Trials
Anca Askanase¹, Simrat Randhawa², Laura Lisk³ and Paola Mina-Osorio⁴, ¹Columbia University Medical Center, New York, NY, ²Aurinia Pharmaceuticals Inc., Seattle, WA, ³Aurinia Pharmaceuticals Inc., Victoria, ON, Canada, ⁴Aurinia Pharmaceuticals Inc., New York, NY
Background/Purpose: Voclosporin is a novel calcineurin inhibitor recently approved for the treatment of adult patients with active lupus nephritis in combination with background immunosuppressive therapy.…
Abstract Number: 1817 • ACR Convergence 2021
Comparison of Composite Indices for Disease Activity in Patients with Psoriatic Arthritis Treated with Upadacitinib: A Post-Hoc Analysis from SELECT-PsA 1
Josef Smolen¹, Ennio Lubrano², Mitsumasa Kishimoto³, Andra R Bălănescu⁴, Vibeke Strand⁵, Tianming Gao⁶, Nancy Vranich⁶, Ralph Lippe⁷ and William Tillett⁸, ¹Medical University of Vienna, Vienna, Austria, ²Department of Medicine and Health Sciences Vincenzo Tiberio, University of Molise, Campobasso, Italy, ³Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, ⁴“Carol Davila” University of Medicine and Pharmacy, Department of Internal Medicine and Rheumatology “Sf. Maria” Hospital, Bucharest, Romania, ⁵Stanford University School of Medicine, Portola Valley, CA, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Deutschland GmbH & Co. KG, Berlin, Germany, ⁸Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom
Background/Purpose: Achieving low disease activity (LDA) or remission is a main treatment target in PsA. Composite indices used to assess disease activity include Disease Activity…
Abstract Number: L10 • ACR Convergence 2020
Targeting Plasmacytoid Dendritic Cells Improves Cutaneous Lupus Erythematosus Skin Lesions and Reduces Type I Interferon Levels: Results of a Phase 1 Study of VIB7734
Victoria Werth¹, Jodi Karnell², William Rees², Nanette Mittereder³, Li Yan², Yanping Wu³, Jorn Drappa², Gabor Illei² and John Ratchford², ¹University of Pennsylvania, Philadelphia, PA, ²Viela Bio, Gaithersburg, MD, ³Viela Bio, Gaithersburg
Background/Purpose: Plasmacytoid dendritic cells (pDCs) secrete large amounts of type I interferon (IFN) and other cytokines upon activation. pDCs migrate to sites of active disease…
Abstract Number: L11 • ACR Convergence 2020
Tofacitinib for the Treatment of Adult Patients with Ankylosing Spondylitis: Primary Analysis of a Phase 3, Randomized, Double-blind, Placebo-controlled Study
Atul Deodhar¹, Paula Sliwinska-Stanczyk², Huji Xu³, Xenofon Baraliakos⁴, Lianne Gensler⁵, Dona Fleishaker⁶, Lisy Wang⁶, Joseph Wu⁶, Sujatha Menon⁶, Cunshan Wang⁶, Oluwaseyi Dina⁷, Lara Fallon⁸, Keith S Kanik⁶ and Désirée van der Heijde⁹, ¹Oregon Health & Science University, Portland, OR, ²Reumatika Centrum Reumatologii, Warszawa, Poland, ³Shanghai Changzheng Hospital, Shanghai, China (People's Republic), ⁴Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum, Germany, ⁵University of California San Francisco, San Francisco, CA, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer Inc, New York, NY, ⁸Pfizer Inc, Montreal, QC, Canada, ⁹Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Tofacitinib is an oral JAK inhibitor that is being investigated for the treatment of adult patients (pts) with AS.Methods: This Phase 3, randomized, double-blind…
Abstract Number: L09 • ACR Convergence 2020
A Phase 2a Randomized, Double-blind, Placebo-controlled Study of Ziritaxestat in Early Diffuse Cutaneous Systemic Sclerosis (NOVESA)
Dinesh Khanna¹, Christopher Denton², Daniel Furst³, Maureen Mayes⁴, Marco Matucci-Cerinic⁵, Vanessa Smith⁶, Dick de Vries⁷, Liesbeth Deberdt⁸, Pieter‑Jan Stiers⁸, Niyati Prasad⁸ and Sohail Ahmed⁹, ¹University of Michigan, Ann Arbor, MI, ²Royal Free Hospital, University College London, London, United Kingdom, ³David Geffen School of Medicine at UCLA, Los Angeles, CA, ⁴University of Texas Health Science Center at Houston, Houston, TX, ⁵Università degli Studi di Firenze, Firenze, Italy, ⁶Ghent University Hospital, Ghent, Belgium, ⁷Galapagos BV, Leiden, Netherlands, ⁸Galapagos NV, Mechelen, Belgium, ⁹Ahmed Science Medicine, Basel, Switzerland
Background/Purpose: There is a high unmet need for systemic sclerosis (SSc) treatments. Ziritaxestat (ziri; GLPG1690) is an autotaxin inhibitor with a novel mechanism of action.…
Abstract Number: 0141 • ACR Convergence 2020
Filgotinib Improved Work Productivity and Activity Impairment in Patients with Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results from FINCH-1 Study
Zobair Younossi¹, Maria Stepanova², Lynn Gerber¹, Susan Lee³, Hao Hu³, Thijs Hendrikx⁴, Annelies Boonen⁵, David Walker⁶, Rieke Alten⁷ and Bernard Combe⁸, 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, ⁶Northumbria Healthcare Trust, North Shields, United Kingdom, ⁷Schlosspark-Klinik, Universitätsmedizin, Berlin, Germany, ⁸University of Montpellier, Montpellier, France
Background/Purpose: Filgotinib (FIL) is a potent oral selective janus kinase 1 inhibitor which is currently being investigated as an agent to treat rheumatoid arthritis (RA).…
Abstract Number: 0224 • ACR Convergence 2020
Efficacy of Long-term Treatment with Baricitinib 2 Mg in Patients with Active Rheumatoid Arthritis
Alvin Wells¹, Bochao Jia², Li Xie², Guillermo Valenzuela³, Edward C Keystone⁴, Zhanguo Li⁵, Amanda Quebe², Kirstin Griffing², Susan Otawa² and Boulos Haraoui⁶, ¹Aurora Rheumatology and Immunotherapy Center, Franklin, ²Eli Lilly and Company, Indianapolis, IN, ³Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁴Mount Sinai Hospital, Toronto, ON, Canada, ⁵Peking University People’s Hospital, Xicheng, Beijing, China (People's Republic), ⁶Institut de Rhumatologie de Montréal, Montreal, QC, Canada
Background/Purpose: The short-term efficacy of baricitinib was demonstrated previously.1,2 The objectives of this post-hoc analysis were to evaluate long-term efficacy of once-daily baricitinib 2 mg…
Abstract Number: 0391 • ACR Convergence 2020
Defining the Optimal Disease Duration of Early Diffuse Systemic Sclerosis for Clinical Trial Design
Robyn Domsic¹, Shiyao Gao², Maureen Laffoon², Steven Wisniewski³, Yuqing Zhang⁴, Robert Lafyatis⁵, Virginia Steen⁶ and Thomas Medsger⁷, ¹University of Pittsburgh School of Medicine, Pittsburgh, PA, ²University of Pittsburgh, Pittsburgh, PA, ³University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, ⁴Massachusetts General Hospital, Harvard Medical School, Boston, ⁵University of Pittsburgh, Arlington, MA, ⁶Division of Rheumatology, Department of Medicine, MedStar Georgetown University Hospital, Washington, DC, ⁷University of Pittsburgh School of Medicine, Verona, PA
Background/Purpose: Clinical trials in early diffuse cutaneous systemic sclerosis (SSc) have historically used the modified Rodnan skin score (mRSS) as the primary outcome measure. These…
Abstract Number: 0823 • ACR Convergence 2020
Identifying Physician-Perceived Barriers to a Pragmatic Treatment Trial in Rheumatoid Arthritis
Haiyan Qu¹, Shamly Austin² and Jasvinder Singh¹, ¹University of Alabama at Birmingham, Birmingham, AL, ²Gateway Health Plan®, Pittsburgh, PA
Background/Purpose: The aim of this qualitative research was to identify physician-perceived patient and clinic barriers to patient recruitment in a RA pragmatic trial of anti-TNF…
Abstract Number: 0985 • ACR Convergence 2020
Early and Sustained Reduction in Severity of Skin Disease with Anifrolumab Treatment in Patients with Active SLE Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI): Pooled Data from 2 Phase 3 Studies
Victoria Werth¹, Richard Furie², Eric Morand³, J. Michelle Kahlenberg⁴, Rubana Kalyani⁵, Gabriel Abreu⁶, Lilia Pineda⁵ and Raj Tummala⁵, ¹University of Pennsylvania and Corporal Michael J. Crescenz Veterans Administration Hospital, Philadelphia, ²Zucker School of Medicine at Hofstra/Northwell, Great Neck, ³Monash University, Melbourne, Australia, ⁴Division of Rheumatology, University of Michigan, Ann Arbor, MI, ⁵BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, ⁶BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
Background/Purpose: Up to 85% of patients with SLE experience skin disease.1 The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated index…
Abstract Number: 1348 • ACR Convergence 2020
What Influence Do Clinical Domains Other Than Arthritis Have on Composite Clinical Outcomes in Psoriatic Arthritis?: Comparison of Treatment Effects in the SEAM-PsA Trial
Philip Helliwell¹, Philip Mease², Arthur Kavanaugh³, Laura Coates⁴, Alexis Ogdie⁵, Atul Deodhar⁶, Vibeke Strand⁷, Ervant Maksabedian⁸, Gregory Kricorian⁹, Lyrica Liu⁹, David Collier¹⁰ and Dafna Gladman¹¹, ¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ²Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, ³UC San Diego Health System, San Diego, CA, ⁴University of Oxford, Oxford, United Kingdom, ⁵University of Pennsylvania, Philadelphia, PA, ⁶Oregon Health & Science University, Portland, OR, ⁷Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, ⁸Amgen Inc., LOS ANGELES, CA, ⁹Amgen Inc., Thousand Oaks, CA, ¹⁰Amgen, Thousand Oaks, CA, ¹¹Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada
Background/Purpose: Psoriatic arthritis is broadly characterized by clinical domains such as enthesitis, dactylitis, nail manifestations, and psoriasis. How these clinical domains influence the response to…
Abstract Number: 1822 • ACR Convergence 2020
Serum Proteomics from a Phase III, Randomized, Placebo-Controlled Study of Patients with Active Lupus Nephritis: Correlation with Baseline Disease Characteristics and Response to Therapy
Shiliang Wang¹, Richard Furie², Mary Anne Dooley³, David Wofsy⁴, Tsutomu Takeuchi⁵, Ana Malvar⁶, Andrea Doria⁷, Juanita Romero-Díaz⁸, Tak Mao Chan⁹, Gerald Appel¹⁰, David Jayne¹¹, Sarah Hu¹², Sheng Gao¹³ and Michael Maldonado¹², ¹Bristol-Myers Squibb Company (at the time of analysis), Princeton, NJ, ²Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ³University of North Carolina, Chapel Hill, NC, ⁴University of California San Francisco, San Francisco, CA, ⁵Division of Rheumatology, Department of internal Medicine, School of Medicine, Keio University, Tokyo, Japan, ⁶Organizacion Medica de Investigacion, Buenos Aires, Argentina, ⁷University of Padua, Padua, Italy, ⁸Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico, ⁹University of Hong Kong, Hong Kong, Hong Kong, ¹⁰Columbia University Medical Center, New York, NY, ¹¹Department of Medicine, Vasculitis and Lupus Research Group, University of Cambridge, Cambridge, UK, Cambridge, United Kingdom, ¹²Bristol-Myers Squibb Company, Princeton, NJ, ¹³Bristol-Myers Squibb Company (at the time of analysis), Princeton, NY
Background/Purpose: The ALLURE study compared efficacy and safety of abatacept (ABA) vs placebo (PBO) on background MMF and CS for the treatment of active proliferative…
Abstract Number: 0142 • ACR Convergence 2020
Filgotinib Improved Work Productivity and Activity Impairment in Patients with Rheumatoid Arthritis and Inadequate Response to Biologic DMARDs: Results from the FINCH 2 Study
Zobair Younossi¹, Maria Stepanova², Lynn Gerber¹, Susan Lee³, I-Heng Lee⁴, Thijs Hendrikx⁵, Annelies Boonen⁶, Rieke Alten⁷, Bernard Combe⁸ and David Walker⁹, 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, ⁴Gilead Sciences, Foster City, CA, ⁵Galapagos BV, Leiden, Netherlands, ⁶Maastricht University Medical Center, Maastricht, Netherlands, ⁷Schlosspark-Klinik, Universitätsmedizin, Berlin, Germany, ⁸University of Montpellier, Montpellier, France, ⁹Northumbria Healthcare Trust, North Shields, United Kingdom
Background/Purpose: Filgotinib (FIL) is a potent oral selective janus kinase 1 inhibitor which is currently being investigated as an agent to treat rheumatoid arthritis (RA).…
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…

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