Abstracts tagged "clinical trial"

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…
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…

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