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Abstracts tagged "clinical trial"

  • 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: 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: 0213 • ACR Convergence 2020

    Sustainability of Response to Upadacitinib as Monotherapy or in Combination Among Patients with Rheumatoid Arthritis and Prior Inadequate Response to Conventional Synthetic DMARDs

    Arthur Kavanaugh1, Maya Buch2, Bernard Combe3, Louis Bessette4, In-Ho Song5, Yanna Song6, Jessica Suboticki5 and Peter Nash7, 1Division of Rheumatology, Allergy, & Immunology, University of California San Diego Medical School, San Diego, CA, 2Centre of Musculoskeletal Research, School of Biological Sciences, University of Manchester, Manchester, United Kingdom, 3University of Montpellier, Montpellier, France, 4Laval University, Quebec, Canada, 5AbbVie Inc., North Chicago, IL, 6AbbVie Inc., North Chicago,, IL, 7School of Medicine Griffith University, Brisbane, Queensland, Australia

    Background/Purpose: To assess long-term sustainability of responses to upadacitinib (UPA), a JAK inhibitor, with or without background csDMARD(s) in patients (pts) with rheumatoid arthritis (RA).Methods:…
  • Abstract Number: 0361 • ACR Convergence 2020

    Response to Treatment with Ixekizumab in Patients with Active Non-Radiographic Axial Spondyloarthritis Based on HLA-B27 Status and Disease Duration

    Victoria Navarro-Compán1, Jose Maldonado-Cocco2, Proton Rahman3, Andris Kronbergs4, David Sandoval4, So Young Park4, Theresa Hunter4 and Marina Magrey5, 1Hospital Universitario La Paz IdiPaz, Madrid, Pais Vasco, Spain, 2University of Buenos Aires School of Medicine, Buenos Aires, Argentina, 3Memorial University of Newfoundland, Department of Medicine, St John's, Canada, 4Eli Lilly and Company, Indianapolis, 5Case Western Reserve University School of Medicine, Cleveland, OH

    Background/Purpose: In this analysis, we evaluate the efficacy of ixekizumab at week 16 in patients with non-radiographic axial spondyloarthritis (nr-axSpA) with or without baseline HLA-B27…
  • Abstract Number: 0717 • ACR Convergence 2020

    Predictors of Clinical Remission in Children with Extended Oligoarticular Arthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis Treated with Etanercept in the CLIPPER Studies

    Jelena Vojinovic1, Vyacheslav Chasnyk1, Joke Dehoorne1, Violeta Panaviene1, Jonathan Akikusa2, Tadej Avcin1, Jeffrey Chaitow1, Bernard Lauwerys1, Jordi Antón1, Inmaculada Penades1, Berit Flato1, Alina Boteanu3, Hans-Iko Huppertz1, Juan Jaller1, Daniela Graham4, Cecilia Borlenghi5, Bonnie Vlahos6, Chuanbo Zang6 and Nicolino Ruperto2, 1Paediatric Rheumatology International Trials Organisation (PRINTO), Genoa, Italy, 2PRINTO, Istituto Giannina Gaslini, Genova, Italy, 3Hospital Universitario Ramón y Cajal, Madrid, Spain, 4Pfizer, Groton, PA, 5Pfizer, New York, NY, 6Pfizer, Collegeville, PA

    Background/Purpose: CLIPPER is an ongoing, 8-year, phase 3b, multicenter, open-label study of the safety and efficacy of etanercept in the treatment of juvenile idiopathic arthritis…
  • Abstract Number: 0900 • ACR Convergence 2020

    Achievement of Low Disease Activity According to BASDAI with Ixekizumab in Patients with Axial Spondyloarthritis: 16-Week Results from the COAST Trials

    Denis Poddubnyy1, Xavier Juanola2, Clément Prati3, Hagen Russ4, Yves Schymura4, Soyi Liu-Leage5, Mani Haschemi Nassab4 and Jean Dudler6, 1Charité – Universitätsmedizin Berlin, Berlin, Germany, 2Rheumatology Service, University Hospital Bellvitge, IDIBELL, Barcelona, Spain, Barcelona, Spain, 3Service de Rhumatologie, Hôpital Jean-Minjoz , Besançon, France, Besançon, France, 4Eli Lilly and Company, Indianapolis, Indiana, USA, Indianapolis, IN, 5Eli Lilly and Company, Indianapolis, IN, 6Department of Rheumatology, HFR Fribourg - Hospital Cantonal, Fribourg, Switzerland, Fribourg, Switzerland

    Background/Purpose: The efficacy of ixekizumab (IXE), a selective interleukin-17A antagonist, was assessed in patients (pts) with axial SpA (axSpA) in three Phase 3, randomized, double-blind,…
  • Abstract Number: 1231 • ACR Convergence 2020

    Radiographic Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib as Monotherapy or in Combination with Methotrexate: Results at 2 Years

    Charles Peterfy1, Vibeke Strand2, Mark Genovese3, Alan Friedman4, Jeffrey Enejosa4, Stephen Hall5, Eduardo Mysler6, Patrick Durez7, Xenofon Baraliakos8, Tim Shaw4, Yanna Song9, Yihan Li4 and In-Ho Song4, 1Spire Sciences, Inc., Boca Raton, FL, 2Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, 3Stanford University Medical Center, Palo Alto, CA, 4AbbVie Inc., North Chicago, IL, 5Cabrini Medical Centre, Monash University and Emeritus Research, Malvern, Victoria, Australia, 6Organización Medica de Investigación, Buenos Aires, Argentina, 7Division of Rheumatology, Cliniques Universitaires Saint-Luc, Bruxelles, Belgium, 8Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, 9AbbVie Inc., North Chicago,, IL

    Background/Purpose: For patients with rheumatoid arthritis (RA), long‑term prevention of structural joint damage is a key treatment goal.1 In the SELECT-EARLY and SELECT-COMPARE trials, upadacitinib…
  • Abstract Number: 1744 • ACR Convergence 2020

    The STAtins to Prevent Rheumatoid Arthritis (STAPRA) Trial: Clinical Results and Subsequent Qualitative Study, a Mixed Method Evaluation

    Laurette van Boheemen1, Marieke ter Wee2, Samina Turk3, Marian van Beers3, Wouter Bos3, Diane Marsman4, Ed Griep5, Mirian Starmans6, Calin Popa7, Alper van Sijl3, Bart Seppen3, Maarten Boers8, Mike Nurmohamed9 and Dirkjan van Schaardenburg8, 1Amsterdam Rheumatology and immunology Center | Reade, Amste, Netherlands, 2Amsterdam Rheumatology and Immunology Center, location Amsterdam UMC, VUmc, Amsterdam, Netherlands, 3Amsterdam Rheumatology and immunology Center | Reade, Amsterdam, Netherlands, 4Sint Maartenskliniek, Nijmegen, Netherlands, 5Antonius Ziekenhuis, Sneek, Netherlands, 6Zuyderland MC, Heerlen, Netherlands, 7Radboudumc, Nijmegen, Netherlands, 8Amsterdam Rheumatology and immunology Center | Reade and Amsterdam UMC, Amsterdam, Netherlands, 9Amsterdam Rheumatology and immunology Center, location Reade and Amsterdam UMC, VU medical center, Amsterdam, Netherlands

    Background/Purpose: Persons at high risk of developing rheumatoid arthritis (RA) may benefit from a low-risk pharmacological intervention aimed at primary prevention. Previous studies demonstrated disease-modifying…
  • Abstract Number: 2028 • ACR Convergence 2020

    Predictors of Maintaining Inactive Disease After Etanercept Withdrawal, and Regaining Inactive Disease Status After Flare and Retreatment, in Adults with Non-radiographic Axial Spondyloarthritis: Results from RE-EMBARK

    Filip Van den Bosch1, James Cheng-Chung Wei2, Francisco Blanco3, Pamela Selema4, Daniela Graham5, Edmund Arthur6, Vassilis Tsekouras7, Bonnie Vlahos4, Chuanbo Zang4, Atul Deodhar8 and Peter Nash9, 1Ghent University Hospital, Ghent, Belgium, 2Chung Shan Medical University Hospital, Taichung, Taiwan (Republic of China), 3INIBIC-Complejo Hospitalario Universitario A Coruña, A Coruna, Spain, 4Pfizer, Collegeville, PA, 5Pfizer, Groton, PA, 6Pfizer, Peapack, NJ, 7Pfizer, Nicosia, Cyprus, 8Oregon Health & Science University, Portland, OR, 9School of Medicine Griffith University, Brisbane, Queensland, Australia

    Background/Purpose: RE-EMBARK was a phase 4, multicenter, open-label, 3-period study that evaluated etanercept (ETN) withdrawal and retreatment in adult patients with non-radiographic axial spondyloarthritis (nr-axSpA)…
  • Abstract Number: 0048 • ACR Convergence 2020

    Determinants of Participation in Clinical Trials Among Patients with Lupus in the United States

    Onengiya Harry1, Carl Langefeld2, Miranda Marion3, Trent Younts3, Lori Crosby4, Mara Vitolins3 and Avani Modi4, 1Wake Forest School of Medicine, Clemmons, NC, 2Wake Forest School of Medicine, Winston Salem, NC, 3Wake Forest School of Medicine, Winston-Salem, 4Cincinnati Children's Hospital Medical Center, Cincinnati

    Background/Purpose: Patient and family participation in research is critical to improving health outcomes, and identifying factors that contribute to participation or lack of participation in…
  • Abstract Number: 0214 • ACR Convergence 2020

    Sustainability of Response Between Upadacitinib and Adalimumab Among Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate

    Peter Nash1, Arthur Kavanaugh2, Maya Buch3, Bernard Combe4, Louis Bessette5, In-Ho Song6, Yanna Song7, Jessica Suboticki6 and Roy Fleischmann8, 1School of Medicine Griffith University, Brisbane, Queensland, Australia, 2Division of Rheumatology, Allergy, & Immunology, University of California San Diego Medical School, San Diego, CA, 3Centre of Musculoskeletal Research, School of Biological Sciences, University of Manchester, Manchester, United Kingdom, 4University of Montpellier, Montpellier, France, 5Laval University, Quebec, Canada, 6AbbVie Inc., North Chicago, IL, 7AbbVie Inc., North Chicago,, IL, 8Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX

    Background/Purpose: The primary treatment goal for patients(pts) with rheumatoid arthritis(RA) is a state of sustained clinical remission(REM) or low disease activity(LDA).1,2 We assess long-term sustainability…
  • Abstract Number: 0384 • ACR Convergence 2020

    Serum Neutrophil Count Predicts Progression of Interstitial Lung Disease and Mortality in Patients with Systemic Sclerosis Related Interstitial Lung Disease

    Nancy Wareing1, Ning Li2, Elizabeth Volkmann3, Marka Lyons4, Michael Roth2, Donald Tashkin2 and Shervin Assassi1, 1University of Texas Houston McGovern Medical School, Division of Rheumatology and Clinical Immunogenetics, Houston, TX, 2University of California, Los Angeles, Los Angeles, 3University of California, Los Angeles, Los Angeles, CA, 4University of Texas Houston, McGovern Medical School, Division of Rheumatology and Clinical Immunogenetics, Houston, TX

    Background/Purpose: Systemic sclerosis (SSc) patients have a prominent neutrophil gene expression signature.  However, investigations into the pathophysiologic role of neutrophils in SSc are lacking. This…
  • Abstract Number: 0798 • ACR Convergence 2020

    A Randomized, Double-blind Phase 3 Study Comparing the Efficacy, Safety and Immunogenicity of PF-06410293 (Abrilada™), an Adalimumab (ADL) Biosimilar, and Reference ADL (Humira®) in Patients with Moderate to Severe Active RA: Results from Weeks 52-92

    Roy Fleischmann1, Daniel Alvarez2, Amy Bock3, Carol Cronenberger4, Ivana Vranic5, Wuyan Zhang6 and Rieke Alten7, 1Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, 2Pfizer, Collegeville, PA, 3Pfizer, Cambridge, MA, 4Pfizer, Collegeville, 5Pfizer, Tadworth, United Kingdom, 6Pfizer, New York, 7Schlosspark-Klinik, Universitätsmedizin, Berlin, Germany

    Background/Purpose: To evaluate the long-term safety, immunogenicity (IG), and efficacy of the adalimumab (ADL) biosimilar, PF-06410293 (ADL-PF), in patients (pts) with moderate to severe active…
  • Abstract Number: 0935 • ACR Convergence 2020

    Efficacy and Safety Results from a Phase 2, Randomized, Double-Blind Trial of BIIB059, an Anti-Blood Dendritic Cell Antigen 2 Antibody, in SLE

    Richard Furie1, Ronald van Vollenhoven2, Kenneth Kalunian3, Sandra Navarra4, Juanita Romero-Díaz5, Victoria Werth6, Xiaobi Huang7, Hua Carroll8, Adam Meyers7, Cristina Musselli7, Catherine Barbey9 and Nathalie Franchimont7, 1Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, 2Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, 3University of California San Diego, La Jolla, CA, 4University of Santo Tomas, Manila, Philippines, 5Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico, 6University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, 7Biogen, Cambridge, MA, 8Biogen, Cambridge, 9Biogen, Baar, Switzerland

    Background/Purpose: Type I interferons (IFN-I), inflammatory mediators principally produced by plasmacytoid dendritic cells (pDCs), components of the innate immune system, have been implicated in the…
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ACR Convergence: Where Rheumatology Meets. All Virtual. November 5-9.

ACR Pediatric Rheumatology Symposium 2020

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