Abstracts tagged "clinical trial"

Abstract Number: 1746 • ACR Convergence 2021
Baricitinib Decreases Anti-dsDNA and IgG Antibodies in Adults with Systemic Lupus Erythematosus from a Phase 2 Double-Blind, Randomized, Placebo-Controlled Trial
Thomas Dörner¹, Ronald Van Vollenhaven², Andrea Doria³, Bochao Jia⁴, Damiano Fantini⁴, Jorge Ross Terres⁴, Maria Silk⁵, Stephanie de Bono⁴, Peter Fischer⁶ and Daniel Wallace⁷, ¹Charite Universitätsmedizin Berlin and Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany, ²University Medical Center, Amsterdam, Netherlands, ³University of Padova, Padova, Italy, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Eli Lilly and Company, Carmel, IN, ⁶Eli Lilly and Company, North Easton, MA, ⁷Cedars-Sinai, Los Angeles, CA
Background/Purpose: Baricitinib (BARI), an oral, selective Janus kinase (JAK)1 and JAK2 inhibitor, improved disease activity in adults with systemic lupus erythematosus (SLE) receiving standard background…
Abstract Number: 1805 • ACR Convergence 2021
Low Rates of Radiographic Progression with 2 Years of Guselkumab (TREMFYA®), a Selective Inhibitor of the Interleukin-23p19 Subunit: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study of Biologic-naïve Patients with Active Psoriatic Arthritis
Philip Mease¹, Alice Gottlieb², Iain McInnes³, Proton Rahman⁴, Alexa Kollmeier⁵, Xie Xu⁶, Yusang Jiang⁶, Shihong Sheng⁶, May Shawi⁷, Soumya Chakravarty⁸, Frederic Lavie⁹ and Désirée van der Heijde¹⁰, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Icahn School of Medicine at Mount Sinai, New York, NY, ³University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, ⁴Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ⁵Janssen Research & Development, LLC, La Jolla, CA, ⁶Janssen Research & Development, LLC, Spring House, PA, ⁷Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁸Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁹Janssen Global Services, LLC, Horsham, PA, ¹⁰Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands
Background/Purpose: Guselkumab (GUS), an IL-23p19-subunit inhibitor, is efficacious in treating patients (pts) with psoriasis and psoriatic arthritis (PsA). In the Phase 3, double-blind, placebo (PBO)-controlled…
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…

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