Abstracts tagged "clinical trial"

Abstract Number: 0862 • ACR Convergence 2020
Voclosporin Does Not Decrease Mycophenolic Acid Concentrations in Patients with SLE
Teun van Gelder¹, Robert Huizinga², Neil Solomons² and Laura Lisk³, ¹Leiden University Medical Centre, Leiden, Zuid-Holland, Netherlands, ²Aurinia Pharmaceuticals, Victoria, BC, Canada, ³Aurinia Pharmaceuticals Inc., Victoria, BC, Canada
Background/Purpose: Voclosporin (VCS) is a novel calcineurin inhibitor, structurally similar to cyclosporine A (CsA). In a Phase 3 clinical trial in patients with active lupus…
Abstract Number: 1201 • ACR Convergence 2020
Effect of Filgotinib on Pain in Patients with Rheumatoid Arthritis: Results from Phase 3 Clinical Trials
Peter Taylor¹, Arthur Kavanaugh², Peter Nash³, Janet Pope⁴, Beatrix Bartok⁵, Ken Hasegawa⁵, Shangbang Rao⁵, Sander Strengholt⁶ and Rene Westhovens⁷, ¹Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²Division of Rheumatology, Allergy, & Immunology, University of California San Diego Medical School, San Diego, CA, ³School of Medicine Griffith University, Brisbane, Queensland, Australia, ⁴Department of Medicine, University of Western Ontario, St. Joseph's Health Centre, London, ON, Canada, ⁵Gilead Sciences, Inc., Foster City, CA, ⁶Galapagos BV, Leiden, Netherlands, ⁷University Hospitals Leuven, Belgium, Leuven, Belgium
Background/Purpose: RA patients (pts) often suffer substantial pain despite ongoing treatment (tx) and regard pain control as a top tx goal. Filgotinib (FIL)—a potent, oral…
Abstract Number: 1490 • ACR Convergence 2020
Pain Rating Variability and Response to Treatment in Osteoarthritis Clinical Trials
Camila Pinto¹, Joana Barroso² and Thomas Schnitzer³, ¹Department of Physiology, Northwestern University Feinberg School of Medicine, Chicago, IL, ²Department of Physiology, Northwestern University, Feinberg School of Medicine, Chicago, IL, ³Northwestern University Feinberg School of Medicine, Chicago, IL
Background/Purpose: Despite the known high inter- and intra-patient variability in analgesic responses in chronic pain, most interventional pain studies rely on single time point pain…
Abstract Number: 1847 • ACR Convergence 2020
Delayed and Immediate Release Prednisone Decrease Fatigue Comparably in Patients with Systemic Lupus Erythematosus
Hope Rainey¹, Kristy Bell¹, Violeta Rus², Daniel Wallace³, Claire Dykas¹, Mary Mora¹, Maggy Comberg¹ and Peter Lipsky¹, ¹AMPEL BioSolutions LLC., Charlottesville, VA, ²University of Maryland School of Medicine, Baltimore, MD, ³Cedars-Sinai Medical Center/UCLA, Los Angeles, CA
Background/Purpose: Morning stiffness and fatigue are common symptoms in patients with SLE. Increased cytokines and disturbed sleep patterns may contribute to morning symptoms and fatigue…
Abstract Number: 0207 • ACR Convergence 2020
Upadacitinib Monotherapy in Methotrexate-naïve Patients with Rheumatoid Arthritis: Results at 72 Weeks
Ronald van Vollenhoven¹, Tsutomu Takeuchi², Maureen Rischmueller³, Ricardo Blanco⁴, Ricardo Xavier⁵, Mark Howard⁶, Alan Friedman⁶, Yanna Song⁷ and Vibeke Strand⁸, ¹Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, ²Division of Rheumatology, Department of internal Medicine, School of Medicine, Keio University, Tokyo, Japan, ³The Queen Elizabeth Hospital and Univ of Adelaide, St Peters, South Australia, Australia, ⁴Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain, ⁵Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rio Grande do Sul, Rio Grande do Sul, Brazil, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., North Chicago,, IL, ⁸Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA
Background/Purpose: Upadacitinib (UPA), an oral JAK inhibitor, demonstrated significant improvements in signs, symptoms, and structural inhibition as monotherapy vs methotrexate (MTX) in a randomized, controlled…
Abstract Number: 0240 • ACR Convergence 2020
Long-term Safety and Efficacy of Sarilumab over 5 Years in Patients with Rheumatoid Arthritis with 1 or >1 Prior Tumor Necrosis Factor Inhibitor Failures
Roy Fleischmann¹, Karina Maslova², Henry Leher³, Amy Praestgaard² and Gerd Burmester⁴, ¹Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, ²Sanofi, Cambridge, MA, ³Regeneron Pharmaceuticals, Inc, Tarrytown, NY, ⁴Charité University Hospital Berlin, Berlin, Germany
Background/Purpose: A proportion of adult patients with RA are refractory to TNF inhibitors (TNFi), and treatment with subsequent biologics may be associated with reduced response.…
Abstract Number: 0572 • ACR Convergence 2020
Two-year Cost-effectiveness Between Two Gradual Tapering Strategies in Rheumatoid Arthritis: Cost-utility Analysis of the TARA Trial
Elise van Mulligen¹, Angelique Weel², Mieke Hazes³, Annette van der Helm - van Mil⁴ and Pascal de Jong¹, ¹Erasmus MC, Rotterdam, Netherlands, ²Erasmus School of Health Policy & Management, Maasstad hospital, Erasmus MC, Rotterdam, Netherlands, ³Erasmus Medical Center, Rotterdam, Netherlands, ⁴Leiden University Medical Center, Erasmus Medical Center, Leiden, Netherlands
Background/Purpose: The benefits of tapering are a decreased risk of long-term adverse events and a reduction of health care costs, especially when bDMARDs are tapered.…
Abstract Number: 0866 • ACR Convergence 2020
Identifying an SLE Patient Cluster with Greater Treatment Effect: Immune Cell Deconvolution of Gene Expression in Two Atacicept Phase II Studies
Joan Merrill¹, Matthew Studham², Eric Morand³, Aida Aydemir², Cristina Vazquez Mateo², Alex Rolfe², Amy Kao² and Robert Townsend², ¹Oklahoma Medical Research Foundation, Oklahoma City, OK, ²EMD Serono (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, ³Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia
Background/Purpose: Atacicept, a dual inhibitor of the B lymphocyte stimulator and a proliferation-inducing ligand (APRIL), has been associated with a reduction of flares in the…
Abstract Number: 1207 • ACR Convergence 2020
Impact of Body Mass Index on Clinical Responses of Novel Subcutaneous Infliximab (CT-P13 SC) in Patients with Active Rheumatoid Arthritis: 1-Year Results from a Part 2 of Phase I/III Randomized Controlled Trial
DaeHyun Yoo¹, Rene Westhovens², Piotr Wiland³, Marek Zawadzki⁴, Delina Ivanova⁵, Alfredo Berrocal Kasay⁶, Elias Chalouhi⁷, Eva Balázs⁸, SangJoon Lee⁹, SungHyun Kim⁹, NooRi Han⁹ and YooBin Jung⁹, ¹Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, ²University Hospitals Leuven, Belgium, Leuven, Belgium, ³Medical Univeristy, Wroclaw, Poland, ⁴Medical Univeristy, Dpt of Rheumatology , Wroclaw, Wroclaw, Poland, ⁵Diagnostic-Consultative Center Aleksandrovska EOOD, Sofia, Bulgaria, ⁶ABK Reuma SRL, LIMA, Peru, ⁷Clinica Internacional Sede Lima, Lima, Peru, ⁸Dr. Bugyi István Hospital, Szentes, Hungary, ⁹Celltrion, Inc., Incheon, Republic of Korea
Background/Purpose: In the analysis of PLANETRA, a Phase III randomized controlled trial (RCT), no significant association was found between body mass index (BMI) and clinical…
Abstract Number: 1495 • ACR Convergence 2020
Tofacitinib for the Treatment of Patients with Juvenile Idiopathic Arthritis: An Interim Analysis of Data up to 5.5 Years from an Open-label, Long-term Extension Study
Hermine I Brunner¹, Jonathan Akikusa², Eslam Al-Abadi², John Bohnsack³, Alina Lucica Boteanu², Gaelle Chedeville⁴, Ruben Cuttica², Wendy De La Pena⁴, Lawrence Jung⁴, Ozgur Kasapcopur², Katarzyna Kobusinska², Grant Schulert¹, Claudia Neiva², Rafael Rivas-Chacon⁴, Juan Cruz Rizo Rodriguez², Monica Vazquez-Del Mercado², Linda Wagner-Weiner⁴, Jennifer E Weiss¹, Carine Wouters², Ricardo M Suehiro⁵, Holly Posner⁶, Ann Wouters⁶, Keith S Kanik⁷, Zhen Luo⁸, Alberto Martini², Daniel J Lovell¹ and Nicolino Ruperto², ¹PRCSG, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ²PRINTO, Istituto Giannina Gaslini, Genova, Italy, ³University of Utah and Primary Children's Hospital, Cincinnati, OH, ⁴PRCSG, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ⁵Pfizer Inc, Collegeville, PA, ⁶Pfizer Inc, New York, NY, ⁷Pfizer Inc, Groton, CT, ⁸Pfizer Inc, Shanghai, China (People's Republic)
Background/Purpose: Tofacitinib is an oral JAK inhibitor that is being investigated for JIA. We report the safety, tolerability, and efficacy of tofacitinib in patients (pts)…
Abstract Number: 1928 • ACR Convergence 2020
Quantitative Ultrasound of Temporal, Axillary and Subclavian Arteries to Monitor Tocilizumab Treatment in Patients with Newly Diagnosed Giant Cell Arteritis: A 24 Week Analysis
Luca Seitz¹, Lisa Christ¹, Godehard Scholz¹, Fabian Lötscher¹, Jennifer Amsler¹, Florian Kollert¹, Stephan Reichenbach¹ and Peter Villiger¹, ¹Department of Rheumatology, Immunology and Allergology, University of Bern, Inselspital, Switzerland, Bern, Switzerland
Background/Purpose: Tocilizumab (TCZ) suppresses CRP. Thus, CRP cannot be used as a marker for disease activity in GCA patients treated with TCZ and monitoring of…
Abstract Number: 0208 • ACR Convergence 2020
Efficacy and Safety of Filgotinib for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: 52-Week Results
Bernard Combe¹, Alan Kivitz², Yoshiya Tanaka³, Désirée van der Heijde⁴, J-Abraham Simon-Campos⁵, Herbert S. Baraf⁶, Uma Kumar⁷, Franziska Matzkies⁸, Beatrix Bartok⁸, Lei Ye⁸, Ying Guo⁹, Chantal Tasset¹⁰, John S. Sundy⁸, Angelika Jahreis⁸, Neelufar Mozaffarian¹¹, Robert Landewé¹², Sang-Cheol Bae¹³, Edward C Keystone¹⁴ and Peter Nash¹⁵, ¹University of Montpellier, Montpellier, France, ²Altoona Center for Clinical Research/Altoona Arthritis and Osteoporosis Center, Duncansville, PA, ³The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁴Leiden University Medical Center, Leiden, Netherlands, ⁵Köhler & Milstein Research, Mérida, Mexico, ⁶The Ctr for Rheumatology and Bone Research, Wheaton, MD, ⁷All India Institute of Medical Sciences, New Delhi, India, ⁸Gilead Sciences, Inc., Foster City, CA, ⁹Gilead Sciences, Inc., Foster City, ¹⁰Galapagos NV, Mechelen, Belgium, ¹¹Ichnos Sciences, Paramus, ¹²Amsterdam University Medical Center & Zuyderland Hospital, Amsterdam, Netherlands, ¹³Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, ¹⁴Mount Sinai Hospital, Toronto, ON, Canada, ¹⁵School of Medicine Griffith University, Brisbane, Queensland, Australia
Background/Purpose: Filgotinib (FIL) is an oral, potent, selective Janus kinase 1 (JAK1) inhibitor. FINCH 1 (NCT02889796) assessed FIL efficacy and safety in patients (pts) with…
Abstract Number: 0280 • ACR Convergence 2020
Compliance and Validation of Patient Reported Outcome Information Collected from Lupus Patients Using a Mobile Application
Kristy Bell¹, Claire Dykas¹, Hope Rainey¹, Maggy Comberg¹, Mary Mora¹ and Peter Lipsky¹, ¹AMPEL BioSolutions LLC., Charlottesville, VA
Background/Purpose: Patient Reported Outcomes (PROs) can provide critical data in measuring the impact of a disease on an individual as well as the quality of…
Abstract Number: 0599 • ACR Convergence 2020
Evaluation of Telephone Consultations in Germany as an Additional Tool in Outpatient Rheumatology Clinics During the COVID-19 Pandemic
Ulrich Drott¹, Axel Braner¹, Thomas Kollewe², Harald Burkhardt³ and Florian Meier¹, ¹Department of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany, Frankfurt, Germany, ²J. W. Goethe-Universität Frankfurt, FB Medizin, Frankfurter Arbeitsstelle für Medizindidaktik, Frankfurt, Germany, Frankfurt, Germany, ³Department of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany, Frankfurt am Main, Germany
Background/Purpose: The Covid-19 pandemic holds multiple challenges for the healthcare system. Quick adoptions and adjustments are the mainstays during these times. Hygiene management and plans…
Abstract Number: 0874 • ACR Convergence 2020
A Multi-Center, Randomized, Double-blind, Placebo-controlled Dose-ranging Study Evaluating Efficacy and Safety of SHR-1314 in Subjects with Moderate-to-Severe Plaque Psoriasis
Chunlei Zhang¹, Kexiang Yan², Qingchun Diao³, Qing Guo⁴, Hongzhong Jin⁵, Sen Yang⁶, Xiang Chen⁷, Tiechi Lei⁸, Jianhua Wu⁹, Hong Yu¹⁰, Min Zheng¹¹, Xinghua Gao¹², Robert Sinclair¹³, Delilah Alonso¹⁴, Yi Zhu¹⁵, Qian Xu¹⁵ and Jinhua Xu², ¹Department of Dermatology, Peking University Third Hospital, Beijing, China (People's Republic), ²Huashan Hospital Affiliated to Fudan University, Shanghai, China (People's Republic), ³Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China (People's Republic), ⁴Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China (People's Republic), ⁵Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China (People's Republic), ⁶The First Affiliated Hospital of Anhui Medical University, Hefei, China (People's Republic), ⁷Xiangya Hospital, Central South University, Changsha, China (People's Republic), ⁸Renmin Hospital of Wuhan University, Hubei General Hospital, Wuhan, China (People's Republic), ⁹Changhai Hospital of Shanghai, Shanghai, China (People's Republic), ¹⁰Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China (People's Republic), ¹¹The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China (People's Republic), ¹²The 1st Hospital of China Medical University, Shenyang, China (People's Republic), ¹³Sinclair Dermatology, East Melbourne, Australia, ¹⁴Revival Research, Doral, ¹⁵Jiangsu Hengrui Medicine Co., Ltd, Shanghai, China (People's Republic)
Background/Purpose: SHR-1314 is a humanized monoclonal immunoglobulin (IgG1/κ isotype) targeting human interleukin-17A (IL-17A). Preliminary data from phase I study has shown that single dose of…

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