Abstracts tagged "clinical trial"

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…
Abstract Number: 1208 • ACR Convergence 2020
Utility of Measuring the Immunogenicity to CT-P13 for Subcutaneous Use in Patients with Active Rheumatoid Arthritis: 1-Year Results from a Multicenter, Randomized Controlled Pivotal Trial
Rene Westhovens¹, DaeHyun Yoo², Piotr Wiland³, Marek Zawadzki⁴, Delina Ivanova⁵, Alfredo Berrocal Kasay⁶, Elias Chalouhi⁷, Eva Balázs⁸, SangJoon Lee⁹, SungHyun Kim⁹, JeeHye Suh⁹, ChanKyoung Hwang⁹ and DaeSeok Choi⁹, ¹University Hospitals Leuven, Belgium, Leuven, Belgium, ²Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 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: Novel subcutaneous infliximab (CT-P13 SC) was developed to augment the flexibility in the therapeutic use of infliximab and non-inferiority (NI) of CT-P13 SC versus…
Abstract Number: 1557 • ACR Convergence 2020
Lymphatics as a Biomarker of Joint Physiology: Near-Infrared Imaging of Indocyanine Green Identifies Novel Routes of Lymphatic Drainage from Metacarpophalangeal Joints in Healthy Human Hands
H. Mark Kenney¹, Gregory Dieudonne¹, Ronald Wood¹, Edward Schwarz¹, Christopher Ritchlin² and Homaira Rahimi³, ¹University of Rochester Medical Center, Rochester, ²Department of Medicine, University of Rochester Medical Center, Rochester, NY, ³University of Rochester Medical Center, Rochester, NY
Background/Purpose: In our previous work, we discovered that patients with active hand RA have reduced lymphatic drainage of indocyanine green (ICG) from the web spaces…
Abstract Number: 1990 • ACR Convergence 2020
Janus Kinase (JAK) Inhibition with Baricitinib in Refractory Juvenile Dermatomyositis
Hanna Kim¹, Lylan Bergeron², Samantha Dill², Michelle O'Brien², Laura Vian³, Minal Jain⁴, Manuk Manukyan², Xiaobai Li⁵, Shajia Lu³, Wanxia L. Tsai³, Kalyani Mishra Thakur⁶, Yinghui Shi⁶, Massimo Gadina⁷, April Brundidge², Michelle Millwood², Lisa G. Rider⁸ and Robert Colbert², ¹Juvenile Myositis Pathogenesis and Therapeutics Unit / NIAMS / National Institutes of Health, Bethesda, MD, ²Pediatric Clinical Trials Unit and Office of Clinical Director, NIAMS, NIH, Bethesda, MD, ³Translational Immunology Section, NIAMS, NIH, Bethesda, MD, ⁴Rehabilitation Medicine Department, Physical Therapy Section, Clinical Research Center, NIH, Bethesda, MD, ⁵Biostatistics and Clinical Epidemiology Service, Clinical Center, NIH, Bethesda, MD, ⁶Office of Clinical Director, NIAMS, NIH, Bethesda, MD, ⁷National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH, Bethesda, MD, ⁸Environmental Autoimmunity Group, Clinical Research Branch, NIEHS, NIH, Garrett Park, MD
Background/Purpose: Juvenile dermatomyositis (JDM) is a systemic autoimmune disease with a prominent interferon (IFN) signature. Treatment often requires prolonged high-dose steroids and other immunosuppressive medications.…
Abstract Number: 0209 • ACR Convergence 2020
Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate: Results at 84 Weeks
Josef Smolen¹, Paul Emery², William Rigby³, Yoshiya Tanaka⁴, Juan Vargas⁵, Nemanja Damjanov⁶, Manish Jain⁷, Yanna Song⁸, Nasser Khan⁹, Jeffrey Enejosa⁹ and Stanley Cohen¹⁰, ¹Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, ²Leeds 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, ³Dartmouth College, Norwichi, VT, ⁴The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵Quantum Research, Puerto Varas, Chile, ⁶University of Belgrade Medical School, Belgrade, Serbia, ⁷Great Lakes Clinical Trials, Chicago, IL, ⁸AbbVie Inc., North Chicago,, IL, ⁹AbbVie Inc., North Chicago, IL, ¹⁰Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: In the SELECT-MONOTHERAPY trial, upadacitinib (UPA), an oral JAK inhibitor, demonstrated significantly greater efficacy compared to continuing methotrexate (MTX) when used as monotherapy over…
Abstract Number: 0347 • ACR Convergence 2020
In Two Phase-3 Trials, Guselkumab Reduced Fatigue over 52 Weeks in Patients with Psoriatic Arthritis and Demonstrated Independent Treatment Effects on Fatigue After Adjustment for Clinical Response (ACR20)
Proton Rahman¹, Philip Helliwell², Atul Deodhar³, Alexa Kollmeier⁴, Elizabeth Hsia⁵, Bei Zhou⁶, Xiwu Lin⁶, Chenglong Han⁶ and Philip Mease⁷, ¹Memorial University of Newfoundland, Department of Medicine, St John's, Canada, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³Oregon Health & Science University, Portland, OR, ⁴Janssen Research & Development, LLC, La Jolla, CA, ⁵Janssen Research & Development, LLC and University of Pennsylvania Medical Center, Spring House, PA, ⁶Janssen Research & Development, LLC, Spring House, PA, ⁷Seattle Rheumatology Associates, P.L.L.C., Seattle, WA
Background/Purpose: DISCOVER 1 & 2 are phase-3 trials of guselkumab (GUS, an IL-23 inhibitor) in patients with psoriatic arthritis (PsA). In both trials, treatment with…
Abstract Number: 0649 • ACR Convergence 2020
A Multicenter, Open-Label, Efficacy and Safety Study of Pegloticase in Patients with Uncontrolled Gout Who Have Undergone Kidney Transplantation: Early Data Report
Abdul Abdellatif¹, Lin Zhao², Paul Peloso³, Katya Cherny², Brad Marder², John Scandling⁴ and Kenneth Saag⁵, ¹Baylor College of Medicine, Division of Nephrology, Houston, TX, ²Horizon Therapeutics plc, Lake Forest, IL, ³Horizon Therapeutics plc, Gurnee, IL, ⁴Stanford Medicine, Department of Nephrology, Stanford, CA, ⁵University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, Birmingham, AL
Background/Purpose: Gout’s high prevalence in kidney transplant (KT) recipients has been associated with heavy residual urate burden, decreased urate excretion related to reduced renal function,…

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