Abstracts tagged "clinical trial"

Abstract Number: 1771 • ACR Convergence 2021
First-in-Human Safety, Pharmacokinetic and Pharmacodynamic Study of Escalating Single- and Multiple-Doses of BMS-986256, a Novel, Potent, Oral Inhibitor of TLR7 and TLR8
Melanie Harrison¹, Manoj Chiney¹, Diane Shevell², Lixian Dong³, Michelle Dawes¹ and Ihab Girgis³, ¹Bristol Myers Squibb, Lawrenceville, NJ, ²Bristol Myers Squibb, Lawrenceville, ³Bristol Myers Squibb, Princeton, NJ
Background/Purpose: Toll-like receptor (TLR)7 and TLR8 are endosomal receptors that are normally activated by pathogen-associated RNA. They are also activated by self-RNA as part of…
Abstract Number: 1900 • ACR Convergence 2021
Urate Lowering Therapy in the Treatment of Gout: A Multicenter, Randomized, Double-blind Comparison of Allopurinol and Febuxostat Using a Treat-to-Target Strategy
James O'Dell¹, Tuhina Neogi², Michael Pillinger³, Paul Palevsky⁴, Jeff Newcomb¹, Mary Brophy⁵, Hongsheng Wu⁵, Annie Davis-Karim⁶, Ryan Ferguson⁵, David Pittman⁶, Robert Terkeltaub⁷, Amy Cannella¹, Bryant England¹, Lindsay Helget¹, Ted Mikuls¹ and Tomas Taylor⁸, ¹University of Nebraska Medical Center, Omaha, NE, ²Boston University School of Medicine, Boston, MA, ³New York University Grossman School of Medicine, New York,, NY, ⁴Pittsburgh University, Pittsburgh, PA, ⁵Boston VA, Boston, MA, ⁶Albuquerque VA, Albuquerque, NM, ⁷VA/UCSD, San Diego, CA, ⁸White River Junction VA, White River Junction, VT
Background/Purpose: Urate lowering therapy (ULT) is a cornerstone treatment in the management of gout. A paucity of data exists about the relative efficacy and safety…
Abstract Number: 0185 • ACR Convergence 2021
Phase 1 Study Results of GS-5718, an Oral IRAK4-Inhibitor: Pharmacodynamics of Single and Multiple Doses of GS-5718 in Healthy Subjects
Silke Roedder¹, Emily Wendt², Chad Burris², Jonathan Nazareon², Grace Park³, Phil Pangilinan², Gianna Huang², Anubhav Mathur², James Taylor², Andrew Billin² and Franziska Matzkies⁴, ¹Gilead Sciences, Menlo Park, CA, ²Gilead Sciences, Foster City, CA, ³Gilead Sciences, Seattle, WA, ⁴Gilead Sciences, Inc., Foster City, CA
Background/Purpose: Adaptive and innate immune pathways are involved in inflammation and pathogenesis of autoimmune diseases including Rheumatoid Arthritis (RA) and Lupus Erythematosus (LE). Immune complexes…
Abstract Number: 0675 • ACR Convergence 2021
Urate-lowering Therapy for Prevention of Gout: Prespecified Analyses from the CKD-FIX Trial
Anushree Tiku¹, Neil Boudville², Fiona Brown³, Alan Cass⁴, Phiilip Clarke⁵, Richard Day⁶, Janak de Zoysa⁷, Bettina Douglas⁸, Randall Faull⁹, David Harris¹⁰, Carmel Hawley¹¹, Graham Jones⁶, John Kanellis³, Elaine Pascoe¹¹, Suetonia Palmer¹², Vlado Perkovic¹³, Gopala Rangan¹⁰, Donna Reidlinger¹¹, Laura Robison¹¹, Robert Walker¹⁴, Giles Walters¹⁵, David Johnson¹¹, Sunil Badve¹³ and Nicola Dalbeth⁷, ¹The George Institute of Australia, Sydney, Australia, ²University of Western Australia, Perth, Australia, ³Monash University, Melbourne, Australia, ⁴Menzies School of Health Research, Darwin, Australia, ⁵University of Oxford, Oxford, United Kingdom, ⁶University of New South Wales, Sydney, Australia, ⁷University of Auckland, Auckland, New Zealand, ⁸Princess Alexandra Hospital, Brisbane, Australia, ⁹University of Adelaide, Adelaide, Australia, ¹⁰University of Sydney, Sydney, Australia, ¹¹University of Queensland, Brisbane, Australia, ¹²University of Otago, Christchurch, New Zealand, ¹³The George Institute for Global Health, Sydney, Australia, ¹⁴University of Otago, Dunedin, New Zealand, ¹⁵The Canberra Hospital, Canberra, Australia
Background/Purpose: The CKD-FIX randomized controlled trial showed that allopurinol did not slow decline of estimated glomerular filtration rate (eGFR) over 104 weeks in patients with…
Abstract Number: 1258 • ACR Convergence 2021
Measurement of Specific Organ Domains in Lupus Randomised Controlled Trials
Kathryn Connelly¹, Jeevan Vettivel², Vera Golder², Rangi Kandane-Rathnayake² and Eric Morand³, ¹Monash University, Camberwell, Australia, ²Monash University, Clayton, Australia, ³Monash University, Melbourne, Australia
Background/Purpose: Randomised controlled trials (RCTs) in SLE typically adopt composite responder definitions as primary efficacy endpoints, however outcomes within individual organ domains are also important…
Abstract Number: 1502 • ACR Convergence 2021
Longitudinal Changes in B Cell Subsets in Patients in the Mesenchymal Stromal Cell Trial in Lupus: Analysis of the First Cohort
Diane Kamen¹, S Sam Lim², Scott Jenks³, Regina Bugrovosky³, Aisha Hill³, Chungwen Wei³, Cristina Drenkard³, Kenneth Kalunian⁴, Ummara Shah⁵, Mariko Ishimori⁶, Rosalind Ramsey-Goldman⁷, Saira Sheikh⁸, Mary Alison Mahieu⁷, Daniel Wallace⁹, Ellen Goldmuntz¹⁰ and Gary Gilkeson¹, ¹Medical University of South Carolina, Charleston, SC, ²Department of Medicine, Division of Rheumatology, Emory University School of Medicine, Atlanta, GA, ³Emory University, Atlanta, GA, ⁴UC San Diego, La Jolla, CA, ⁵University of Rochester, Rochester, NY, ⁶Cedars-Sinai Health System, Los Angeles, CA, ⁷Northwestern University, Chicago, IL, ⁸University of North Carolina, Chapel Hill, NC, ⁹Attune Health, Beverly Hills, CA, ¹⁰National Institutes of Health, Bethesda, MD
Background/Purpose: Recent advances allow expanded identification of B cell subtypes of pathogenic potential in lupus. Of particular interest are IgD- CD27- double negative (DN2) B…
Abstract Number: 1733 • ACR Convergence 2021
Classification of Patients with Systemic Lupus Erythematosus Enrolled in 2 Phase 3 Trials by EULAR/ACR 2019 Criteria
Martin Aringer¹, Ian N. Bruce², Richard Furie³, Eric Morand⁴, Emmanuelle Maho⁵, Catharina Lindholm⁶ and Raj Tummala⁷, ¹University Medical Center and Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany, ²University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ³Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ⁴Monash University, Melbourne, Australia, ⁵BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ⁶BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁷BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD
Background/Purpose: The TULIP-1 and TULIP-2 trials of anifrolumab, an anti–type I IFN receptor mAb, enrolled autoantibody-positive (ANA, anti-dsDNA, and/or anti-Smith [anti-Sm]) patients, who fulfilled the…
Abstract Number: 1772 • ACR Convergence 2021
Autologous EBV-specific Cytotoxic T Cells in Systemic Lupus Erythematosus: An Innovative Phase I/IIa Clinical Trial
Antoine Enfrein¹, Beatrice Clemenceau², Soraya Saiagh³, Céline Bressollette⁴, Zahir Amoura⁵, Henri Vie² and Mohamed Hamidou¹, ¹Médecine interne, CHU de Nantes, Nantes, France, ²Inserm U1232, Université de Nantes, Nantes, France, ³Unité de Thérapie Cellulaire et Génique, CHU de Nantes, Nantes, France, ⁴Laboratoire de Virologie, CHU de Nantes, Nantes, France, ⁵Médecine interne, Hôpital Pitié Salpêtrière, AP-HP, Paris, France
Background/Purpose: Epstein-Barr Virus (EBV) has been suggested as a potential environmental factor in systemic lupus erythematosus (SLE) onset and disease activity. Here, we report the…
Abstract Number: 1940 • ACR Convergence 2021
Malignancies in Patients Aged ≥ 50 Years with RA and ≥ 1 Additional Cardiovascular Risk Factor: Results from a Phase 3b/4 Randomized Safety Study of Tofacitinib vs TNF Inhibitors
Jeffrey Curtis¹, Kunihiro Yamaoka², Yi-Hsing Chen³, Levent M Gunay⁴, Naonobu Sugiyama⁵, Carol A Connell⁶, Cunshan Wang⁶, Joseph Wu⁶, Sujatha Menon⁶, Ivana Vranic⁷ and Juan J Gomez-Reino⁸, ¹Division of Clinical Immunology and Rheumatology, Department of Medicine, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, ²School of Medicine, Department of Rheumatology and Infectious Diseases, Kitasato University, Sagamihara, Japan, ³Taichung Veterans General Hospital, Taichung, Taiwan (Republic of China), ⁴Pfizer Inc, Istanbul, Turkey, ⁵Pfizer Japan Inc, Tokyo, Japan, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer Inc, Tadworth, Surrey, United Kingdom, ⁸Hospital Clínico Universitario, Santiago de Compostela, Spain
Background/Purpose: ORAL Surveillance (NCT02092467) was a post-authorization safety study to assess the relative risk of tofacitinib vs TNF inhibitors (TNFi), based on observed increases in…
Abstract Number: 0196 • ACR Convergence 2021
A Single Center, Double Blind, Randomized, Placebo-Controlled Trial of Anakinra in Adult Patients with Features of Cytokine Storm Syndrome in COVID-19
Lesley Jackson¹, Randy Cron¹, Nitasha Khullar², Christopher Chapleau³, Dongmei Sun⁴ and Winn Chatham¹, ¹University of Alabama at Birmingham, Birmingham, AL, ²University of Alabama Birmingham, Birmingham, AL, ³UAB Pharmacy, University of Alabama at Birmingham, Birmingham, AL, ⁴Division of Clinical Immunology and Rheumatology, The University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Some patients with COVID-19 develop respiratory distress and cytokine storm syndrome (CSS) which is characterized by hyperinflammation and may progress to multi-organ failure. Anakinra…
Abstract Number: 0726 • ACR Convergence 2021
Joint Safety of Tanezumab versus NSAIDs; A Combined Assessment of Benefit and Harm
Robert Fountaine¹, Robert Dworkin², Anne Hickman¹, Glenn Pixton³, Ed Whalen⁴, Christine West¹ and Kenneth Verburg¹, ¹Pfizer Inc., Groton, CT, ²University of Rochester, Rochester, NY, ³Pfizer Inc., Morrisville, NC, ⁴Pfizer Inc., New York, NY
Background/Purpose: Tanezumab, a monoclonal antibody against nerve growth factor, is in development for the relief of signs and symptoms of moderate to severe osteoarthritis (OA)…
Abstract Number: 1273 • ACR Convergence 2021
A 12-week Aerobic Exercise Training Program in Women with Systemic Lupus Erythematosus (SLE) Improves Fatigue, Mitochondrial Dysfunction and Associated Interferon Gene Signature
Sarfaraz Hasni¹, Marquis Chapman², Rebekah Feng¹, Anam Ahmad¹, Sarthak Gupta³, Mohammad Naqi¹, Adam Munday¹, Shajia Lu¹, Massimo Gadina², Zerai Manna¹, Xiaobai Li⁴, Yinghui Shi¹, Kalyani Mishra-Thakur¹, Michael Davis⁵, Jun Chu³, Elaine Poncio⁶, Yenealem Temesgen-Oyelakin⁷, Jonathan Martinez¹, Zoe Morris¹, Isabel Ochoa⁶, Shuichiro Nakabo⁸, Bart Drinkard¹, Gayle McCrossin¹, Marybeth Stockman¹, Mariana Kaplan¹, Leorey Saligan¹, Randall Keyser⁹, Leighton Chan¹ and Lisa Chin¹, ¹National Institutes of Health, Bethesda, MD, ²National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, MD, ³National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Bethesda, MD, ⁴Clinical Center, National Institutes of Health, Bethesda, MD, ⁵NIAMS, Bethesda, MD, ⁶NIH/NIAMS, Bethesda, MD, ⁷National Institutes of Health (NIH), Bethesda, MD, ⁸NIAMS/NIH, Bethesda, MD, ⁹George Mason University, Bethesda
Background/Purpose: Fatigue in SLE patients is ubiquitous and is reported as one of the most debilitating symptoms. Yet mechanisms underlying the pathophysiology of SLE-related fatigue…
Abstract Number: 1553 • ACR Convergence 2021
Low-dose Tocilizumab in the Treatment of COVID-19 Pneumonitis: 90-day Mortality Follow-up
Lauren He¹, Garth Strohbehn² and Pankti Reid³, ¹University of Chicago, Chicago, IL, ²VA Ann Arbor Center for Clinical Management and Research, Chicago, IL, ³University of Chicago Medical Center, Chicago, IL
Background/Purpose: Tocilizumab (TCZ) for treatment of severe coronavirus disease 2019 (COVID-19) pneumonia decreases the probability of progression to invasive mechanical ventilation (CORIMUNO-TOCI) or death (REMAP-CAP,…
Abstract Number: 1734 • ACR Convergence 2021
Efavaleukin Alfa, a Novel IL-2 Mutein, Selectively Expands Regulatory T Cells in Patients with SLE: Interim Results of a Phase 1b Multiple Ascending Dose Study
Nadia Tchao¹, Hamid Amouzadeh², Nandita Sarkar¹, Vincent Chow², Xuguang Hu¹, Mark Kroenke², Hui Wang², Rong Zhang², Kevin Gorski¹, Richard Furie³, Alan Kivitz⁴ and Stanley Cohen⁵, ¹Amgen Inc., South San Francisco, CA, ²Amgen Inc., Thousand Oaks, CA, ³Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ⁴Altoona Center for Clinical Research, Duncansville, PA, ⁵Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: Diminished IL-2 as well as both quantitative and qualitative abnormalities in regulatory T cells (Treg) are associated with autoimmune diseases including SLE. Efavaleukin alfa…
Abstract Number: 1773 • ACR Convergence 2021
Comparing Efficacy of Guselkumab versus Ustekinumab in Patients with Psoriatic Arthritis: An Adjusted Comparison Using Individual Patient Data from DISCOVER 1&2 and PSUMMIT Trials
Joris Diels¹, Pushpike Thilakarathne², Agata Schubert³, Fareen Hassan⁴, Steven Peterson⁵ and Wim Noël¹, ¹Janssen Pharmaceutica, HEMAR Department, Beerse, Belgium, ²JanssenCilag Ltd, HEMAR Department, Beerse, Belgium, ³Janssen-Cilag Poland, HEMAR Department, Warsaw, Poland, ⁴Janssen-Cilag Ltd, HEMAR Department, High Wycombe, United Kingdom, ⁵Janssen Immunology Global Commercial Strategy Organization, Raritan, NJ
Background/Purpose: Guselkumab is an anti-interleukin (IL)-23 monoclonal antibody recently approved for the treatment of psoriatic arthritis (PsA). In two large Phase III trials of patients…

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