Abstracts tagged "clinical trial"

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: 1459 • ACR Convergence 2021
Attainment of the Lupus Low Disease Activity State in Response to Anifrolumab in 2 Phase 3 Trials
Eric Morand¹, Gabriel Abreu², Richard Furie³ and Raj Tummala⁴, ¹Monash University, Melbourne, Australia, ²BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ³Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ⁴BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD
Background/Purpose: The Lupus Low Disease Activity State (LLDAS), a treat-to-target (T2T) endpoint for SLE, is prospectively validated as protective from flares and damage accrual.1 LLDAS…
Abstract Number: 1708 • ACR Convergence 2021
The Efficacy and Safety of Piclidenoson vs Methotrexate in Early Rheumatoid Arthritis: Phase 3 Randomized, Double-blind, Placebo-controlled Study
Tatiana Reitblat¹, Alexandra Gurman- Balbir², Zivit Harpaz³, Motti Farbstein³, Michael Silverman³, William Kerns³ and Pnina Fishman³, ¹Barzilai Medical Center, Ashkelon, Israel, ²Rambam Medical Center, Haifa, Israel, ³Can-Fite BioPharma, Petah Tikva, Israel
Background/Purpose: Piclidenoson, a highly selective A3 adenosine receptor (A3AR) agonist, demonstrated safety and efficacy in phase 2 clinical studies in rheumatoid arthritis (RA) and psoriasis.…
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: 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: 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: 0226 • ACR Convergence 2021
High Efficacy, Safety, and Tolerability of Secukinumab Injection with 2 mL Auto-injector (300 Mg) in Adult Patients with Moderate to Severe Plaque Psoriasis: 52-week Results from MATURE, a Randomised, Placebo-controlled Trial
Bardur Sigurgeirsson¹, John Browning², Stephen Tyring³, Jacek Szepietowski⁴, Raquel Rivera‐Díaz⁵, Isaak Effendy⁶, Deborah Keefe⁷, Gerard Bruin⁸, Bertrand Paguet⁹, Rong Fu¹⁰, Isabelle Hampele⁹ and Maximilian Reinhardt⁹, ¹University of Iceland, Reykjavík, Iceland, ²Texas Dermatology and Laser Specialists, Texas, TX, ³Center for Clinical Studies, Texas, ⁴Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland, ⁵Hospital Universitario 12 de Octubre, Madrid, Spain, ⁶Departrment of Dermatology and Allergology, University Hospital of Bielefeld, Bielefeld, Germany, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁸Novartis Institutes for Biomedical Research, Basel, Switzerland, ⁹Novartis Pharma AG, Basel, Switzerland, ¹⁰Novartis Institutes of for Biomedical Research, Shanghai, China (People's Republic)
Background/Purpose: The MATURE study investigated administration of 300 mg secukinumab (SEC) using a 2 mL autoinjector (AI) device. The objective of this study was to…
Abstract Number: 0828 • ACR Convergence 2021
Long-Term Safety and Efficacy of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 3 Years from the SELECT-COMPARE Study
Roy Fleischmann¹, Eduardo Mysler², Louis Bessette³, Charles Peterfy⁴, Patrick DUREZ⁵, Yoshiya Tanaka⁶, Jerzy Swierkot⁷, Nasser Khan⁸, Xianwei Bu⁹, Yihan Li⁹ and In-Ho Song⁸, ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²Organización Medica de Investigación, Rheumatology, Buenos Aires, Argentina, ³Centre de l'Ostoporose et de Rhumatologie de Qubec, Québec City, QC, Canada, ⁴Spire Sciences, Inc., Boca Raton, FL, ⁵Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Brussels, Belgium, ⁶University of Occupational and Environmental Health, Kitakyushu, Japan, ⁷Department of Rheumatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland, ⁸AbbVie Inc., North Chicago, IL, ⁹AbbVie Inc., North Chicago
Background/Purpose: In the SELECT-COMPARE study, the Janus kinase inhibitor, upadacitinib (UPA), demonstrated significant improvement in the signs and symptoms of rheumatoid arthritis (RA) when administered…
Abstract Number: 1329 • ACR Convergence 2021
Guselkumab (TREMFYA®) Maintains Resolution of Dactylitis and Enthesitis in Patients with Active Psoriatic Arthritis: Results Through 2 Years from a Phase 3 Study
Proton Rahman¹, Iain McInnes², Atul Deodhar³, Georg Schett⁴, Philip Mease⁵, May Shawi⁶, Daniel Cua⁷, Jonathan Sherlock⁸, Alexa Kollmeier⁹, Xie Xu⁷, Yusang Jiang⁷, Shihong Sheng⁷, Christopher Ritchlin¹⁰ and Dennis McGonagle¹¹, ¹Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ²University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, ³Oregon Health & Science University, Portland, OR, ⁴Universitätsklinikum Erlangen, Department of Internal Medicine 3 – Rheumatology and Immunology, Erlangen, Germany, Erlangen, Germany, ⁵Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁶Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁷Janssen Research & Development, LLC, Spring House, PA, ⁸Janssen Research & Development, LLC and University of Oxford, Spring House, PA, ⁹Janssen Research & Development, LLC, La Jolla, CA, ¹⁰Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ¹¹University of Leeds, Leeds, United Kingdom
Background/Purpose: Guselkumab (GUS), a selective inhibitor of IL-23, significantly improved the diverse manifestations of active psoriatic arthritis (PsA), including dactylitis and enthesitis, in the DISCOVER…

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