Abstracts tagged "clinical trial"

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…
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…
Abstract Number: 1941 • ACR Convergence 2021
The Risk of Venous Thromboembolic Events in Patients with RA Aged ≥ 50 Years with ≥ 1 Cardiovascular Risk Factor: Results from a Phase 3b/4 Randomized Safety Study of Tofacitinib vs TNF Inhibitors
Christina Charles-Schoeman¹, Roy Fleischmann², Eduardo Mysler³, Maria Greenwald⁴, Cunshan Wang⁵, All-shine Chen⁵, Carol A Connell⁵, John C Woolcott⁶, Sujatha Menon⁵, Yan Chen⁷, Kristen Lee⁷ and Zoltan Szekanecz⁸, ¹Department of Medicine, University of California, Los Angeles, Los Angeles, CA, ²Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ³Organización Médica de Investigación, Buenos Aires, Argentina, ⁴Desert Medical Advances, Palm Desert, CA, ⁵Pfizer Inc, Groton, CT, ⁶Pfizer Inc, Collegeville, PA, ⁷Pfizer Inc, New York, NY, ⁸Division of Rheumatology, University of Debrecen, Faculty of Medicine, Debrecen, Hungary
Background/Purpose: ORAL Surveillance (NCT02092467) was a randomized, open-label, non-inferiority, Phase 3b/4 study that assessed the relative risk of major adverse cardiovascular (CV) events (MACE) and…
Abstract Number: 0249 • ACR Convergence 2021
Open-label, Long-term (10-year) Study of the Safety of Etanercept in Children with Extended Oligoarticular Arthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis
Jelena Vojinović¹, Joke Dehoorne², Violeta Panaviene³, Gordana Susic⁴, Gerd Horneff⁵, Valda Stanevicha⁶, Katarzyna Kobusinska⁷, Zbigniew Zuber⁸, Bogna Dobrzyniecka⁹, Jonathan Akikusa¹⁰, Tadej Avcin¹¹, Alberto Martini¹², Cecilia Borlenghi¹³, Edmund Arthur¹⁴, Svitlana Tatulych¹⁵, Chuanbo Zang¹⁶, Bonnie Vlahos¹⁶ and Nicolino Ruperto¹⁷, ¹Paediatric Rheumatology International Trials Organisation (PRINTO), Nis, Serbia, ²Paediatric Rheumatology International Trials Organisation (PRINTO), Gent, Belgium, ³Paediatric Rheumatology International Trials Organisation (PRINTO), Vilnius, Lithuania, ⁴Paediatric Rheumatology International Trials Organisation (PRINTO), Belgrade, Serbia, ⁵Paediatric Rheumatology International Trials Organisation (PRINTO), Sankt Augustin, Germany, ⁶Paediatric Rheumatology International Trials Organisation (PRINTO), Riga, Latvia, ⁷Paediatric Rheumatology International Trials Organisation (PRINTO), Bydgoszcz, Poland, ⁸Paediatric Rheumatology International Trials Organisation (PRINTO), Lodz, Poland, ⁹Paediatric Rheumatology International Trials Organisation (PRINTO), Warsaw, Poland, ¹⁰Paediatric Rheumatology International Trials Organisation (PRINTO), Melbourne, Australia, ¹¹Paediatric Rheumatology International Trials Organisation (PRINTO), Ljubljana, Slovenia, ¹²Paediatric Rheumatology International Trials Organisation (PRINTO), Genoa, Italy, ¹³Pfizer, Buenos Aires, Argentina, Buenos Aires, Argentina, ¹⁴Pfizer, Peapack, NJ, ¹⁵Pfizer, Groton, CT, ¹⁶Pfizer, Collegeville, PA, ¹⁷IRCCS Istituto Giannina Gaslini; PRINTO, Clinica Pediatrica e Reumatologia, Genova, Italy
Background/Purpose: CLIPPER2 was an 8-year, open-label extension of the phase 3b, multicenter, 2-year CLIPPER study of the safety and efficacy of etanercept (ETN) in the…
Abstract Number: 0837 • ACR Convergence 2021
Sustainability of Response Between Upadacitinib and Adalimumab in Patients with Rheumatoid Arthritis: Results Through 3 Years from the SELECT-COMPARE Trial
Peter Nash¹, Arthur Kavanaugh², Maya Buch³, Bernard Combe⁴, Louis Bessette⁵, In-Ho Song⁶, Tim Shaw⁷, Yanna Song⁶, Jessica Suboticki⁶ and Roy Fleischmann⁸, ¹Griffith University, Brisbane, Australia, ²University of California San Diego, La Jolla, CA, ³University of Leeds, Leeds, United Kingdom, ⁴CHU Montpellier Montpellier University, Montpellier, France, ⁵Laval University, Québec City, QC, Canada, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., North Chicago, ⁸Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: The primary treatment target for patients with active rheumatoid arthritis (RA) is sustained clinical remission (REM) or low disease activity (LDA).1,2 A greater proportion…

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