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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Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. Academic institutions, private organizations and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part a scientific presentation or presentation of additional new information that will be available at the time of the meeting) is under embargo until Saturday, November 11, 2023.

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