Abstracts tagged "clinical trial"

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…
Abstract Number: 1330 • ACR Convergence 2021
Effect of Guselkumab (TREMFYA®), a Selective IL-23p19 Inhibitor, on Axial-Related Endpoints in Patients with Active PsA: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study Through 2 Years
Philip Mease¹, Philip S Helliwell², Dafna Gladman³, Denis Poddubnyy⁴, Xenofon Baraliakos⁵, Soumya Chakravarty⁶, Alexa Kollmeier⁷, Xie Xu⁸, Shihong Sheng⁸, Stephen Xu⁸, May Shawi⁹, Désirée van der Heijde¹⁰ and Atul Deodhar¹¹, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ⁴Department of Rheumatology, Charité – Universitätsmedizin, Berlin, Germany, ⁵Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, ⁶Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁷Janssen Research & Development, LLC, La Jolla, CA, ⁸Janssen Research & Development, LLC, Spring House, PA, ⁹Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ¹⁰Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, ¹¹Oregon Health & Science University, Portland, OR
Background/Purpose: Guselkumab (GUS), a selective IL-23p19 inhibitor, resulted in greater mean improvements in BASDAI scores vs placebo (PBO) at W24 among patients (pts) with active…
Abstract Number: 1585 • ACR Convergence 2021
Suprascapular Nerve Block for the Treatment of Adhesive Capsulitis
Ernst Shanahan¹, Elizabeth Briggs¹, Tiffany Gill², Catherine Hill³ and Tim Morris⁴, ¹SA Health, Adelaide, Australia, ²University of Adelaide, Adelaide, Australia, ³Queen Elizabeth Hospital, Woodville, Australia, ⁴Flinders University, Adelaide, Australia
Background/Purpose: To investigate the value of suprascapular nerve block (SSNB) as a treatment option for adhesive capsulitis.Methods: Patients with adhesive capsulitis confirmed by a rheumatologist…
Abstract Number: 1739 • ACR Convergence 2021
SLE Treatment History and Anifrolumab Efficacy by Baseline Standard Therapies in Patients with SLE from 2 Phase 3 Trials
Susan Manzi¹, Richard Furie², Eric Morand³, Yoshiya Tanaka⁴, Gabriel Abreu⁵, Catharina Lindholm⁵ and Raj Tummala⁶, ¹Allegheny Health Network, Pittsurgh, PA, ²Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ³Monash University, Melbourne, Australia, ⁴University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁶BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD
Background/Purpose: In the phase 3 TULIP-1 and TULIP-2 trials, anifrolumab, a type I IFN receptor mAb, improved disease activity versus placebo in patients with moderate…
Abstract Number: 1801 • ACR Convergence 2021
The Effect of Ixekizumab versus Adalimumab on Individual Components of the ACR Composite Score, with and Without Concomitant Methotrexate or Other Conventional Synthetic DMARDs at 52 Weeks in Patients with Psoriatic Arthritis
Elaine Husni¹, Sona Kamat², Keri Stenger³, Rebecca Bolce³, Thorsten Holzkaemper⁴, Cameron Helt³, So Young Park³, Jeffrey Lisse⁵ and Luca Idolazzi⁶, ¹Cleveland Clinic, Cleveland, OH, ²St Louis University, Saint Louis, MO, ³Eli Lilly and Company, Indianapolis, IN, ⁴Eli Lilly and Company, Bad Homburg, Germany, ⁵Eli Lilly and Company, Tucson, AZ, ⁶University of Verona, Verona, Italy
Background/Purpose: It is important to understand how to select among the multiple treatment options for active psoriatic arthritis (PsA). Since individual patient domains may influence…
Abstract Number: 0411 • ACR Convergence 2021
Pharmacokinetics, Safety, and Efficacy of Subcutaneous Brodalumab for Systemic Sclerosis with Moderate-to-severe Skin Thickening: A Single-arm, Open-label, Multi-dose, Phase 1 Trial
Takemichi Fukasawa¹, Ayumi Yoshizaki², Satoshi Ebata² and Shinichi Sato², ¹Department of Dermatology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan, ²University of Tokyo Graduate School of Medicine, Tokyo, Japan
Background/Purpose: The exact role of interleukin-17 in systemic sclerosis (SSc) has not been established. This trial assessed the pharmacokinetics (PK), safety, and efficacy of multiple…

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