Abstracts tagged "Randomized Trial"

Abstract Number: 0597 • ACR Convergence 2023
Efficacy of Anifrolumab in Systemic Lupus Erythematosus by Overall and Organ-Specific SLEDAI-2K Improvements: Results from the Randomized, Placebo-Controlled Phase 3 Long-Term Extension Study
Richard A. Furie¹, Kenneth Kalunian², Eric Morand³, Ian Bruce⁴, Susan Manzi⁵, Yoshiya Tanaka⁶, Kevin Withrop⁷, Ihor Hupka⁸, Micki Hultquist⁹, Raj Tummala⁹, Gabriel Abreu¹⁰, Catharina Lindholm¹⁰ and Hussein Al-Mossawi¹¹, ¹Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ²University of California San Diego, La Jolla, CA, ³Monash University, Centre for Inflammatory Diseases, Melbourne, Australia, ⁴University of Manchester, Manchester, United Kingdom, ⁵Lupus Center of Excellence, Autoimmunity Institute, Allegheny Health Network, Pittsburgh, PA, ⁶University of Occupational and Environmental Health, Kitakyushu, Japan, ⁷Oregon Health & Science University, Schools of Medicine and Public Health,, Portland, OR, ⁸BioPharmaceuticals R&D, AstraZeneca, Warsaw, Poland, ⁹BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ¹⁰BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹¹BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom
Background/Purpose: SLE is a systemic autoimmune disease requiring long-term treatment. In this placebo-controlled phase 3 TULIP long-term extension (LTE) study,1 the impact of anifrolumab in…
Abstract Number: 1432 • ACR Convergence 2023
Experiences and Perspectives of Patients with Psoriatic Arthritis Participating in a Randomized Controlled Trial of Dietary Interventions
Lihi Eder¹, Sanjana Tarannum², Kathleen Bush³, Sarah Cohen⁴, Charlene Compher⁴, Helen Emanoilidis², Sarah Gillespie³, Dafna Gladman⁵, Vinod Chandran⁶, Jose Scher⁷ and Alexis R Ogdie⁴, ¹Women’s College Research Institute, Division of Rheumatology, University of Toronto, Toronto, ON, Canada, ²Women's College Hospital, Toronto, ON, Canada, ³Division of Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, PA, ⁴University of Pennsylvania, Philadelphia, PA, ⁵Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Department of Medicine, University of Toronto, Toronto, ON, Canada, ⁶Schroeder Arthritis Institute, Krembil Research Institute, University Health Network and Division of Rheumatology, Department of Medicine, University of Toronto, Toronto, ON, Canada, ⁷New York University School of Medicine, New York, NY
Background/Purpose: Dietary Interventions in psoriatic arthritis (DIPSA) is a randomized controlled trial (RCT) assessing the efficacy of dietary modifications in patients with psoriatic arthritis (PsA).…
Abstract Number: 1997 • ACR Convergence 2023
A Randomized, Double-blind, Phase III Study to Compare SB16 (Proposed Denosumab Biosimilar) to Reference Denosumab in Patients with Postmenopausal Osteoporosis
Richard Eastell¹, Bente Langdahl², Yoon-Sok Chung³, Rafal Plebanski⁴, Edward Czerwinski⁵, Eva Dokoupilova⁶, Jerzy Supronik⁷, Jan Rosa⁸, Anna Rowińska-Osuch⁹, Ki-Hyun Baek¹⁰, Audrone Urboniene¹¹, Sohui Ahn¹², Younghee Rho¹² and Jisuk Ban¹², ¹University of Sheffield, Sheffield, United Kingdom, ²Aarhus University Hospital, Aarhus, Denmark, ³Ajou University Hospital, Suwon, South Korea, ⁴Klinika Zdrowej Kosci, Łódź, Poland, ⁵Futuremeds, Krakowskie Centrum Medyczne sp z oo, Krakow, Poland, ⁶Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology; MEDICAL PLUS sro, Brno, Czech Republic, ⁷OsteoMedic sc A Racewicz J Supronik, Bialystok, Poland, ⁸Affidea Praha, s.r.o.; Faculty of Medicine in Hradec Kralove, Charles University, Prague; Hradec Kralove, Czech Republic, ⁹ETG Warszawa, Warszawa, Poland, ¹⁰Yeouido ST. Mary's Hospital, Seoul, South Korea, ¹¹JSC Saules seimos medicinos centras, Kaunas, Lithuania, ¹²Samsung Bioepis, Incheon, South Korea
Background/Purpose: SB16 is a human monoclonal antibody to the receptor activator of nuclear factor κΒ ligand that has been developed as a proposed biosimilar to…
Abstract Number: 0623 • ACR Convergence 2023
Nailfold Capillaroscopy in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) Treated with Nintedanib
Vanessa Smith¹, Christopher Denton², Ariane Herrick³, Carina Ittrich⁴, Margarida Alves⁵ and Maurizio Cutolo⁶, ¹Ghent University Hospital, Gent, Belgium, ²University College London, London, United Kingdom, ³University of Manchester, Salford, United Kingdom, ⁴Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany, Biberach an der Riss, Germany, ⁵Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, ⁶Laboratory of Experimental Rheumatology, Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, IRCCS San Martino Polyclinic, Genova, Italy
Background/Purpose: Microvascular damage is part of the pathogenesis of systemic sclerosis and is associated with internal organ involvement. Nintedanib is a tyrosine kinase inhibitor approved…
Abstract Number: 1515 • ACR Convergence 2023
Performance of the Revised CRISS in a Phase 3 Trial of Early Systemic Sclerosis
Dinesh Khanna¹, Christopher Denton², Masataka Kuwana³, Daniel Furst⁴, Suiyuan Huang¹, Barbara White⁵ and Robert Spiera⁶, ¹University of Michigan, Ann Arbor, MI, ²University College London, London, United Kingdom, ³Nippon Medical School Graduate School of Medicine, Tokyo, Japan, ⁴University of California Los Angeles, Los Angeles, CA, ⁵SFJ Pharmaceuticals, Towson, MD, ⁶Hosptial for Special Surgery, New York, NY
Background/Purpose: Revised CRISS has been proposed an approvable outcome measure in early diffuse cutaneous SSc (dcSSc)1. The index is undergoing the FDA review as part…
Abstract Number: 2113 • ACR Convergence 2023
Impact of Sociodemographic Factors on Efficacy and Safety of Tofacitinib in Patients with Rheumatoid Arthritis: A Post Hoc Analysis of Phase 2/3/3b/4 Studies
Grace Wright¹, Eduardo Mysler², Kevin Roberts³, Lindsay Sweet⁴ and Ahmed Shelbaya⁵, ¹Grace C Wright MD PC, New York, NY, ²Organizacion Medica de Investigacion, Buenos Aires, Argentina, ³Pfizer Inc., Cambridge, MA, ⁴Pfizer Inc., Collegeville, PA, ⁵Pfizer Inc., New York, NY
Background/Purpose: Sociodemographic factors can impact treatment response and safety outcomes in patients (pts) with RA. Here, we explore the impact of sociodemographic index (SDI) on…
Abstract Number: 0624 • ACR Convergence 2023
Outcomes in Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) Based on Serological Profiles: Focus on Anti-Centromere Antibody (ACA) and Anti-RNA Polymerase III (ARA) Antibodies
Elizabeth Volkmann¹, Shervin Assassi², Christopher Denton³, Rozeta Simonovska⁴, Steven Sambevski⁵ and Elana Bernstein⁶, ¹University of California Los Angeles, Los Angeles, CA, ²University of Texas McGovern Medical School at Houston, Houston, TX, ³University College London, London, United Kingdom, ⁴Mainanalytics GmbH, Sulzbach (Taunus), Sulzbach, Germany, ⁵Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, ⁶Division of Rheumatology, Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY
Background/Purpose: Autoantibody profiles are associated with organ involvement and outcomes in patients with SSc. Anti-topoisomerase I antibody (ATA) positivity has been associated with a greater…
Abstract Number: 1566 • ACR Convergence 2023
Exposure-Response Analysis of Sarilumab in Patients with Polymyalgia Rheumatica
Christine Xu¹, Ying Liu¹, Jennifer Sloane², Remco Diab³, Hubert van Hoogstraten¹, Hisham Abdallah⁴, Sreeraj Macha¹ and Bhaskar Dasgupta⁵, ¹Sanofi, Bridgewater, NJ, ²Sanofi, Cambridge, MA, ³Sanofi, Rotkreuz, Switzerland, ⁴Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁵Anglia Ruskin University, East Anglia, United Kingdom
Background/Purpose: Sarilumab blocks interleukin-6 (IL-6) from binding to the membrane-bound and soluble IL-6 receptor-α subunit (IL-6Rα). Sarilumab is now approved for both rheumatoid arthritis (RA)…
Abstract Number: 2125 • ACR Convergence 2023
Comparing the ITIS Diet and the Mediterranean Diet in Rheumatoid Arthritis: Preliminary Findings on Clinical and Microbiome Outcomes
Marta Sala Climent¹, Martha Cedeno¹, Roxana Coras², Tiffany Holt¹, Soo-In Choi³, Abha Singh⁴, Katherine Nguyen Nguyen⁵, Susan Lee¹, Simone Zuffa Zuffa¹, Meritxell Agustin-Perez¹, Marta Fernandez-Bustamante¹, Shahrokh Golshan¹, Arthur Kavanaugh⁶ and Monica Guma⁵, ¹University of California San Diego, San Diego, CA, ²Cedars-Sinai Medical Center, Los Angeles, CA, ³University of California San Diego, Alicante, CA, ⁴Department of Medicine, University of California San Diego, La Jolla, CA, ⁵University of California San Diego, La Jolla, CA, ⁶University of California San Diego, School of Medicine, Riverside, CA
Background/Purpose: Rheumatoid arthritis (RA) is a chronic condition characterized by persistent joint inflammation, functional impairment, and disability. Adhering to a Western diet has been associated…
Abstract Number: 0246 • ACR Convergence 2023
Safety & Efficacy of SEL-212 in Patients with Gout Refractory to Conventional Treatment: Primary Outcomes from Two Randomized, Double Blind, Placebo-Controlled, Multicenter Phase 3 Studies
Herbert Baraf¹, Alan Kivitz², Sheri Rhodes³, Sheldon Leung⁴, Olu Folarin⁴, Tania Gonzalez-Rivera⁵, Joanna Sobierska⁵, Jacquie Christie⁵, Anand Patel⁶, Wesley DeHaan⁴, Rehan Azeem⁴ and Peter Traber⁷, ¹The Center for Rheumatology and Bone Research, George Washington University, Rheumatology, Bethesda, MD, ²Altoona Center for Clinical Research, Duncansville, PA, ³Selecta Biosciences, Atlanta, GA, ⁴Selecta Biosciences, Inc., Watertown, MA, ⁵Swedish Orphan Biovitrum (Sobi), Stockholm, Sweden, ⁶Pioneer Research Solutions, Houston, TX, ⁷Selecta Biosciences, Gladwyne, PA
Background/Purpose: In patients with refractory gout, the inability to maintain serum uric acid (sUA) levels < 6 mg/dL leads to severe clinical manifestations for which…
Abstract Number: 0673 • ACR Convergence 2023
Reporting of Race, Ethnicity, Sex, Gender, Socioeconomic Status and Representativeness of Race and Ethnicity in ANCA-associated Vasculitis Randomized Trials
Michele Iudici¹, Juan C. Rueda² and Xavier Puéchal³, ¹Division of Rheumatology, Department of Internal Medicine Specialties, Geneva University Hospitals, Geneva, Switzerland, ²Universidad de La Sabana, Chía, Colombia, Chia, Colombia, ³National Referral Center for Rare Systemic Autoimmune Diseases, Paris, France
Background/Purpose: To assess how and to what extent race, ethnicity, sex, gender and socioeconomic status of participants are reported in ANCA-associated vasculitis (AAV) randomized controlled…
Abstract Number: 1610 • ACR Convergence 2023
Digital Acceptance and Commitment Therapy Improves Fibromyalgia Outcomes: Results from a Pivotal, Multi-center, Randomized Controlled Trial
Michael Gendreau¹, Andrea Chadwick², Lance McCracken³, David Williams⁴, Daniel Clauw⁵, Juan Luciano⁶, Yifei Dai⁷, Nicolette Vega⁸, Zunera Ghalib⁸, Kristen Guthrie⁸, Allison Kraus⁸, Michael Rosenbluth⁸, Jennifer Zomnir⁹, Dana Reddy¹⁰ and Lesley arnold¹¹, ¹Gendreau Consulting, LLC, Poway, CA, ²Department of Anesthesiology, Pain, and Perioperative Medicine, University of Kansas School of Medicine, Kansas City, KS, ³Department of Psychology, Uppsala University, Uppsala, Sweden, ⁴Chronic Pain and Fatigue Research Center, Department of Anesthesiology, University of Michigan, Ann Arbor, MI, ⁵Department of Anesthesiology, University of Michigan, Ann Arbor, MI, ⁶Department of Clinical and Health Psychology, Universitat Autónoma de Barcelona, Barcelona, Spain, ⁷Swing Therapeutics, Gainesville, FL, ⁸Swing Therapeutics, San Francisco, CA, ⁹DelRicht Resesarch, Mckinney, TX, ¹⁰Curavit, Scarsdale, NY, ¹¹Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati, Cincinnati, OH
Background/Purpose: Acceptance and Commitment Therapy (ACT), a form of guideline-recommended Cognitive Behavioral Therapy (CBT), has been empirically validated as a non-drug treatment for fibromyalgia (FM).…
Abstract Number: 2143 • ACR Convergence 2023
Efficacy of Filgotinib in Patients with Rheumatoid Arthritis: Week 156 Results from a Long-term Extension Study
Maya Buch¹, Daniel Aletaha², Roberto F. Caporali³, Bernard G. Combe⁴, Hendrik Schulze-Koops⁵, Jacques-Eric Gottenberg⁶, Yoshiya Tanaka⁷, Ricardo Blanco⁸, Tsutomu Takeuchi⁹, Edmund V. Ekoka Omoruyi¹⁰, Katrien Van Beneden¹¹, Vijay Rajendran¹², Chris Watson¹³, Francesco De Leonardis¹⁴ and Paul Emery¹⁵, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, Wien, Austria, ³Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milano, Italy, ⁴Department of Rheumatology, Montpellier University, Montpellier, France, ⁵Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig-Maximilians–University Munich, Munich, Germany, ⁶Rheumatology Department, Strasbourg University Hospital, Strasbourg, France, ⁷University of Occupational and Environmental Health, Kitakyushu, Japan, ⁸Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain, ⁹Keio University School of Medicine and Saitama Medical University, Tokyo, Japan, ¹⁰Biostatistics, Galapagos NV, Mechelen, Belgium, ¹¹Medical Safety, Galapagos NV, Mechelen, Belgium, ¹²Clinical Research, Galapagos NV, Mechelen, Belgium, ¹³Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹⁴Medical Affairs, Galapagos GmbH, Basel, Switzerland, ¹⁵Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Background/Purpose: In the treatment of RA, JAK inhibitors are a valuable option to meet remission or low disease activity (LDA) treatment targets following an inadequate…
Abstract Number: 0360 • ACR Convergence 2023
Increasing the Etanercept Dose in Juvenile Idiopathic Arthritis Patients: Does It Help Reaching the Treatment Target? A Post-hoc Analysis of the Best4Kids Randomised Clinical Trial
Bastiaan van Dijk¹, Sytske Anne Bergstra¹, Merlijn van den Berg², Dieneke Schonenberg-Meinema², Lisette van Suijlekom-Smit², Marion van Rossum³, Yvonne Koopman⁴, Rebecca Ten Cate¹, CF Allaart¹, Danielle Brinkman¹ and Petra Hissink Muller¹, ¹Leiden University Medical Center, Leiden, Netherlands, ²Emma Children's Hospital, Amsterdam University Medical Centers, Amsterdam, Netherlands, ³Amsterdam Rheumatology and Immunology Center | Reade, Amstelveen, Netherlands, ⁴HagaZiekenhuis Juliana Children's Hospital, The Hague, Netherlands
Background/Purpose: The relation between etanercept dose and clinical outcomes of juvenile idiopathic arthritis (JIA) is unclear. Most studies only evaluated doses up to 0.8 mg/kg/week…
Abstract Number: 0835 • ACR Convergence 2023
Abatacept in Individuals at Risk of Developing Rheumatoid Arthritis: Results from the Arthritis Prevention in the Pre-clinical Phase of RA with Abatacept (APIPPRA) Trial
Andrew Cope¹, Marianna Jasenecova², Joana Vasconcelos³, Andrew Filer⁴, Karim Raza⁵, Sumera Qureshi², Maria Antonietta D'Agostino⁶, Iain McInnes⁷, John Isaacs⁸, Arthur Pratt⁹, Benjamin A Fisher⁴, Christopher Buckley¹⁰, Paul Emery¹¹, Pauline Ho¹², Maya Buch¹³, Coziana Ciurtin¹⁴, René Toes¹⁵, Thomas Huizinga¹⁵, Dirkjan van Schaardenburg¹⁶, Caroline Caroline¹⁷ and Toby Prevost³, ¹King's College London, London, United Kingdom, ²Centre for Rheumatic Diseases, King's College London, London, United Kingdom, ³Nightingale-Saunders Clinical Trials & Epidemiology Unit, King's College London, London, United Kingdom, ⁴University of Birmingham, Birmingham, United Kingdom, ⁵Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom, ⁶Division of Rheumatology - Catholic University of the Sacred Heart, Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy, ⁷University of Glasgow, Glasgow, United Kingdom, ⁸Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom, ⁹Translational & Clinical Research Institute, University of Newcastle, Newcastle, United Kingdom, ¹⁰University of Oxford, Oxford, United Kingdom, ¹¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ¹²Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom, ¹³University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ¹⁴Centre for Rheumatology Research, University College London, London, United Kingdom, ¹⁵Leiden University Medical Center, Leiden, Netherlands, ¹⁶Reade, Amsterdam, Netherlands, ¹⁷King's Clinical Trials Unit, King's College London, London, United Kingdom
Background/Purpose: The definition of higher risk states for rheumatoid arthritis (RA) has been refined in more recent years through inclusion of serum autoantibodies and symptom…

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