Abstracts tagged "Randomized Trial"

Abstract Number: L16 • ACR Convergence 2023
Withdrawal of Immunosuppressant and Low-dose Steroids in IgG4-RD Patients with Stable Disease (WInS IgG4-RD): An Investigator-initiated, Multi-center, Open-label, Randomized Controlled Trial
Linyi Peng¹, Yuxue nie¹, Jiaxin Zhou¹, Lijun Wu², Fang Wang³, Xiaomei Chen⁴, Jieqiong Li¹, Yu Peng¹, Hui Lu¹, Lidan Zhao¹, Mengtao Li¹, Yan Zhao¹, Xiaofeng Zeng⁵, Yunyun Fei¹ and Wen Zhang¹, ¹Peking Union Medical College Hospital，Department of Rheumatology and Clinical Immunology, National Clinical Research Center for Dermatologic and Immunologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Beijing, China, ²Xinjiang Uygur Autonomous Region People's Hospital, XinJiang, China, ³Beijing Hospital, Beijing, China, ⁴Xinjiang Uygur Autonomous Region People's Hospital, Wulumuqi, China, ⁵Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China
Background/Purpose: IgG4-related disease (IgG4-RD) is a fibroinflammatory disease. Remission induction treatment with glucocorticoid (GC) is usually effective, but its tendency of relapse makes the strategy…
Abstract Number: 0595 • ACR Convergence 2023
Renal Involvement in Patients with Systemic Lupus Erythematosus Treated with Anifrolumab Compared with Placebo over a 4-Year Period
Richard A. Furie¹, Kenneth Kalunian², Eric Morand³, Ian Bruce⁴, Susan Manzi⁵, Gelareh Atefi⁶, Gary Bryant⁶, Micki Hultquist⁷, Raj Tummala⁷, Gabriel Abreu⁸, Catharina Lindholm⁸ and Hussein Al-Mossawi⁹, 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, ⁶BioPharmaceuticals Medical, AstraZeneca, Wilmington, DE, ⁷BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁸BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁹BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom
Background/Purpose: In patients with SLE, nephritis is present in 50%–60% during the first 10 years of disease.1 Renal involvement is associated with poor clinical outcomes…
Abstract Number: 1431 • ACR Convergence 2023
Izokibep, a Unique IL-17A Inhibitor, Improves Patient-Reported Outcomes in Patients with Active Psoriatic Arthritis up to Week 46 – Phase 2 RCT Results
Peter C. Taylor¹, Kurt de Vlam², Philip J. Mease³, Paul M. Peloso⁴, Dieter Wetzel⁵, Apinya Lertratanakul⁶, Nikolai Brun⁷, Brian Wiens⁸, Jan Brandt-Juergens⁹, Edit Drescher¹⁰, Eva Dokoupilova¹¹, Anna Rowińska-Osuch¹², Nadia Abdel-Kader Martin¹³ and Frank Behrens¹⁴, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²University Hospitals Leuven, Leuven, Belgium, ³Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁴ACELYRIN, INC., Naples, FL, ⁵toclinco GmbH, Freiburg im Breisgau, Germany, ⁶ACELYRIN, Chicago, IL, ⁷Affibody AB, Solna, Sweden, ⁸ACELYRIN, Inc., Half Moon Bay, CA, ⁹rheumatologische Schwerpunktpraxis, Berlin, Germany, ¹⁰Csolnoky Ferenc Hospital / Vital Medical Center Private Clinci, Veszprém, Hungary, ¹¹Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology; MEDICAL PLUS sro, Brno, Czech Republic, ¹²ETG Warszawa, Warsaw, Poland, ¹³Hospital Quironsalud Infanta Luisa, Sevilla, Spain, ¹⁴Goethe University, Division of Rheumatology, University Hospital and Fraunhofer Institute for Translational Medicine & Pharmacology, Frankfurt, Germany
Background/Purpose: Izokibep is a novel small protein IL-17A inhibitor, unique for its high IL-17A binding affinity, a small size at 18.6 kD and albumin binding…
Abstract Number: 1988 • ACR Convergence 2023
Extended-Release versus Immediate-Release Triamcinolone Acetonide for Osteoarthritis of the Knee with Comorbid Diabetes Type 2 Diabetes Mellitus: A Post Hoc Analysis
Andrew Spitzer¹, Helena Rodbard², Sheikh Usman Iqbal³, Masato Nakazawa³, Mary DiGiorgi³ and Roy Winston³, ¹Cedars-Sinai Medical Center, Los Angeles, CA, ²Endocrine and Metabolic Consultants, Rockville, MD, ³Pacira BioSciences, Inc., Tampa, FL
Background/Purpose: Intraarticular (IA) corticosteroids are generally considered safe and effective to treat osteoarthritis of the knee (OAK) but may cause hyperglycemia that may last for…
Abstract Number: 2543 • ACR Convergence 2023
Clinical and Radiographic Results of Tapering and Withdrawing CsDMARDs versus Stable Treatment in Patients with Rheumatoid Arthritis in Remission: 3-year Results from a Randomized Controlled Trial
Kaja Eriksrud Kjørholt¹, Nina Paulshus Sundlisæter¹, Anna-Birgitte Aga¹, Joseph Sexton¹, Inge Olsen², Hallvard Fremstad³, Cristina Spada⁴, Tor Magne Madland⁵, Christian A Høili⁶, Gunnstein Bakland⁷, Åse Lexberg⁸, Inger Johanne Widding Hansen⁹, Inger Myrnes Hansen¹⁰, Hilde Haukland¹¹, Maud-Kristine Aga Ljoså¹², Ellen Moholt¹, Till Uhlig¹, Tore Kvien¹, Daniel Solomon¹³, Désirée van der Heijde¹⁴, Espen Haavardsholm¹ and Siri Lillegraven¹, ¹Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway, ²Oslo University Hospital, Oslo, Norway, ³Møre og Romsdal Hospital Trust, Ålesund, Norway, ⁴Lillehammer Hospital for Rheumatic Diseases, Lillehammer, Norway, ⁵Haukeland University Hospital, Bergen, Norway, ⁶Østfold Hospital Trust, Moss, Norway, ⁷University Hospital of North Norway, Tromsø, Norway, ⁸Drammen Hospital, Vestre Viken HF, Drammen, Norway, ⁹Sørlandet Hospital HF, Kristiansand, Norway, ¹⁰Helgeland Hospital Trust Mo i Rana, Mo i Rana, Norway, ¹¹Martina Hansens Hospital, Bærum, Norway, ¹²Ålesund Hospital, Ålesund, Norway, ¹³Brigham and Women's Hospital, Newton, MA, ¹⁴Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Tapering of disease-modifying antirheumatic drugs (DMARDs) to achieve drug-free remission is a potential goal for the growing group of patients with rheumatoid arthritis (RA)…
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…

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