Abstracts tagged "Randomized Trial"

Abstract Number: 0589 • ACR Convergence 2023
A Comparative Evaluation of IgA2 Anti-dsDNA Antibodies and Clinical Outcome in Two Clinical Trials of Belimumab After Rituximab in SLE
Muhammad RA Shipa¹, Daniel McCluskey¹, Laura Cooney² and Michael Ehrenstein¹, ¹University College London, London, United Kingdom, ²Immune Tolerance Network, Seattle, WA
Background/Purpose: We have shown that serum IgA2 anti-dsDNA antibody levels is a biomarker of response to belimumab after rituximab in SLE (BEAT-lupus trial) (1). We…
Abstract Number: 1426 • ACR Convergence 2023
Distinct Treatment Response Trajectories in Patients with Psoriatic Arthritis Receiving Tofacitinib
Dafna Gladman¹, William R Tillett², David Gruben³, Laura Coates⁴, Stefanie Hahne⁵ and Mikhail Volkov⁶, ¹Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Department of Medicine, University of Toronto, Toronto, ON, Canada, ²Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ³Pfizer Inc., Groton, CT, ⁴University of Oxford, Oxford, United Kingdom, ⁵Pfizer Pharma GmbH, Berlin, Germany, ⁶Pfizer BV, Capelle aan den IJssel, Netherlands
Background/Purpose: PsA is a heterogeneous disease, and identifying clinical phenotypes may assist clinical decision making. Patients (pts) treated with advanced therapies demonstrate varying treatment responses.…
Abstract Number: 1983 • ACR Convergence 2023
Heated Mittens for Patients with Hand Osteoarthritis: A Randomized Trial
Cecilie Bartholdy¹, Anna Døssing², Zara Stisen¹, Sabrina Mai Nielsen³, Henning Bliddal¹, Robin Christensen⁴, Marius Henriksen¹ and Karen Ellegaard¹, ¹The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark, ²The Parker Institutte, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark, ³The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, ⁴Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Denmark
Background/Purpose: Hand Osteoarthritis (OA) is common and causes pain and disability. Heat is anecdotally known to moderate symptoms and is conditionally recommended as a treatment…
Abstract Number: 2519 • ACR Convergence 2023
A Phase II Clinical Study to Investigate the Efficacy and Safety of Hemay005 Tablets in Patients with Active Behçet`sDisease
Charles Jones¹, Zhanguo Li², Zhuoli Zhang³, Jian Wu⁴, Guixiu Shi⁵, Wenjie Zheng⁶, Jianping Tang⁷, Xiaobing Wang⁸, Lie Dai⁹, Lin Chen¹⁰, Yasong Li¹¹, Ling Wu¹², Yongfu Wang¹³, Shengyun Liu¹⁴, Yao Ke¹⁵, Jin Lin¹⁶, Zhenchun Zhang¹⁷, Jiankang Hu¹⁸, Wantai Dang¹⁹, Songlou Yin²⁰, Xin Tang²¹, Mingfei Zhu²², Jinfeng Lin²², Richard Jones²², Weiguo Wan²³ and xianjun Hu²², ¹Hemay Pharmaceuticals, Tianjin, China, ²Peking University Health Science Center, Department of Rheumatology and Immunology, People's Hospital, Beijing, China, ³Peking University First Hospital, Rheumatology and Immunology Department, Beijing, China, ⁴Suzhou University Affiliated First Hospital, Suzhou, China, ⁵the First Affiliated Hospital of Xiamen University, Xiamen, China, ⁶Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Beijing, China, ⁷Shanghai Tongji Hospital, Shanghai, China, ⁸The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, ⁹Department of Rheumatology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China, ¹⁰Jilin Provincial People's Hospital, Changchun, China, ¹¹11Zhejiang Provincial People's Hospital, Hangzhou, China, ¹²University of Hong Kong Shenzhen Hospital, Shenzhen, China, ¹³The First Affiliated Hospital of Baotou Medical College, Baotou, China, ¹⁴The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China, ¹⁵Jiangsu Provincial People's Hospital, Nanjing, China, ¹⁶The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China, ¹⁷Linyi People's Hospital, Linyi, China, ¹⁸Pingxiang People’s Hospital, PingXiang, China, ¹⁹The First Affiliated Hospital of Chengdu Medical College, Chengdu, China, ²⁰Xuzhou Medical University Affiliated Hospital, Xuzhou, China, ²¹Bestudy (Shanghai) Medical Technology Co., Ltd, Shanghai, China, ²²Clinical Department, Tianjin Hemay Pharmaceutical Co., Ltd., Tianjin, China, ²³Huashan Hospital Affiliated to Fudan University, Shanghai, China
Background/Purpose: Behçet's disease (BD) is a chronic and recurrent vascular inflammatory disease with major manifestations including oral ulcers, genital ulcers, skin damage and ophthalmitis, and…
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…

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