Abstracts tagged "Randomized Trial"

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: L05 • ACR Convergence 2022
Effect of Denosumab on Structure Modification in Erosive Hand Osteoarthritis: Results of a 48-Week, Monocentric, Randomized, Placebo-controlled, Double-blind Phase 2 Study and Open Label Extension Phase
Ruth Wittoek¹, August Verbruggen², Tine Vanhaverbeke² and Dirk Elewaut³, ¹Dept. of Rheumatology, Ghent University Hospital, Ghent University, Ghent, Oost-Vlaanderen, Belgium, ²Ghent University Hospital, Ghent, Belgium, ³Ghent University and VIB Center for Inflammation Research, Ghent, Belgium
Background/Purpose: Erosive hand osteoarthritis (OA) is a disabling disease with limited therapeutic options. Denosumab, a Receptor Activator of Nuclear Factor kappa-b Ligand inhibitor, affects bone…
Abstract Number: L07 • ACR Convergence 2022
Telitacicept, a Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), in Systemic Lupus Erythematosus (SLE): Results of a Phase 3 Study
Di Wu¹, Jing Li¹, Dong Xu¹, Li Wang¹, Jianmin Fang², Dan Ross³ and Fengchun Zhang⁴, ¹Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China, Beijing, China, ²Shanghai Tongji Hospital, Tongji University, Shanghai 200065, China School of Life Science and Technology, Tongji University, Shanghai 200092, China, Shanghai, China, ³RemeGen Co., San Diego, CA, ⁴Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China; Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China, Beijing, China
Background/Purpose: Telitacicept is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor…
Abstract Number: L14 • ACR Convergence 2022
Bimekizumab Maintains Improvements in Efficacy Endpoints and Has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies
Xenofon Baraliakos¹, Atul Deodhar², Désirée van der Heijde³, Marina Magrey⁴, Walter Maksymowych⁵, Tetsuya Tomita⁶, Huji Xu⁷, Marga Oortgiesen⁸, Ute Massow⁹, Carmen Fleurinck¹⁰, Alicia M Ellis⁸, Tom Vaux¹¹, Julie Shepherd-Smith¹¹, Alexander Marten⁹ and Lianne S Gensler¹², ¹Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, ²Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ³Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁴Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, US, Richfield, OH, ⁵Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka City, Osaka City, Osaka, Japan, ⁷Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China (People's Republic), ⁸UCB Pharma, Morrisvile, NC, ⁹UCB Pharma, Monheim am Rhein, Nordrhein-Westfalen, Germany, ¹⁰UCB Pharma, Brussels, Brussels Hoofdstedelijk Gewest, Belgium, ¹¹UCB Pharma, Slough, United Kingdom, ¹²Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL‑17A. In the phase 3 BE MOBILE 1 and 2…
Abstract Number: L15 • ACR Convergence 2022
Effect of Secukinumab versus Adalimumab Biosimilar on Radiographic Progression in Patients with Radiographic Axial Spondyloarthritis: A Randomized Phase IIIb Study
Xenofon Baraliakos¹, Mikkel Østergaard², Denis Poddubnyy³, Désirée van der Heijde⁴, Atul Deodhar⁵, Pedro M. Machado⁶, Victoria Navarro-Compán⁷, Kay Geert Hermann⁸, Mitsumasa Kishimoto⁹, Eun Young Lee¹⁰, Lianne S Gensler¹¹, Uta Kiltz¹, Marco Eigenmann¹², Patricia Pertel¹³, Aimee Readie¹⁴, Hanno B. Richards¹², Brian Porter¹⁵ and Juergen Braun¹, ¹Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, ²Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, ³Charité - Universitätsmedizin Berlin and German Rheumatism Research Centre, Berlin, Germany, ⁴Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁵Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁶Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, United Kingdom, ⁷Department of Rheumatology, University Hospital La Paz, IdiPaz, Madrid, Spain, ⁸Department of Radiology, University Hospital Charité - Campus Mitte, Charitéplatz, Berlin, Germany, ⁹Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, ¹⁰Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea, ¹¹Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, ¹²Novartis Pharma AG, Basel, Switzerland, ¹³Novartis Pharma AG, Reinach, Switzerland, ¹⁴Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁵Novartis Pharmaceuticals Corporation, Far Hills, NJ
Background/Purpose: Biologics are clinically efficacious in patients (pts) with axial spondyloarthritis (axSpA) including radiographic axSpA (r-axSpA). Limited data exist on the effect of biologics in…
Abstract Number: 0997 • ACR Convergence 2022
Withdrawal of Maintenance Glucocorticoid versus Other Immunosuppressants Among Patients with Systemic Lupus Erythematosus in Long Term Clinical Remission: Interim Analysis of a Non-inferiority Randomised Controlled Trial
Aishwarya Gopal¹, Chengappa Kavadichanda², Devender Bairwa³, Molly Mary Thabah⁴ and Vir Singh Negi⁵, ¹Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, Puducherry, India, ²JIPMER, Pondicherry, Puducherry, India, ³Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, Puducherry, India, ⁴JIPMER, Puducherry, Puducherry, India, ⁵AIIMS Bilaspur, Puducherry, Puducherry, India
Background/Purpose: Attempts to stop glucocorticoids among Systemic Lupus Erythematosus(SLE) patients in long term remission have been successful. Continuing other immunosuppressive (IS) agents indefinitely is currently…

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