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: 1827 • ACR Convergence 2023
Revolutionizing Fibromyalgia Treatment: Exploring the Efficacy of a New FDA Cleared Photoceutical Device
Timothy Demchak¹, Ernesto Leal-Junior², Neide Ribeiro², Heliodora Casalechi², Douglas Johnson³ and Shaiane Tomazoni⁴, ¹Indiana State University, Terre Haute, IN, ²Nove de Julho University, São Paulo, Brazil, ³Multi Radiance Medical, Solon, OH, ⁴University of Bergen, Bergen, Norway
Background/Purpose: Fibromyalgia syndrome effects 2-8% of the general population and is characterized by specific tender points. FM annual economic impact $12-$14 billion.Current treatments are only…
Abstract Number: 2320 • ACR Convergence 2023
Predicting Remission and Low Disease Activity Attainment in Patients with Systemic Lupus Erythematosus
Raffaele Da Mutten¹, Nursen Cetrez², Julius Lindblom², Shereen Oon³, Dionysis Nikolopoulos¹, Mandana Nikpour⁴ and Ioannis Parodis², ¹Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, ²Karolinska Institutet, Stockholm, Sweden, ³St Vincent's Hospital, Fitzroy, Australia, ⁴The University of Melbourne at St. Vincent’s Hospital Melbourne, Departments of Medicine and Rheumatology, Melbourne, Australia
Background/Purpose: Response to therapy in SLE varies significantly and presents a considerable challenge in terms of predictability. Development of predictive models with ability to accurately…
Abstract Number: 0519 • ACR Convergence 2023
Long-Term Safety and Efficacy of Bimekizumab in Patients with Active Ankylosing Spondylitis: 5-Year Results from a Phase 2b Study and Its Open-Label Extension
Atul Deodhar¹, Victoria Navarro-Compán², Denis Poddubnyy³, Lianne Gensler⁴, Sofia Ramiro⁵, Tetsuya Tomita⁶, Helena Marzo-Ortega⁷, Carmen Fleurinck⁸, Thomas Vaux⁹, Ute Massow¹⁰, Désirée van der Heijde⁵ and Xenofon Baraliakos¹¹, ¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ²Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ³Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁴University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ⁵Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka, Japan, ⁷NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁸UCB Pharma, Oosterzele, Belgium, ⁹UCB Pharma, Slough, United Kingdom, ¹⁰UCB Pharma, Monheim am Rhein, Germany, ¹¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Bimekizumab (BKZ), a monoclonal IgG1 antibody, selectively inhibits IL-17F in addition to IL17A. BKZ has demonstrated clinical efficacy and safety up to 3 years…
Abstract Number: 1343 • ACR Convergence 2023
Cardiovascular (CV) and Malignancy Events in the Filgotinib Rheumatoid Arthritis (RA) Clinical Development Program up to 8.3 Years
Xavier Mariette¹, Sven Borchmann², Sandrine Aspeslagh³, Jaime Calvo- Alén⁴, Richard Moriggl⁵, Zoltan Szekanecz⁶, Francesco De Leonardis⁷, Nadia Verbruggen⁸, Paul Van Hoek⁹, Marc Schmalzing¹⁰, Andreas Stallmach¹¹, Christina Charles-Schoeman¹², Vijay Rajendran¹³, Christine Rudolph⁹, Chris Watson¹⁴, Yoshiya Tanaka¹⁵ and Ernest Choy¹⁶, ¹Université Paris-Saclay, Le Kremlin-Bicêtre, France, ²Department of Internal Medicine, University of Cologne, Cologne, Germany, ³Department of Medical Oncology, UZ Brussel, Brussels, Belgium, ⁴Rheumatology, Bioaraba Research Unit, Hospital Universitario Araba, Vitoria, Spain, ⁵Institute of Animal Breeding and Genetics, University of Veterinary Medicine, Vienna, Austria, ⁶Division of Rheumatology, University of Debrecen, Debrecen, Hungary, ⁷Medical Affairs, Galapagos GmbH, Basel, Switzerland, ⁸Biostatistics, Galapagos NV, Mechelen, Belgium, ⁹Medical Safety, Galapagos NV, Mechelen, Belgium, ¹⁰University Hospital, Rheumatology/Clinical Immunology, Department of Internal Medicine II, Würzburg, Germany, ¹¹Department of Internal Medicine, Jena University Hospital, Jena, Germany, ¹²UCLA Medical Center, Santa Monica, CA, ¹³Clinical Research, Galapagos NV, Mechelen, Belgium, ¹⁴Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹⁵University of Occupational and Environmental Health, Kitakyushu, Japan, ¹⁶Section of Rheumatology, Cardiff University, Cardiff, United Kingdom
Background/Purpose: Filgotinib (FIL) is a Janus kinase (JAK) 1 preferential inhibitor for the treatment of RA. Data from the ORAL Surveillance post-marketing study (NCT02092467) suggest…
Abstract Number: 1898 • ACR Convergence 2023
Patient After Visit Instructions at a University Rheumatology Outpatient Clinic: Do They Make a Difference?
Dijo Joseph, Rong Hu, Robert Min, Meenakshi Jolly and Sobia Hassan, Rush University Medical Center, Chicago, IL
Background/Purpose: As low health literacy (HL) has been linked to poor health outcomes in rheumatic diseases, it is important to optimize organizational HL. One way…
Abstract Number: 2334 • ACR Convergence 2023
Remission Attainment in Patients with Systemic Lupus Erythematosus Treated with Anifrolumab Compared with Placebo over a 4-Year Period
Ronald van Vollenhoven¹, Eric Morand², Richard A. Furie³, Kenneth Kalunian⁴, Raj Tummala⁵, Gabriel Abreu⁶, Hussein Al-Mossawi⁷ and Catharina Lindholm⁶, ¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ²Monash University, Centre for Inflammatory Diseases, Melbourne, Australia, ³Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ⁴University of California San Diego, La Jolla, CA, ⁵BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁶BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁷BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom
Background/Purpose: In patients with SLE, remission is an established therapeutic goal associated with reduced damage accrual and flares, and improved health-related quality of life.1 Here,…
Abstract Number: 0530 • ACR Convergence 2023
Impact of Upadacitinib on Wearable Device-Measured Physical Activity in Patients with Ankylosing Spondylitis from the SELECT-AXIS 2 Trial
Jeffrey Curtis¹, Rebecca Grainger², Dan Webster³, Jie Shen⁴, Ana Biljan⁵, Anna Shmagel⁴, Peter Wung⁴ and Philip J. Mease⁶, ¹University of Alabama at Birmingham, Birmingham, AL, ²University of Otago, Wellington, New Zealand, ³AbbVie, Inc., Libertyville, IL, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie, Inc., Buffalo Grove, IL, ⁶Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA
Background/Purpose: Physical activity is associated with reduced pain, improved mobility and physical function in people with ankylosing spondylitis (AS) and plays a crucial role in…
Abstract Number: 1397 • ACR Convergence 2023
Sustainability of Clinical Response at Week 52 to Upadacitinib Among Patients with Axial SpA: Data from the SELECT-AXIS 1 and SELECT-AXIS 2 Trials
Victoria Navarro-Compán¹, Lianne Gensler², Martin Rudwaleit³, Fabiana Ganz⁴, Shirley Chen⁴, Jayne Stigler⁴, Anna Schmagel⁴ and Xenofon Baraliakos⁵, ¹Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ²University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ³University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany, ⁴AbbVie, Inc., North Chicago, IL, ⁵Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Bochum, Germany
Background/Purpose: Upadacitinib 15 mg (UPA), an oral Janus kinase inhibitor, has shown efficacy and tolerability through 14 weeks in patients (pts) with active radiographic axial…
Abstract Number: 1982 • ACR Convergence 2023
Effect of Denosumab on Knee Pain and Bone Marrow Lesions in Symptomatic Knee Osteoarthritis
Terence O'Neill¹, Matthew Parkes¹, Michael Bowes², Richard Hodgson¹ and David Felson³, ¹University of Manchester, Manchester, United Kingdom, ²Imorphics, Manchester, United Kingdom, ³Boston University, Boston, MA
Background/Purpose: There are currently no licensed therapies which reduce progression of knee OA. Current therapies focus on reducing pain, have limited effect, and some have…
Abstract Number: 2487 • ACR Convergence 2023
Phase 2 Safety and Efficacy of Subcutaneous (s.c.) Dose Ianalumab (VAY736; Anti-BAFFR mAb) Administered Monthly over 28 Weeks in Patients with Systemic Lupus Erythematosus (SLE) of Moderate-to-Severe Activity
Nan Shen¹, Stanislav Ignatenko², Alexander Gordienko³, Josefina Cortés Hernández⁴, Nancy Agmon-Levin⁵, Pongthorn Narongroeknawin⁶, Katarzyna Romanowska -Prochnicka⁷, Hana Ciferska⁸, Masanari Kodera⁹, James Cheng-Chung Wei¹⁰, Piotr Leszczynski¹¹, Joung-Liang Lan¹², Eduardo Mysler¹³, Rafal Wojciechowski¹⁴, Tunde Tarr¹⁵, Elena Vishneva¹⁶, Yi-Hsing Chen¹⁷, Yuko Kaneko¹⁸, Stephanie Finzel¹⁹, Alberta Hoi²⁰, Ajchara Koolvisoot²¹, Shin-Seok Lee²², Lie Dai²³, Hiroshi Kaneko²⁴, Bernadette Rojkovich²⁵, Lingyun Sun²⁶, Eugeny Zotkin²⁷, Jean-Francois Viallard²⁸, Masao Katayama²⁹, Berta Paula Magallares-Lopez³⁰, Tirtha Sengupta³¹, Carol Sips³² and Stephen J Oliver³², ¹Shanghai Institute of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University (SJTUSM), Shanghai, China, ²Charité Research Organisation GmbH, Berlin, Germany, ³SM Kirov Military Medical Academy, St. Petersburg, Russia, ⁴Lupus Unit, Rheumatology Department, Vall d’Hebron Hospitals, Barcelona, Spain, ⁵Yabludowicz Center for Autoimmune Disease, Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel, ⁶Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand, ⁷Department of Systemic Connective Tissue Diseases, National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland, ⁸Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ⁹Department of Dermatology, Japan Community Healthcare Organization Chukyo Hospital, Nagoya, Japan, ¹⁰Chung Shan Medical University Hospital, Department of Rheumatology, Taichung, Taiwan, ¹¹Department of Internal Medicine, Poznan University of Medicine Sciences, Poznan, PL, Poznań, Poland, ¹²China Medical University Hospital, Taichung, Taiwan, ¹³Organizacion Medica de Investigacion, Buenos Aires, Argentina, ¹⁴Department of Rheumatology and Systemic Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, Poland, ¹⁵Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary, ¹⁶LLC Family Clinic, Yekaterinburg, RU, Yekaterinburg, Russia, ¹⁷Taichung Veterans General Hospital, Taichung, Taiwan, ¹⁸Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, ¹⁹Department of Rheumatology and Clinical Immunology, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany, ²⁰Monash University, Department of Medicine, Sub-faculty of Clinical and Molecular Medicine, Melbourne, Australia, ²¹Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, ²²Chonnam National University Medical School & Hospital, Gwangju, South Korea, ²³Department of Rheumatology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China, ²⁴Division of Rheumatic Disease, National Center for Global Health and Medicine, Tokyo, Japan, ²⁵Department of Rheumatology and Physiotherapy, Polyclinic of the Hospitaller Brothers of St. John of God, Semmelweis University, Budapest, Hungary, ²⁶Department of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China, ²⁷VA Nasonova Research Institute of Rheumatology, Moscow, Russia, ²⁸CHU de Bordeaux, Hôpital Haut-Lévêque, Pessac, France, ²⁹National Hospital Organization, Nagoya Medical Center, Nagoya, JP, Nagoya, Japan, ³⁰Department of Rheumatology, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain, ³¹Novartis Pharma India, Hyderabad, Hyderabad, India, ³²Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Ianalumab is a novel defucosylated human IgG1 mAb targeting the receptor for B cell Activating Factor belonging to the TNF Family (BAFF-R) providing potent…
Abstract Number: 0582 • ACR Convergence 2023
Evaluation of Anifrolumab Treatment Responses by the Short Form 36 Health Survey Version 2 in SLE: A Post Hoc Analysis of the Placebo-Controlled Phase 3 Long-Term Extension Trial
Vibeke Strand¹, Kenneth Kalunian², Barnabas Desta³, Caroline Seo⁴, Gabriel Abreu⁵, Raj Tummala³, Catharina Lindholm⁵ and Hussein Al-Mossawi⁶, ¹Stanford University, Palo Alto, CA, ²University of California San Diego, La Jolla, CA, ³BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁴BioPharmaceuticals Medical Evidence, AstraZeneca, Gaithersburg, MD, ⁵BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁶BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom
Background/Purpose: SLE is a chronic disease that progressively reduces patients’ health-related quality of life.1 In a post hoc analysis of the TULIP trials, patients with…
Abstract Number: 1423 • ACR Convergence 2023
Impact of Upadacitinib on Enthesitis and Dactylitis by Location in Patients with Psoriatic Arthritis and an Inadequate Response to Biologic DMARDs from the SELECT-PsA 2 Trial
Laura Coates¹, Catherine Bakewell², Majed Khraishi³, Shirley Chen⁴, Tianming Gao⁴, Arathi Setty⁴, Heather Jones⁵, Sandra Ciecinski⁴ and Eduardo Mysler⁶, ¹University of Oxford, Oxford, United Kingdom, ²Intermountain Healthcare Medical Group, Salt Lake City, UT, ³Memorial University of Newfoundland, St. John's, NL, Canada, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie, Inc., Mettawa, IL, ⁶Organización Medica de Investigación, Buenos Aires, Argentina
Background/Purpose: Enthesitis and dactylitis are associated with reduced quality of life and greater impairment in daily activities. In the SELECT-PsA 2 phase 3 trial, the…
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…

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