Abstracts tagged "clinical trial"

Abstract Number: 1175 • ACR Convergence 2024
Physical Activity and Symmetry Following Total Knee Arthroplasty:Results of an Exploratory Trial
Kelli Allen¹, Liubov Arbeeva², Daniel Bracey³, Derek Hales³, Carla Hill⁴, Katie Huffman⁵, Todd Schwartz⁶ and Robin Queen⁷, ¹University of North Carolina, Durham, NC, ²University of North Carolina, Chapel Hill, Carrboro, NC, ³University of North Carolina at Chapel HIll, Chapel Hill, NC, ⁴UNC Health, Raleigh, NC, ⁵UNC Thurston Arthritis Research Center, Chapel Hill, NC, ⁶University of North Carolina-Chapel Hill, Chapel Hill, NC, ⁷Virginia Tech, Blacksburg, VA
Background/Purpose: Studies have identified two key deficits in individuals’ activity-related trajectories following total knee arthroplasty (TKA). First, overall physical activity (PA) levels remain very low.…
Abstract Number: 1453 • ACR Convergence 2024
Efficacy and Safety of the Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection (XKH004) in Patients with Active Ankylosing Spondylitis: Findings from a 24-Week, Phase 2 Multicenter, Randomized, Placebo-Controlled Study
Ling Zhou¹, Juan Zhao¹, Lingyun Sun², Xuan Zhang³, Xiaomei Li⁴, Jiankang Hu⁵, Lijun Wu⁶, Zhenyu Jiang⁷, Min Yang⁸, Xiaoxia Wang⁹, Yongjun Mei¹⁰, Qingchun Huang¹¹, Yongtao Chen¹², Yang Li¹³, Lingli Dong¹⁴, Hui Luo¹⁵, Li Guo¹⁶, Jianguo You¹⁶, Yunpeng Zhang¹⁶, Ke Ren¹⁶ and Huji Xu¹, ¹Shanghai Changzheng Hospital, Shanghai, China (People's Republic), ²Nanjing Drum Tower Hospital, Nanjing, China (People's Republic), ³Beijing Hospital, Beijing, China, ⁴The First Affiliated Hospital of University of Science and Technology of China, Anhui, China (People's Republic), ⁵Department of Rheumatology, Pingxiang People's Hospital, Pingxiang, China, Pingxiang, China (People's Republic), ⁶People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China (People's Republic), ⁷The First Hospital of Jilin University, Changchun, China (People's Republic), ⁸Nanfang Hospital, Guangzhou, China (People's Republic), ⁹Second Hospital of Shanxi Medical University, Taiyuan, China (People's Republic), ¹⁰The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, ¹¹The Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China (People's Republic), ¹²West China Hospital, Sichuan University, Chengdu, China (People's Republic), ¹³Guangdong Provincial People's Hospital, Guangzhou, China (People's Republic), ¹⁴Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (People's Republic), ¹⁵Xiangya Hospital, Central South University, Changsha, China (People's Republic), ¹⁶Kanova Biopharma, Zhejiang, China (People's Republic)
Background/Purpose: XKH004, the first recombinant anti-human IL-17A/F humanized monoclonal antibody in China (also known as XKH004), shares the same therapeutic target as Bimekizumab from UCB…
Abstract Number: 1603 • ACR Convergence 2024
Antineutrophil Cytoplasmic Autoantibody Levels in Patients in the Avacopan Phase 3 Trial
Frank B. Cortazar¹, Duvuru Geetha², Salem Almaani³, Christina Song⁴, Tomasz M. Wilmanski⁴, Alana M. Bozeman⁴, Peter Merkel⁵ and David Jayne⁶, and ADVOCATE Study Group, ¹New York Nephrology Vasculitis and Glomerular Center, Saint Peter’s Hospital-Albany, Albany, NY, ²Johns Hopkins University, Baltimore, MD, ³The Ohio State University Medical Center, Columbus, OH, ⁴Amgen Inc., Thousand Oaks, CA, ⁵University of Pennsylvania, Philadelphia, PA, ⁶University of Cambridge, Cambridge, United Kingdom
Background/Purpose: The utility of measuring serial antineutrophil cytoplasmic autoantibody (ANCA) levels to guide treatment in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) is controversial.…
Abstract Number: 2012 • ACR Convergence 2024
Safety, Tolerability and Efficacy of Pegloticase Administered with a Shorter Infusion Duration in Subjects with Uncontrolled Gout Receiving Methotrexate: Primary Findings of the AGILE Open-label Trial
Orrin Troum¹, John Botson², Fang Fang³, Katie Obermeyer³, Supra Verma³ and Brian LaMoreaux⁴, ¹Providence Health Care/Doctor's of St John's (MDSJ) Santa Monica, CA, Santa Monica, CA, ²Orthopedic Physicians Alaska, Anchorage, AK, ³Amgen, Inc., Thousand Oaks, CA, ⁴Amgen, Inc., Deerfield, IL
Background/Purpose: Pegloticase, infused every 2 weeks over ≥2 hrs, lowers serum urate (SU) in patients with refractory gout. Decreasing infusion time is expected to improve…
Abstract Number: 2281 • ACR Convergence 2024
Assessment of Comparative Efficacy Between Candidate Biosimilar AVT05 and Reference Golimumab
Monica Luque¹, Kristina Zhelyazkova¹, Laxmikant Vashishta², Masna Rai³, Abid Sattar⁴, Richard Bucknall⁴, Steffen Leutz³ and FAUSTO BERTI¹, ¹Alvotech, Zürich, Switzerland, ²Alvotech, Bangalore, India, ³Alvotech, Jülich, Germany, ⁴Alvotech, London, United Kingdom
Background/Purpose: Golimumab is a safe and effective treatment for RA. Biosimilars to the reference product (RP) may make treatment more accessible. We assessed comparable efficacy…
Abstract Number: 2482 • ACR Convergence 2024
Long-Term Safety of Mepolizumab in Eosinophilic Granulomatosis with Polyangiitis (EGPA): Pooled Results from Two Open-Label Extension Studies
Gerhard Wolff¹, Michael E Wechsler², Jared Silver³, Robert Price⁴, Rejina Verghis⁵, Peter Weller⁶, Peter Merkel⁷, Thomas Corbridge⁸ and Paneez Khoury⁹, ¹Clinical Development-Respiratory, GSK, Collegeville, ²Department of Medicine, National Jewish Health, Denver, CO, ³US Medical Affairs-Respiratory, GSK, Durham, ⁴Biostatistics, GSK, Stevenage, United Kingdom, ⁵Biostatistics, Development Respiratory, GSK, Brentford, United Kingdom, ⁶Beth Israel Deaconess Medical Center, Department of Medicine, Division of Allergy and Inflammation, Harvard Medical School, Boston, MA, ⁷Division of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, ⁸US Value Evidence and Outcomes, GSK, Durham, NC, ⁹National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD
Background/Purpose: The 52-week Phase III MIRRA trial demonstrated the safety and efficacy of anti-IL-5 mepolizumab in patients with EGPA. However, longer-term safety data are limited.…
Abstract Number: L12 • ACR Convergence 2023
Efficacy and Safety Outcomes of TAK-279, a Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, from a Randomized, Double-blind, Placebo-controlled Phase 2b Trial in Patients with Active Psoriatic Arthritis
Alan Kivitz¹, Elena Tomaselli Muensterman², Arthur Kavanaugh³, Désirée van der Heijde⁴, Piotr A. Klimiuk⁵, Guillermo Valenzuela⁶, Eva Dokoupilova⁷, Gabrielle Poirier⁸, Bhaskar Srivastava⁸, Sue Dasen⁸, Xinyan Zhang⁸, Mona Trivedi², Haoling Holly Weng⁹, Ting Hong¹⁰, Peter Pothula¹⁰ and Xenofon Baraliakos¹¹, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Takeda Development Center Americas, Inc., Cambridge, MA, ³Division of Rheumatology, Allergy & Immunology, University of California San Diego Medical School, San Diego, CA, ⁴Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, ⁵Department of Rheumatology and Internal Diseases, Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Białystok, Poland, ⁶Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁷Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University and MEDICAL PLUS, s.r.o., Brno and Uherské Hradiště, Czech Republic, ⁸Nimbus Discovery, Inc., Boston, MA, ⁹HW MedAdvice LLC, San Diego, CA, ¹⁰Takeda Development Center Americas, Inc., Boston, MA, ¹¹Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum, Germany
Background/Purpose: TYK2 mediates signaling by key cytokines involved in the pathogenesis of immune-mediated inflammatory diseases such as psoriatic arthritis (PsA) and psoriasis (PsO). TAK-279 is…
Abstract Number: L13 • ACR Convergence 2023
An Open-label, Multicenter, Phase 1/2 Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323, a Rapid Manufacturing CAR-T Cell Therapy Targeting CD19 on B Cells, for Severe Refractory Systemic Lupus Erythematosus: Preliminary Results
Josefina Cortés Hernández¹, Pere Barba², Mònica Linares Alberich³, Ozana Fischer⁴, Beata Kovacs⁴, Thomas Calzascia⁴, David Pearson⁴, Ana-Laura Jordán Garrote⁵, Tiina Kirsilä⁴, Richard Siegel⁴, Tamas Shisha⁴, Giulio Cavalli⁴ and Peter Gergely⁴, ¹Vall d'Hebron Institute of Research (VHIR) and Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona, Catalonia, Spain, ²Vall d'Hebron Institute of Oncology and Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona, Catalonia, Spain, ³Banc de Sang i Teixits, Hospital Universitari Vall d'Hebron, Barcelona, Catalonia, Spain, ⁴Novartis Biomedical Research, Basel, Basel-Stadt, Switzerland, ⁵Novartis Farmacéutica, Barcelona, Catalonia, Spain
Background/Purpose: Systemic lupus erythematosus (SLE) is characterized by pathogenic autoreactive B cells producing autoantibodies against multiple self-antigens. Recently, a series of clinical cases suggested that…
Abstract Number: L17 • ACR Convergence 2023
Safety, Tolerability, and Exploratory Efficacy of Afimetoran, a TLR7/8 Inhibitor, in Patients with Cutaneous Lupus Erythematosus: A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study
Fareeda Hosein¹, Stanislav Ignatenko², Kristina Chadwick¹, Lin Zhu¹, Frédéric Baribaud¹, Thanh Bach¹, Hazem Karabeber¹, Michelle Dawes¹, Leon Carayannopoulos¹ and Gopal Krishna¹, ¹Bristol Myers Squibb, Princeton, NJ, ²Charité Research Organisation GmbH, Berlin, Germany
Background/Purpose: Over 50 years have passed since the last therapy was approved for cutaneous lupus erythematosus (CLE).1 Parenteral administration, off-label use, or toxicity with long-term…
Abstract Number: L20 • ACR Convergence 2023
Telitacicept, a Human Recombinant Fusion Protein Targeting and Neutralizing B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), in Rheumatoid Arthritis (RA) Patients with an Inadequate Response to Methotrexate (MTX): A Randomized, Double-Blind, Phase 3 Study
Li Wang¹, Dong Xu², Jianmin Fang³, Qing Zuraw⁴ and Fengchun Zhang¹, ¹Peking Union Medical College Hospital, Beijing, China, ²Peking Union Medical College Hospital, Dong Cheng District, China, ³RemeGen Co, Ltd., Yantai, China, ⁴RemeGen Biosciences, Inc., San Francisco, CA
Background/Purpose: Telitacicept is a recombinant fusion protein targeting and neutralizing BLyS and APRIL. This phase 3, randomized, double-blind study evaluated the efficacy and safety of…
Abstract Number: L04 • ACR Convergence 2023
EP-104IAR (Extended-Release Fluticasone Propionate for Injectable Suspension): Topline and Key Secondary Results from a Phase 2 Randomized, Double-blind, Vehicle-Controlled Trial in Subjects with Knee Osteoarthritis
James Helliwell¹, Amanda Malone¹, Mark Kowalski², Asger Reinstrup Bihlet³, Claire Miller⁴, Alejandro Castillo Mondragon⁵, Yanqi Li⁶, Christine Dobek⁷, Vik Peck¹, Mike Wilmink⁸ and Lee Simon⁹, ¹Eupraxia Pharmaceuticals, Victoria, BC, Canada, ²Eupraxia Pharmaceuticals, Winchester, VA, ³NBCD A/S, Soeborg, Denmark, ⁴NBCD A/S, Copenhagen, Denmark, ⁵NBCD, Copenhagen, Denmark, ⁶NBCD A/S, Soborg, Denmark, ⁷Eupraxia Pharmaceuticals, Edmonton, AB, Canada, ⁸OrthoArizona, Phoenix, AZ, ⁹SDG LLC, Cambridge, MA
Background/Purpose: EP-104IAR is being developed to treat OA symptoms. Previous results from non-clinical studies evaluating local joint safety in beagle dogs, in contrast to other…
Abstract Number: L05 • ACR Convergence 2023
DICKENS: A Multicentre Randomised Controlled Trial of Diacerein for Knee Osteoarthritis with Effusion-Synovitis
Guoqi Cai¹, Graeme Jones², Flavia Cicuttini³, Anita Wluka³, Yuanyuan Wang³, Catherine Hill⁴, Helen Keen⁵, Benny Antony², barbara de Graaff², Michael Thompson², Tania Winzenberg², Kathy Buttigieg², Petr Otahal² and Dawn Aitken², ¹School of Public Health, Anhui Medical University, Hefei, China, ²Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia, ³Monash University, Melbourne, Australia, ⁴The Queen Elizabeth Hospital, University of Adelaide, Adelaide, Australia, ⁵Fiona Stanley Hospital, Murdoch, Australia
Background/Purpose: There is an unmet need for treatments of knee OA. Diacerein is recommended for alleviating pain in OA patients for its anti-inflammatory effect by…
Abstract Number: L08 • ACR Convergence 2023
Early Clinical Development of CIT-013, a First in Class NETosis Inhibitor, in a Randomized Phase I Dose Escalation Study in Healthy Volunteers Demonstrating Potent Inhibition of LPS Induced Neutrophil Extracellular Trap Formation
Leonie Middelink¹, Renato Chirivi², Helmuth van Es², Eric Meldrum², Peter van Zandvoort², Tirza Bruurmijn², Matthijs Moerland³ and Patrick Round², ¹Middelinc., Utrecht, Netherlands, ²Citryll BV, Oss, Netherlands, ³CHDR, Leiden, Netherlands
Background/Purpose: Aberrant Neutrophil Extracellular Traps (NETs) production contributes to the pathophysiology of multiple inflammatory and autoimmune diseases such as Rheumatoid arthritis (RA) Hidradenitis suppurativa (HS),…
Abstract Number: L09 • ACR Convergence 2023
Efficacy and Safety of LNK01001 in Chinese Patients with Moderate to Severe Active Rheumatoid Arthritis with an Inadequate Response to Conventional Synthetic DMARDs: 24-week Results from a Phase 2 Trial
Chanyuan Wu¹, Xuebin Wang², Jiankang Hu³, Xiaofei Shi⁴, Xiaoxia Wang⁵, Xuan Zhang⁶, Ju Liu⁷, Hui Rao⁸, Jianhong Zhao⁹, Rong Du¹⁰, Zhenyu Jiang¹¹, Huaxiang liu¹², Lin Liu¹³, Shengyun Liu¹⁴, Changhao Xie¹⁵, Xiangping Liao¹⁶, Lie Dai¹⁷, Zhiduo Hou¹⁸, Jingchun Jin¹⁹, Tianwang Li²⁰, Deqian Meng²¹, Yongfu Wang²², Jian Wu²³, Jieruo Gu²⁴, Wei Wei²⁵, Yu Zhuang²⁶, Kuanting Wang²⁷, Rong Zhang²⁸, Xiao Zhang²⁹, Huaping Wei³⁰, Zhao-Kui Wan³¹, Jun Wang³¹, Michael Vazquez³², Henry Wu³³ and Xiaofeng Zeng¹, ¹Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China, ²Binzhou Medical University Hospital, Binzhou, China, ³Pingxiang People's Hospital, Pingxiang, China, ⁴The 1st Affiliated Hospital of He'nan University, Luoyang, China, ⁵Second Hospital of Shanxi Medical University, Taiyuan, China, ⁶Beijing Hospital, Beijing, China, ⁷Jiujiang No. 1 People's Hospital, Jiujiang, China, ⁸Hunan Provincial People's Hospital, Changsha, China, ⁹Jining First People's Hospital, Jining, China, ¹⁰Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, ¹¹First Affiliated Hospital of Jilin University, Changchun, China, ¹²Qilu Hospital of Shandong University, Jinan, China, ¹³Central Hospital of Xuzhou City, Xuzhou, China, ¹⁴The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China, ¹⁵The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, ¹⁶Chenzhou First People's Hospital, Binzhou, China, ¹⁷Sun Yat-Sen Memorial Hospital, Guangzhou, China, ¹⁸Shantou University Medical College No.1 Affiliated Hospital, Shantou, China, ¹⁹Yanbian University Affiliated Hospital, Yanbian, China, ²⁰guangdong second provincial general hospital, Guangzhou, China, ²¹Huai'an First People's Hospital, Huaian, China, ²²The First Affiliated Hospital of Baotou Medical College, Baotou, China, ²³The First Affiliated Hospital of Soochow University, Suzhou, China, ²⁴The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, ²⁵Tianjin Medical University General Hospital, Tianjin, China, ²⁶Huizhou Central People's Hospital, Huizhou, China, ²⁷Peking University Shougang Hospital, Beijing, China, ²⁸The First Hospital of China Medial University, Shenyang, China, ²⁹Guangdong Provincial People's Hospital, Guangzhou, China, ³⁰Lynk Pharmaceuticals Co., Ltd., Hangzhou, China, ³¹Lynk Pharma, Hangzhou, China, ³²Lynk Pharma, Saint Louis, MO, ³³Lynk Pharma, Nanjing, China
Background/Purpose: LNK01001 is a selective oral JAK1 inhibitor in clinical development for treating autoimmune and inflammatory diseases, including rheumatoid arthritis (RA). Here, we report the…
Abstract Number: 0372 • ACR Convergence 2023
Efficacy and Safety of Secukinumab in Juvenile Idiopathic Arthritis: Interim Results from the Extension of the JUNIPERA Trial
Hermine Brunner¹, Ivan Foeldvari², Ekaterina Alexeeva³, Nuray Aktay Ayaz⁴, Grant Schulert⁵, Seza Ozen⁶, Artem Popov⁷, Athimalaipet V Ramanan⁸, Christiaan Scott⁹, Betul Sozeri¹⁰, Elena Zholobova¹¹, Sudhanshu Chakraborty¹², Xuan Zhu¹³, Ruvie Martin¹³, Sarah Whelan¹⁴, Sharonjeet Kaur¹⁵, Luminita Pricop¹³, Daniel J Lovell¹⁶, Alberto Martini¹⁷ and Nicolino Ruperto¹⁸, ¹Cincinnati Children's Hospital Medical Center, Division of Rheumatology, Cincinnati, OH, ²Hamburger Zentrum fuer Kinder und Jugendrheumatologie, Rheumatology, Hamburg, Germany, ³National Scientific and Practical Center of Children's Health, Rheumatology, Moscow, Russia, ⁴Department of Pediatric Rheumatology, Faculty of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey, ⁵Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ⁶Hacettepe University Medical Faculty, Ankara, Turkey, ⁷Ural State Medical University Ekaterinburg, Sverdlovsk, Russia, ⁸Bristol Royal Hospital for Children & Translational Health Sciences, University of Bristol, Bristol, United Kingdom, ⁹Department of Paediatric Rheumatology, Red Cross War Memorial Children’s Hospital, University of Cape Town, Cape Town, South Africa, ¹⁰Division of Pediatric Rheumatology, University of Health Sciences, Ümraniye Training and Research Hospital, Istanbul, Turkey, ¹¹First Moscow State Medical University, n.a. I.M.Sechenov, Moscow, Russia, ¹²IQVIA, Durrham, NC, ¹³Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁴Novartis Ireland Ltd, Dublin, Ireland, ¹⁵Novartis Pharma AG, Basel, Switzerland, ¹⁶UC Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, OH, ¹⁷Università di Genova, Genova, Italy, ¹⁸IRCCS Istituto Giannina Gaslini, UOSID Centro Trial, Genova, Italy
Background/Purpose: Secukinumab has demonstrated efficacy and safety in patients with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) categories of juvenile idiopathic arthritis (JIA) for…

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