Abstracts tagged "clinical trial"

Abstract Number: 1221 • ACR Convergence 2024
Efficacy of Immersive Virtual Reality-based Biofeedback on Chronic Pain and Daily Life Impact in Fibromyalgia: A Pilot Randomized Controlled Trial
Luca Chittaro¹, Simone Longhino², Marta Serafini¹, Sofia Cacioppo² and Luca Quartuccio³, ¹Human-Computer Interaction Lab, Department of Mathematics, Computer Science and Physics, University of Udine, Udine, Italy, ²Division of Rheumatology, Department of Medicine, University of Udine, UDine, Italy, ³Division of Rheumatology, Department of Medicine (DMED), University of Udine, Udine, Italy, Udine, Italy
Background/Purpose: Fibromyalgia (FM) affects 2% of the global population, causing chronic musculoskeletal pain, fatigue, sleep and mood disorders, significantly impacting quality of life. Although many…
Abstract Number: 1471 • ACR Convergence 2024
Sex-related Differences in Efficacy and Safety Outcomes in Axial Spondyloarthritis Randomized Clinical Trials: A Systematic Literature Review and Meta-analysis
Angel Gao¹, Jordi Pardo Pardo², Steven Dang³, Lianne S Gensler⁴, Philip Mease⁵ and Lihi Eder⁶, ¹Queens University, Kingston, Canada, ²University of Ottawa, Ottawa, Canada, ³Women's College Hospital, Institute of Medical Science, University of Toronto, Toronto, ON, Canada, ⁴Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁵Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ⁶University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada
Background/Purpose: Limited information exists on sex-related differences in axial spondyloarthritis (axSpA) randomized controlled trials (RCTs). Through a systematic literature review and meta-analysis we aimed to assess…
Abstract Number: 1733 • ACR Convergence 2024
Safety and Efficacy of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-MyositisTM and RESET-SLETM Clinical Trials
Saira Sheikh¹, Tahseen Mozaffar², Vimal Derebail¹, Natalie Grover¹, Jonathan Hogan³, Courtney Little³, Yvonne White³, Claire Miller³, Rebecca Estremera³, Jenell Volkov³, Daniel Nunez³, Jason Stadanlick³, Mallorie Werner³, Zachary Vorndran³, Alexandra Ellis³, Jazmean Williams³, Justin Cicarelli³, Quynh Lam³, thomas Furmanak³, Chris Schmitt³, Fatemeh Nezhad³, Dan Thompson³, Samik Basu³ and David Chang³, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²University of California, Irvine, Irvine, CA, ³Cabaletta Bio, Philadelphia, PA
Background/Purpose: CD19 targeting chimeric antigen receptor (CAR) T cells have demonstrated durable drug-free responses and remission in patients with idiopathic inflammatory myopathies (IIM) and systemic…
Abstract Number: 2023 • ACR Convergence 2024
A PEGylated Mammalian Uricase Suitable for Intramuscular Administration to Patients with Refractory Chronic Gout
Frank Fan¹, Riyong Liu¹ and Yu Wang², ¹Chongqing PegBio Biopharm Co.,Ltd., Chongqing, China (People's Republic), ²Hangzhou Grand Biologic Pharmaceutical, Inc., Hangzhou, China (People's Republic)
Background/Purpose: For patients with refractory chronic gout, i.e., those who have frequent gout flares and/or persistent tophi despite treatment with the highest tolerable doses of…
Abstract Number: 2342 • ACR Convergence 2024
Guselkumab Shows Similar Domain-Specific Efficacy in Females and Males with Active Psoriatic Arthritis: Post Hoc Analyses of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies
Lihi Eder¹, Carlo Selmi², Philip Mease³, Alexis Ogdie⁴, Francois Nantel⁵, Frederic Lavie⁶, Mohamed Sharaf⁷, Oyediran Adelakun⁸, Emmanouil Rampakakis⁹, Laura PINA VEGAS¹⁰ and Laura Coates¹¹, ¹University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada, ²IRCCS Istituto Clinico Humanitas, Rozzano, Italy, ³Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ⁴Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁵Nantel MedSci Consult, Montreal, QC, Canada, ⁶Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁷Johnson & Johnson, Middle East FZ LLC, Dubai, UAE, Dubai, United Arab Emirates, ⁸Janssen Research & Development, LLC, Titusville, NJ, ⁹McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, ¹⁰Leiden University Medical Center, Leiden, Netherlands, ¹¹University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom
Background/Purpose: PsA occurs in males and females at similar rates. Females participating in randomized controlled trials (RCTs) have shown lower treatment efficacy based on composite…
Abstract Number: 2578 • ACR Convergence 2024
Safety, Biomarker Response, and Efficacy of E6742, a Dual Antagonist of Toll-Like Receptor 7 and 8, in a First-in-Patient, Randomized, Double-Blind, Phase1/2 Study in Systemic Lupus Erythematosus
Yoshiya Tanaka¹, Atsushi Kumanogoh², Tatsuya Atsumi³, Tomonori Ishii⁴, Fumitoshi Tago⁵, Mari Aoki⁵, Shintaro Yamamuro⁵, Keisuke Sakayori⁵, Kentaro Takahashi⁵ and Shizuo Akira⁶, ¹Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ²Osaka University, Osaka, Japan, ³Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan, Sapporo, Japan, ⁴Tohoku Medical and Pharmaceutical University / Department of Hematology and Rheumatology, sendai, Japan, ⁵Eisai Company, Ltd., Tokyo, Japan, ⁶Osaka University Immunology Frontier Research Center, Osaka, Japan
Background/Purpose: There is strong evidence for the relationship between Toll-like receptor (TLR)7/8 and systemic lupus erythematosus (SLE) pathophysiology. Dual inhibition of TLR7/8 will modulate innate…
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: 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: 0444 • ACR Convergence 2023
Safety, Tolerability, and Pharmacokinetics of a Novel Synthetic Disease Modifying Antirheumatic Drug, TCK-276, After Single Ascending Dose in Healthy Subjects and Multiple Ascending Doses in Patients with Rheumatoid Arthritis
Chie Watai¹, Kazuoki Tsuruda², Yoshinori Tsumura¹ and Daisuke Tasaki¹, ¹Teijin Pharma Limited, Chiyoda City Tokyo, Japan, ²Teijin America, Inc., Sausalito, CA
Background/Purpose: TCK-276 is a highly potent, orally active, and selective cyclin dependent kinase 4/6 (CDK4/6) inhibitor that is in development as a novel synthetic disease…

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