Abstracts tagged "clinical trial"

Abstract Number: 2113 • ACR Convergence 2024
Discontinuation and Non-publication of Postmenopausal Osteoporosis Clinical Studies: A Cross-sectional Analysis of 345,435 Patients
Mohamed Abdelsalam¹, yasmeen Alabdallat², Yousef Hussein³, Mona Sajed⁴, Maryam Taha⁵, Rawan morse⁶, Wessam Selima⁷ and Ahmed Zabady⁸, ¹Rheumatology, Rehabilitation and Physical medicine department - faculty of medicine -Misr University for science and technology, 6th of October, Al Jizah, Egypt, ²Faculty of medicine - Hashemite university, Zarqa, Jordan, ³Faculty of medicine - Benha university, Benha, Egypt, ⁴Faculty of Pharmacy - Al-Azhar university for girls, Mansoura, Ad Daqahliyah, Egypt, ⁵Faculty of medicine - Ain Shams university, Madinat Nasr, Al Qahirah, Egypt, ⁶Medical Research Group of Egypt, Bur sa'id, Egypt, ⁷Anaesethia & pain management department, Faculty of medicine, Ain Shams University, Cairo, Egypt, ⁸Faculty of science - Damanhour university, Cairo, Egypt
Background/Purpose: Postmenopausal osteoporosis (PMOP) significantly contributes to global fracture rates annually, with its silent progression complicating early detection and intervention. Effective management strategies are crucial,…
Abstract Number: 2430 • ACR Convergence 2024
Dapirolizumab Pegol Impacts Important Immunologic Pathways in Systemic Lupus Erythematosus: Pharmacodynamic Analysis of T Cell and Antigen Presenting Cell Pathways from a Phase 2b Trial
Alex S. Powlesland¹, Ioana Cutcutache¹, Andrew Skelton¹, Anthony Shock¹, Matthew Page¹, Eris Bame², Janine Gaiha-Rohrbach², George Stojan³, Ania Skowera¹, Christian Stach⁴ and Thomas Dörner⁵, ¹UCB Pharma, Slough, United Kingdom, ²Biogen Inc., Cambridge, MA, ³UCB Pharma, Atlanta, GA, ⁴UCB Pharma, Monheim am Rheim, Germany, ⁵Department of Medicine, Rheumatology and Clinical Immunology,Charite Universitätsmedizin Berlin, Germany and DRFZ, Berlin, Berlin, Germany
Background/Purpose: CD40-CD40L interactions play a pivotal role in systemic lupus erythematosus (SLE) pathogenesis by orchestrating a range of immune and inflammatory responses involving B cells,…
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: 0271 • ACR Convergence 2023
Successful Treatment of Refractory IgG4-Related Disease with Tofacitinib: Experiences from 7 Patients
Huaqun Zhu, Sumei Tang, Yun Li, Feng Sun, Yuzhou Gan and Hua Ye, Peking University People’s Hospital, Beijing, China
Background/Purpose: Our observational cohort study aimed at assessing the effectiveness and safety of the Janus kinase (JAK) inhibitor tofacitinib in refractory IgG4-Related Disease (IgG4-RD).Methods: Seven…
Abstract Number: 0524 • ACR Convergence 2023
Efficacy of Certolizumab Pegol in Preventing Anterior Uveitis Flares Compared with Standard Non-Biologic Treatment: A Matched Control Study in High-Risk Patients with Axial Spondyloarthritis
Nigil Haroon¹, Zeynep Baskurt², Tina Chim³, Robert Inman⁴, Diana Paez⁵, Thomas Kumke⁶, Rachel Tham⁷, Mindy Kim⁸, Irene van der Horst-Bruinsma⁹ and Lianne Gensler¹⁰, ¹University of Toronto, University Health Network, Schroeder Arthritis Institute, Department of Medicine/Rheumatology, Toronto, ON, Canada, ²Department of Biostatistics, University Health Network, Toronto, ON, Canada, ³University Health Network, Schroeder Arthritis Institute, Department of Rheumatology, Toronto, ON, Canada, ⁴University Health Network, Toronto, ON, Canada, ⁵University of California San Francisco, Department of Medicine/Rheumatology, San Francisco, CA, ⁶UCB Pharma, Monheim am Rhein, Germany, ⁷UCB Pharma, Slough, United Kingdom, ⁸UCB Pharma, Atlanta, GA, ⁹Radboud University Medical Centre, Department of Rheumatology, Nijmegen, Netherlands, ¹⁰University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA
Background/Purpose: Acute anterior uveitis (AAU) is the most common extra-musculoskeletal manifestation in axial spondyloarthritis (axSpA), affecting more than a third of patients. However, long-term interventional…
Abstract Number: 0837 • ACR Convergence 2023
A Randomized, Double-Blind, Sham-Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis
Matthew Baker¹, Sarah Kavanagh², Stanley Cohen³, Alan Matsumoto⁴, Ara Dikranian⁵, John Tesser⁶, Alan Kivitz⁷, Konstantinos Alataris⁸ and Mark Genovese⁹, ¹Stanford University, Menlo Park, CA, ²Kavanagh Statistical Consulting, LLC, Apex, NC, ³Metroplex Clinical Research Center, Dallas, TX, ⁴Arthritis and Rheumatism Associates, Wheaton, MD, ⁵Cabrillo Center for Rheumatic Disease, San Diego, CA, ⁶Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ⁷Altoona Center for Clinical Research, Duncansville, PA, ⁸Nēsos, Menlo Park, CA, ⁹Stanford University, Sunnyvale, CA
Background/Purpose: Vagus nerve stimulation (VNS) has emerged in recent decades as a potential therapy for RA.We have previously shown that auricular VNS produced an average…
Abstract Number: 1326 • ACR Convergence 2023
Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis Refractory to Biologic DMARDs: Results Through Week 204 from the SELECT-CHOICE Study
Andrea Rubbert-Roth¹, Koji Kato², Boulos Haraoui³, Maureen Rischmueller⁴, Yanxi Liu², Nasser Khan⁵, Heidi Camp² and Ricardo Xavier⁶, ¹Cantonal Hospital St. Gallen, St. Gallen, Switzerland, ²AbbVie, Inc., North Chicago, IL, ³Institut de Rhumatologie de Montréal, Montreal, QC, Canada, ⁴The Queen Elizabeth Hospital and Basil Hetzel Institute; Adelaide Medical School, University of Adelaide, Adelaide, Australia, ⁵Pharmacovigilance and Patient Safety, AbbVie, Inc., North Chicago, IL, ⁶Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil
Background/Purpose: To evaluate the long-term safety and efficacy of upadacitinib (UPA), an oral JAK inhibitor, through week 204 in patients with RA from the long-term…
Abstract Number: 1492 • ACR Convergence 2023
Pre-treatment Differentially Expressed Metagenes Characterize Systemic Lupus Patients Who Subsequently Achieve Clinical Response to Belimumab
Miles Smith¹, Kevin Thomas¹, Nicolas Dominguez¹, Susan Macwana¹, Wade DeJager¹, Stan Kamp¹, Carla Guthridge¹, Bridget Parrish¹, Cristina Arriens², Judith James¹, Joan Merrill¹ and Joel Guthridge¹, ¹Oklahoma Medical Research Foundation, Oklahoma City, OK, ²Oklahoma Medical Research Foundation and University of Oklahoma Health Sciences Center, Department of Arthritis & Clinical Immunology, Oklahoma City, OK
Background/Purpose: Belimumab, which targets the B Cell activator and survival factor BLyS, is an approved treatment for systemic lupus (SLE) and has demonstrated efficacy in…

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