Abstracts tagged "clinical trial"

Abstract Number: 2366 • ACR Convergence 2024
Improvement in Pain-Associated Biomarkers with Deucravacitinib, a First-in-Class, Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Patients with PsA in a Double-Blind Phase 2 Study (IM011-084)
Philip Mease¹, Christopher Ritchlin², Lu Gao³, Peter Schafer⁴, Miroslawa Nowak³, Ian M. Catlett³ and Jinqi Liu³, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²Department of Medicine, Allergy, Immunology, and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, ³Bristol Myers Squibb, Princeton, NJ, ⁴Bristol Myers Squibb, BELLE MEAD, NJ
Background/Purpose: Pain is a core domain of PsA, and reduction of pain is a primary treatment concern for patients with PsA. Pain has been reported…
Abstract Number: 2611 • ACR Convergence 2024
Continuation versus Temporary Interruption of Immunomodulatory Agents in Case of an Infection in IRD Patients: Results of a Randomized Controlled Trial
Merel Opdam¹, Nathan den Broeder², Reinout van Crevel³, Lisa Schapink⁴, Léon Raijmakers⁴, Jasper Broen⁵, Lise Verhoef⁴ and Alfons den Broeder¹, ¹Sint Maartenskliniek, Ubbergen, Netherlands, ²Sint Maartenskliniek, Ubbergen, Gelderland, Netherlands, ³Radboudumc, Nijmegen, Netherlands, ⁴Sint Maartenskliniek, Nijmegen, Netherlands, ⁵Máxima Medical Centre, Eindhoven, Netherlands
Background/Purpose: Immunomodulatory agents (IA) are widely used for the treatment of inflammatory rheumatic diseases (IRDs). Although IA are safe and effective, management of infections and infection…
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: 0480 • ACR Convergence 2023
Non-random Sampling in Rheumatology Randomized Controlled Trials: Evidence of Concerning Trial Conduct?
Victoria Le¹, Mats Junek², Mike Putman³, Maximilian Casey¹, Kenrick Manswell¹, Jay Goldsher¹, Elizabeth Nettleton¹, Desh Nepal¹ and Sanket Shah¹, ¹Medical College of Wisconsin, Milwaukee, WI, ²McMaster University, Hamilton, ON, Canada, ³Division of Rheumatology, Medical College of Wisconsin, Milwaukee, WI
Background/Purpose: Non-random sampling of baseline variables in randomized controlled trials (RCTs) may be due unintentional errors, stratified randomization strategies, or data fabrication. Prior studies have…
Abstract Number: 0818 • ACR Convergence 2023
Efficacy of XT-150, a Novel Non-Viral Gene Therapy Delivering IL-10v, on Moderate to Severe Pain Due to Osteoarthritis of the Knee: Results of a Phase 2 Trial
Eric Grigsby¹, Stephen D. Collins², Leonard Kapural³, Mark McBride⁴, Jayson Rieger⁵, Morgan Stokes⁶, Howard Rutman⁶ and Flavia Cicuttini⁷, ¹Neurovations Clinical Research, Napa, CA, ²Xalud Therapeutics, Inc., Chicago, IL, ³Center for Clinical Research, Winston-Salem, NC, ⁴Instat Clinical Research, Chatham, NJ, ⁵PBM Capital, Charlottesville, VA, ⁶Xalud Therapeutics, Inc., Berkeley, CA, ⁷Monash University, Melbourne, Australia
Background/Purpose: Interleukin (IL)-10 is a regulator of cytokine activity and has the potential to restore homeostasis in osteoarthritis (OA) of the knee. Unfortunately, relatively short…
Abstract Number: 1314 • ACR Convergence 2023
Safety Results from a Phase 1 Double-blind Randomized Clinical Trial of Allogeneic Mesenchymal Stem Cells in Early RA
Nora Singer¹, Maya Breitman², Maricela Haghiac², Larraine Gordesky³, Jane Reese⁴, Steven Lewis², Emma Barnboym², Noor Hussein⁵, Susan Lasalvia⁶, Elizabeth Mellins⁷, Tracey Bonfield⁸, Donald Anthony⁹, Arnold Caplan¹⁰ and Hillard Lazarus⁸, ¹The MetroHealth System at Case Western Reserve University School of Medicine, Cleveland, OH, ²The MetroHealth System at CWRU, Cleveland, OH, ³The MetroHealth System at CWRU and Louis Stokes Cleveland VA, Cleveland, OH, ⁴CWRU, University Hospitals of Cleveland, Cleveland, OH, ⁵Stanford University, Palo Alta, CA, ⁶The MetroHealth System, Cleveland, OH, ⁷Stanford University, Stanford, CA, ⁸CWRU and University Hospitals of Cleveland, Cleveland, OH, ⁹Case Western Reserve University, Cleveland VA Medical Center, The MetroHealth System, Cleveland, OH, ¹⁰CWRU, Center for Skeletal Biology, Cleveland, OH
Background/Purpose: The purpose of this study was to evaluate the safety of bone-marrow derived allogeneic mesenchymal stem cells (MSCs) as therapeutic agents in early rheumatoid…
Abstract Number: 1436 • ACR Convergence 2023
Secukinumab Demonstrates a Consistent Safety Profile in Patients with Psoriasis, Psoriatic Arthritis and Axial Spondyloarthritis: Updated Pooled Safety Analysis from Clinical Trials
Atul Deodhar¹, Iain McInnes², Xenofon Baraliakos³, Alice B. Gottlieb⁴, Uta Kiltz⁵, Stefan Schreiber⁶, Braja Gopal Sahoo⁷, Weibin Bao⁸, Hanno Richards⁹, Luminita Pricop¹⁰, Corine Gaillez¹¹, Victor Dong¹⁰ and Philip J. Mease¹², ¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ²University of Glasgow, Glasgow, United Kingdom, ³Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁴Icahn School of Medicine at Mount Sinai, New York, NY, ⁵Rheumazentrum Ruhrgebiet, Herne, Germany, ⁶University Hospital Schleswig-Holstein, Kiel, Germany, ⁷Novartis Healthcare Pvt, Hyderabad, India, ⁸Novartis Pharmaceuticals Corporation, Hanover, NJ, ⁹Novartis Pharma AG, Basel, Switzerland, ¹⁰Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹¹Novartis Pharma AG, Croissy Sur Seine, France, ¹²Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA
Background/Purpose: Pooled safety data have been reported for secukinumab administration in patients with psoriasis (PsO), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA).1,2 The aim of…
Abstract Number: 1652 • ACR Convergence 2023
Lupus Research Action Network: Increasing Minority Clinical Trial Participation Through Peer Leaders
Melicent Miller¹, Stephanie Slan¹, Rosalind Ramsey-Goldman², Rodlescia Sneed³, Candace Feldman⁴, Patrick Wildman¹, Tori Justin⁵, Lydia Oberholtzer⁵ and Joy Buie⁶, ¹Lupus Foundation of America, Washington, DC, ²Northwestern University, Chicago, IL, ³Wayne State University, Detroit, MI, ⁴Brigham and Women's Hospital, Boston, MA, ⁵Sharp Insight, LLC, Montgomery County, MD, ⁶Lupus Foundation of America, York, SC
Background/Purpose: Black/African American people with lupus (PWL) experience greater disease prevalence and severity than White PWL. The need for more racial and ethnic diversity amongst…

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