Abstracts tagged "clinical trial"

Abstract Number: 0443 • ACR Convergence 2023
The Potential of an Oral TNFα Inhibitor with TNFR1 Specificity: Results of a Phase 1b Proof-of-mechanism Trial in Psoriasis
Anna Fishbein¹, Mai Anh Nguyen², Ohn Chow³, Tiago Matos⁴, Caroline Dreis⁵, Hong Zhang³, Marion Poirel⁶, Johann Gassenhuber⁵, Michael Dufault³, Wagner Frank-Dietrich⁷, Laurent Perrin⁸, Markus Rehberg⁵, Markus Kohlmann⁵ and Nassr Nassr⁵, ¹Sanofi, Bridgewater, NJ, ²Sanofi, Berlin, Germany, ³Sanofi, Cambridge, MA, ⁴Sanofi, Amsterdam, Netherlands, ⁵Sanofi, Frankfurt, Germany, ⁶IT&M Stats, Neuilly-sur-Seine, France, ⁷Charité Research Organisation, Berlin, Germany, ⁸Sanofi, Montpellier, France
Background/Purpose: TNFα inhibition is a cornerstone of therapy for rheumatologic disease, yet there is no orally administered TNFα inhibitor available. A novel oral TNFα inhibitor…
Abstract Number: 0775 • ACR Convergence 2023
Effectiveness of Dose Reduction and Withdrawal Strategies of TNF Inhibitors in Psoriatic Arthritis and Axial Spondyloarthritis: Long Term Extension of the DRESS-PS Study
Amy Peeters, C.A.J Michielsens, Elien Mahler, Lise Verhoef, Alfons den Broeder, Nathan den Broeder and Noortje van Herwaarden, Sint Maartenskliniek, Nijmegen, Netherlands
Background/Purpose: Tumor Necrosis Factor inhibitors (TNFi) are effective in PsA and axial SpA, but are associated with increased infections risk, patient burden and high costs.…
Abstract Number: 1124 • ACR Convergence 2023
A Double-blind, Placebo-parallel Controlled Phase III Clinical Study of the Efficacy and Safety of Hemay005 Tablets in Patients with Moderate to Severe Chronic Plaque Psoriasis in China
Charles Jones¹, Jianzhong Zhang², Lihua Wang³, Xunyi Dai⁴, Huimin Wang⁵, Xiadong Bi⁶, Xinsuo Duan⁷, Zudong Meng⁸, Zhongwei Tian⁹, Aie Xu¹⁰, Bin Yang¹¹, Shuping Guo¹², Wei Li¹³, Qingchun Diao¹⁴, Hong Fang¹⁵, Yongjun Liu¹⁶, Juanli Fan¹⁷, Min Yan¹⁸, Sensen Lin¹⁹, Mingfei Zhu²⁰, xianjun Hu²⁰, Jinfeng Lin²⁰ and Mingye Bi²¹, ¹Hemay Pharmaceuticals, Tianjin, China, ²Peking University People’s Hospital, Beijing, China, ³Jinan Central Hospital, Jinan, China, ⁴Wuxi Second People's Hospital, Wuxi, China, ⁵Jinzhong First People's Hospital, Jinzhong, China, ⁶Nanyang First People's Hospital, Nanyang, China, ⁷Chengde Medical College Affiliated Hospital, Chengde, China, ⁸Shiyan City People's Hospital, Shiyan, China, ⁹The First Affiliated Hospital of Xinxiang Medical College, Weihui, China, ¹⁰Hangzhou Third People's Hospital, Hangzhou, China, ¹¹Skin Disease Hospital of Southern Medical University, Guangzhou, China, ¹²The First Hospital of Shanxi Medical University, Taiyuan, China, ¹³West China Hospital of Sichuan University, Chengdu, China, ¹⁴Chongqing Traditional Chinese Medicine Hospital, Chongqing, China, ¹⁵The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China, ¹⁶Qiqihar Traditional Chinese Medicine Hospital, Qiqihar, China, ¹⁷Yuncheng Central Hospital, Yuncheng, China, ¹⁸Shengli Oilfield Central Hospital, Dongying, China, ¹⁹Hangzhou Tigermed, Hangzhou, China, ²⁰Clinical Department, Tianjin Hemay Pharmaceutical Co., Ltd., Tianjin, China, ²¹Wuxi People's Hospital, Wuxi, China
Background/Purpose: Hemay005 is an orally active selective PDE4 inhibitor under clinical development for treating chronic inflammatory diseases. Hemay005 significantly inhibits the activation of T lymphocytes,…
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: 1517 • ACR Convergence 2023
Comparing Deep Neural Network to Modified Rodnan Skin Score in a Trial for Belumosudil in Systemic Sclerosis Patients
Baran Gunes¹, Lucy Duran Camacho¹, Shawn Cowper², Gauri Panse², Elizabeth Bundschuh³, Alyssa Williams⁴, Nicolas Page⁵, Mary Karns⁶, Kathleen Aren⁶, Niki Pradhan⁷, Elana Bernstein⁸, Sarah Fantus⁹, Elizabeth Volkmann¹⁰, Heather Bukiri¹⁰, Chase Correia¹¹, Francis Wilson¹, Seamus Mawe¹², J. Matthew Mahoney¹³, Monique Hinchcliff¹⁴ and Rui Wang¹⁵, ¹Yale University School of Medicine, New Haven, CT, ²Yale School of Medicine - Dermatopathology, New Haven, CT, ³Yale University School of Medicine, New York, NY, ⁴Yale University School of Medicine, Winchester, MA, ⁵Yale University School of Medicine, Salem, CT, ⁶Northwestern University Division of Rheumatology, Chicago, IL, ⁷Columbia University Irving Medical Center, New York, NY, ⁸Division of Rheumatology, Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, ⁹Kansas City Physician Partners- Center for Rheumatic Disease, Kansas City, MO, ¹⁰University of California Los Angeles, Los Angeles, CA, ¹¹Riverside Medical Group, Hampton, VA, ¹²The Jackson Laboratory, Bar Harbor, ME, ¹³Jackson Laboratory, Bar Harbor, ME, ¹⁴Yale School of Medicine, Westport, CT, ¹⁵Sanofi, Cambridge, MA
Background/Purpose: We previously published a proof-of-principle study demonstrating the potential utility of computer vision (Deep Neural Network/DNN) methods applied to stained skin biopsy sections from…
Abstract Number: 1992 • ACR Convergence 2023
Association Between Knee Osteoarthritis Pain and Concomitant Drug Use: A Post-hoc Analysis of Two Phase 3 Clinical Trials
Claire Miller¹, Matthew Baker², Peter Alexandersen³, Alejandro Mondragón¹, Ida Sofie Adrian¹, Morten Karsdal⁴, Jeppe Andersen⁵ and Asger Bihlet¹, ¹NBCD, Soeborg, Denmark, ²Stanford University, Menlo Park, CA, ³Sanos Clinics, Gandrup, Denmark, ⁴Nordic Bioscience, Herlev, Denmark, ⁵Sanos Group, Soeborg, Denmark
Background/Purpose: Patients with knee osteoarthritis are often overweight and suffer from comorbidities, which are frequently treated pharmacologically. Our understanding of the potential disease-modifying and/or symptom-modifying…
Abstract Number: 2249 • ACR Convergence 2023
Bimekizumab-Treated Patients with Active PsA Showed Sustained Improvement in Disease Symptoms Assessed by the PsA Impact of Disease (PsAID)-12 Questionnaire: 1-Year Results Reported from Two Phase 3 Studies
Dafna Gladman¹, Laura Coates², Maarten de Wit³, Alexis R Ogdie⁴, Ana-Maria Orbai⁵, Barbara Ink⁶, Vanessa Taieb⁷, Jérémy Lambert⁸ and Laure Gossec⁹, ¹Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Department of Medicine, University of Toronto, Toronto, ON, Canada, ²University of Oxford, Oxford, United Kingdom, ³Patient Research Partner, Stichting Tools, Amsterdam, Netherlands, ⁴University of Pennsylvania, Philadelphia, PA, ⁵Johns Hopkins University School of Medicine, Division of Rheumatology, Baltimore, MD, ⁶UCB Pharma, Slough, United Kingdom, ⁷UCB Pharma, Colombes, France, ⁸UCB Pharma, Irigny, France, ⁹Sorbonne Université and Pitié Salpêtrière Hospital, Paris, France
Background/Purpose: The PsA Impact of Disease‑12 (PsAID‑12) questionnaire is a patient (pt)-reported outcome measure assessing the impact of PsA on 12 physical, social, and psychological…
Abstract Number: 2490 • ACR Convergence 2023
Safety and Efficacy of Mycophenolate Mofetil in New-onset Systemic Lupus Erythematosus with High Titer of Anti-dsDNA Antibody and Without Major Organ Involvement: A Multicenter Randomized Controlled Trial
Junna Ye¹, Yijun You², Zhuochao Zhou², Jingyi Wu², Fan wang² and Chengde Yang², ¹Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China, ²Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Background/Purpose: Previous clinical trials of mycophenolate mofetil (MMF) in SLE were mainly focused on lupus nephritis (LN) (patients have been diagnosed with LN). In the…
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…
Abstract Number: 0776 • ACR Convergence 2023
Efficacy and Safety of Intravenous Secukinumab for the Treatment of Active Psoriatic Arthritis: 16- and 52-Week Results from a Randomized, Double-Blind, Phase 3 Study
Alan Kivitz¹, Liliana Sedova², Melvin Churchill³, Roshan Kotha⁴, Atul Singhal⁵, Alexander Torres⁶, Guillermo Valenzuela⁷, Sarah Whelan⁸, Thomas Dumortier⁹, Xuan Zhu¹⁰, Ruvie Martin¹⁰ and Luminita Pricop¹⁰, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Institute of Rheumatology, Prague, Czech Republic, ³Arthritis Center of Nebraska, Lincoln, NE, ⁴Sharp Community Medical Group, La Mesa, CA, ⁵Southwest Arthritis Research Group, Mesquite, TX, ⁶Highlands Advanced Rheumatology and Arthritis Center, Avon Park, FL, ⁷Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁸Novartis Ireland Ltd, Dublin, Ireland, ⁹Novartis Pharma AG, Basel, Switzerland, ¹⁰Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: To investigate the long-term efficacy, safety, and tolerability of intravenous (IV) secukinumab (SEC) in patients with active psoriatic arthritis (PsA) through 52 weeks.Methods: INVIGORATE-2…
Abstract Number: 1183 • ACR Convergence 2023
CoLchicine for Treatment of OsteoArthritis of the Knee—Updated Data from a Double-blind, Placebo-controlled Trial
Katherine Tse¹, Roni Meidan², Michael Toprover³, David Wei², Nicole Leung⁴, Maryfe Coronel², Julia Cai², Aryan Jain², maria lessa², Renata La Rocca Vieira², Svetlana Krasnokutsky Samuels², Michael Pillinger⁵ and Jonathan Samuels⁶, ¹NYU Langone, New York, NY, ²NYU Langone Helath, New York, NY, ³New York University Langone Health, New York, NY, ⁴New York University Langone Hospital, New York, NY, ⁵New York University Grossman School of Medicine, New York, NY, ⁶NYU Langone, Rye Brook, NY
Background/Purpose: Knee osteoarthritis (OA) has a probable inflammatory role for IL-1b. The presence of calcium and urate crystals may contribute to OA by activating the…
Abstract Number: 1429 • ACR Convergence 2023
Longitudinal Evaluation of the Novel Psoriatic Arthritis 5-Thermometer Scale (PsA-5Ts) Domains During Treatment with Guselkumab: Pooled Analysis of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies
Carlo Selmi¹, Fausto Salaffi², Sibel Aydin³, Enrique Soriano⁴, Emmanouil Rampakakis⁵, Mohamed Sharaf⁶, Miriam Zimmermann⁷, Frederic Lavie⁸, Peter Nash⁹ and Philip J. Mease¹⁰, ¹Rheumatology and Clinical Immunology, Humanitas Research Hospital / Internal Medicine, Humanitas University, Rozzano, Italy, ²Polytechnic University of Marche, Department of Clinical and Molecular Sciences, Carlo Urbani Hospital, Ancona, Italy, ³Department of Medicine, Ottawa Hospital Riverside Campus, Ottawa, ON, Canada, ⁴Rheumatology Section, Internal Medicine Services, Hospital Italiano de Buenos Aires, and University Institute Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁵McGill University, Department of Pediatrics / JSS Medical Research, Scientific Affairs, Montreal, QC, Canada, ⁶Immunology, Janssen MEA, Dubai, United Arab Emirates, ⁷Immunology, Janssen Medical Affairs, LLC, Zug, Switzerland, ⁸The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France, ⁹School of Medicine, Griffith University, Brisbane, Australia, ¹⁰Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA
Background/Purpose: PsA-5Ts is a simple multidimensional composite measure, assessing pain, fatigue, physical function, skin problems, and depression, recently developed to measure overall health in PsA…
Abstract Number: 1525 • ACR Convergence 2023
Chelation Therapy in the Management of Calcinosis Associated with Systemic Sclerosis
Alison Fernandes, Ashraf El-Meanawy and ME Csuka, Medical College of Wisconsin, Milwaukee, WI
Background/Purpose: Calcinosis is a common complication of systemic sclerosis (SSc), though effective treatment options are limited. Of the several medical therapies that have been employed…
Abstract Number: 2003 • ACR Convergence 2023
Effects of Abaloparatide on Cortical and Trabecular Compartments by 3D-DXA in Men with Osteoporosis
Ruban Dhaliwal¹, John Boxberger², Yamei Wang², Bruce Mitlak², Ludovic Humbert³ and Neil Binkley⁴, ¹Massachusetts General Hospital, Boston, MA, ²Radius Health, Inc., Boston, MA, ³3D-Shaper Medical, Barcelona, Spain, ⁴University of Wisconsin Osteoporosis Clinical Research Program, Madison, WI
Background/Purpose: Abaloparatide (ABL) increases BMD in men with osteoporosis. In the Abaloparatide for the Treatment of Men with Osteoporosis (ATOM) trial, DXA-measured BMD change with…
Abstract Number: 2255 • ACR Convergence 2023
Bimekizumab versus Secukinumab for the Treatment of Nail Psoriasis in Patients with Moderate to Severe Plaque Psoriasis: Results from the BE RADIANT Phase 3b Trial
Kilian Eyerich¹, Alice B. Gottlieb², Stefano Piaserico³, Stefan Beissert⁴, Melinda Gooderham⁵, Brian Kirby⁶, Nicola Tilt⁷, Cynthia Madden⁸, Susanne Wiegratz⁹, Dirk de Cuyper¹⁰, Joseph F. Merola¹¹ and Boni Elewski¹², ¹Department of Dermatology, Medical Center, University of Freiburg, Freiburg, Germany, ²Icahn School of Medicine at Mount Sinai, New York, NY, ³Dermatology Unit, Department of Medicine, Università di Padova, Padova, Italy, ⁴Department of Dermatology, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany, ⁵SKiN Centre for Dermatology, Probity Medical Research, Peterborough, ON, Canada, and Queen’s University, Kingston, ON, Canada, ⁶Elm Park and the Charles Institute, St Vincent's University Hospital, University College Dublin, Dublin, Ireland, ⁷UCB Pharma, Slough, United Kingdom, ⁸UCB Pharma, Morrisville, NC, ⁹UCB Pharma, Monheim am Rhein, Germany, ¹⁰UCB Pharma, Brussels, Belgium, ¹¹Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ¹²Department of Dermatology, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, OH
Background/Purpose: Psoriatic lesions in highly visible areas, including the nails, disproportionately affect patients' health‑related quality of life.[1] Here, we compare the efficacy of bimekizumab (BKZ)…

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