Abstracts tagged "clinical trial"

Abstract Number: 1512 • ACR Convergence 2023
Rituximab Objective Outcome Measures Trial in SLE (ROOTS): Randomised and Rescue Therapy Outcomes from a Randomised Controlled Trial
Khaled Mahmoud, Michelle Wilson, Md Yuzaiful Md Yusof, Sarah Brown, Elizabeth Hensor and Ed Vital, University of Leeds, Leeds, United Kingdom
Background/Purpose: New medicines in SLE have not met endpoints in placebo-controlled RCTs when other evidence indicates they are effective. Reasons suggested are inclusion of patients…
Abstract Number: 1991 • ACR Convergence 2023
Therapeutic Efficacy of Intra Articular Injection of Human Bone Marrow Derived Mesenchymal Stem Cells in Knee Osteoarthritis; Randomized, Double-blind, Placebo-controlled Clinical Trial
Ji Won Yang, Bong-Woo Lee, Jennifer Lee and Ji Hyeon Ju, Division of Rheumatology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
Background/Purpose: Osteoarthritis (OA) is severe and intractable musculoskeletal disease that eventually leads to joint failure and pain due to inflammation and joint injury. Mesenchymal stem…
Abstract Number: 2245 • ACR Convergence 2023
Drug Survival of Risankizumab vs Other Biologics After 13 Months of Treatment Among Patients with PsA in the Multicountry Postmarketing Observational VALUE Study
Lars Erik¹, Kim A Papp², Andrew Östör³, Vassilis Stakias⁴, Tshepiso Madihlaba⁴, Ralph Lippe⁵, Ran Liu⁴ and Diamant Thaçi⁶, ¹Bispebjerg-Frederiksberg Hospital, Vedbæk, Denmark, ²Alliance Clinical Research and Probity Medical Research, Waterloo, and University of Toronto, Toronto, ON, Canada, ³Monash University & Emeritus Research; Australian National University, Melbourne, Australia, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, ⁶Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany
Background/Purpose: Risankizumab (RZB) is an optimized IL-23 inhibitor (IL-23i) currently approved for the treatment of plaque psoriasis (PsO), PsA, and Crohn's disease. In a post…
Abstract Number: 2488 • ACR Convergence 2023
Efficacy and Safety of ABBV-599 High Dose (Elsubrutinib 60 mg and Upadacitinib 30 mg) and Upadacitinib Monotherapy for the Treatment of Systemic Lupus Erythematosus: A Phase 2, Double-blind, Placebo-controlled Trial
Joan Merrill¹, Yoshiya Tanaka², David D'Cruz³, Karina Vila-Rivera⁴, Daniel Siri⁵, Xiaofeng Zeng⁶, Kristin D'Silva⁷, Ling Cheng⁷, Thierry Sornasse⁷, Thao Doan⁷, Denise Kruzikas⁷ and Alan Friedman⁷, ¹Oklahoma Medical Research Foundation, Oklahoma City, OK, ²University of Occupational and Environmental Health, Kitakyushu, Japan, ³King's College London, London, United Kingdom, ⁴GCM Medical, San Juan, PR, ⁵CAICI SRL, Rosario, Argentina, ⁶Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, ⁷AbbVie, Inc., North Chicago, IL
Background/Purpose: ABBV-599 is a novel combination of elsubrutinib (ELS; a selective BTK inhibitor) and upadacitinib (UPA; a JAK inhibitor) that targets non-overlapping signaling pathways associated…
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…

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