Abstracts tagged "clinical trial"

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: 010 • 2023 Pediatric Rheumatology Symposium
Remotely Delivered Psychological Intervention May Be Beneficial to Youth with Childhood-Onset Lupus: A Preliminary Investigation
Natoshia Cunningham¹, Michelle Adler², Ashley Danguecan³, Mallet Reid², Samantha Ely⁴, Mathew Reeves², Lawrence Ng³, Paris Moaf³, Sarah Mossad³, Tala El Tal³, Luana Flores Pereira³, Deborah Levy³, Linda Hiraki³, Jennifer Stinson³, Sarah Ahola Kohut³, Khalid Abulaban⁵, Elizabeth Kessler⁵, Stacy Allen⁵, Tamar Rubinstein⁶, Evin Rothschild⁶, Natalie Rosenwasser⁷, Kabita Nanda⁷, Susan Canny⁷, Emily Smitherman⁸, Livie Huie⁸, James Birmingham⁹, Allison Thompson¹⁰, Janel Thompson¹⁰, Miranda Moyer¹⁰, Emily Nguyen¹⁰, Angela Chapson¹⁰ and Andrea Knight³, ¹Michigan State University, Grand Rapids, MI, ²Michigan State University, East Lansing, ³The Hospital for Sick Children, Toronto, ON, Canada, ⁴Wayne State University, Michigan State University, Detroit, MI, ⁵Helen DeVos Children's Hospital, Grand Rapids, MI, ⁶Children's Hospital at Montefiore, New York, NY, ⁷Seattle Children's Hospital, Seattle, WA, ⁸University of Alabama at Birmingham, Birmingham, AL, ⁹Metro Health, Cleveland, ¹⁰Patient Co-Investigative Team
Background/Purpose: Childhood-onset systemic lupus erythematosus (cSLE) is associated with fatigue, pain, and depressive symptoms that adversely impact health-related quality of life. The Treatment and Education…
Abstract Number: 126 • 2023 Pediatric Rheumatology Symposium
Facilitating Peer-to-Peer Conversations Around Key Clinical Trial Recruitment Barriers in the Limit-JIA Trial Using Low-Fidelity Video Capture
Melanie Kohlheim¹, Eveline Wu², Laura Schanberg³, Vincent Del Gaizo¹, Catherine Lavallee⁴, Marc Natter⁵, Katie Clem⁶, Brian Shakley⁶ and Kevin Urban⁷, ¹CARRA, Washington, DC, ²UNC Chapel Hill, Chapel Hill, NC, ³Duke University Medical Center, Durham, NC, ⁴Virginia Tech Carilion School of Medicine, ROANOKE, VA, ⁵Boston Children's Hospital, Boston, MA, ⁶LIFT 1428, Llc, Ooltewah, TN, ⁷Business Coaching for Creatives, New York, NY
Background/Purpose: The LIMIT-JIA trial aims to study if early abatacept treatment can prevent disease extension in children with recent-onset, uncomplicated, and oligoarticular or limited JIA.…
Abstract Number: L06 • ACR Convergence 2022
Risk of Extended Major Adverse Cardiovascular Event Endpoints with Tofacitinib vs TNF Inhibitors in Patients with Rheumatoid Arthritis: A Post Hoc Analysis of a Phase 3b/4 Randomized Safety Study
Maya H. Buch¹, Deepak L. Bhatt², Christina Charles-Schoeman³, Jon T. Giles⁴, Ted R. Mikuls⁵, Gary Koch⁶, Steven Ytterberg⁷, Edward Nagy⁸, Hyejin Jo⁹, Kenneth Kwok⁹, Carol A. Connell¹⁰, Karim R. Masri¹¹ and Arne Yndestad¹², ¹Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Division of Cardiovascular Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, ³Division of Rheumatology, Department of Medicine, University of California, Los Angeles, CA, ⁴Division of Rheumatology, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, ⁵Division of Rheumatology, University of Nebraska Medical Center and VA Nebraska-Western Iowa Health Care System, Omaha, NE, ⁶Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁷Division of Rheumatology, Mayo Clinic, Rochester, MN, ⁸Pfizer Ltd, Tadworth, Surrey, United Kingdom, ⁹Pfizer Inc, New York, NY, ¹⁰Pfizer Inc, Groton, CT, ¹¹Pfizer Inc, Collegeville, PA, ¹²Pfizer Inc, Oslo, Norway
Background/Purpose: ORAL Surveillance (NCT02092467; a post-authorization safety study of tofacitinib 5 and 10 mg twice daily [BID] vs TNF inhibitors [TNFi]) found higher risk of…
Abstract Number: L07 • ACR Convergence 2022
Telitacicept, a Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), in Systemic Lupus Erythematosus (SLE): Results of a Phase 3 Study
Di Wu¹, Jing Li¹, Dong Xu¹, Li Wang¹, Jianmin Fang², Dan Ross³ and Fengchun Zhang⁴, ¹Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China, Beijing, China, ²Shanghai Tongji Hospital, Tongji University, Shanghai 200065, China School of Life Science and Technology, Tongji University, Shanghai 200092, China, Shanghai, China, ³RemeGen Co., San Diego, CA, ⁴Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China; Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China, Beijing, China
Background/Purpose: Telitacicept is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor…
Abstract Number: L14 • ACR Convergence 2022
Bimekizumab Maintains Improvements in Efficacy Endpoints and Has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies
Xenofon Baraliakos¹, Atul Deodhar², Désirée van der Heijde³, Marina Magrey⁴, Walter Maksymowych⁵, Tetsuya Tomita⁶, Huji Xu⁷, Marga Oortgiesen⁸, Ute Massow⁹, Carmen Fleurinck¹⁰, Alicia M Ellis⁸, Tom Vaux¹¹, Julie Shepherd-Smith¹¹, Alexander Marten⁹ and Lianne S Gensler¹², ¹Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, ²Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ³Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁴Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, US, Richfield, OH, ⁵Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka City, Osaka City, Osaka, Japan, ⁷Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China (People's Republic), ⁸UCB Pharma, Morrisvile, NC, ⁹UCB Pharma, Monheim am Rhein, Nordrhein-Westfalen, Germany, ¹⁰UCB Pharma, Brussels, Brussels Hoofdstedelijk Gewest, Belgium, ¹¹UCB Pharma, Slough, United Kingdom, ¹²Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL‑17A. In the phase 3 BE MOBILE 1 and 2…
Abstract Number: L02 • ACR Convergence 2022
Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3, Randomized, Placebo-Controlled, Active Reference Study
Christopher Ritchlin¹, Laura Coates², Iain McInnes³, Philip J. Mease⁴, Joseph Merola⁵, Yoshiya Tanaka⁶, Akihiko Asahina⁷, Laure Gossec⁸, Alice Gottlieb⁹, Diamant Thaci¹⁰, Barbara Ink¹¹, Deepak Assudani¹¹, Rajan Bajracharya¹¹, Vish Shende¹¹, Jason Coarse¹² and Robert Landewé¹³, ¹University of Rochester Medical Center, Rochester, NY, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, United Kingdom, ³College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom, ⁴Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁵Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, ⁶University of Occupational and Environmental Health Japan, Kitakyushu, Japan, ⁷Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan, ⁸Sorbonne Universités, UPMC Univ Paris 06, GRC-UPMC 08 (EEMOIS); AP-HP, Hôpital Pitié Salpêtrière, Rheumatology Department, Paris, France, Paris, France, ⁹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ¹⁰Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, ¹¹UCB Pharma, Slough, United Kingdom, ¹²UCB Pharma, Raleigh, NC, ¹³Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, and Zuyderland MC, Heerlen, Netherlands
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. BKZ treatment has demonstrated superior efficacy in joints and…
Abstract Number: 0281 • ACR Convergence 2022
Clinical Outcomes of Filgotinib in Patients with RA Aged ≥65 Years: A Post Hoc Subgroup Analysis of Phase 2 and 3 Clinical Trials and Ongoing Long-Term Extensions
Maya Buch¹, BERNARD COMBE², Jose A Gomez-Puerta³, Roberto Felice Caporali⁴, jacques-eric gottenberg⁵, Paul Van Hoek⁶, Vijay Rajendran⁷, Pieter-Jan Stiers⁶, Katrien Van Beneden⁶, Daniel Aletaha⁸, Gerd Burmester⁹, Rene Westhovens¹⁰ and Yoshiya Tanaka¹¹, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Montpellier University, Montpellier, France, ³Hospital Clínic de Barcelona, Barcelona, Spain, ⁴University of Milan, Milano, Italy, ⁵Strasbourg University Hospital, Strasbourg, France, ⁶Galapagos NV, Mechelen, Belgium, ⁷Galapagos NV, Gent, Belgium, ⁸Medical University Vienna, Wien, Austria, ⁹Charité University Medicine Berlin, Berlin, Germany, ¹⁰University Hospitals Leuven, Leuven, Belgium, ¹¹University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan
Background/Purpose: Filgotinib (FIL) is a Janus kinase 1 preferential inhibitor approved for the treatment of moderate to severe active RA.1 It was previously reported that…
Abstract Number: 0359 • ACR Convergence 2022
Attainment of Remission with Anifrolumab: A Post Hoc Analysis of Pooled TULIP-1 and TULIP-2 Datasets
Ronald Van Vollenhoven¹, Eric F. Morand², Richard A. Furie³, Ian N. Bruce⁴, Gabriel Abreu⁵, Raj Tummala⁶, Hussein Al-Mossawi⁷ and Catharina Lindholm⁸, ¹Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, University of Amsterdam, Amsterdam, Netherlands, ²Monash University, Melbourne, Australia, ³Northwell Health, Great Neck, NY, ⁴The University of Manchester, Manchester, United Kingdom, ⁵AstraZeneca, Mölndal, Sweden, ⁶AstraZeneca, Gaithersburg, MD, ⁷AstraZeneca, Cambridge, United Kingdom, ⁸AstraZeneca, Gothenburg, Sweden
Background/Purpose: In patients with SLE, achieving remission is a treat-to-target goal. Remission is associated with lower rates of hospitalization and damage accrual and better quality…
Abstract Number: 0525 • ACR Convergence 2022
Recovery of Renal Function Among ANCA-Associated Vasculitis Patients with Baseline eGFR ≤20 in the Avacopan ADVOCATE Trial
David Jayne¹, Peter Merkel², Frank Cortazar³, John Niles⁴ and Pirow Bekker⁵, ¹University of Cambridge, Cambridge, United Kingdom, ²U of Pennsylvania, Philadelphia, PA, ³St. Peter's Hospital, Albany, NY, ⁴Harvard, Boston, MA, ⁵ChemoCentryx, San Juan Capistrano, CA
Background/Purpose: In the 330-patient ADVOCATE trial of avacopan for the treatment of ANCA-associated vasculitis, in which 81% of patients with ANCA-associated vasculitis had renal involvement,…

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