Abstracts tagged "clinical trial"

Abstract Number: 2242 • ACR Convergence 2023
Irrespective of the Number of Erosions at Baseline, Patients with Psoriatic Arthritis Treated with Ixekizumab Show Improved Clinical Outcomes
M. Elaine Husni¹, Vinod Chandran², Jeffrey Lisse³, Rebecca Bolce³, Carlos Diaz³, Baojin Zhu³, Elaine Lui⁴ and Laura Coates⁵, ¹Cleveland Clinic / Department of Rheumatic and Immunologic Diseases, Cleveland, OH, ²Schroeder Arthritis Institute, Krembil Research Institute, University Health Network and Division of Rheumatology, Department of Medicine, University of Toronto, Toronto, ON, Canada, ³Eli Lilly and Company, Indianapolis, IN, ⁴Brightech International, An Everest Clinical Research Company, Somerset, NJ, ⁵University of Oxford, Oxford, United Kingdom
Background/Purpose: Psoriatic arthritis (PsA) is a chronic and progressive disease characterized by high rates of early joint erosions, which have been associated with impaired quality…
Abstract Number: 2487 • ACR Convergence 2023
Phase 2 Safety and Efficacy of Subcutaneous (s.c.) Dose Ianalumab (VAY736; Anti-BAFFR mAb) Administered Monthly over 28 Weeks in Patients with Systemic Lupus Erythematosus (SLE) of Moderate-to-Severe Activity
Nan Shen¹, Stanislav Ignatenko², Alexander Gordienko³, Josefina Cortés Hernández⁴, Nancy Agmon-Levin⁵, Pongthorn Narongroeknawin⁶, Katarzyna Romanowska -Prochnicka⁷, Hana Ciferska⁸, Masanari Kodera⁹, James Cheng-Chung Wei¹⁰, Piotr Leszczynski¹¹, Joung-Liang Lan¹², Eduardo Mysler¹³, Rafal Wojciechowski¹⁴, Tunde Tarr¹⁵, Elena Vishneva¹⁶, Yi-Hsing Chen¹⁷, Yuko Kaneko¹⁸, Stephanie Finzel¹⁹, Alberta Hoi²⁰, Ajchara Koolvisoot²¹, Shin-Seok Lee²², Lie Dai²³, Hiroshi Kaneko²⁴, Bernadette Rojkovich²⁵, Lingyun Sun²⁶, Eugeny Zotkin²⁷, Jean-Francois Viallard²⁸, Masao Katayama²⁹, Berta Paula Magallares-Lopez³⁰, Tirtha Sengupta³¹, Carol Sips³² and Stephen J Oliver³², ¹Shanghai Institute of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University (SJTUSM), Shanghai, China, ²Charité Research Organisation GmbH, Berlin, Germany, ³SM Kirov Military Medical Academy, St. Petersburg, Russia, ⁴Lupus Unit, Rheumatology Department, Vall d’Hebron Hospitals, Barcelona, Spain, ⁵Yabludowicz Center for Autoimmune Disease, Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel, ⁶Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand, ⁷Department of Systemic Connective Tissue Diseases, National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland, ⁸Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ⁹Department of Dermatology, Japan Community Healthcare Organization Chukyo Hospital, Nagoya, Japan, ¹⁰Chung Shan Medical University Hospital, Department of Rheumatology, Taichung, Taiwan, ¹¹Department of Internal Medicine, Poznan University of Medicine Sciences, Poznan, PL, Poznań, Poland, ¹²China Medical University Hospital, Taichung, Taiwan, ¹³Organizacion Medica de Investigacion, Buenos Aires, Argentina, ¹⁴Department of Rheumatology and Systemic Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, Poland, ¹⁵Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary, ¹⁶LLC Family Clinic, Yekaterinburg, RU, Yekaterinburg, Russia, ¹⁷Taichung Veterans General Hospital, Taichung, Taiwan, ¹⁸Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, ¹⁹Department of Rheumatology and Clinical Immunology, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany, ²⁰Monash University, Department of Medicine, Sub-faculty of Clinical and Molecular Medicine, Melbourne, Australia, ²¹Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, ²²Chonnam National University Medical School & Hospital, Gwangju, South Korea, ²³Department of Rheumatology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China, ²⁴Division of Rheumatic Disease, National Center for Global Health and Medicine, Tokyo, Japan, ²⁵Department of Rheumatology and Physiotherapy, Polyclinic of the Hospitaller Brothers of St. John of God, Semmelweis University, Budapest, Hungary, ²⁶Department of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China, ²⁷VA Nasonova Research Institute of Rheumatology, Moscow, Russia, ²⁸CHU de Bordeaux, Hôpital Haut-Lévêque, Pessac, France, ²⁹National Hospital Organization, Nagoya Medical Center, Nagoya, JP, Nagoya, Japan, ³⁰Department of Rheumatology, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain, ³¹Novartis Pharma India, Hyderabad, Hyderabad, India, ³²Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Ianalumab is a novel defucosylated human IgG1 mAb targeting the receptor for B cell Activating Factor belonging to the TNF Family (BAFF-R) providing potent…
Abstract Number: 0440 • ACR Convergence 2023
Baseline T Cell and B Cell-related Markers and HLA-DRB1 Shared Epitope Alleles Predict the Therapeutic Efficacy of Abatacept in Patients with Moderate to Severe Rheumatoid Arthritis
Ting Wang¹, Natalia V. Giltiay², Christian Lood² and Bobby Kwanghoon Han², ¹University of Washington, Seattle, WA, ²Division of Rheumatology, University of Washington, Seattle, WA
Background/Purpose: Abatacept, a CTLA-4-Ig fusion protein, is widely used as a treatment for rheumatoid arthritis (RA). However, data on predictive biomarkers associated with therapeutic response…
Abstract Number: 0749 • ACR Convergence 2023
Impact of Sprifermin on Denuded Areas of Subchondral Bone (dABs): A Post Hoc Analysis of the FORWARD Study
Felix Eckstein¹, Wolfgang Wirth², Philip Conaghan³, Marc Hochberg⁴, Ali Guermazi⁵, Jade Andrade⁶, Luping Zhao⁶ and Niti Goel⁷, ¹Paracelsus Medical University, Institute of Anatomy & Ludwig Boltzmann Institute, and Chondrometrics GmbH, Salzburg, Austria, ²Paracelsus Medical University, Institute of Anatomy & Ludwig Boltzmann Institute, and Chondrometrics GmbH, Freilassing, Germany, ³University of Leeds, Leeds, United Kingdom, ⁴University of Maryland School of Medicine, Baltimore, MD, ⁵Boston University, Boston, MA, ⁶TrialSpark, New York, NY, ⁷TrialSpark, Duke University, Durham, NC
Background/Purpose: Sprifermin, recombinant human fibroblast growth factor 18 (rhFGF-18), is being investigated as a potential disease-modifying osteoarthritis drug. The Phase 2 FORWARD study demonstrated that…
Abstract Number: 1112 • ACR Convergence 2023
AR882, a Potent Uricosuric Agent, Shows Favorable Uric Acid Excretion Profile Following Multiple Doses
Zancong Shen¹, Elizabeth Polvent², sarah Morris³, Rongzi Yan⁴, Shunqi Yan⁵, Robert Keenan⁶ and Li-Tain Yeh⁷, ¹Arthrosi Therapeutics, San Diego, CA, ²Arthrosi Therapeutics, Inc., Roseville, CA, ³Arthrosi Therapeutics Inc, San Diego, CA, ⁴Arthrosi Therapeutics, Inc, Irvine, CA, ⁵Arthrosi Therapeutics, Inc., Laguna Hills, CA, ⁶Arthrosi Therapeutics, Chapel Hill, NC, ⁷Arthrosi Therapeutics, Inc., Irvine, CA
Background/Purpose: The uric acid transporter inhibitor (URAT1) is responsible for the reabsorption of filtered uric acid from the renal tubular lumen. Uricosuric agents inhibit URAT1…
Abstract Number: 1422 • ACR Convergence 2023
Long-Term Safety of Risankizumab in Patients with Psoriatic Disease: Integrated Analysis of Psoriasis and Psoriatic Arthritis Clinical Trial Data
Kenneth Gordon¹, Andrew Blauvelt², Herve Bachelez³, Laura Coates⁴, Blair Kaplan⁵, Willem Koetse⁵, Leonidas Drogaris⁵, Ranjeeta Sinvhal⁵ and Kim A Papp⁶, ¹Medical College of Wisconsin, Milwaukee, WI, ²Oregon Medical Research Center, Portland, OR, ³APHP Hopital Saint-Louis, Universite de Paris, Paris, France, ⁴University of Oxford, Oxford, United Kingdom, ⁵AbbVie, Inc., North Chicago, IL, ⁶Alliance Clinical Research and Probity Medical Research, Waterloo, and University of Toronto, Toronto, ON, Canada
Background/Purpose: Risankizumab, an interleukin-23 inhibitor, was efficacious and well tolerated in plaque psoriasis (PsO) and psoriatic arthritis (PsA) clinical trials.The objective of this integrated data…
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…

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