Abstracts tagged "clinical trial"

Abstract Number: 0403 • ACR Convergence 2022
Efficacy and Safety of Ixekizumab in Chinese Patients with Radiographic Axial Spondyloarthritis: 16-Week Results from a Phase 3 Study
Yu Xue¹, Jiankang Hu², Dongzhou Liu³, Jingyang Li⁴, Huaxiang Wu⁵, Chunyu Tan⁶, Lie Dai⁷, Mengru Liu⁸, Hongying Li⁸ and Hejian Zou¹, ¹Huashan Hospital affiliated to Fudan University, Shanghai, China, ²Jiangxi Pingxiang People’s Hospital, Shanghai, China, ³Shenzhen People’s Hospital （The Second Clinical Medical College of Jinan University）, Shanghai, China, ⁴Zhuzhou Central Hospital, Shanghai, China, ⁵The Second Affiliated Hospital Zhejiang University School of Medicine, Shanghai, China, ⁶West China Hospital of Sichuan University, Shanghai, China, ⁷Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Shanghai, China, ⁸Eli Lilly and Company, Shanghai, China
Background/Purpose: Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, has demonstrated efficacy in global clinical trials in patients with radiographic axial spondyloarthritis (r-axSpA)/ankylosing spondylitis…
Abstract Number: 0890 • ACR Convergence 2022
Long Term Efficacy of a 2-year MRI Treat-to-target Treatment Strategy on Disease Activity, MRI Inflammation and Physical Function in Rheumatoid Arthritis Patients in Clinical Remission: Five Year Follow-up of the IMAGINE-RA Cohort
Signe Møller-Bisgaard¹, Kim Hørslev-Petersen², Daniel Glinatsi³, Bo Ejbjerg⁴, Merete Lund Hetland⁵, Jakob Møllenbach Møller⁶, Robin Christensen⁷, Sabrina Mai Nielsen⁸, Mikael Boesen⁹, Kristian Stengaard-Pedersen¹⁰, Ole Rintek Madsen¹¹, Bente Jensen¹², Jan Alexander Villadsen¹³, Ellen Margrethe Hauge¹⁰, Oliver Hendricks², Hanne Merete Lindegaard¹⁴, Niels Steen Krogh¹⁵, Anne Grethe Jurik¹⁶, Henrik Thomsen¹⁷ and Mikkel Østergaard¹⁸, ¹Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, ²Department of Rheumatology, Danish Hospital for Rheumatic Diseases, Sønderborg, Denmark, ³Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, ⁴Department of Rheumatology, Slagelse Hospital, Slagelse, Denmark, ⁵Copenhagen University Hospital - Rigshospitalet, Glostrup, Denmark, ⁶Department of Radiology, Herlev-Gentofte Hospital, Copenhagen, Denmark, ⁷Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Denmark, ⁸The Parker Institute, Section for Biostatistics and Evidence-Based Research, Bispebjerg-Frederiksberg Hospital, Frederiksberg, Denmark, ⁹Department of Radiology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark, ¹⁰Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark, ¹¹Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Herlev-Gentofte, Copenhagen, Denmark, ¹²Center for Rheumatology and Spine Diseases, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark, ¹³Department of Rheumatology, Silkeborg Hospital, Silkeborg, Denmark, ¹⁴Department of Rheumatology, Odense University Hospital, Odense, Denmark, ¹⁵ZiteLab ApS, Frederiksberg, Denmark, ¹⁶Department of Radiology, Aarhus University Hospital, Aarhus, Denmark, ¹⁷Department of Radiology, Herlev and Gentofte Hospital, Copenhagen, Denmark, ¹⁸Rigshospitalet, University of Copenhagen, Glostrup, Denmark
Background/Purpose: Targeting MRI remission in rheumatoid arthritis (RA) patients in clinical remission may improve long term clinical, functional and MRI outcomes. The purpose of the…
Abstract Number: 1077 • ACR Convergence 2022
Safety of Avacopan in ANCA-Associated Vasculitis: Combined Data from Three Clinical Trials
Pirow Bekker¹, Peter Merkel² and David Jayne³, ¹ChemoCentryx, San Juan Capistrano, CA, ²U of Pennsylvania, Philadelphia, PA, ³University of Cambridge, Cambridge, United Kingdom
Background/Purpose: Avacopan is approved as adjunctive treatment for adults with ANCA-associated vasculitis (AAV). This study aimed to combine and report on data of the safety…
Abstract Number: 1579 • ACR Convergence 2022
The TICOG Study: Tight Control of Gout – A Randomized, Controlled Trial of Targeted versus Conventional Treatment for Gout Including Ultrasonography
Sarah Black, Natalie McKee, Jonathan McKnight, Annmarie McShane, Adrian Pendleton, Taggart Alister and Gary Wright, Musgrave Park Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland, United Kingdom
Background/Purpose: Gout is a common inflammatory arthritis triggered by deposition of monosodium urate crystals in joints, bone and soft tissues, with a prevalence of 1-4%…
Abstract Number: 1832 • ACR Convergence 2022
Efficacy and Safety Similarity of Biosimilar Adalimumab-aqvh to Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Phase III Study
Barbara Finck, Helen Tang, Kathy Jensen, Francesca Civoli and Suzanna Tatarewicz, Coherus BioSciences, Redwood City, CA
Background/Purpose: This study aimed to demonstrate that there were no clinically meaningful differences between adalimumab-aqvh, a US Food and Drug Administration–approved biosimilar, and adalimumab in…
Abstract Number: 2008 • ACR Convergence 2022
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of Dazodalibep (VIB4920/HZN4920) in Patients with Rheumatoid Arthritis Having Inadequate Response to Conventional/Biological DMARDs
Alan Kivitz¹, Liangwei Wang², Ilias Alevizos², Michele Gunsior², Judith Falloon² and Gabor Illei³, ¹Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, ²Horizon Therapeutics, Gaithersburg, MD, ³Horizon Therapeutics, Rockville, MD
Background/Purpose: Dazodalibep (DAZ), a non-antibody biologic antagonist of CD40L, led to higher/durable response rates vs. placebo (PBO) in a double-blind, Phase 1b trial of patients…
Abstract Number: 2142 • ACR Convergence 2022
Strong Correlation Between Short- vs Long-form Composite Measures of Psoriatic Arthritis Disease Activity in a TNFi-IR Population Treated with Guselkumab: Data from the Phase 3b COSMOS Trial
William Tillett¹, Laura Coates², Mohamed Sharaf³, Marlies Neuhold⁴, Elke Theander⁵, Paul Bergmans⁶, May Shawi⁷, Michelle Perate⁸, Christine Contré⁹ and Philip Helliwell¹⁰, ¹Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom, ³Johnson & Johnson, Middle East FZ LLC, Dubai, United Arab Emirates, ⁴Takeda Europe & Canada Business Unit (EUCAN) Medical Affairs, Zurich, Switzerland; formerly at Janssen Scientific Affairs, LLC, Zug, Switzerland, ⁵Formerly at Janssen Scientific Affairs, LLC, Solna, Sweden, ⁶Formerly at Janssen, Breda, Netherlands, ⁷Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁸Janssen Scientific Affairs, LLC, Horsham, PA, ⁹Formerly at Janssen Scientific Affairs, LLC, Issy-les-Moulineaux, France, Issy-les-Moulineaux, France, ¹⁰Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom
Background/Purpose: Accurate assessment of psoriatic arthritis (PsA) disease activity in clinical practice requires a feasible, continuous, multidimensional composite instrument to assess key domains of this…
Abstract Number: 0036 • ACR Convergence 2022
Patient-specific and Disease-related Determinants for Cardiovascular Disease (CVD) Risk Stratification in the APPLE (Atherosclerosis Prevention in Paediatric Lupus Erythematosus) Clinical Trial Cohort
Junjie Peng¹, George Robinson¹, Stacy P Ardoin², Laura Schanberg³, Elizabeth Jury¹ and Coziana Ciurtin⁴, ¹University College London, London, United Kingdom, ²Division of Rheumatology, Nationwide Children's Hospital and Department of Pediatrics, The Ohio State University, Columbus, OH, ³Duke University Medical Center, Durham, NC, ⁴Centre for Adolescent Rheumatology Versus Arthritis, Department of Medicine, University College London, London, United Kingdom
Background/Purpose: The risk of developing cardiovascular disease (CVD) through atherosclerosis in juvenile-onset systemic lupus erythematosus (JSLE) patients is significantly increased. This study aimed to stratify…
Abstract Number: 0304 • ACR Convergence 2022
Rheumatoid Arthritis Patients Who Switched Treatment from Adalimumab to Upadacitinib Demonstrate a Robust Reduction of Inflammation-related Biomarkers: Proteomics Analysis from the SELECT-COMPARE Phase 3 Study
Thierry Sornasse¹, Fang Cai², Heidi Camp³, In-Ho Song⁴ and Iain B McInnes⁵, ¹AbbVie, South San Francisco, CA, ²AbbVie, Redwood City, CA, ³Abbvie, Winnetka, IL, ⁴AbbVie, Inc., North Chicago, IL, ⁵Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, United Kingdom
Background/Purpose: Upadacitinib 15 mg QD (UPA), an oral JAK inhibitor, showed greater efficacy compared to adalimumab (ADA) in patients (pts) with active rheumatoid arthritis (RA)…
Abstract Number: 0411 • ACR Convergence 2022
Bimekizumab Improves Signs and Symptoms Including Inflammation in Patients with Active Ankylosing Spondylitis: 24-Week Efficacy & Safety from a Phase 3, Multicenter, Randomized, Placebo Controlled Study
Désirée van der Heijde¹, Xenofon Baraliakos², Maxime Dougados³, Matthew Brown⁴, Denis Poddubnyy⁵, Filip Van den bosch⁶, Nigil Haroon⁷, Huji Xu⁸, Tetsuya Tomita⁹, Lianne Gensler¹⁰, Marga Oortgiesen¹¹, Carmen Fleurinck¹², Natasha de Peyrecave¹³, Thomas Vaux¹⁴, Alexander Marten¹⁵ and Atul Deodhar¹⁶, ¹Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Leiden, Netherlands, ²Rheumazentrum Ruhrgebiet Herne, Herne, Germany, ³Department of Rheumatology, Hôpital Cochin, Paris, France, Paris, France, ⁴Genomics England, London, United Kingdom, ⁵Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁶Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium, ⁷Schroeder Arthritis Institute, University Health Network; University of Toronto, Toronto, ON, Canada, ⁸Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China, ⁹Department of Orthopaedic Biomaterial Science, Osaka University Graduate School of Medicine, Osaka, Japan, Suita Osaka, Japan, ¹⁰Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, ¹¹UCB Pharma, Raleigh, NC, ¹²UCB Pharma, Brussels, Belgium, Oosterzele, Belgium, ¹³UCB Pharma, Brussels, Belgium, ¹⁴UCB Pharma, Slough, United Kingdom, ¹⁵UCB Pharma, Monheim am Rhein, Germany, ¹⁶Oregon Health & Science University, Portland, OR, USA, Portland, OR
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. In a phase 2b study, BKZ showed rapid and…
Abstract Number: 0911 • ACR Convergence 2022
Peer Coach Intervention to Improve Primary Cardiovascular Disease Screening for Patients with Rheumatoid Arthritis
Iris Navarro-Millan¹, Mackenzie Brown², Yuliana Domínguez Páez³, Geyanne Lui⁴, Joan Weiner¹, Shelley fritz¹, Tien Sydnor-Campbell⁵, Aberdeen Allen⁶, Assem Jabri¹, Shilpa Venkatachalam⁷, Kelly Gavigan⁸, William Benjamin Nowell⁹, Jeffrey Curtis¹⁰, Liana Fraenkel¹¹ and Monika Safford¹, ¹Weill Cornell Medicine, New York, NY, ²Weill Cornell Medicine, Brooklyn, NY, ³Weill Cornell Medicine, Bronx, NY, ⁴Albert Einstein College of Medicine, New York, NY, ⁵Weill Cornell Medicine, Philedelphia, ⁶Weill Cornell Medicine, Parlin, ⁷Global Healthy Living Foundation, New York, NY, ⁸Global Healthy Living Foundation, Upper Nyack, NY, ⁹Global Healthy Living Foundation, Nyack, NY, ¹⁰University of Alabama at Birmingham, Hoover, AL, ¹¹Berkshire Medical Center, Lenox, MA
Background/Purpose: Only 37% of patients with rheumatoid arthritis (RA) receive screening for cardiovascular disease (CVD) despite their high risk. To improve CVD prevention, we designed…
Abstract Number: 1078 • ACR Convergence 2022
Glucocorticoid Use and Related Adverse Events in ADVOCATE Trial of Avacopan in ANCA-Associated Vasculitis
Emil De Gomma¹, Peter Merkel², Michael George³, Rennie Rhee³, Andreas Kronbichler⁴, David Jayne⁵, Huibin Yue¹ and Pirow Bekker¹, ¹ChemoCentryx, San Juan Capistrano, CA, ²U of Pennsylvania, Philadelphia, PA, ³University of Pennsylvania, Philadelphia, PA, ⁴Cambridge University, Sale Creek, TN, ⁵University of Cambridge, Cambridge, United Kingdom
Background/Purpose: Although the 2021 ACR/VF guidelines for ANCA-associated vasculitis (AAV) recommend reduced-dose glucocorticoids (GCs) over standard-dose GCs (1), this approach still leads to substantial toxicity,…
Abstract Number: 1583 • ACR Convergence 2022
Race and Disease Severity Predict Reduced Response to Treat-to-Target Urate Lowering Therapy in Gout: Post-hoc Analysis of a Multicenter, Randomized, Double-Blind, Non-Inferiority Trial
Lindsay Helget¹, James O'Dell¹, Jeff Newcomb¹, Maria Androsenko², Mary Brophy², Anne Davis-Karim³, Bryant England¹, Ryan Ferguson², Michael Pillinger⁴, Tuhina Neogi⁵, Paul Palevsky⁶, Hongsheng Wu² and Ted Mikuls⁷, ¹University of Nebraska Medical Center, Omaha, NE, ²VA Boston Cooperative Studies Program Coordinating Center, Boston, MA, ³VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, ⁴NYU Grossman School of Medicine, New York, NY, ⁵Boston University School of Medicine, Boston, MA, ⁶University of Pittsburgh School of Medicine, Pittsburgh, Pittsburgh, ⁷Division of Rheumatology, University of Nebraska Medical Center, Omaha, NE
Background/Purpose: The ACR recommends a treat-to-target strategy in the management of gout, involving titration of urate lowering therapy (ULT) to a serum urate (SU) goal…
Abstract Number: 1862 • ACR Convergence 2022
Lenabasum Reduces IFNγ and pIRF3 in Dermatomyositis Skin: Biomarker Results from a Double-Blind Phase 3 International Randomized Controlled Trial
Thomas Vazquez¹, Meena Sharma¹, Rui Feng², DeAnna Diaz³, Nilesh Kodali¹, Josh Dan³, Madison Grinnell³, Emily Keyes³, Grant Sprow³, Barbara White⁴ and Victoria Werth³, ¹Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ²University of Pennsylvania, Philadelphia, ³Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, ⁴Corbus Pharmaceuticals, Pleasanton, CA
Background/Purpose: Dermatomyositis (DM) is an autoimmune connective tissue disease that primarily affects the skin and lung; few effective treatment options are available. Lenabasum is a…
Abstract Number: 2016 • ACR Convergence 2022
Safety and Efficacy Associated with Long-Term Low Dose Glucocorticoids in Rheumatoid Arthritis: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials
Andriko Palmowski¹, Sabrina Mai Nielsen², Zhivana Boyadzhieva³, Abelina Schneider³, Anne Pankow³, Linda Hartman⁴, Jose Pereira da Silva⁵, John Kirwan⁶, Siegfried Wassenberg⁷, Christian Dejaco⁸, Robin Christensen⁹, Maarten Boers¹⁰ and Frank Buttgereit¹¹, ¹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ²The Parker Institute, Section for Biostatistics and Evidence-Based Research, Bispebjerg-Frederiksberg Hospital, Frederiksberg, Denmark, ³Charité-Universitätsmedizin Berlin, Berlin, Germany, ⁴Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, Netherlands, ⁵University of Coimbra, Rheumatology, Columbia, Portugal, ⁶University of Bristol, Bristol, United Kingdom, ⁷Rheumazentrum Ratingen, Ratingen, Germany, ⁸Department of Rheumatology, Hospital of Brunico (SABES-ASDAA), Brunico, Italy, and Department of Rheumatology and Immunology, Medical University of Graz, Graz, Austria, ⁹Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Denmark, ¹⁰Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, ¹¹Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin / DRFZ Berlin, Berlin, Germany
Background/Purpose: There is ongoing controversy about the safety and efficacy of long-term low dose glucocorticoids (GCs) in rheumatoid arthritis (RA). Our aim was to study…

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