Abstracts tagged "Randomized Trial"

Abstract Number: 1477 • ACR Convergence 2024
Zasocitinib (TAK-279), a Highly Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, Elicits Early Skin Responses and Minimal Disease Activity in Patients with Active Psoriatic Arthritis: Results from a Randomized Phase 2b Study
Alice Gottlieb¹, Elena Muensterman², Alan Kivitz³, Eva Dokoupilova⁴, Apinya Lertratanakul⁵, Ting Hong⁵, Jingjing Chen⁵ and Xenofon Baraliakos⁶, ¹Icahn School of Medicine at Mount Sinai, Department of Dermatology, Seattle, WA, ²Takeda Development Center Americas, Cambridge, MA, ³Altoona Center for Clinical Research, Duncansville, PA, ⁴Medical Plus, s.r.o., Uherske Hradiste, and Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Prague, Czech Republic, ⁵Takeda Development Center Americas, Inc., Cambridge, MA, ⁶Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany
Background/Purpose: Zasocitinib (TAK-279) is a highly selective, oral, allosteric tyrosine kinase 2 (TYK2) inhibitor. In a phase 2b trial in patients with active psoriatic arthritis…
Abstract Number: 1696 • ACR Convergence 2024
Comparison of Mycophenolate Mofetil Plus Methotrexate versus Cyclophosphamide with Sequential Azathioprine for Active Takayasu’s Arteritis: An Open-Label, Randomized-Controlled Trial
XIAOCHUAN SUN¹, Jing Li¹, Xinwang Duan², Liyun Zhang³, Dongyun Yao⁴, Jing Xue⁵, zhenbiao wu⁶, Yi Zhao⁷, Lijun Wu⁸, HONGFENG ZHANG⁹, MENGTAO LI¹, Xiaofeng Zeng¹⁰, Peter Merkel¹¹ and Xinping Tian¹², ¹Peking Union Medical College Hospital, Beijing, China, ²The Second Affiliated Hospital of Nanchang University, Nanchang, China (People's Republic), ³Shanxi Bethune Hosptial, Taiyuan, China (People's Republic), ⁴Jiaozuo People's Hospital, Jiaozuo, Henan, China (People's Republic), ⁵Second Affiliated Hospital,Zhejiang University School of Medcine, Hangzhou, China (People's Republic), ⁶Xijing Hospital, Fourth Military Medical University, Xi'an, China (People's Republic), ⁷Xuanwu Hospital, Beijing, China, ⁸People's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang, China (People's Republic), ⁹The First Affiliated Hospital of Dalian Medical University, Dalian, ¹⁰Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China, ¹¹University of Pennsylvania, Philadelphia, PA, ¹²Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
Background/Purpose: The management of Takayasu’s arteritis (TAK) is challenging for lack of large-scale, high-quality clinical trials. Cyclophosphamide (CYC) is a conventional first-line immunosuppressant but is…
Abstract Number: 2316 • ACR Convergence 2024
Gene Expression Profile Is Different Between Men and Women in Psoriatic Disease
Pauline KRUG¹, angela De Sousa Leite², Frédéric Lecouvet¹, Maria Simona stoenoiu¹ and Adrien Nzeusseu Toukap³, ¹Cliniques universitaires St-Luc, Brussel, Belgium, ²Cliniques universitaires St-Luc, Brussels, Belgium, ³Cliniques universitaires Saint-Luc,, St.-Lambrechts-Woluwe, Belgium
Background/Purpose: Psoriatic arthritis (PsA) is a highly heterogenous chronic inflammatory condition. Recent publications highlight differences between men and women in disease manifestation and response to…
Abstract Number: 2634 • ACR Convergence 2024
Transcriptomic Stratification Predicts Response to Rituximab, Abatacept or the Association of Hydroxychloroquine and Leflunomide in 3 Randomized Controlled Clinical Trials in Sjögren’s Disease
Baptiste Chevet¹, Valerie Devauchelle², Elena Pontarini³, Valentin Baloche⁴, Michele Bombardieri⁵, Simon Bowman⁶, Michael Barnes⁷, Antoine Sreih⁸, Jinqi Liu⁸, Sheila Kelly⁹, Antonia Christodoulou⁸, Hussain Badani¹⁰, Philippe Moigeon¹¹, Laurence LAIGLE¹², Perrine Soret¹³, Christelle Le dantec¹⁴, Jacques-Olivier Pers¹⁵, Marta Alarcon-Riquelme¹⁶, Guillermo Barturen¹⁷, Xavier Mariette¹⁸, Joel Van Roon¹⁹, Raphaele Seror²⁰, Gaetane Nocturne¹⁸, Divi Cornec²¹ and Nathan Foulquier¹⁴, and PRECSEADS Clinical Consortium and NECESSITY consortium, ¹University Hospital of Brest, Brest, France, ²UBO, Brest, France, ³William Harvey Research Institute, London, United Kingdom, ⁴University Medical Center, Utrecht, Utrecht, Netherlands, ⁵Centre for Experimental Medicine and Rheumatology, The William Harvey Research Institute, Queen Mary University of London, London, United Kingdom, ⁶Department of Rheumatology, University Hospital Birmingham, Birmingham, United Kingdom, ⁷William Harvey Research institute, Centre for Translational Bioinformatics, London, United Kingdom, ⁸Bristol Myers Squibb, Princeton, NJ, ⁹Bristol Myers Squibb, Doylestown, PA, ¹⁰Bristol Myers Squibb, Lawrence Township, NJ, ¹¹Servier Laboratories, France, Gif sur Yvette, France, ¹²Servier Laboratories, France, SURESNES, France, ¹³Servier, Paris-Saclay, Paris, Ile-de-France, France, ¹⁴LBAI. UMR 1227, University of Brest, Brest, France, ¹⁵University of Brest, Brest, France, ¹⁶Fundación Progreso y Salud, Andalusian Government, Granada, Spain, ¹⁷Center for Genomics and Oncological Research (GENYO), Andalusia, Spain, ¹⁸Service de Rhumatologie, Hôpital Bicêtre, AP-HP, Le Kremlin Bicetre, France, ¹⁹University Medical Center Utrecht, Utrecht, Netherlands, ²⁰Service de Rhumatologie, Hôpital Bicêtre, AP-HP, le Kremlin Bicetre, Ile-de-France, France, ²¹Service de Rhumatologie, CHU de Brest, Brest, France
Background/Purpose: Sjögren’s disease (SjD) is a clinically and biologically heterogeneous disease. To date, no phase-III trial showed efficacy in reducing the symptoms or systemic activity…
Abstract Number: 0823 • ACR Convergence 2024
A Randomized, Double-Blind, Placebo-Controlled Trial of Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis
Carol Langford¹, Nader Khalidi², Jason Springer³, Marcia Friedman⁴, Bernhard Hellmich⁵, Christian Pagnoux⁶, Natasha Dehghan⁷, Ora Singer⁸, Curry Koening⁹, Yih Chang Lin¹⁰, Paul Monach¹¹, Larry Moreland¹², Aurore Fifi-Mah¹³, Oliver Flossmann¹⁴, Lindsy Forbess¹⁵, Peter Lanyon¹⁶, Eamonn Molloy¹⁷, Ulrich Specks¹⁸, Robert Spiera¹⁹, Elaine Yacyshyn²⁰, Carol McAlear²¹, Cristina Burroughs¹⁰, Rachel Jones²², Rennie Rhee²¹, Rula A. Hajj-Ali²³, Kenneth Warrington¹⁸, David Cuthbertson¹⁰, Jeffrey Krischer¹⁰, David Jayne²² and Peter Merkel²¹, and the Vasculitis Clinical Research Consortium and the European Vasculitis Society, ¹Cleveland Clinic, Moreland Hills, OH, ²McMaster University, Hamilton, ON, Canada, ³Vanderbilt University Medical Center, Franklin, TN, ⁴Oregon Health and Science University, Portland, OR, ⁵Medius Kliniken, Kirchheim unter Teck, Germany, ⁶Mount Sinai Hospital, Toronto, ON, Canada, ⁷University of British Columbia - Vancouver, Vancouver, BC, Canada, ⁸University of Michigan, Huntington Woods, MI, ⁹University of Texas Dell Medical School, Austin, TX, ¹⁰University of South Florida, Tampa, FL, ¹¹VA Boston Healthcare System, Boston, MA, ¹²University of Colorado, Denver, CO, ¹³University of Calgary, Calgary, AB, Canada, ¹⁴Royal Berkshire Hospital, Reading, United Kingdom, ¹⁵Cedars-Sinai Medical Center, Los Angeles, CA, ¹⁶University of Nottingham, Nottingham, United Kingdom, ¹⁷St Vincent's University Hospital, Dublin, Ireland, ¹⁸Mayo Clinic, Rochester, MN, ¹⁹Scleroderma, Vasculitis, and Myositis Center, Hospital for Special Surgery, Weill Cornell Medical College, New York, NY, ²⁰University of Alberta, Edmonton, AB, Canada, ²¹University of Pennsylvania, Philadelphia, PA, ²²University of Cambridge, Cambridge, United Kingdom, ²³Cleveland Clinic, Cleveland, OH
Background/Purpose: Granulomatosis with polyangiitis (GPA) is a small-vessel vasculitis associated with frequent relapses. Following encouraging results from an open-label study, a randomized, double-blind, placebo-controlled trial…
Abstract Number: 1478 • ACR Convergence 2024
Associations Between Clinical Characteristics and Screening MRI Findings: Exploratory Analysis of the Ongoing Phase 4, Multicenter, Randomized, Controlled STAR Study of Biologic-Naïve Patients with PsA with MRI-Confirmed Axial Involvement
Xenofon Baraliakos¹, Paul Bird², Atul Deodhar³, Dafna Gladman⁴, Philip S. Helliwell⁵, Denis Poddubnyy⁶, Arthur Kavanaugh⁷, Mikkel Ostergaard⁸, Enrique R. Soriano⁹, Lai-shan Tam¹⁰, Soumya Chakravarty¹¹, Evan Leibowitz¹², Cinty Gong¹³, Stephen Xu¹⁴, Thomas Fuerst¹⁵, Nadeem Saeed¹⁶, Robert Landewé¹⁷ and Philip Mease¹⁸, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ²University of New South Wales, Randwick, NSW, Sydney, New South Wales, Australia, ³Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁴University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ⁵Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK, Leeds, United Kingdom, ⁶Charite-Universitatsmedizin Berlin, Berlin, Germany, ⁷University of California San Diego, La Jolla, CA, ⁸Department of Clinical Medicine, University of Copenhagen and Center for Rheumatology, Copenhagen Center for Arthritis Research, Glostrup, Denmark, ⁹Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ¹⁰The Chinese University of Hong Kong, New Territories, Hong Kong, ¹¹Janssen Scientific Affairs, LLC, Horsham/ Drexel University College of Medicine, Philadelphia, Horsham, PA, ¹²Janssen Scientific Affairs, LLC, Fair Lawn, NJ, ¹³Janssen Scientific Affairs, Horsham, PA, ¹⁴Janssen Research & Development, LLC, Spring House, PA, USA, Spring House, PA, ¹⁵Clario, San Mateo, CA, ¹⁶Clario, San Mateo, ¹⁷Amsterdam University Medical Center, Meerssen, Netherlands, ¹⁸Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA
Background/Purpose: Patients (pts) with PsA can develop axial inflammation in the SI joints (SIJs) and/or spine. Although validated classification criteria for axial spondyloarthritis exist, established…
Abstract Number: 1697 • ACR Convergence 2024
Results of a One Year Randomized Double-Blind Placebo-Controlled Trial with Methotrexate 25mg Per Week for Recently Diagnosed PolyMyalgia Rheumatica
Thomas Bolhuis¹, Noortje Kooijman¹, Diane Marsman¹, Gijs Snijders², Alfons den Broeder³, Nathan den Broeder⁴ and Aatke Van der maas⁵, ¹Department of Rheumatology, Sint Maartenskliniek, Ubbergen, The Netherlands, Ubbergen, Netherlands, ²Department of Rheumatology, Gelre Ziekenhuizen, Apeldoorn, The Netherlands, Gelre, Netherlands, ³Sint Maartenskliniek, Ubbergen, Netherlands, ⁴Sint Maartenskliniek, Ubbergen, Gelderland, Netherlands, ⁵St Maartenskliniek, Ubbergen, Netherlands
Background/Purpose: The most effective treatment for Polymyalgia rheumatica (PMR) are glucocorticoids (GC), but these are associated with toxicity. Three randomized controlled trials (RCTs) suggest methotrexate…
Abstract Number: 2340 • ACR Convergence 2024
Direct to Patient Screening for Psoriatic Arthritis in Patients with Psoriasis: Diagnosis Rates, Referral Pathways, and Educational Value of Screening
Jessica A Walsh¹, Shaobo Pei², Gopi Penmetsa³, Swetha Alexander⁴, Nga Lori Ly⁵, Rosario Adriana Molano-Romero⁴, April Conlon⁶, Catherine Bakewell⁷, Soumya Reddy⁸, Jose Scher⁹ and Alexis Ogdie¹⁰, ¹Division of Rheumatology, Salt Lake City Veterans Affairs Health and University of Utah Health, Salt Lake City, UT, ²University of Utah, Thousand Oaks, CA, ³University Of Utah Hospital, Salt Lake City, UT, ⁴University of Utah Health, Salt Lake City, UT, ⁵University of Utah, Salt Lake City, UT, ⁶University of Utah, Sandy, UT, ⁷Intermountain Healthcare, Salt Lake City, UT, ⁸NYU Grossman School of Medicine, New York, NY, ⁹New York University School of Medicine, New York, NY, ¹⁰Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: Diagnostic delays are common in psoriatic arthritis (PsA). Screening surveys administered in clinic can identify psoriasis patients at elevated risk for PsA who should…
Abstract Number: 2656 • ACR Convergence 2024
Short-Term Effectiveness of a Walk with Ease Program Delivered by Telephone on Arthritis-Related Symptoms, Function, and Physical Activity
Christine Pellegrini, Sara Wilcox, Yesil Kim, Katherine Devivo, Scott Jamieson, Kailyn Horn and Daniel Heidtke, University of South Carolina, Columbia, SC
Background/Purpose: Walk With Ease (WWE) is a 6-week arthritis-appropriate evidence-based physical activity program traditionally offered in a face-to-face format. However, as many populations encounter participation…
Abstract Number: 0828 • ACR Convergence 2024
Efficacy of Eosinophil-Targeting Therapies on Specific Disease Manifestations of Eosinophilic Granulomatosis with Polyangiitis in the Phase 3 MANDARA Trial
Peter Merkel¹, David Jayne², Ulrich Specks³, Christian Pagnoux⁴, Benjamin Terrier⁵, Bernhard Hellmich⁶, Sofia Necander⁷, Anat Shavit⁸, Claire Walton⁹ and Michael Wechsler¹⁰, ¹University of Pennsylvania, Philadelphia, PA, ²University of Cambridge, Cambridge, United Kingdom, ³Mayo Clinic, Rochester, MN, ⁴Mount Sinai Hospital, Toronto, ON, Canada, ⁵Service de Médecine interne, Hôpital Cochin, AP-HP, Paris, Ile-de-France, France, ⁶Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, ⁷Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁸BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ⁹Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ¹⁰National Jewish Health, Denver, CO
Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare inflammatory disorder characterized by small- to medium-vessel vasculitis, asthma and eosinophilia. In the head-to-head MANDARA trial…
Abstract Number: 1492 • ACR Convergence 2024
Timing of SLEDAI-2K Item Improvements During the First Year of Intravenous Anifrolumab Treatment of Moderate to Severe SLE
Edward Vital¹, Richard Furie², Eric Morand³, Ian Bruce⁴, Jacob Knagenhjelm⁵ and Catharina Lindholm⁶, ¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom, Leeds, England, United Kingdom, ²Northwell Health, Manhasset, NY, ³School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia, ⁴Centre for Musculoskeletal Research, The University of Manchester, Manchester, United Kingdom, ⁵BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden, ⁶BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden, Gothenburg, Sweden
Background/Purpose: SLE is a chronic disease in which irreversible organ damage can accumulate over time; treatments associated with rapid responses in patients are therefore desirable.1…
Abstract Number: 1718 • ACR Convergence 2024
Randomization to Holding versus Continuing (JAKi, IL17) and Autoimmune Patient Responses to COVID-19 Boosters: Results from the Covid-19 VaccinE Response in Rheumatology Patients (COVER) Study
Amy Mudano¹, Gary Cutter², Emily Holladay³, Kevin Winthrop⁴, Ted Mikuls⁵, Geoffrey Thiele⁵, Mark Law⁵, Monique Bastidas⁶, Mike Zikry⁶, Kelly Chun⁶, Michael George⁷, Jayashree Sinha⁸, Naiara Alvarez⁹, John Tesser¹⁰ and Jeffrey Curtis¹¹, and COVER Site Principal Investigator Group, ¹Illumination Health, Hoover, AL, ²University of Alabama at Birmingham, Birmingham, AL, ³University of Alabama at Birmingham, Edmond, OK, ⁴School of Medicine, Oregon Health and Science University, Portland, OR, ⁵University of Nebraska Medical Center, Omaha, NE, ⁶Labcorp, Calabasas, CA, ⁷University of Pennsylvania, Philadelphia, PA, ⁸self employed, Clovis, NM, ⁹Integrative Rheumatology of South Texas, McAllen, TX, ¹⁰Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ¹¹University of Alabama at Birmingham, Hoover, AL
Background/Purpose: Best practice for the use of immunosuppression to optimize vaccine response remains uncertain. We conducted the Covid VaccinE Response (COVER) trial, a multicenter, randomized…
Abstract Number: 2341 • ACR Convergence 2024
Influence of Patient Baseline Characteristics on Zasocitinib (TAK-279) Efficacy, a Selective Oral Tyrosine Kinase 2 Inhibitor: A Randomized Phase 2b Trial in Psoriatic Arthritis
Lihi Eder¹, Elena Muensterman², Desiree van der Heijde³, Alan Kivitz⁴, Mona Trivedi⁵, Ting Hong⁵, Muhammad Rehman⁵, Haoling Weng⁶, Jingjing Chen⁵ and Xenofon Baraliakos⁷, ¹University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada, ²Takeda Development Center Americas, Cambridge, MA, ³Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, ⁴Altoona Center for Clinical Research, Duncansville, PA, ⁵Takeda Development Center Americas, Inc., Cambridge, MA, ⁶HW MedAdvice LLC, San Diego, CA, ⁷Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany
Background/Purpose: Zasocitinib (TAK-279) is a potent, highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor. In a recent phase 2b trial in active psoriatic arthritis…
Abstract Number: 2672 • ACR Convergence 2024
Prevention of the Development of Rheumatoid Arthritis by a 1-year Course of Methotrexate in ACPA-negative Arthralgia Patients at Increased Risk for Rheumatoid Arthritis: 4 Year Results of the TREAT EARLIER Trial
Quirine Dumoulin¹, Doortje Krijbolder², Karen Visser³, Leroy Lard⁴ and Annette van der Helm-van Mil⁵, ¹Leiden University Medical Centre, Leiden, Zuid-Holland, Netherlands, ²Leiden University Medical Centre, Leiden, Netherlands, ³Haga Hospital The Hague, Amsterdam, Netherlands, ⁴Haaglanden Medical Center The Hague, Leidschendam, Netherlands, ⁵LUMC, Leiden, Zuid-Holland, Netherlands
Background/Purpose: Currently, prevention possibilities of developing ACPA-negative rheumatoid arthritis (RA) are unknown. Studying this is challenging because many ACPA-negative at-risk individuals have low risk of…
Abstract Number: 0858 • ACR Convergence 2024
Baricitinib in Early Polymyalgia Rheumatica (BACHELOR Study)
Alain SARAUX¹, Guillermo CARVAJAL ALEGRIA², Emmanuelle Dernis³, christian roux⁴, Christophe Richez⁵, Alice TISON⁶, Baptiste Quere⁷, Sandrine Jousse-Joulin⁸, Dewi Guellec⁷, Thierry Marhadou⁹, Patrice Kervarrec⁷, Divi Cornec¹⁰, Catherine Le Henaff⁷, Sandra Lesven⁷, nowak emmanuel⁷, Aghiles Souki⁷ and Valerie Devauchelle¹¹, ¹CHU Brest, Brest, France, ²CHRU de Tours, Tours, France, ³CH LE MANS, LE MANS, Pays de la Loire, France, ⁴rheumatology department, university Cote d'Azur, nice, France, ⁵Université de Bordeaux, Bordeaux, France, ⁶CHU de la Cavale Blanche, Brest, France, Brest, France, ⁷Centre Hospitalier Regional Universitaire (CHU) de Brest, Brest, France, ⁸cavale blanche hospital, brest, France, ⁹CHU Cavale Blanche, Brest, France, ¹⁰University of Brest, Brest, France, ¹¹UBO, Brest, France
Background/Purpose: Moderate glucocorticoids (GCs) improve nearly all cases of polymyalgia rheumatica (PMR) but related adverse events are common in senior patients. The purpose of this…

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