Abstracts tagged "Randomized Trial"

Abstract Number: 1554 • ACR Convergence 2024
Belimumab Increases SLE Responder Index-4 Response Rates versus Placebo in Early Active Systemic Lupus Erythematosus: A Large Integrated Analysis of Belimumab Trials
Karen Costenbader¹, Joan Merrill², Marta Mosca³, Holly Quasny⁴, Christine Henning⁵, Steven Bloom⁶, Julia Harris⁶, Ciara O’Shea⁷, Tatsuya Atsumi⁸ and Ronald van Vollenhoven⁹, ¹Brigham and Women’s Hospital, Division of Rheumatology, Inflammation and Immunity, Harvard Medical School, Boston, MA, ²Oklahoma Medical Research Foundation, Arthritis & Clinical Immunology Program, Oklahoma City, OK, ³University of Pisa, Department of Clinical and Experimental Medicine - Rheumatology Unit, Pisa, Italy, ⁴GSK, Clinical Sciences, Durham, NC, ⁵GSK, Global Medical Affairs, Durham, NC, ⁶GSK, Immunology Biostatistics, Brentford, United Kingdom, ⁷GSK, Rheumatology, Global Medical Affairs, Dublin, Ireland, ⁸Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan, Sapporo, Japan, ⁹Amsterdam Rheumatology and Immunology Center and Amsterdam University Medical Centers, Department of Rheumatology, Amsterdam, Netherlands

Background/Purpose: There are benefits of early treatment for autoimmune diseases; however, data are not available for patients (pts) with SLE as there is no definition…
Abstract Number: 2047 • ACR Convergence 2024
Safety in Patients with Latent Tuberculosis Who Received Concomitant Anti-Tuberculosis Medications: Analysis of 11 Studies of Guselkumab in Psoriatic Disease
Luis Puig¹, Tsen-Fang Tsai², Enrique R. Soriano³, Tina Bhutani⁴, Megan Miller⁵, Alexa P. Kollmeier⁵, Shu Li⁵, Yin You⁵, Melissa Petrick⁵, Hewei Li⁶, Hetal Patel⁷, Frederic Lavie⁸, Melinda Gooderham⁹, Angela Londoño¹⁰, Mark Lebwohl¹¹ and Peter Nash¹², ¹Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain, ²National Taiwan University Hospital, Taipei, Taiwan (Republic of China), ³Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁴University of California San Francisco Medical Center, San Francisco, CA, ⁵Janssen Research & Development, LLC, Spring House, PA/San Diego, CA, ⁶Janssen Pharmaceutical, Hopewell Township, NJ, ⁷Pharmaceutical Companies of Johnson & Johnson, Naperville, IL, ⁸Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁹SKiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada, ¹⁰CES University, Medellín, Colombia, ¹¹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ¹²School of Medicine, Griffith University, Sunshine Coast, Queensland, Australia
Background/Purpose: Certain psoriatic disease treatments, including TNF-α inhibitors (TNFi), increase risk of latent tuberculosis infection (LTBI) activation.1,2 Current treatment guidelines recommend TB screening before initiating…
Abstract Number: 2361 • ACR Convergence 2024
Assessment of Laboratory Parameter Changes in a Phase 2b Trial of Zasocitinib (TAK-279), an Oral, Highly Selective TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis
Arthur Kavanaugh¹, Elena Muensterman², Apinya Lertratanakul³, Ting Hong³, Jingjing Chen³, Peter Pothula⁴, Ejim Mark⁵ and Alan Kivitz⁶, ¹University of California San Diego, La Jolla, CA, ²Takeda Development Center Americas, Cambridge, MA, ³Takeda Development Center Americas, Inc., Cambridge, MA, ⁴Takeda Development Center Americas, Inc., Cambridge, ⁵Takeda Development Center Americas Inc., Cambridge, ⁶Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: Zasocitinib (TAK-279) is an oral, highly selective, allosteric tyrosine kinase 2 (TYK2) inhibitor that binds with high specificity to the Janus homology 2 domain…
Abstract Number: L07 • ACR Convergence 2023
3-year Results of Tapering TNFi to Withdrawal Compared to Stable TNFi Among Rheumatoid Arthritis Patients in Sustained Remission: A Multicenter Randomized Trial
Kaja Kjørholt¹, Nina Sundlisæter¹, Anna-Birgitte Aga¹, Joseph Sexton¹, Inge Christoffer Olsen², Åse Lexberg³, Tor Magne Madland⁴, Hallvard Fremstad⁵, Christian A. Høili⁶, Gunnstein Bakland⁷, Cristina Spada⁸, Hilde Haukeland⁹, Inger Myrnes Hansen¹⁰, Ellen Moholt¹, Karen Holten¹, Till Uhlig¹, Tore Kvien¹, Daniel Solomon¹¹, Désirée van der Heijde¹², Espen Haavardsholm¹ and Siri Lillegraven¹, ¹Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway, ²Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Nepal, ³Department of Rheumatology, Drammen Hospital, Vestre Viken HF, Drammen, Norway, ⁴Department of Rheumatology, Haukeland University Hospital, Bergen, Norway, ⁵Department of Rheumatology, Møre og Romsdal Hospital Trust, Ålesund, Norway, ⁶Department of Rheumatology, Østfold Hospital Trust, Moss, Norway, ⁷Department of Rheumatology, University Hospital of North Norway, Tromsø, Norway, ⁸Department of Rheumatology, Revmatismesykehuset AS, Lillehammer, Norway, ⁹Department of Rheumatology, Martina Hansens Hospital, Bærum, Norway, ¹⁰Deptartment of Rheumatology, Helgelandssykehuset, Mo i Rana, Norway, ¹¹Division of Rheumatology, Brigham and Women's Hospital, Newton, MA, ¹²Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands
Background/Purpose: Tapering of tumor necrosis factor inhibitor (TNFi) treatment in patients who have reached sustained remission is debated in current guidelines, and further data are…
Abstract Number: L14 • ACR Convergence 2023
Efficacy and Safety of Benralizumab Compared with Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Patients Receiving Standard of Care Therapy: Phase 3 MANDARA Study
Michael Wechsler¹, Parameswaran Nair², Benjamin Terrier³, Bastian Walz⁴, Arnaud Bourdin⁵, David Jayne⁶, David Jackson⁷, Florence Roufosse⁸, Lena Börjesson Sjö⁹, Ying Fan¹⁰, Maria Jison¹⁰, Christopher McCrae¹¹, Sofia Necander⁹, Anat Shavit¹², Claire Walton¹² and Peter Merkel¹³, ¹National Jewish Health, Denver, CO, ²McMaster University, Hamilton, ON, Canada, ³Cochin Hospital, Paris, France, ⁴University of Tübingen, Kirchheim-Teck, Germany, ⁵University of Montpellier, CHU Montpellier, INSERM, Montpellier, Montpellier, France, ⁶Addenbrooke's Hospital, Cambridge, United Kingdom, ⁷Guy's Severe Asthma Centre, School of Immunology & Microbial Sciences, King's College London,, London, United Kingdom, ⁸Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium, ⁹Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹⁰Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca,, Gaithersburg, MD, ¹¹Translational Science & Experimental Medicine, Early Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ¹²BioPharmaceutials Medical, AstraZeneca, Cambridge, United Kingdom, ¹³University of Pennsylvania, Philadelphia, PA
Background/Purpose: Eosinophilic inflammation is a key pathophysiological mechanism of eosinophilic granulomatosis with polyangiitis (EGPA). Oral glucocorticoids (OGCs) and immunosuppressants remain the basis for the standard…
Abstract Number: L10 • ACR Convergence 2023
Dazodalibep, a CD40L Antagonist, in a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial of Subjects with Sjögren’s Disease Having Unacceptable Symptomatic Burden but Limited Extraglandular Organ Involvement
E. William St. Clair¹, Liangwei Wang², Ilias Alevizos², William A. Rees², Alan N. Baer³, Wan-Fai Ng⁴, Ghaith Noaiseh⁵ and Chiara Baldini⁶, ¹Department of Medicine, Duke University Medical Center, Durham, NC, USA, Durham, NC, ²Horizon Therapeutics plc, Rockville, MD, ³Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA, Baltimore, MD, ⁴Translational and Clinical Research Institute, Newcastle University, Newcastle, United Kingdom, ⁵Division of Allergy, Clinical Immunology and Rheumatology, Department of Medicine, University of Kansas, Kansas City, KS, USA, Kansas CIty, KS, ⁶Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Pisa, Pisa, Italy
Background/Purpose: Dazodalibep (DAZ) is a non-antibody fusion protein that acts as a CD40L antagonist and blocks costimulatory signals between immune cells, including T cells, B…
Abstract Number: L15 • ACR Convergence 2023
AR882, an Efficacious and Selective URAT1 Inhibitor for Patients with Chronic Gouty Arthritis and Subcutaneous Tophi: Results from a Global, Prospective, Proof-of-Concept Trial Using Dual Energy Computed Tomography
Robert Keenan¹, James Cheng-Chung WEI², Sarah Morris³, Pamella Mundell³, Wen Wei³, Ke Shi³, Zancong Shen³, Vijay Hingorani⁴, Shunqi Yan³, Bahram Kiani⁵ and Litain Yeh³, ¹Arthrosi Therapeutics, Inc., Chapel Hill, NC, ²Chung Shan Medical University, Taichung, Taiwan (Republic of China), ³Arthrosi Therapeutics, Inc., San Diego, CA, ⁴Vanguard Healthsciences, Inc., San Diego, CA, ⁵Wake Forest University School of Medicine, Winston-Salem, NC
Background/Purpose: AR882 is a novel and selective URAT1 inhibitor currently in clinical stage development for the treatment of gout and tophaceous gout and has demonstrated…
Abstract Number: L12 • ACR Convergence 2023
Efficacy and Safety Outcomes of TAK-279, a Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, from a Randomized, Double-blind, Placebo-controlled Phase 2b Trial in Patients with Active Psoriatic Arthritis
Alan Kivitz¹, Elena Tomaselli Muensterman², Arthur Kavanaugh³, Désirée van der Heijde⁴, Piotr A. Klimiuk⁵, Guillermo Valenzuela⁶, Eva Dokoupilova⁷, Gabrielle Poirier⁸, Bhaskar Srivastava⁸, Sue Dasen⁸, Xinyan Zhang⁸, Mona Trivedi², Haoling Holly Weng⁹, Ting Hong¹⁰, Peter Pothula¹⁰ and Xenofon Baraliakos¹¹, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Takeda Development Center Americas, Inc., Cambridge, MA, ³Division of Rheumatology, Allergy & Immunology, University of California San Diego Medical School, San Diego, CA, ⁴Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, ⁵Department of Rheumatology and Internal Diseases, Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Białystok, Poland, ⁶Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁷Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University and MEDICAL PLUS, s.r.o., Brno and Uherské Hradiště, Czech Republic, ⁸Nimbus Discovery, Inc., Boston, MA, ⁹HW MedAdvice LLC, San Diego, CA, ¹⁰Takeda Development Center Americas, Inc., Boston, MA, ¹¹Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum, Germany
Background/Purpose: TYK2 mediates signaling by key cytokines involved in the pathogenesis of immune-mediated inflammatory diseases such as psoriatic arthritis (PsA) and psoriasis (PsO). TAK-279 is…
Abstract Number: L16 • ACR Convergence 2023
Withdrawal of Immunosuppressant and Low-dose Steroids in IgG4-RD Patients with Stable Disease (WInS IgG4-RD): An Investigator-initiated, Multi-center, Open-label, Randomized Controlled Trial
Linyi Peng¹, Yuxue nie¹, Jiaxin Zhou¹, Lijun Wu², Fang Wang³, Xiaomei Chen⁴, Jieqiong Li¹, Yu Peng¹, Hui Lu¹, Lidan Zhao¹, Mengtao Li¹, Yan Zhao¹, Xiaofeng Zeng⁵, Yunyun Fei¹ and Wen Zhang¹, ¹Peking Union Medical College Hospital，Department of Rheumatology and Clinical Immunology, National Clinical Research Center for Dermatologic and Immunologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Beijing, China, ²Xinjiang Uygur Autonomous Region People's Hospital, XinJiang, China, ³Beijing Hospital, Beijing, China, ⁴Xinjiang Uygur Autonomous Region People's Hospital, Wulumuqi, China, ⁵Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China
Background/Purpose: IgG4-related disease (IgG4-RD) is a fibroinflammatory disease. Remission induction treatment with glucocorticoid (GC) is usually effective, but its tendency of relapse makes the strategy…
Abstract Number: 0451 • ACR Convergence 2023
Long-term Clinical Profile of Filgotinib in Patients with Rheumatoid Arthritis by Cardiovascular Risk Factors: A Post Hoc Subgroup Analysis
Maya Buch¹, Jose A Gomez-Puerta², Gerd Burmester³, Bernard G. Combe⁴, Vijay Rajendran⁵, Pieter-Jan Stiers⁶, Paul Van Hoek⁷, Katrien Van Beneden⁷, Jacques-Eric Gottenberg⁸, Yoshiya Tanaka⁹, Daniel Aletaha¹⁰, René Westhovens¹¹ and Roberto F. Caporali¹², ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Department of Rheumatology, Hospital Clinic of Barcelona, Barcelona, Spain, ³Charité – Universitätsmedizin Berlin, Department of Rheumatology and Clinical Immunology, Berlin, Germany, ⁴Department of Rheumatology, Montpellier University, Montpellier, France, ⁵Clinical Research, Galapagos NV, Mechelen, Belgium, ⁶Biostatistics, Galapagos NV, Mechelen, Belgium, ⁷Medical Safety, Galapagos NV, Mechelen, Belgium, ⁸Rheumatology Department, Strasbourg University Hospital, Strasbourg, France, ⁹University of Occupational and Environmental Health, Kitakyushu, Japan, ¹⁰Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, Wien, Austria, ¹¹Department of Rheumatology, KU Leuven, Skeletal Biology and Engineering Research Center, Leuven, Belgium, ¹²Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milano, Italy
Background/Purpose: Filgotinib (FIL) is an oral Janus kinase 1 preferential inhibitor for the treatment of moderate to severe active RA. A previous pooled analysis reported…
Abstract Number: 1005 • ACR Convergence 2023
Telemedicine for Rheumatology Care: A Randomized, Single-Blind, Parallel Group, Noninferiority Trial
Lesley E. Jackson¹, Jinoos Yazdany², Kiara Aaron¹, Sarah Goglin³, Mary Margaretten², David Chae⁴, Jeffrey Curtis¹, Diana Paez⁵, Gary Cutter¹, Kenneth Saag¹ and Maria I. ("Maio") Danila⁶, ¹University of Alabama at Birmingham, Birmingham, AL, ²University of California San Francisco, San Francisco, CA, ³University of California San Francisco, Burlingame, CA, ⁴Tulane University School of Public Health & Tropical Medicine, New Orleans, LA, ⁵University of California San Francisco, Department of Medicine/Rheumatology, San Francisco, CA, ⁶University of Alabama at Birmingham (UAB), Birmingham VA Medical Center, Birmingham, AL
Background/Purpose: In the wake of the COVID-19 pandemic, telemedicine rapidly became standard of care for people with rheumatic diseases. Observational data on effectiveness and acceptability…
Abstract Number: 1638 • ACR Convergence 2023
CD40L Inhibition with Dazodalibep Rapidly Reduces Blood Biomarkers of T and B Cell Costimulation in Subjects with Sjögren’s Having High Disease Activity or High Symptom Burden
Tuyet-Hang Pham¹, Michael A. Smith¹, Nannette Mittereder¹, William A. Rees², Ilias Alevizos², E. William St. Clair³ and Claire Emson¹, ¹Horizon Therapeutics plc, Rockville, MD, ²Horizon Therapeutics, Rockville, MD, ³Duke University Medical Center, Durham, NC
Background/Purpose: Dazodalibep (DAZ) is a non-antibody fusion protein that acts as a CD40L antagonist and blocks costimulatory signals between immune cells, including T cells, B…
Abstract Number: 2161 • ACR Convergence 2023
Pharmacokinetic and Safety Similarity of High- and Low-Concentration Formulations of Adalimumab Biosimilar ABP 501
Vincent Chow, Muhan Zhou, Daniel Mytych, Alexander Colbert, Mieke Jill Miller, Iwona Wala and Waldemar Radziszewski, Amgen, Inc., Thousand Oaks, CA
Background/Purpose: ABP 501 has been developed as a biosimilar for Humira® (adalimumab), a fully human monoclonal antibody targeting tumor necrosis factor alpha (TNFα). ABP 501…
Abstract Number: 0459 • ACR Convergence 2023
Upadacitinib Monotherapy versus Methotrexate in Patients with Rheumatoid Arthritis: Efficacy and Safety Through 5 Years in the SELECT-EARLY Randomized Controlled Trial
Ronald van Vollenhoven¹, Vibeke Strand², Tsutomu Takeuchi³, Nilmo Chávez⁴, Pablo Mannucci Walter⁵, Attul Singhal⁶, Jerzy Swierkot⁷, Nasser Khan⁸, Xianwei Bu⁹, Yihan Li⁹, Sara Penn⁹, Heidi Camp⁹ and Jacob Aelion¹⁰, ¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ²Stanford University, Portola Valley, CA, ³Keio University School of Medicine and Saitama Medical University, Tokyo, Japan, ⁴Instituto Guatemalteco de Seguridad Social, Guatemala, Guatemala, ⁵Aprillus Asistencia e Investigación, Buenos Aires, Argentina, ⁶Southwest Rheumatology Research Group, Dallas, TX, ⁷Department of Rheumatology and Internal Medicine, Wrocław Medical Hospital, Wrocław, Poland, ⁸Pharmacovigilance and Patient Safety, AbbVie, Inc., North Chicago, IL, ⁹AbbVie, Inc., North Chicago, IL, ¹⁰West Tennessee Research Institute, Jackson, TN
Background/Purpose: To evaluate the efficacy and safety of upadacitinib (UPA) monotherapy vs MTX monotherapy over 5 yrs among MTX-naïve patients with moderately to severely active…
Abstract Number: 1020 • ACR Convergence 2023
An Increase in Safety Outcome Trials and the Issue of Informed Consent
Ayse Ozdede¹, Sinem Nihal Esatoglu² and Hasan Yazici³, ¹Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Internal Medicine, Division of Rheumatology, İstanbul, Turkey, ²Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Internal Medicine, Division of Rheumatology, Istanbul, Turkey, ³Academic Hospital, Istanbul, Turkey
Background/Purpose: The randomized controlled trial (RCT remains a most important research tool and a necessary document for drug licensing. Informed consent is an integral component…

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