Abstracts tagged "Randomized Trial"

Abstract Number: 2125 • ACR Convergence 2023
Comparing the ITIS Diet and the Mediterranean Diet in Rheumatoid Arthritis: Preliminary Findings on Clinical and Microbiome Outcomes
Marta Sala Climent¹, Martha Cedeno¹, Roxana Coras², Tiffany Holt¹, Soo-In Choi³, Abha Singh⁴, Katherine Nguyen Nguyen⁵, Susan Lee¹, Simone Zuffa Zuffa¹, Meritxell Agustin-Perez¹, Marta Fernandez-Bustamante¹, Shahrokh Golshan¹, Arthur Kavanaugh⁶ and Monica Guma⁵, ¹University of California San Diego, San Diego, CA, ²Cedars-Sinai Medical Center, Los Angeles, CA, ³University of California San Diego, Alicante, CA, ⁴Department of Medicine, University of California San Diego, La Jolla, CA, ⁵University of California San Diego, La Jolla, CA, ⁶University of California San Diego, School of Medicine, Riverside, CA
Background/Purpose: Rheumatoid arthritis (RA) is a chronic condition characterized by persistent joint inflammation, functional impairment, and disability. Adhering to a Western diet has been associated…
Abstract Number: 0246 • ACR Convergence 2023
Safety & Efficacy of SEL-212 in Patients with Gout Refractory to Conventional Treatment: Primary Outcomes from Two Randomized, Double Blind, Placebo-Controlled, Multicenter Phase 3 Studies
Herbert Baraf¹, Alan Kivitz², Sheri Rhodes³, Sheldon Leung⁴, Olu Folarin⁴, Tania Gonzalez-Rivera⁵, Joanna Sobierska⁵, Jacquie Christie⁵, Anand Patel⁶, Wesley DeHaan⁴, Rehan Azeem⁴ and Peter Traber⁷, ¹The Center for Rheumatology and Bone Research, George Washington University, Rheumatology, Bethesda, MD, ²Altoona Center for Clinical Research, Duncansville, PA, ³Selecta Biosciences, Atlanta, GA, ⁴Selecta Biosciences, Inc., Watertown, MA, ⁵Swedish Orphan Biovitrum (Sobi), Stockholm, Sweden, ⁶Pioneer Research Solutions, Houston, TX, ⁷Selecta Biosciences, Gladwyne, PA
Background/Purpose: In patients with refractory gout, the inability to maintain serum uric acid (sUA) levels < 6 mg/dL leads to severe clinical manifestations for which…
Abstract Number: 0673 • ACR Convergence 2023
Reporting of Race, Ethnicity, Sex, Gender, Socioeconomic Status and Representativeness of Race and Ethnicity in ANCA-associated Vasculitis Randomized Trials
Michele Iudici¹, Juan C. Rueda² and Xavier Puéchal³, ¹Division of Rheumatology, Department of Internal Medicine Specialties, Geneva University Hospitals, Geneva, Switzerland, ²Universidad de La Sabana, Chía, Colombia, Chia, Colombia, ³National Referral Center for Rare Systemic Autoimmune Diseases, Paris, France
Background/Purpose: To assess how and to what extent race, ethnicity, sex, gender and socioeconomic status of participants are reported in ANCA-associated vasculitis (AAV) randomized controlled…
Abstract Number: 1610 • ACR Convergence 2023
Digital Acceptance and Commitment Therapy Improves Fibromyalgia Outcomes: Results from a Pivotal, Multi-center, Randomized Controlled Trial
Michael Gendreau¹, Andrea Chadwick², Lance McCracken³, David Williams⁴, Daniel Clauw⁵, Juan Luciano⁶, Yifei Dai⁷, Nicolette Vega⁸, Zunera Ghalib⁸, Kristen Guthrie⁸, Allison Kraus⁸, Michael Rosenbluth⁸, Jennifer Zomnir⁹, Dana Reddy¹⁰ and Lesley arnold¹¹, ¹Gendreau Consulting, LLC, Poway, CA, ²Department of Anesthesiology, Pain, and Perioperative Medicine, University of Kansas School of Medicine, Kansas City, KS, ³Department of Psychology, Uppsala University, Uppsala, Sweden, ⁴Chronic Pain and Fatigue Research Center, Department of Anesthesiology, University of Michigan, Ann Arbor, MI, ⁵Department of Anesthesiology, University of Michigan, Ann Arbor, MI, ⁶Department of Clinical and Health Psychology, Universitat Autónoma de Barcelona, Barcelona, Spain, ⁷Swing Therapeutics, Gainesville, FL, ⁸Swing Therapeutics, San Francisco, CA, ⁹DelRicht Resesarch, Mckinney, TX, ¹⁰Curavit, Scarsdale, NY, ¹¹Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati, Cincinnati, OH
Background/Purpose: Acceptance and Commitment Therapy (ACT), a form of guideline-recommended Cognitive Behavioral Therapy (CBT), has been empirically validated as a non-drug treatment for fibromyalgia (FM).…
Abstract Number: 2143 • ACR Convergence 2023
Efficacy of Filgotinib in Patients with Rheumatoid Arthritis: Week 156 Results from a Long-term Extension Study
Maya Buch¹, Daniel Aletaha², Roberto F. Caporali³, Bernard G. Combe⁴, Hendrik Schulze-Koops⁵, Jacques-Eric Gottenberg⁶, Yoshiya Tanaka⁷, Ricardo Blanco⁸, Tsutomu Takeuchi⁹, Edmund V. Ekoka Omoruyi¹⁰, Katrien Van Beneden¹¹, Vijay Rajendran¹², Chris Watson¹³, Francesco De Leonardis¹⁴ and Paul Emery¹⁵, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, Wien, Austria, ³Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milano, Italy, ⁴Department of Rheumatology, Montpellier University, Montpellier, France, ⁵Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig-Maximilians–University Munich, Munich, Germany, ⁶Rheumatology Department, Strasbourg University Hospital, Strasbourg, France, ⁷University of Occupational and Environmental Health, Kitakyushu, Japan, ⁸Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain, ⁹Keio University School of Medicine and Saitama Medical University, Tokyo, Japan, ¹⁰Biostatistics, Galapagos NV, Mechelen, Belgium, ¹¹Medical Safety, Galapagos NV, Mechelen, Belgium, ¹²Clinical Research, Galapagos NV, Mechelen, Belgium, ¹³Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹⁴Medical Affairs, Galapagos GmbH, Basel, Switzerland, ¹⁵Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Background/Purpose: In the treatment of RA, JAK inhibitors are a valuable option to meet remission or low disease activity (LDA) treatment targets following an inadequate…
Abstract Number: 0360 • ACR Convergence 2023
Increasing the Etanercept Dose in Juvenile Idiopathic Arthritis Patients: Does It Help Reaching the Treatment Target? A Post-hoc Analysis of the Best4Kids Randomised Clinical Trial
Bastiaan van Dijk¹, Sytske Anne Bergstra¹, Merlijn van den Berg², Dieneke Schonenberg-Meinema², Lisette van Suijlekom-Smit², Marion van Rossum³, Yvonne Koopman⁴, Rebecca Ten Cate¹, CF Allaart¹, Danielle Brinkman¹ and Petra Hissink Muller¹, ¹Leiden University Medical Center, Leiden, Netherlands, ²Emma Children's Hospital, Amsterdam University Medical Centers, Amsterdam, Netherlands, ³Amsterdam Rheumatology and Immunology Center | Reade, Amstelveen, Netherlands, ⁴HagaZiekenhuis Juliana Children's Hospital, The Hague, Netherlands
Background/Purpose: The relation between etanercept dose and clinical outcomes of juvenile idiopathic arthritis (JIA) is unclear. Most studies only evaluated doses up to 0.8 mg/kg/week…
Abstract Number: 0835 • ACR Convergence 2023
Abatacept in Individuals at Risk of Developing Rheumatoid Arthritis: Results from the Arthritis Prevention in the Pre-clinical Phase of RA with Abatacept (APIPPRA) Trial
Andrew Cope¹, Marianna Jasenecova², Joana Vasconcelos³, Andrew Filer⁴, Karim Raza⁵, Sumera Qureshi², Maria Antonietta D'Agostino⁶, Iain McInnes⁷, John Isaacs⁸, Arthur Pratt⁹, Benjamin A Fisher⁴, Christopher Buckley¹⁰, Paul Emery¹¹, Pauline Ho¹², Maya Buch¹³, Coziana Ciurtin¹⁴, René Toes¹⁵, Thomas Huizinga¹⁵, Dirkjan van Schaardenburg¹⁶, Caroline Caroline¹⁷ and Toby Prevost³, ¹King's College London, London, United Kingdom, ²Centre for Rheumatic Diseases, King's College London, London, United Kingdom, ³Nightingale-Saunders Clinical Trials & Epidemiology Unit, King's College London, London, United Kingdom, ⁴University of Birmingham, Birmingham, United Kingdom, ⁵Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom, ⁶Division of Rheumatology - Catholic University of the Sacred Heart, Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy, ⁷University of Glasgow, Glasgow, United Kingdom, ⁸Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom, ⁹Translational & Clinical Research Institute, University of Newcastle, Newcastle, United Kingdom, ¹⁰University of Oxford, Oxford, United Kingdom, ¹¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ¹²Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom, ¹³University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ¹⁴Centre for Rheumatology Research, University College London, London, United Kingdom, ¹⁵Leiden University Medical Center, Leiden, Netherlands, ¹⁶Reade, Amsterdam, Netherlands, ¹⁷King's Clinical Trials Unit, King's College London, London, United Kingdom
Background/Purpose: The definition of higher risk states for rheumatoid arthritis (RA) has been refined in more recent years through inclusion of serum autoantibodies and symptom…
Abstract Number: 1612 • ACR Convergence 2023
Design and Validation of a Comparator for Randomized Controlled Trials of a Digital Cognitive Behavioral Therapy
Michael Gendreau¹, Yifei Dai², Michael Rosenbluth³, David Williams⁴ and Daniel Clauw⁵, ¹Gendreau Consulting, LLC, Poway, CA, ²Swing Therapeutics, Gainesville, FL, ³Swing Therapeutics, San Francisco, CA, ⁴Chronic Pain and Fatigue Research Center, Department of Anesthesiology, University of Michigan, Ann Arbor, MI, ⁵Department of Anesthesiology, University of Michigan, Ann Arbor, MI
Background/Purpose: The use of a control arm (comparator) in randomized controlled trials (RCTs) is considered the gold standard for trial conduct and interpretation. Choosing an…
Abstract Number: 2144 • ACR Convergence 2023
Pharmacodynamic Effects of Nipocalimab in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA): Results from the Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2A IRIS-RA Study
Rohit Panchakshari¹, Matthew Loza², Thomas Huizinga³, Georg Schett⁴, Keying Ma², Jocelyn H. Leu², Sophia G. Liva², Fowzia Ibrahim⁵, Bei Zhou⁶, Qingmin Wang², Ricardo Rojo Cella², Chetan S. Karyekar², Kaiyin Fei², Carolyn Cuff⁷ and Sheng Gao², ¹Janssen Research & Development, LLC, La Jolla, CA, ²Janssen Research & Development, LLC, Spring House, PA, ³Leiden University Medical Center, Leiden, Netherlands, ⁴Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, ⁵Janssen Research & Development, LLC, High Wycombe, United Kingdom, ⁶Janssen Research & Development, LLC, Chesterbrook, PA, ⁷Janssen Research & Development, LLC, Cambridge, MA
Background/Purpose: Nipocalimab is a fully human, immunoglobulin G (IgG) 1 monoclonal antibody that blocks the neonatal crystallizable fragment receptor (FcRn), thereby lowering IgG levels. RA…
Abstract Number: 0406 • ACR Convergence 2023
Obesity Is a Risk Factor for Poor Response to Treatment in Early Rheumatoid Arthritis – a NORD-STAR Spin-Off Study
Violetta Dubovyk¹, Gerdur Maria Grondal², Bjorn Gudbjornsson³, Espen A Haavardsholm⁴, Marte Schrumpf Heiberg⁴, Merete Hetland⁵, Kim Hørslev-Petersen⁶, Meliha Kapetanovic⁷, Alf Kastbom⁸, John Lampa⁹, Kristina Lend¹⁰, Dan Nordstrom¹¹, Michael Nurmohamed¹², Milad Rizk¹³, Annika Söderbergh¹⁴, Till Uhlig¹⁵, Mikkel Østergaard¹⁶, Ronald van Vollenhoven¹², Anna Rudin¹⁷ and Cristina Maglio¹⁸, ¹University of Gothenburg, Gothenburg, Sweden, ²Department for Rheumatology, Landspitali University Hospital, Reykjavik, Iceland, ³Centre for Rheumatology Research, University Hospital, Reykjavik, Iceland, ⁴Diakonhjemmet Hospital, Oslo, Norway, ⁵Copenhagen Center for Arthritis Research, Rigshospitalet, Copenhagen, Denmark, ⁶University of Southern Denmark, Odense, Denmark, ⁷Lund University and Skåne University Hospital, Lund, Sweden, ⁸Linköping University, Linköping, Sweden, ⁹Stockholm County, Hãsselby, Sweden, ¹⁰Amsterdam UMC, Karolinska Institute, Stockholm, Sweden, ¹¹Helsinki University Hospital, Helsinki, Finland, ¹²Amsterdam University Medical Centers, Amsterdam, Netherlands, ¹³Västmanlands Hospital Västerås, Västerås, Sweden, ¹⁴Örebro University Hospital, Örebro, Sweden, ¹⁵Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway, ¹⁶Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet; University of Copenhagen, Copenhagen, Denmark, ¹⁷Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, ¹⁸Institute of Medicine, University of Gothenburg, Gothenburg, Sweden
Background/Purpose: Several therapeutic options are currently available to treat rheumatoid arthritis (RA); however, the response to treatment is highly variable, and not all patients achieve…
Abstract Number: 0839 • ACR Convergence 2023
Efficacy and Safety of Nipocalimab in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA): The Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2a IRIS-RA Study
Peter C. Taylor¹, Georg Schett², Fowzia Ibrahim³, Bei Zhou⁴, Jocelyn H. Leu⁵, Sophia G. Liva⁵, Qingmin Wang⁵, Ricardo Rojo Cella⁵, Chetan S. Karyekar⁵ and Kaiyin Fei⁵, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, ³Janssen Research & Development, LLC, High Wycombe, United Kingdom, ⁴Janssen Research & Development, LLC, Chesterbrook, PA, ⁵Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: RA is a chronic inflammatory disease associated with autoantibodies. Despite the use of targeted therapies, up to half of patients fail to achieve remission…
Abstract Number: 1634 • ACR Convergence 2023
Iscalimab (CFZ533) in Patients with Sjögren’s Disease: Week 24 Efficacy and Safety Results of a Randomized, Placebo-controlled, Phase 2b Dose-ranging Study
Benjamin A Fisher¹, Xavier Mariette², Athena S Papas³, Thomas Grader-Beck⁴, Hendrika Bootsma⁵, Wan-Fai Ng⁶, Paul Van Daele⁷, Stephanie Finzel⁸, Sergio Elgueta⁹, Josef Hermann¹⁰, Sara McCoy¹¹, Arthur Bookman¹², Monika Sopala¹³, Wen-Lin Luo¹⁴, Cornelia Scheurer¹³ and Wolfgang Hueber¹³, ¹University of Birmingham, Birmingham, United Kingdom, ²Université Paris-Saclay, Le Kremlin-Bicêtre, France, ³Division of Oral Medicine, Tufts School of Dental Medicine, Boston, MA, ⁴Division of Rheumatology, Johns Hopkins School of Medicine, Baltimore, MD, ⁵Department of Rheumatology, University Medical Centre Groningen, Groningen, Netherlands, ⁶NIHR Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom, ⁷Department of internal medicine, Erasmus MC, Rotterdam, Netherlands, ⁸Department of Rheumatology and Clinical Immunology, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany, ⁹Clinical Research Chile SpA, Biomedical Research Centre, Valdivia, Chile, ¹⁰Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University Graz, Graz, Austria, ¹¹University of Wisconsin School of Medicine and Public Health, Middleton, WI, ¹²Toronto Western Hospital, Toronto, ON, Canada, ¹³Novartis Pharma AG, Basel, Switzerland, ¹⁴Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: Sjögren's disease (SjD) is an autoimmune disease affecting secretory glands and other organs with no approved systemic treatments. Iscalimab (CFZ533) is a mAb directed…
Abstract Number: 2151 • ACR Convergence 2023
Effects of Methotrexate on Blood Pressure in Rheumatoid Arthritis: A Randomized Controlled Trial
Sara Tommasi¹, Richard Woodman¹, Michael Wiese², Michael Shanahan¹ and Arduino Mangoni¹, ¹Flinders University, Adelaide, Australia, ²University of South Australia, Adelaide, Australia
Background/Purpose: Treatment with methotrexate (MTX) has been shown to be associated with lower cardiovascular risk and lower blood pressure (BP) compared with other disease modifying…
Abstract Number: 0439 • ACR Convergence 2023
Humoral Immune Response to 13 Valent-conjugate and 23-valent Polysaccharide Pneumococcal Vaccines in RA Patients Treated with Abatacept: Results of the Open Randomized Controlled Trial VACINA (Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients)
JACQUES MOREL¹, Olivier Brocq², Cécile Gaujoux Viala³, Arnaud Constantin⁴, Slim Lassoued⁵, Emanuelle Dernis⁶, Christophe Richez⁷, Cedric Lukas⁸, Claire Daien⁹ and Claire Duflos¹⁰, ¹Protocole thérapeutique immuno-rhumatologie, Montpellier, France, ²Hospital of Princesse Grâce de Monaco, Monaco, Monaco, ³IDESP Univ Montpellier, INSERM, Rheumatology, CHU Nîmes, Montpellier, France, ⁴Teaching hospital Purpan, and University of Paul Sabatier, Toulouse, France, ⁵Hospital of Jean-Rougié, Cahors, France, ⁶CH Le Mans, Le Mans, France, ⁷Université de Bordeaux, Bordeaux, France, ⁸CHU Montpellier, Montpellier, France, ⁹University Hospital, Montpellier, France, ¹⁰CHU and University of Montpellier, Montpellier, France
Background/Purpose: To prevent infections, EULAR recommends to vaccinate RA patients against streptococcal pneumoniae. PCV13 is a T- cell dependent vaccine whereas PPSV23 induces a T-independent…
Abstract Number: 0840 • ACR Convergence 2023
Head-to-Head Comparison of TLL-018 and Tofacitinib in Patients with Active Rheumatoid Arthritis: Final Results from a Phase IIa Study
Xiaofeng Zeng¹, chanyuan wu², Jiankang Hu³, SHENGYUN LIU⁴, Zhenyu Jiang⁵, Jingyang Li⁶, Xiaoxia Wang⁷, Ju Liu⁸, Chaofan Yuan⁹, Guang Yang¹⁰ and Chris Liang¹⁰, ¹Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, ²Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, ³Pingxiang People’s Hospital, PingXiang, China, ⁴The First Affiliated Hospital Of Zhengzhou University, Zhengzhou, China, ⁵The First Hospital of Jilin University, Changchun, China, ⁶Zhuzhou Central Hospital, Zhuzhou, China, ⁷Second Hospital of Shanxi Medical University, Taiyuan, China, ⁸Jiujiang No. 1 People’s Hospital, JiuJiang, China, ⁹Hangzhou Highlightll Pharmaceutical Co., Ltd, Beijing, China, ¹⁰Hangzhou Highlightll Pharmaceutical Co., Ltd, HangZhou, China
Background/Purpose: None of the currently approved treatments for rheumatoid arthritis (RA) can achieve ACR50 in >50% of the patients, and 5 – 20% of the…

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