Abstracts tagged "Randomized Trial"

Abstract Number: 1515 • ACR Convergence 2023
Performance of the Revised CRISS in a Phase 3 Trial of Early Systemic Sclerosis
Dinesh Khanna¹, Christopher Denton², Masataka Kuwana³, Daniel Furst⁴, Suiyuan Huang¹, Barbara White⁵ and Robert Spiera⁶, ¹University of Michigan, Ann Arbor, MI, ²University College London, London, United Kingdom, ³Nippon Medical School Graduate School of Medicine, Tokyo, Japan, ⁴University of California Los Angeles, Los Angeles, CA, ⁵SFJ Pharmaceuticals, Towson, MD, ⁶Hosptial for Special Surgery, New York, NY
Background/Purpose: Revised CRISS has been proposed an approvable outcome measure in early diffuse cutaneous SSc (dcSSc)1. The index is undergoing the FDA review as part…
Abstract Number: 2113 • ACR Convergence 2023
Impact of Sociodemographic Factors on Efficacy and Safety of Tofacitinib in Patients with Rheumatoid Arthritis: A Post Hoc Analysis of Phase 2/3/3b/4 Studies
Grace Wright¹, Eduardo Mysler², Kevin Roberts³, Lindsay Sweet⁴ and Ahmed Shelbaya⁵, ¹Grace C Wright MD PC, New York, NY, ²Organizacion Medica de Investigacion, Buenos Aires, Argentina, ³Pfizer Inc., Cambridge, MA, ⁴Pfizer Inc., Collegeville, PA, ⁵Pfizer Inc., New York, NY
Background/Purpose: Sociodemographic factors can impact treatment response and safety outcomes in patients (pts) with RA. Here, we explore the impact of sociodemographic index (SDI) on…
Abstract Number: 0624 • ACR Convergence 2023
Outcomes in Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) Based on Serological Profiles: Focus on Anti-Centromere Antibody (ACA) and Anti-RNA Polymerase III (ARA) Antibodies
Elizabeth Volkmann¹, Shervin Assassi², Christopher Denton³, Rozeta Simonovska⁴, Steven Sambevski⁵ and Elana Bernstein⁶, ¹University of California Los Angeles, Los Angeles, CA, ²University of Texas McGovern Medical School at Houston, Houston, TX, ³University College London, London, United Kingdom, ⁴Mainanalytics GmbH, Sulzbach (Taunus), Sulzbach, Germany, ⁵Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, ⁶Division of Rheumatology, Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY
Background/Purpose: Autoantibody profiles are associated with organ involvement and outcomes in patients with SSc. Anti-topoisomerase I antibody (ATA) positivity has been associated with a greater…
Abstract Number: 1566 • ACR Convergence 2023
Exposure-Response Analysis of Sarilumab in Patients with Polymyalgia Rheumatica
Christine Xu¹, Ying Liu¹, Jennifer Sloane², Remco Diab³, Hubert van Hoogstraten¹, Hisham Abdallah⁴, Sreeraj Macha¹ and Bhaskar Dasgupta⁵, ¹Sanofi, Bridgewater, NJ, ²Sanofi, Cambridge, MA, ³Sanofi, Rotkreuz, Switzerland, ⁴Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁵Anglia Ruskin University, East Anglia, United Kingdom
Background/Purpose: Sarilumab blocks interleukin-6 (IL-6) from binding to the membrane-bound and soluble IL-6 receptor-α subunit (IL-6Rα). Sarilumab is now approved for both rheumatoid arthritis (RA)…
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…

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