Abstracts tagged "clinical trial"

Abstract Number: 1614 • ACR Convergence 2023
Therapy Combining Millimeter Wave-based Neuromodulation with Coaching for the Improvement in Quality of Life of Patients with Fibromyalgia: A Prospective, Multicenter, Randomized, Controlled Trial
Caroline Maindet¹, Anne Dumolard², Mélanie Veloso², Mario Barmaki³, Rodrigue Deleens⁴, Raphaël Gonon-Demoulian⁵, Alberta Lorenzi-Pernot⁶, Mireille Michel-Cherqui⁷, Alain Serrie⁸, Stanislas Velliet⁹ and Jean-Luc Bosson², ¹University Hospital Grenoble Alpes, Grenoble, France, ²Grenoble Alpes University Hospital, Grenoble, France, ³Médipôle Lyon Villeurbanne, Lyon, France, ⁴Rouen University Hospital, Rouen, France, ⁵Montpellier University Hospital, Montpellier, France, ⁶Neurology private practice, Mornant, France, ⁷Foch hospital, Suresnes, France, ⁸Paris University Hospital, Paris, Guinea, ⁹Valenciennes hospital, Valenciennes, France
Background/Purpose: Fibromyalgia is a chronic syndrome with symptoms of moderate to severe intensity, including diffuse pain, fatigue, sleep disturbance, and cognitive impairment. While first-line recommendation…
Abstract Number: 2055 • ACR Convergence 2023
A Randomized Controlled Trial of Two Hepatitis a Vaccine Doses Among Adolescents with Juvenile Idiopathic Arthritis and Crohn’s Disease on Immunosuppressive Therapy: A Pilot Study
Racheal Githumbi¹, Susan Kuhn¹, Carla Osiowy², Jennifer DeBruyn¹, Marvin Fritzler¹, Nicole Johnson¹, Otto G Vanderkooi¹ and Heinrike Schmeling¹, ¹University of Calgary, Calgary, AB, Canada, ²National Microbiology Laboratory, Public Health Agency of Canada, Winnepig, MB, Canada
Background/Purpose: Juvenile idiopathic arthritis (JIA) and Crohn's disease (CD) are now controlled using immunosuppressive medications. However, disease control comes at the risk of increased infection.…
Abstract Number: 2326 • ACR Convergence 2023
Efficacy and Safety of Voclosporin in Patients with Proteinuria > 2 G/g
Emily Littlejohn¹, Salem Almaani², Vanessa Birardi³, Ernie Yap⁴ and Christopher Collins⁵, ¹Cleveland Clinic, Cleveland, OH, ²Ohio State University Medical Center, Columbus, OH, ³Aurinia Pharmaceuticals Inc, Edmonton, AB, Canada, ⁴Aurinia Pharmaceuticals Inc., Edmonton, AB, Canada, ⁵Formerly Aurinia Pharmaceuticals Inc., Copenhagen, Denmark
Background/Purpose: Proteinuria is the most common manifestation of lupus nephritis and is a mediator of progressive kidney damage. Early reductions in urine protein creatinine ratio…
Abstract Number: 2545 • ACR Convergence 2023
Efficacy and Safety of Intravenous Secukinumab for the Treatment of Active Axial Spondyloarthritis: Results from a Randomized, Double-Blind, Phase 3 Study
Atul Deodhar¹, Jerzy Supronik², Alan Kivitz³, Guillermo Valenzuela⁴, Karen Kapur⁵, Susanne Rohrer⁶, Eva Dokoupilova⁷, Hanno Richards⁶ and Karel Pavelka⁸, ¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ²OsteoMedic sc A Racewicz J Supronik, Bialystok, Poland, ³Altoona Center for Clinical Research, Duncansville, PA, ⁴Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁵Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁶Novartis Pharma AG, Basel, Switzerland, ⁷Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology; MEDICAL PLUS sro, Brno, Czech Republic, ⁸Institut of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Praha, Czech Republic
Background/Purpose: While subcutaneous secukinumab (SEC) is approved for the treatment of axial spondyloarthritis (axSpA), some patients may benefit more from intravenous (IV) administration. This study…
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: 0817 • ACR Convergence 2023
Comparative Effectiveness of Yoga and Strengthening Exercise for Treating Knee OsteoArthritis: A Randomised Controlled Trial (YOGA Trial)
Bedru Abafita¹, Ambrish Singh¹, Dawn Aitken¹, Steffany Moonaz², Andrew J Palmer¹, Leigh Blizzard¹, Changhai Ding¹, Stan Drummen¹, Graeme Jones³, Kim Bennell⁴ and Benny Samuel Antony¹, ¹Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia, ²Department of Clinical and Health Services Research, Southern California University of Health Sciences, Whittier, CA, ³Menzies Institute for Medical Research, University of Tasmania, Melbourne, Australia, ⁴University of Melbourne, Melbourne, Australia
Background/Purpose: There is uncertainty about the best type of exercise to optimise outcomes for people with knee osteoarthritis (OA). Strengthening exercise is commonly recommended. However,…
Abstract Number: 1265 • ACR Convergence 2023
Changes in the Endocannabinoid Tone in Rheumatoid Arthritis and Osteoarthritis – Discovery of a Novel Target for the Treatment of Pain and Inflammation?
Jost Klawitter¹, Andrew Clauw¹, Jennifer Seifert¹, Jelena Klawitter¹, Bridget Tompson¹, Cristina Sempio¹, Uwe Christians¹ and Larry Moreland², ¹University of Colorado Anschutz Medical Campus, Aurora, CO, ²University of Colorado, Denver, CO

Background/Purpose: Inflammation is a complicated physiological process that results in a variety of disorders. Several inflammatory mediators are produced during this process, which is responsible…
Abstract Number: 1435 • ACR Convergence 2023
Long-Term Efficacy and Safety of Risankizumab for CsDMARD-IR Patients with Active Psoriatic Arthritis: 148-Week Results from the KEEPsAKE 1 Trial
Lars Erik¹, Mauro Keiserman², Kim A Papp³, Leslie McCasland⁴, Douglas White⁵, Vassilis Stakias⁶, Thomas Iyile⁶, Kyle Carter⁶, Ahmed Soliman⁶, Leonidas Drogaris⁶, Michael Chen⁶, Byron Padilla⁶ and Frank Behrens⁷, ¹Bispebjerg-Frederiksberg Hospital, Vedbæk, Denmark, ²Pontifical Catholic University School of Medicine, Porto Alegre, Brazil, ³Alliance Clinical Research and Probity Medical Research, Waterloo, and University of Toronto, Toronto, ON, Canada, ⁴Arthritis and Rheumatism Associates, Jonesboro, AR, ⁵Waikato Clinical School, University of Auckland, Hamilton, New Zealand, ⁶AbbVie, Inc., North Chicago, IL, ⁷Goethe-University & Fraunhofer ITMP, Frankfurt, Germany
Background/Purpose: Risankizumab (RZB), a humanized immunoglobulin G1 monoclonal antibody that inhibits interleukin-23 by targeting its p19 subunit with high affinity and specificity, is approved for…
Abstract Number: 1633 • ACR Convergence 2023
Dose Dependent Modulation of a B Cell Protein Signature by Ianalumab in Patients with Sjögren’s Disease
Stephanie Finzel¹, Andrea Grioni², Benjamin A Fisher³, Athena S Papas⁴, Alexandre Avrameas², Danny Tuckwell², Jonas Zierer², Celine Rauld², Valeria De Luca², Enrico Ferrero², Andre Nogueira da Costa², Rainer Hillenbrand², Isabelle Isnardi² and Wolfgang Hueber², ¹Department of Rheumatology and Clinical Immunology, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany, ²Novartis Pharma AG, Basel, Switzerland, ³University of Birmingham, Birmingham, United Kingdom, ⁴Division of Oral Medicine, Tufts School of Dental Medicine, Boston, MA
Background/Purpose: Ianalumab (VAY736) is an afuscosylated monoclonal antibody targeting the B cell activating factor receptor (BAFFR) that depletes B cells via enhanced antibody dependent cellular…
Abstract Number: 2063 • ACR Convergence 2023
Training to Increase Minority Enrollment in Lupus Clinical Trials with CommunitY Engagement (TIMELY): Assessing Behavioral Predictors of Clinical Trial Referrals Among Healthcare Providers
Saira Sheikh¹, Tessa Englund¹, Andrew Simkus², Nicole Wanty³, Annie McNeill⁴, Kristen Holtz⁴, Tenesha Hood⁵, Starla Blanks⁶, Maria Allen⁷ and Allen Anandarajah⁷, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²KDH Research & Communication, Asheville, NC, ³KDH Research & Communication, Marietta, GA, ⁴KDH Research & Communication, Atlanta, GA, ⁵ACR, Atlanta, GA, ⁶American College of Rheumatology, Atlanta, GA, ⁷University of Rochester Medical Center, Rochester, NY
Background/Purpose: The aim of this study is to assess outcomes among healthcare providers in the American College of Rheumatology's (ACR) Training to Increase Minority Enrollment…
Abstract Number: 2330 • ACR Convergence 2023
Disease-Related Outcomes of Cognitive Behavioral Therapy in Randomized Control Trial for Youth with Childhood-onset SLE: A Secondary Analysis
Natoshia Cunningham¹, Michelle Adler¹, Ashley Danguecan², Mallet Reid¹, Samantha Ely³, Mathew Reeves⁴, Lawrence Ng², Paris Moaf², Tala El Tal⁵, Sarah Mossad², Luana Flores Pereira², Deborah Levy², Linda Hiraki², Jennifer Stinson², Sara Ahola Kohut², khalid abulaban⁶, Elizabeth Kessler⁷, Stacy Allen⁸, Tamar Rubinstein⁹, Evin Rothschild¹⁰, Natalie Rosenwasser¹¹, Kabita Nanda¹², Susan Canny¹³, Emily Smitherman¹⁴, Livie Huie¹⁵, James Birmingham¹⁶, Ekemini Ogbu¹⁷, Hermine Brunner¹⁸, Dhriti Sharma¹⁹, Allison Thompson²⁰, Janel Thompson²¹, Miranda Moyer²⁰, Emily Nguyen²⁰, Angela Chapson²⁰ and Andrea Knight², ¹Michigan State University, Grand Rapids, MI, ²The Hospital for Sick Children, Toronto, ON, Canada, ³Michigan State University, Wayne State University, Grand Rapids, MI, ⁴Michigan State University, East Lansing, MI, ⁵Children's Hospital of Eastern Ontario (CHEO), Ottawa, ON, Canada, ⁶Helen DeVos Children's Hospital, Ada, MI, ⁷Spectrum Health, Grand Rapids, MI, ⁸Helen DeVos Children's Hospital, Caledonia, MI, ⁹Albert Einstein College of Medicine, Children's Hospital at Montefiore, White Plains, NY, ¹⁰Albert Einstein Medical Center, Children's Hospital at Montefiore, Bronx, NY, ¹¹Seattle Children's Hospital, Seattle, WA, ¹²Seattle Children's Hospital/University of Washington, Seattle, WA, ¹³Seattle Children's Hospital/University of Washington, Seattle, WA, ¹⁴University of Alabama at Birmingham, Birmingham, AL, ¹⁵University of Alabama at Birmingham, Gardendale, AL, ¹⁶Self, Ada, MI, ¹⁷Cincinnati Children's Hospital Medical Center, University of Cincinnati School of Medicine, Johns Hopkins University, Cincinnati, OH, ¹⁸Cincinnati Children's Hospital Medical Center, Division of Rheumatology, Cincinnati, OH, ¹⁹Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ²⁰Patient Co-Investigative Team, n/a, ²¹Patient Co-Investigative Team, Revere, PA
Background/Purpose: Childhood-onset systemic lupus erythematosus (cSLE) is associated with symptoms such as fatigue, pain, and depressive symptoms that contribute to poor health-related quality of life.…
Abstract Number: 2548 • ACR Convergence 2023
Low Uveitis Rates in Patients with Axial Spondyloarthritis Treated with Bimekizumab: Pooled Results from Phase 2b/3 Trials
Martin Rudwaleit¹, Matthew A. Brown², Floris Van Gaalen³, Nigil Haroon⁴, Lianne Gensler⁵, Carmen Fleurinck⁶, Alexander Marten⁷, Ute Massow⁸, Natasha De Peyrecave⁹, Thomas Vaux¹⁰, Katy White¹⁰, Atul Deodhar¹¹ and Irene van der Horst-Bruinsma¹², ¹University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany, ²Genomics England, London, United Kingdom, ³Leiden University Medical Center, Department of Rheumatology, Leiden, Netherlands, ⁴University of Toronto, University Health Network, Schroeder Arthritis Institute, Department of Medicine/Rheumatology, Toronto, ON, Canada, ⁵University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ⁶UCB Pharma, Oosterzele, Belgium, ⁷UCB Pharma, Monheim, Germany, ⁸UCB Pharma, Monheim am Rhein, Germany, ⁹UCB Pharma, Brussels, Belgium, ¹⁰UCB Pharma, Slough, United Kingdom, ¹¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ¹²Radboud University Medical Centre, Department of Rheumatology, Nijmegen, Netherlands
Background/Purpose: Acute anterior uveitis ('uveitis'), or 'iritis', is a common extra-musculoskeletal manifestation among patients (pts) with axial spondyloarthritis (axSpA).1 IL-17 has been implicated in the…
Abstract Number: 0480 • ACR Convergence 2023
Non-random Sampling in Rheumatology Randomized Controlled Trials: Evidence of Concerning Trial Conduct?
Victoria Le¹, Mats Junek², Mike Putman³, Maximilian Casey¹, Kenrick Manswell¹, Jay Goldsher¹, Elizabeth Nettleton¹, Desh Nepal¹ and Sanket Shah¹, ¹Medical College of Wisconsin, Milwaukee, WI, ²McMaster University, Hamilton, ON, Canada, ³Division of Rheumatology, Medical College of Wisconsin, Milwaukee, WI
Background/Purpose: Non-random sampling of baseline variables in randomized controlled trials (RCTs) may be due unintentional errors, stratified randomization strategies, or data fabrication. Prior studies have…
Abstract Number: 0818 • ACR Convergence 2023
Efficacy of XT-150, a Novel Non-Viral Gene Therapy Delivering IL-10v, on Moderate to Severe Pain Due to Osteoarthritis of the Knee: Results of a Phase 2 Trial
Eric Grigsby¹, Stephen D. Collins², Leonard Kapural³, Mark McBride⁴, Jayson Rieger⁵, Morgan Stokes⁶, Howard Rutman⁶ and Flavia Cicuttini⁷, ¹Neurovations Clinical Research, Napa, CA, ²Xalud Therapeutics, Inc., Chicago, IL, ³Center for Clinical Research, Winston-Salem, NC, ⁴Instat Clinical Research, Chatham, NJ, ⁵PBM Capital, Charlottesville, VA, ⁶Xalud Therapeutics, Inc., Berkeley, CA, ⁷Monash University, Melbourne, Australia
Background/Purpose: Interleukin (IL)-10 is a regulator of cytokine activity and has the potential to restore homeostasis in osteoarthritis (OA) of the knee. Unfortunately, relatively short…
Abstract Number: 1314 • ACR Convergence 2023
Safety Results from a Phase 1 Double-blind Randomized Clinical Trial of Allogeneic Mesenchymal Stem Cells in Early RA
Nora Singer¹, Maya Breitman², Maricela Haghiac², Larraine Gordesky³, Jane Reese⁴, Steven Lewis², Emma Barnboym², Noor Hussein⁵, Susan Lasalvia⁶, Elizabeth Mellins⁷, Tracey Bonfield⁸, Donald Anthony⁹, Arnold Caplan¹⁰ and Hillard Lazarus⁸, ¹The MetroHealth System at Case Western Reserve University School of Medicine, Cleveland, OH, ²The MetroHealth System at CWRU, Cleveland, OH, ³The MetroHealth System at CWRU and Louis Stokes Cleveland VA, Cleveland, OH, ⁴CWRU, University Hospitals of Cleveland, Cleveland, OH, ⁵Stanford University, Palo Alta, CA, ⁶The MetroHealth System, Cleveland, OH, ⁷Stanford University, Stanford, CA, ⁸CWRU and University Hospitals of Cleveland, Cleveland, OH, ⁹Case Western Reserve University, Cleveland VA Medical Center, The MetroHealth System, Cleveland, OH, ¹⁰CWRU, Center for Skeletal Biology, Cleveland, OH
Background/Purpose: The purpose of this study was to evaluate the safety of bone-marrow derived allogeneic mesenchymal stem cells (MSCs) as therapeutic agents in early rheumatoid…

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