Abstracts tagged "clinical trial"

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: 126 • 2023 Pediatric Rheumatology Symposium
Facilitating Peer-to-Peer Conversations Around Key Clinical Trial Recruitment Barriers in the Limit-JIA Trial Using Low-Fidelity Video Capture
Melanie Kohlheim¹, Eveline Wu², Laura Schanberg³, Vincent Del Gaizo¹, Catherine Lavallee⁴, Marc Natter⁵, Katie Clem⁶, Brian Shakley⁶ and Kevin Urban⁷, ¹CARRA, Washington, DC, ²UNC Chapel Hill, Chapel Hill, NC, ³Duke University Medical Center, Durham, NC, ⁴Virginia Tech Carilion School of Medicine, ROANOKE, VA, ⁵Boston Children's Hospital, Boston, MA, ⁶LIFT 1428, Llc, Ooltewah, TN, ⁷Business Coaching for Creatives, New York, NY
Background/Purpose: The LIMIT-JIA trial aims to study if early abatacept treatment can prevent disease extension in children with recent-onset, uncomplicated, and oligoarticular or limited JIA.…
Abstract Number: 010 • 2023 Pediatric Rheumatology Symposium
Remotely Delivered Psychological Intervention May Be Beneficial to Youth with Childhood-Onset Lupus: A Preliminary Investigation
Natoshia Cunningham¹, Michelle Adler², Ashley Danguecan³, Mallet Reid², Samantha Ely⁴, Mathew Reeves², Lawrence Ng³, Paris Moaf³, Sarah Mossad³, Tala El Tal³, Luana Flores Pereira³, Deborah Levy³, Linda Hiraki³, Jennifer Stinson³, Sarah Ahola Kohut³, Khalid Abulaban⁵, Elizabeth Kessler⁵, Stacy Allen⁵, Tamar Rubinstein⁶, Evin Rothschild⁶, Natalie Rosenwasser⁷, Kabita Nanda⁷, Susan Canny⁷, Emily Smitherman⁸, Livie Huie⁸, James Birmingham⁹, Allison Thompson¹⁰, Janel Thompson¹⁰, Miranda Moyer¹⁰, Emily Nguyen¹⁰, Angela Chapson¹⁰ and Andrea Knight³, ¹Michigan State University, Grand Rapids, MI, ²Michigan State University, East Lansing, ³The Hospital for Sick Children, Toronto, ON, Canada, ⁴Wayne State University, Michigan State University, Detroit, MI, ⁵Helen DeVos Children's Hospital, Grand Rapids, MI, ⁶Children's Hospital at Montefiore, New York, NY, ⁷Seattle Children's Hospital, Seattle, WA, ⁸University of Alabama at Birmingham, Birmingham, AL, ⁹Metro Health, Cleveland, ¹⁰Patient Co-Investigative Team
Background/Purpose: Childhood-onset systemic lupus erythematosus (cSLE) is associated with fatigue, pain, and depressive symptoms that adversely impact health-related quality of life. The Treatment and Education…
Abstract Number: L02 • ACR Convergence 2022
Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3, Randomized, Placebo-Controlled, Active Reference Study
Christopher Ritchlin¹, Laura Coates², Iain McInnes³, Philip J. Mease⁴, Joseph Merola⁵, Yoshiya Tanaka⁶, Akihiko Asahina⁷, Laure Gossec⁸, Alice Gottlieb⁹, Diamant Thaci¹⁰, Barbara Ink¹¹, Deepak Assudani¹¹, Rajan Bajracharya¹¹, Vish Shende¹¹, Jason Coarse¹² and Robert Landewé¹³, ¹University of Rochester Medical Center, Rochester, NY, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, United Kingdom, ³College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom, ⁴Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁵Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, ⁶University of Occupational and Environmental Health Japan, Kitakyushu, Japan, ⁷Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan, ⁸Sorbonne Universités, UPMC Univ Paris 06, GRC-UPMC 08 (EEMOIS); AP-HP, Hôpital Pitié Salpêtrière, Rheumatology Department, Paris, France, Paris, France, ⁹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ¹⁰Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, ¹¹UCB Pharma, Slough, United Kingdom, ¹²UCB Pharma, Raleigh, NC, ¹³Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, and Zuyderland MC, Heerlen, Netherlands
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. BKZ treatment has demonstrated superior efficacy in joints and…
Abstract Number: L06 • ACR Convergence 2022
Risk of Extended Major Adverse Cardiovascular Event Endpoints with Tofacitinib vs TNF Inhibitors in Patients with Rheumatoid Arthritis: A Post Hoc Analysis of a Phase 3b/4 Randomized Safety Study
Maya H. Buch¹, Deepak L. Bhatt², Christina Charles-Schoeman³, Jon T. Giles⁴, Ted R. Mikuls⁵, Gary Koch⁶, Steven Ytterberg⁷, Edward Nagy⁸, Hyejin Jo⁹, Kenneth Kwok⁹, Carol A. Connell¹⁰, Karim R. Masri¹¹ and Arne Yndestad¹², ¹Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Division of Cardiovascular Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, ³Division of Rheumatology, Department of Medicine, University of California, Los Angeles, CA, ⁴Division of Rheumatology, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, ⁵Division of Rheumatology, University of Nebraska Medical Center and VA Nebraska-Western Iowa Health Care System, Omaha, NE, ⁶Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁷Division of Rheumatology, Mayo Clinic, Rochester, MN, ⁸Pfizer Ltd, Tadworth, Surrey, United Kingdom, ⁹Pfizer Inc, New York, NY, ¹⁰Pfizer Inc, Groton, CT, ¹¹Pfizer Inc, Collegeville, PA, ¹²Pfizer Inc, Oslo, Norway
Background/Purpose: ORAL Surveillance (NCT02092467; a post-authorization safety study of tofacitinib 5 and 10 mg twice daily [BID] vs TNF inhibitors [TNFi]) found higher risk of…
Abstract Number: L07 • ACR Convergence 2022
Telitacicept, a Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), in Systemic Lupus Erythematosus (SLE): Results of a Phase 3 Study
Di Wu¹, Jing Li¹, Dong Xu¹, Li Wang¹, Jianmin Fang², Dan Ross³ and Fengchun Zhang⁴, ¹Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China, Beijing, China, ²Shanghai Tongji Hospital, Tongji University, Shanghai 200065, China School of Life Science and Technology, Tongji University, Shanghai 200092, China, Shanghai, China, ³RemeGen Co., San Diego, CA, ⁴Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China; Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China, Beijing, China
Background/Purpose: Telitacicept is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor…

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