Abstracts tagged "clinical trial"

Abstract Number: 2055 • ACR Convergence 2022
SRI-4 and BICLA: How Well Do They Agree Across Trials of Active Systemic Lupus Erythematosus?
Alfredo Aguirre¹, Mimi Kim², Kosalaram Goteti³, Ying Li³, Amy Kao⁴, Nathalie Franchimont⁵, George Kong⁵, Catherine Barbey⁶, Qing Zuraw⁷, Robert Gordon⁷, David Manner⁸, Maria Silk⁹, Teodora Staeva¹⁰, Hoang Nguyen¹¹, Richard Furie¹², Matthew Linnik¹³ and Maria Dall'Era¹⁴, ¹University of California, San Francisco, San Francisco, CA, ²Albert Einstein College of Medicine, Larchmont, NY, ³EMD Serono, Boston, MA, ⁴EMD Serono, Billerica, MA, ⁵Biogen, Cambridge, MA, ⁶Biogen, Baar, Switzerland, ⁷Janssen Research and Development, LLC, Spring House, PA, ⁸Eli Lilly and Company, Indianapolis, IN, ⁹Eli Lilly, Carmel, IN, ¹⁰Lupus Research Alliance, New York, NY, ¹¹Lupus Research Alliance, Houston, TX, ¹²Northwell Health, Great Neck, NY, ¹³Eli Lilly and Company, San Diego, CA, ¹⁴University of California, Division of Rheumatology, San Francisco, CA
Background/Purpose: The Systemic Lupus Erythematosus Responder Index 4 (SRI-4) and the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) are currently the most…
Abstract Number: 2212 • ACR Convergence 2022
Long-term Efficacy and Safety of Subcutaneous Tocilizumab in Patients with Polyarticular or Systemic Juvenile Idiopathic Arthritis – an Extension Study of 2 Phase 1b Clinical Trials
Hermine Brunner¹, Athimalaipet Ramanan², Gerd Horneff³, Kirsten Minden⁴, Inmaculada Calvo Penades⁵, Mauro Zucchetto⁶, Laura Brockwell⁷, Oliver Gordon⁷ and Fabrizio De Benedetti⁸, ¹Division of Rheumatology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Department of Pediatrics, Cincinnati, OH, ²Bristol Royal Hospital for Children, Bristol, United Kingdom, ³Pediatrics, Asklepios Klinik Sankt Augustin GmbH, Sankt Augustin, Germany, ⁴Charité Universitätsmedizin Berlin, Berlin, Germany, ⁵Pediatric Rheumatology Unit, Hospital Universitario y Politécnico La Fe, València, Spain, ⁶Parexel International, Milano, Italy, ⁷Roche Products Ltd, Welwyn Garden City, United Kingdom, ⁸Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesu', Rome, Italy
Background/Purpose: Dosing regimens for subcutaneous tocilizumab (SC-TCZ) in patients with polyarticular-course or systemic juvenile idiopathic arthritis (pJIA or sJIA) were determined for SC-TCZ in 2…
Abstract Number: 0140 • ACR Convergence 2022
Continued Treatment with Nintedanib in Patients with Progressive Fibrosing Autoimmune Disease-Related Interstitial Lung Diseases (ILDs): Data from INBUILD-ON
Eric Matteson¹, Danielle Antin-Ozerkis², Francesco Bonella³, Nazia Chaudhuri⁴, Vincent Cottin⁵, Heiko Müller⁶, Carl Coeck⁷, Klaus Rohr⁸ and Wim Wuyts⁹, ¹Mayo Clinic College of Medicine and Science, Rochester, MN, USA, Rochester, MN, ²Section of Pulmonary, Critical Care and Sleep Medicine, Yale University School of Medicine, New Haven, CT, ³Center for Interstitial and Rare Lung Diseases, Pneumology Department, Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany, ⁴North West Interstitial Lung Disease Unit, Manchester University Foundation Trust, Wythenshawe, Manchester, United Kingdom, ⁵Coordinating Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, University of Lyon, INRAE, Lyon, France, ⁶Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, Biberach, Germany, ⁷Boehringer Ingelheim SComm, Brussels, Brussels, Belgium, ⁸Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, ⁹Unit for Interstitial Lung Diseases, Department of Pulmonary Medicine, University Hospitals Leuven, Leuven, Belgium, Leuven, Belgium
Background/Purpose: In the INBUILD trial in patients with progressive fibrosing ILDs other than idiopathic pulmonary fibrosis, nintedanib reduced the rate of decline in forced vital…
Abstract Number: 0355 • ACR Convergence 2022
Long-term Use of Voclosporin in Patients with Class V Lupus Nephritis: Results from the AURORA 2 Continuation Study
Amit Saxena¹, Dawn Caster², Salem Almaani³, Amber Rosales⁴ and Henry Leher⁵, ¹NYU School of Medicine, New York, NY, ²University of Louisville, Louisville, KY, ³The Ohio State University Medical Center, Columbus, OH, ⁴Aurinia Pharmaceuticals Inc., Rockville, MD, ⁵Aurinia Pharmaceuticals Inc, Rockville, MD
Background/Purpose: Persistent proteinuria increases the risk of comorbidities in lupus nephritis, and rapid reductions in protein have shown to be predictive of improved long-term renal…
Abstract Number: 0519 • ACR Convergence 2022
Myeloablation Followed by Hematopoietic Stem Cell Transplantation Leads to Long-term Normalization of Systemic Sclerosis Molecular Signatures
Nancy Wareing¹, Xuan Wang², Lynette Keyes-Elstein³, Ellen Goldmuntz⁴, Marka Lyons⁵, Peter McSweeney⁶, Daniel Furst⁷, Richard Nash⁶, Leslie Crofford⁸, Beverly Welch⁹, Ashley Pinckney¹⁰, Maureen Mayes¹¹, Keith Sullivan¹² and Shervin Assassi¹³, ¹UTHealth Houston McGovern Medical School, Houston, TX, ²Baylor Institute for Immunology Research, Dallas, TX, ³Rho, Chapel Hill, NC, ⁴NIAID/ NIH, Washington, DC, ⁵University of Texas McGovern Medical School at Houston, Houston, TX, ⁶Colorado Blood Cancer Institute, Denver, CO, ⁷University of California Los Angeles, Los Angeles, CA, ⁸Vanderbilt University Medical Center, Nashville, TN, ⁹NIAID/NIH, Bethesda, MD, ¹⁰Rho, St. Louis Park, MN, ¹¹Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, TX, ¹²Duke University, Durham, NC, ¹³McGovern Medical School, University of Texas, Houston, TX
Background/Purpose: In the randomized Scleroderma: Cyclophosphamide Or Transplantation (SCOT trial), normalization of systemic sclerosis (SSc) peripheral blood gene expression signatures at the 26-month visit was…
Abstract Number: 0936 • ACR Convergence 2022
Immediate and Long-term Effects of the MTX Discontinuation for 1 vs. 2 Weeks on Vaccine Response to Seasonal Influenza Vaccine: A Non-inferiority Randomized Controlled Trial
Jin Kyun Park¹, Yun Jong Lee², Kichul Shin³, Eun Ha Kang², You-Jung Ha², Min Jung Kim⁴, Jun Won Park⁵, SE RIM CHOI⁵, Mi Hyeon Kim⁵, Ji In Jung⁵, Ju Yeon Kim⁵, Kevin Winthrop⁶ and Eun Bong Lee⁵, ¹Seoul National University College of Medicine, Jongno-gu, Seoul, South Korea, ²Seoul National University Bundang Hospital, Seongnam, Republic of Korea, ³Seoul Metropolitan Government- Seoul National University Boramae Medical Center, Seoul, Republic of Korea, ⁴Seoul Metropolitan Government Boramae Medical center, Dongjak-gu, Seoul, Republic of Korea, ⁵Seoul National University Hospital, Seoul, Republic of Korea, ⁶Oregon Health & Science University, Portland, OR
Background/Purpose: Methotrexate (MTX) significantly decreases the vaccine response to pneumococcal and seasonal influenza vaccines and temporarily discontinuing MTX for 2 weeks in patients with rheumatoid…
Abstract Number: 1427 • ACR Convergence 2022
Impact of Upadacitinib versus Abatacept on Individual Disease Outcomes in Patients with Rheumatoid Arthritis and Inadequate Responses to Biologic DMARDs
Ronald van Vollenhoven¹, Andrea Rubbert-Roth², Stephen Hall³, Ricardo Xavier⁴, Anna K Shmagel⁵, Yanna Song⁵, Samuel Anyanwu⁵ and Vibeke Strand⁶, ¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ²Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland, ³Emeritus Research and Monash University, Melbourne, Australia, ⁴Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil, ⁵AbbVie, Inc., North Chicago, IL, ⁶Stanford University School of Medicine, Stanford, CA
Background/Purpose: The phase 3 SELECT-CHOICE trial of patients with rheumatoid arthritis (RA) and prior inadequate response to biologic DMARD(s) (bDMARD-IR) demonstrated superiority of the JAK…
Abstract Number: 1614 • ACR Convergence 2022
Females with Non-Radiographic but Not with Radiographic Axial Spondyloarthritis Are Less Likely to Achieve Inactive Disease State Than Males: Results from a Multicountry Prospective Observational Study
Denis Poddubnyy¹, Joachim Sieper², Servet Akar³, Santiago Muñoz-Fernández⁴, Hildrun Haibel², Torsten Diekhoff⁵, Mikhail Protopopov⁶, Elisabeth Altmaier⁷, Fabiana Ganz⁸ and Robert Inman⁹, ¹Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ²Charité - Universitätsmedizin, Berlin, Berlin, Germany, ³Izmir Katip Celebi University School of Medicine, Izmir, Turkey, ⁴Servicio de Reumatología, Hospital Universitario Infanta Sofía, Universidad Europea, Madrid, Spain, ⁵Department of Radiology, Charité-Universitätsmedizin Berlin, Berlin, Germany, ⁶Charité Universitätsmedizin Berlin, Berlin, Germany, ⁷GKM Gesellschaft für Therapieforschung mbH, Munich, Germany, ⁸AbbVie, Inc., Luzern, Switzerland, ⁹University Health Network, Toronto, ON, Canada
Background/Purpose: Emerging evidence suggests that men and women experience axial spondyloarthritis (axSpA) differently. Some studies suggested that the probability of treatment response was lower in…
Abstract Number: 1899 • ACR Convergence 2022
A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (OA-10) to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
Yusuf Yazici¹, Christopher Swearingen², Heli Ghandehari³, Victor Lopez⁴, ismail simsek⁵, Mark Fineman⁶, Sarah Kennedy⁷, Jeyanesh Tambiah⁸ and Timothy McAlindon⁹, ¹New York University School of Medicine, La Jolla, CA, ²Samumed LLC, San Diego, CA, ³Biosplice Therapeutics, Inc., San Diego, CA, ⁴Biosplice Therapeutics, Santa Clarita, CA, ⁵Alpine Immunesciences, San Diego, CA, ⁶Biosplice Therapeutics, San Diego, CA, ⁷Biosplice Therapeutics, Inc, San Diego, CA, ⁸Biosplice Ther Inc., San Diego, CA, ⁹Tufts Medical Center, Arlington, MA
Background/Purpose: Knee osteoarthritis (OA) is a common joint disorder associated with pain, disability, and joint damage. There remains a large unmet need for treatments that…
Abstract Number: 2108 • ACR Convergence 2022
Changes in Serum Cytokines by Week 24 Correlate with Long-Term Efficacy of Guselkumab Through Two Years in Bio-Naïve Adults with PsA
Stefan Siebert¹, Georg Schett², Siba P. Raychaudhuri³, Monica Guma⁴, Warner Chen⁵, Sheng Gao⁵, Soumya Chakravarty⁶, May Shawi⁷ and Proton Rahman⁸, ¹Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, Scotland, United Kingdom, ²Universitätsklinikum Erlangen, Erlangen, Germany, ³Rheumatology, Allergy, and Clinical Immunology, University of California Davis, School of Medicine, Sacramento, CA, ⁴Division of Rheumatology, Allergy, and Immunology, Department of Medicine, University of California San Diego, La Jolla, CA, ⁵Janssen Research and Development, LLC, Spring House, PA, ⁶Janssen Scientific Affairs, LLC; Drexel University College of Medicine, Villanova, PA, ⁷Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁸Memorial University, St. John's, NL, Canada
Background/Purpose: The IL-23p19 inhibitor guselkumab has shown robust efficacy vs placebo (PBO) in the phase 3 DISCOVER-1 and DISCOVER-2 studies of adults with active PsA,1,2…
Abstract Number: 2235 • ACR Convergence 2022
Clinical Impact of a Digital Behavioral Therapy for Fibromyalgia Management in a Decentralized Trial
Yifei Dai¹, Michael Rosenbluth², Michael Gendreau³, Nicolette Vega⁴, Zunera Ghalib⁴, Allison Kraus⁴ and Brian Keefe⁵, ¹Swing Therapeutics, Gainesville, FL, ²Swing Therapeutics, San Francisco, CA, ³GENDREAU CONSULTING, LLC, Poway, CA, ⁴Swing Therapeutics, San Francisco, ⁵Swing Therapeutics, New York, NY
Background/Purpose: Cognitive behavioral therapy (CBT) has demonstrated level 1A evidence for management of fibromyalgia (FM). Acceptance and Commitment Therapy (ACT), a form of CBT, has…
Abstract Number: 0159 • ACR Convergence 2022
B Cell Phenotype in Adult Patients with Idiopathic Inflammatory Myositis (IIM) Before and After Belimumab
Tam Quach¹, Anne Davidson² and Galina Marder³, ¹Feinstein Institute for Medical Research, Manhasset, NY, ²Feinstein Institutes for Medical Research, Manhasset, NY, ³Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY
Background/Purpose: Recent observations suggest the importance of the BAFF pathway in the pathogenesis of Idiopathic Inflammatory Myositis (IIM). Elevated serum levels of circulating BAFF in…
Abstract Number: 0356 • ACR Convergence 2022
Early Reductions in Proteinuria with Voclosporin Treatment Across Lupus Nephritis Biopsy Classes: Pooled Data from the AURA-LV and AURORA 1 Trials
Anca Askanase¹, Lucy Hodge², Vanessa Birardi³ and Henry Leher³, ¹Columbia University Medical Center, New York, NY, ²Aurinia Pharmaceuticals, Seattle, WA, ³Aurinia Pharmaceuticals Inc, Rockville, MD
Background/Purpose: Voclosporin, a novel calcineurin inhibitor, is approved for the treatment of adults with lupus nephritis in combination with background immunotherapy and was successfully tested…
Abstract Number: 0520 • ACR Convergence 2022
Combination Therapy of Mycophenolate Mofetil and Pirfenidone vs. Mycophenolate Alone: Results from the Scleroderma Lung Study III
Dinesh Khanna¹, Cathie Spino², Elana Bernstein³, Jonathan Goldin⁴, Donald Tashkin⁴, Michael roth⁴ and On Behalf of SLS III Investigators², ¹Division of Rheumatology, Department of Internal Medicine, Scleroderma Program, University of Michigan, Ann Arbor, MI, ²University of Michigan, Ann Arbor, MI, ³Columbia University, New York, NY, ⁴University of California Los Angeles, Los Angeles, CA
Background/Purpose: Scleroderma Lung Study (SLS) II established mycophenolate mofetil (MMF) as an active therapy for scleroderma-related interstitial lung disease (SSc-ILD) and the need to consider…
Abstract Number: 0987 • ACR Convergence 2022
A Randomized Placebo-Controlled Phase 1 Study in Healthy Adult Volunteers of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-303, a Potent Dual BAFF/APRIL Antagonist for the Treatment of Systemic Lupus Erythematosus and Other Autoantibody-Associated Diseases
Stacey Dillon¹, Pille Harrison², Jason Lickliter³, Kristi Manjarrez¹, Alina Smith¹, Mary Lessig¹, Lori Blanchfield¹, Russell Sanderson¹, Allison Chunyk¹, Tiffany Blair¹, Amanda Enstrom¹, Martin Wolfson¹, Mark Rixon¹, Hany Zayed⁴, Rupert Davies¹ and Stanford Peng¹, ¹Alpine Immune Sciences, Seattle, WA, ²Alpine Immune Sciences, Taunton, United Kingdom, ³Nucleus Network, Melbourne, Australia, ⁴Alpine Immune Sciences, San Francisco, CA
Background/Purpose: B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) are tumor necrosis factor (TNF) superfamily members that bind TACI (transmembrane activator and CAML…

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Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. Academic institutions, private organizations and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part a scientific presentation or presentation of additional new information that will be available at the time of the meeting) is under embargo until Saturday, November 11, 2023.

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