Abstracts tagged "clinical trial"

Abstract Number: L14 • ACR Convergence 2022
Bimekizumab Maintains Improvements in Efficacy Endpoints and Has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies
Xenofon Baraliakos¹, Atul Deodhar², Désirée van der Heijde³, Marina Magrey⁴, Walter Maksymowych⁵, Tetsuya Tomita⁶, Huji Xu⁷, Marga Oortgiesen⁸, Ute Massow⁹, Carmen Fleurinck¹⁰, Alicia M Ellis⁸, Tom Vaux¹¹, Julie Shepherd-Smith¹¹, Alexander Marten⁹ and Lianne S Gensler¹², ¹Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, ²Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ³Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁴Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, US, Richfield, OH, ⁵Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka City, Osaka City, Osaka, Japan, ⁷Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China (People's Republic), ⁸UCB Pharma, Morrisvile, NC, ⁹UCB Pharma, Monheim am Rhein, Nordrhein-Westfalen, Germany, ¹⁰UCB Pharma, Brussels, Brussels Hoofdstedelijk Gewest, Belgium, ¹¹UCB Pharma, Slough, United Kingdom, ¹²Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL‑17A. In the phase 3 BE MOBILE 1 and 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: 1362 • ACR Convergence 2022
Validation of the 2016 ACR/EULAR Myositis Response Criteria in Juvenile Dermatomyositis (JDM) Clinical Trials and Consensus Profiles
Hanna Kim¹, Didem Saygin², Christian Douglas³, john mcgrath³, Jesse Wilkerson³, angela Pistorio⁴, Ann Reed⁵, Chester Oddis⁶, Frederick Miller⁷, Jiří Vencovský⁸, Nicola Ruperto⁹, Rohit Aggarwal¹⁰ and Lisa G Rider⁷, ¹Division of Rheumatology, Department of Medicine, George Washington University School of Medicine and Health Sciences; Juvenile Myositis Therapeutic and Translation Studies Unit, PTRB, NIAMS, NIH, Bethesda, MD, ²University of Chicago, Chicago, IL, ³Social and Scientific Systems, Inc., Durham, NC, ⁴IRCCS Istituto Giannina Gaslini, Genoa, Italy, ⁵Duke University School of Medicine, Durham, NC, ⁶University of Pittsburgh, Pittsburgh, PA, ⁷Environmental Autoimmunity Group, Clinical Research Branch, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, Bethesda, MD, ⁸Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ⁹IRCCS Istituto Giannina Gaslini; PRINTO, Clinica Pediatrica e Reumatologia, Genova, Italy, ¹⁰Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA
Background/Purpose: Juvenile dermatomyositis (JDM) ACR-EULAR myositis response criteria (MRC) were developed based on absolute % changes in 6 core set measures (CSM) differentially weighted to…
Abstract Number: 1604 • ACR Convergence 2022
Hydroxychloroquine Does Not Prevent the Future Development of Rheumatoid Arthritis in a Population with Baseline High Levels of Antibodies to Citrullinated Protein Antigens and Absence of Inflammatory Arthritis: Interim Analysis of the StopRA Trial
Kevin D Deane¹, Christopher Striebich², Marie Feser³, Kristen Demoruelle³, LauraKay Moss⁴, Elizabeth Bemis³, Ashley Frazer-Abel⁴, Chelsie Fleischer⁴, Jeffrey Sparks⁵, Elizabeth Solow⁶, Judith James⁷, Joel Guthridge⁷, John Davis⁸, Jonathan Graf⁹, Jonathan Kay¹⁰, Maria Danila¹¹, S. Louis Bridges, Jr.¹², Lindsy Forbess¹³, James O'Dell¹⁴, Maureen McMahon¹⁵, Jennifer Grossman¹⁵, Diane Horowitz¹⁶, Athan Tiliakos¹⁷, Elena Schiopu¹⁸, David Fox¹⁹, Jeffrey Carlin²⁰, Cristina Arriens⁷, Vivian Bykerk¹², Reem Jan²¹, Mathilde Pioro²², M. Elaine Husni²³, Ana Fernandez-Pokorny²⁴, Sarah Walker²⁵, Susan Booher²⁶, Melissa Greenleaf²⁷, Margie Byron²⁵, Lynette Keyes-Elstein²⁵, Ellen Goldmuntz²⁸ and V. Michael Holers²⁹, ¹University of Colorado Denver Anschutz Medical Campus, Denver, CO, ²University of Colorado, Aurora, CO, ³University of Colorado Anschutz Medical Campus, Aurora, CO, ⁴University of Colorado Denver, Denver, CO, ⁵Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ⁶UT Southwestern Medical Center, Dallas, TX, ⁷Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁸Mayo Clinic, Rochester, MN, ⁹Ucsf, San Francisco, CA, ¹⁰Division of Rheumatology, Department of Medicine, UMass Chan Medical School and UMass Memorial Medical Center, Worcester, MA, ¹¹University of Alabama at Birmingham, Birmingham, AL, ¹²Hospital for Special Surgery, New York, NY, ¹³Cedars-Sinai Medical Center, Los Angeles, CA, ¹⁴University of Nebraska Medical Center, Omaha, NE, ¹⁵University of California Los Angeles, Los Angeles, CA, ¹⁶Northwell Health, Jericho, NY, ¹⁷Emory University, Roswell, GA, ¹⁸Michigan Medicine, Ann Arbor, MI, ¹⁹University of Michigan, Ann Arbor, MI, ²⁰Virginia Mason Medical Center, Seattle, WA, ²¹University of Chicago, Chicago, IL, ²²University of Washington, Seattle, WA, ²³Cleveland Clinic, Cleveland, OH, ²⁴Essentia Health, Duluth, MN, ²⁵Rho, Chapel Hill, NC, ²⁶NIH NIAID, Bethesda, MD, ²⁷NIH, Rock Hill, SC, ²⁸NIAID/ NIH, Washington, DC, ²⁹University of Colorado, Denver, CO
Background/Purpose: The Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis (StopRA) (ClinicalTrials.gov NCT02603146) is a randomized, double-masked, placebo-controlled, multi-center (20 sites) clinical trial evaluating…
Abstract Number: 1894 • ACR Convergence 2022
A Phase 2, 104-Week Study of Repeat Lorecivivint Injections Evaluating Safety, Efficacy, and Bone Health Utilizing Quantitative Computed Tomography (qCT) in Knee Osteoarthritis (OA-06)
Yusuf Yazici¹, Christopher Swearingen², Heli Ghandehari³, Jon Britt⁴, ismail simsek⁵, Mark Fineman⁶, Sarah Kennedy², Jeyanesh Tambiah⁷ and Nancy Lane⁸, ¹New York University School of Medicine, La Jolla, CA, ²Biosplice Therapeutics, Inc, San Diego, CA, ³Biosplice Therapeutics, Inc., San Diego, CA, ⁴Biosplice Therapeutics, Inc., Los Angeles, CA, ⁵Alpine Immunesciences, San Diego, CA, ⁶Biosplice Therapeutics, San Diego, CA, ⁷Biosplice Ther Inc., San Diego, CA, ⁸University of California Davis, Hillsborough, CA
Background/Purpose: Knee osteoarthritis (OA) is a common joint disorder associated with pain, disability, and joint damage. There is a large unmet need for safe and…
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: 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…
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…

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