Abstracts tagged "Randomized Trial"

Abstract Number: 0193 • ACR Convergence 2021
Tocilizumab for the Treatment of Familial Mediterranean Fever – a Randomized, Double Blind, Placebo-controlled Phase II Study
Jorg Henes¹, Sebastian Saur², David Kofler³, Martin Krusche⁴, Theodoros Xenitidis⁵, Christoph Meisner⁶, Claudia Kedor⁷, Ina Koetter⁸, Hendrik Schulze-Koops⁹ and Eugen Feist¹⁰, ¹University Hospital Tuebingen, Tuebingen, Germany, ²Universtiy Hostpiatl Tübingen, Tuebingen, Germany, ³Division of Rheumatology and Clinical Immunology, Department I of Internal Medicine; University Hospital Cologne, Cologne, Germany, ⁴Charite Berlin, Berlin, Germany, ⁵University Hospital Tuebingen, Rheumatology, Tuebingen, Germany, ⁶University Tuebingen, Statistics, Tuebingen, Germany, ⁷Charite University Hospital Berlin, Berlin, Germany, ⁸University Hospital Hamburg Eppendorf, Hamburg, Germany, ⁹Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany, ¹⁰Helios Department of Rheumatology, Vogelsang-Gommern, Germany
Background/Purpose: Familial Mediterranean Fever (FMF) is the most common auto-inflammatory disease characterized by chronic inflammation, recurrent episodes of fever, abdominal and thoracic pain due to…
Abstract Number: 0957 • ACR Convergence 2021
Vitamin D and Marine n-3 Fatty Acid Supplementation and Prevention of Autoimmune Disease in the VITAL Randomized Controlled Trial
Jill Hahn¹, Nancy Cook², Erik Alexander³, Sonia Friedman³, Vadim Bubes³, Joseph Walter³, Gregory Kotler³, I-Min Lee³, JoAnn Manson³ and Karen Costenbader⁴, ¹Harvard T.H. Chan School of Public Health, Boston, MA, ²Brigham and Womens' Hospital, Boston, MA, ³Brigham and Women's Hospital/ Harvard Medical School, Boston, MA, ⁴Brigham and Women's Hospital, Belmont, MA
Background/Purpose: In observational studies, vitamin D has been inconsistently associated with reduced risk of several autoimmune diseases, and a large randomized, controlled trial has been…
Abstract Number: 0441 • ACR Convergence 2021
A Randomized, Double-blind, Placebo-controlled Study of Arimoclomol in Patients with Inclusion Body Myositis
Pedro Machado¹, Richard Barohn², Michael McDermott³, Thomas Blaetter⁴, Tom Lloyd⁵, Aziz Shaibani⁶, Miriam Freimer⁷, Anthony Amato⁸, Emma Ciafaloni³, Sarah Jones⁹, Tahseen Mozaffar¹⁰, Summer Gibson¹¹, Matthew Wicklund¹², Todd Levine¹³, Claus Sundgreen⁴, Tim Carstensen⁴, Karen Bonefeld⁴, Anders Jørgensen⁴, Karina Phonekeo⁴, Andrew Heim¹⁴, Laura Herbelin¹⁴, Michael Hanna¹⁵ and Mazen Dimachkie¹⁴, ¹Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, United Kingdom, ²University of Missouri - Columbia, Columbia, MO, ³University of Rochester, Rochester, NY, ⁴Orphazyme A/S, Copenhagen, Denmark, ⁵Johns Hopkins University, Baltimore, MD, ⁶Nerve and Musle Center, Houston, TX, ⁷Ohio State University, Columbus, OH, ⁸Brigham and Women's Hospital, Boston, MA, ⁹University of Virginia, Charlottesville, VA, ¹⁰University of California Irvine, Irvine, CA, ¹¹University of Utah, Salt Lake City, UT, ¹²University of Colorado, Denver, CO, ¹³Phoenix Neurological Associates, Phoenix, AZ, ¹⁴University of Kansas Medical Center, Kansas City, KS, ¹⁵University College London, London, United Kingdom
Background/Purpose: Inclusion body myositis (IBM) is the most common idiopathic inflammatory myopathy occurring in patients over the age of 45 years. Since immune suppression has…
Abstract Number: 1212 • ACR Convergence 2021
Prediction of 1-Year Intravenous Abatacept Retention in Patients with RA Using Novel Machine Learning Techniques: Directionality and Importance of Predictors
Rieke Alten¹, Claire Behar², Christine Boileau³, Pierre Merckaert⁴, Ebenezer Afari⁵, Virginie Vannier-Moreau⁶, Anael Ohayon⁶, Sean Connolly⁷, Aurelie Najm⁸, Pierre Antoine Juge⁹, Gengyuan Liu⁷, Angshu Rai¹⁰, Yedid Elbez¹¹ and Karissa Lozenski⁷, ¹Schlosspark-Klinik University, Berlin, Germany, ²Tulsy, Paris, France, ³Excelya, Boulogne-Billancourt, France, ⁴Data Revenue GmbH, Berlin, Germany, ⁵Private Practice, Brunoy, France, ⁶Bristol Myers Squibb, Rueil-Malmaison, France, ⁷Bristol Myers Squibb, Princeton, NJ, ⁸Institute of Infection, Immunity and Inflammation, College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom, ⁹Hopital Bichat-Claude Bernard, Service de Rhumatologie, Paris, France, ¹⁰Bristol Myers Squibb (at the time of analysis), Princeton, NJ, ¹¹Deepscover, Puteaux, France
Background/Purpose: In the ACTION study (NCT02109666), previous multivariable Cox proportional-hazards regression models showed that predictors of 1-year retention to intravenous abatacept treatment included: patient global…
Abstract Number: L08 • ACR Convergence 2020
Long Term Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Chronic Gout: The Febuxostat versus Allopurinol Streamlined Trial (on Behalf of the FAST Investigators)
Thomas MacDonald¹, Isla Mackenzie¹, George Nuki² and Ian Ford³, ¹University of Dundee, Dundee, Scotland, United Kingdom, ²University of Edinburgh, Edinburgh, Scotland, United Kingdom, ³University of Glasgow, Glasgow, Scotland, United Kingdom
Background/Purpose: Febuxostat and allopurinol are uric acid lowering agents. Following concerns about the cardiovascular safety of febuxostat, the European Medicines Agency (EMA) recommended a post-authorization…
Abstract Number: L09 • ACR Convergence 2020
A Phase 2a Randomized, Double-blind, Placebo-controlled Study of Ziritaxestat in Early Diffuse Cutaneous Systemic Sclerosis (NOVESA)
Dinesh Khanna¹, Christopher Denton², Daniel Furst³, Maureen Mayes⁴, Marco Matucci-Cerinic⁵, Vanessa Smith⁶, Dick de Vries⁷, Liesbeth Deberdt⁸, Pieter‑Jan Stiers⁸, Niyati Prasad⁸ and Sohail Ahmed⁹, ¹University of Michigan, Ann Arbor, MI, ²Royal Free Hospital, University College London, London, United Kingdom, ³David Geffen School of Medicine at UCLA, Los Angeles, CA, ⁴University of Texas Health Science Center at Houston, Houston, TX, ⁵Università degli Studi di Firenze, Firenze, Italy, ⁶Ghent University Hospital, Ghent, Belgium, ⁷Galapagos BV, Leiden, Netherlands, ⁸Galapagos NV, Mechelen, Belgium, ⁹Ahmed Science Medicine, Basel, Switzerland
Background/Purpose: There is a high unmet need for systemic sclerosis (SSc) treatments. Ziritaxestat (ziri; GLPG1690) is an autotaxin inhibitor with a novel mechanism of action.…
Abstract Number: L11 • ACR Convergence 2020
Tofacitinib for the Treatment of Adult Patients with Ankylosing Spondylitis: Primary Analysis of a Phase 3, Randomized, Double-blind, Placebo-controlled Study
Atul Deodhar¹, Paula Sliwinska-Stanczyk², Huji Xu³, Xenofon Baraliakos⁴, Lianne Gensler⁵, Dona Fleishaker⁶, Lisy Wang⁶, Joseph Wu⁶, Sujatha Menon⁶, Cunshan Wang⁶, Oluwaseyi Dina⁷, Lara Fallon⁸, Keith S Kanik⁶ and Désirée van der Heijde⁹, ¹Oregon Health & Science University, Portland, OR, ²Reumatika Centrum Reumatologii, Warszawa, Poland, ³Shanghai Changzheng Hospital, Shanghai, China (People's Republic), ⁴Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum, Germany, ⁵University of California San Francisco, San Francisco, CA, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer Inc, New York, NY, ⁸Pfizer Inc, Montreal, QC, Canada, ⁹Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Tofacitinib is an oral JAK inhibitor that is being investigated for the treatment of adult patients (pts) with AS.Methods: This Phase 3, randomized, double-blind…
Abstract Number: 0220 • ACR Convergence 2020
Impact of Concomitant Glucocorticoids on the Clinical Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: An Ad Hoc Analysis of Data from Three Phase 3 Studies
Bernard Combe¹, Frank Buttgereit², Andrew Östör³, Ricardo Xavier⁴, Alain Saraux⁵, Capucine Daridon⁶, Kirsten Famulla⁷, Yanna Song⁸, Ivan Lagunes-Galindo⁹ and Gerd Burmester¹⁰, ¹University of Montpellier, Montpellier, France, ²Charité University Medicine, Berlin, Germany, ³Cabrini Medical Center, Monash University, Malvern, Victoria, Australia, ⁴Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rio Grande do Sul, Rio Grande do Sul, Brazil, ⁵Department of Rheumatology, UBO, CHU, INSERM 1227 (LBAI), Brest, France, ⁶AbbVie France, Rungis, France, ⁷AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, ⁸AbbVie Inc., North Chicago,, IL, ⁹AbbVie Inc., North Chicago, IL, ¹⁰Charité University Hospital Berlin, Berlin, Germany
Background/Purpose: Glucocorticoid (GC) therapy has strong anti-inflammatory effects and helps slow radiographic progression in RA1; however, GCs can be associated with adverse events (AEs) such…
Abstract Number: 0986 • ACR Convergence 2020
BIIB059, a Humanized Monoclonal Antibody Targeting Blood Dendritic Cell Antigen 2 on Plasmacytoid Dendritic Cells, Shows Dose-Related Efficacy in a Phase 2 Study in Participants with Active Cutaneous Lupus Erythematosus
Victoria Werth¹, Richard Furie², Juanita Romero-Díaz³, Sandra Navarra⁴, Kenneth Kalunian⁵, Ronald van Vollenhoven⁶, Filippa Nyberg⁷, Benjamin Kaffenberger⁸, Saira Sheikh⁹, Goran Radunovic¹⁰, Xiaobi Huang¹¹, Hua Carroll¹², Francois Gaudreault¹², Adam Meyers¹¹, Catherine Barbey¹³, Cristina Musselli¹¹ and Nathalie Franchimont¹¹, ¹University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, ²Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ³Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico, ⁴University of Santo Tomas, Manila, Philippines, ⁵University of California San Diego, La Jolla, CA, ⁶Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, ⁷Karolinska University Hospital, Stockholm, Sweden, ⁸Ohio State University, Columbus, OH, ⁹Division of Rheumatology, Allergy and Immunology, University of North Carolina, Chapel Hill, NC, ¹⁰Institute of Rheumatology, University of Belgrade, Belgrade, Serbia, ¹¹Biogen, Cambridge, MA, ¹²Biogen, Cambridge, ¹³Biogen, Baar, Switzerland
Background/Purpose: No approved targeted therapies have been developed for cutaneous lupus erythematosus (CLE), a disfiguring autoimmune disease that severely impairs quality of life.1 BIIB059 is…
Abstract Number: 1633 • ACR Convergence 2020
A Randomized, Double-Blind, Placebo-Controlled Study of Anakinra in Pediatric and Adult Patients with Still’s Disease
Laura Schanberg¹, Peter Nigrovic², Ashley Cooper³, Winn Chatham⁴, Shoghik Akoghlanian⁵, Namrata Singh⁶, C. Egla Rabinovich⁷, Akaluck Thatayatikom⁸, Alysha Taxter⁹, Jonathan Hausmann¹⁰, Milan Zdravkovic¹¹, Sven Ohlman¹¹, Henrik Andersson¹¹, Susanna Cederholm¹¹, Gunilla Huledal¹¹, Rayfel Schneider¹² and Fabrizio De Benedetti¹³, ¹Duke University Medical Center, Durham, NC, ²Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Division of Immunology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA, Boston, ³Children's Mercy Kansas City, Kansas City, MO, ⁴University of Alabama at Birmingham, Birmingham, AL, ⁵Nationwide Children’s Hospital, Columbus, ⁶University of Washington, Bellevue, WA, ⁷Duke University Hospital, Durham, NC, ⁸Department of Pediatrics, University of Florida, Gainesville, FL, ⁹Wake Forest Baptist Medical Center, Winston-Salem, ¹⁰Boston Children's Hospital / Beth Israel Deaconess Medical Center, Cambridge, MA, ¹¹Sobi, Stockholm, Sweden, ¹²University of Toronto, The Hospital for Sick Children, Toronto, Canada, ¹³Division of Rheumatology, Laboratory of Immuno-Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy, Rome, Italy
Background/Purpose: Still’s disease, including both systemic juvenile idiopathic arthritis (SJIA) and adult-onset Still’s disease (AOSD), is a rare systemic auto-inflammatory disorder associated with an activated…
Abstract Number: 0228 • ACR Convergence 2020
Impact of Upadacitinib or Adalimumab as Initial Therapy on the Achievement of 48-Week Treatment Goals in Patients with Rheumatoid Arthritis and Inadequate Response to Methotrexate: Post Hoc Analysis of a Phase 3 Study
Eduardo Mysler¹, Yoshiya Tanaka², Arthur Kavanaugh³, Daniel Aletaha⁴, Peter Taylor⁵, In-Ho Song⁶, Tim Shaw⁶, Yanna Song⁷, Ryan DeMasi⁶, Mira Ali⁶ and Roy Fleischmann⁸, ¹Organización Medica de Investigación, Buenos Aires, Argentina, ²The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ³Division of Rheumatology, Allergy, & Immunology, University of California San Diego Medical School, San Diego, CA, ⁴Division of Rheumatology, Department of Medicine III, Medical University of Vienna,, Vienna, Austria, ⁵Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., North Chicago,, IL, ⁸Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: In the randomized, double-blinded, Phase 3 SELECT-COMPARE study, upadacitinib (UPA) + MTX demonstrated greater clinical and functional responses vs adalimumab (ADA) + MTX in…
Abstract Number: 0987 • ACR Convergence 2020
Efficacy and Safety of Iberdomide in Patients with Active Systemic Lupus Erythematosus: 24-Week Results of a Phase 2, Randomized, Placebo-Controlled Study
Joan Merrill¹, Victoria Werth², Richard Furie³, Ronald van Vollenhoven⁴, Milan Petronijevic⁵, Benito Velasco Zamora⁶, Maria Majdan⁷, Fedra Irazoque-Palazuelos⁸, Michael Weiswasser⁹, Shimon Korish⁹, Peter Schafer⁹, Zhaohui Liu⁹, Allison Gaudy⁹, Nataliya Agafonova⁹ and Nikolay Delev⁹, ¹Oklahoma Medical Research Foundation, Oklahoma City, OK, ²University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, ³Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ⁴Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁵Military Medical Academy, Belgrade, Serbia, ⁶Instituto CER S.A., Buenos Aires, Argentina, ⁷Medical University of Lublin and Samodzielny Publicnzy Szpital Kliniczny Nr 4 w Lublinie, Lublin, Poland, ⁸Centro de Investigación y Tratamiento Reumatológico S.C, Miguel Hidalgo, Mexico, ⁹Bristol Myers Squibb, Princeton
Background/Purpose: Iberdomide is a high-affinity cereblon ligand that promotes ubiquitination and proteasomal degradation of Ikaros (IKZF1) and Aiolos (IKZF3), transcription factors linked to the genetic…
Abstract Number: 1842 • ACR Convergence 2020
Repository Corticotropin Injection (Acthar® Gel) for Persistently Active Systemic Lupus Erythematosus: Post Hoc Analyses of Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-blind, Placebo-Controlled Trial
Anca Askanase¹, George Wan², Mary Panaccio², Enxu Zhao², Julie Zhu², Roman Bilyk² and Richard Furie³, ¹Columbia University College of Physicians and Surgeons, New York, NY, ²Mallinckrodt Pharmaceuticals, Bedminster, NJ, ³Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY
Background/Purpose: Repository corticotropin injection (RCI, Mallinckrodt Pharmaceuticals) is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides approved for the treatment…
Abstract Number: 0369 • ACR Convergence 2020
Effect of Upadacitinib on Reducing Pain in Patients with Active Ankylosing Spondylitis and Inadequate Response to Nonsteroidal Anti-inflammatory Drugs
Atul Deodhar¹, Xenofon Baraliakos², Iain McInnes³, Kurt de Vlam⁴, Louis Bessette⁵, Anna Maniccia⁶, Ralph Lippe⁷, Christopher Saffore⁶, Tianming Gao⁶, In-Ho Song⁶ and Andrew Östör⁸, ¹Oregon Health & Science University, Portland, OR, ²Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, ³Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, ⁴Department of Rheumatology, University of Leuven, Belgium, Leuven, Belgium, ⁵Laval University, Quebec, Canada, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, ⁸Cabrini Medical Center, Monash University, Malvern, Victoria, Australia
Background/Purpose: Pain is a debilitating symptom of ankylosing spondylitis (AS) and negatively impacts patient (pt) lives. Upadacitinib (UPA), a Janus kinase (JAK) inhibitor engineered for…
Abstract Number: 0989 • ACR Convergence 2020
Withdrawal of MMF Is Safe in Quiescent Renal and Non-Renal SLE: Results from a Multi-Center Randomized Trial
Eliza Chakravarty¹, Tammy Utset², Diane Kamen³, Gabriel Contreras⁴, W. Joseph McCune⁵, Kenneth Kalunian⁶, Cynthia Aranow⁷, Megan Clowse⁸, Elena Massarotti⁹, Ellen Goldmuntz¹⁰, Jessica Springer¹⁰, Lynette Keyes-Elstein¹¹, Bill Barry¹¹, Ashley Pinckney¹¹ and Judith James¹², ¹Oklahoma Medical Research Foundation, Oklahoma City, OK, ²University of Chicago, Chicago, IN, ³Medical University of South Carolina, Charleston, SC, ⁴University of Miami Miller School of Medicine, Miami, ⁵University of Michigan, Ann Arbor, MI, ⁶University of California San Diego, La Jolla, CA, ⁷Feinstein Institutes for Medical Research, Manhasset, NY, ⁸Duke University, Chapel Hill, NC, ⁹Brigham and Women's hospital, Boston, MA, ¹⁰NIH/NIAID, Rockville, MD, ¹¹Rho, Durham, NC, ¹²Oklahoma Medical Research Foundation, Oklahoma City
Background/Purpose: Mycophenolate Mofetil (MMF) is standard of care therapy for long term treatment of lupus nephritis and other manifestations of SLE. However, it is associated…

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