Abstracts tagged "Randomized Trial"

Abstract Number: 0411 • ACR Convergence 2022
Bimekizumab Improves Signs and Symptoms Including Inflammation in Patients with Active Ankylosing Spondylitis: 24-Week Efficacy & Safety from a Phase 3, Multicenter, Randomized, Placebo Controlled Study
Désirée van der Heijde¹, Xenofon Baraliakos², Maxime Dougados³, Matthew Brown⁴, Denis Poddubnyy⁵, Filip Van den bosch⁶, Nigil Haroon⁷, Huji Xu⁸, Tetsuya Tomita⁹, Lianne Gensler¹⁰, Marga Oortgiesen¹¹, Carmen Fleurinck¹², Natasha de Peyrecave¹³, Thomas Vaux¹⁴, Alexander Marten¹⁵ and Atul Deodhar¹⁶, ¹Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Leiden, Netherlands, ²Rheumazentrum Ruhrgebiet Herne, Herne, Germany, ³Department of Rheumatology, Hôpital Cochin, Paris, France, Paris, France, ⁴Genomics England, London, United Kingdom, ⁵Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁶Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium, ⁷Schroeder Arthritis Institute, University Health Network; University of Toronto, Toronto, ON, Canada, ⁸Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China, ⁹Department of Orthopaedic Biomaterial Science, Osaka University Graduate School of Medicine, Osaka, Japan, Suita Osaka, Japan, ¹⁰Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, ¹¹UCB Pharma, Raleigh, NC, ¹²UCB Pharma, Brussels, Belgium, Oosterzele, Belgium, ¹³UCB Pharma, Brussels, Belgium, ¹⁴UCB Pharma, Slough, United Kingdom, ¹⁵UCB Pharma, Monheim am Rhein, Germany, ¹⁶Oregon Health & Science University, Portland, OR, USA, Portland, OR
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. In a phase 2b study, BKZ showed rapid and…
Abstract Number: 1628 • ACR Convergence 2022
The Sjogren Tool for Assessing Response (STAR): Assessment of Response Rates Overall, According to Baseline Activity and by Domain: Reanalysis of 9 Clinical Trials in Primary Sjogren Syndrome
Raphaèle Seror¹, Gabriel Baron², Divi CORNEC³, Elodie Perrodeau², Marine Camus⁴, Professor Simon Bowman⁵, Michele Bombardieri⁶, Hendrika Bootsma⁷, Suzanne Arends⁷, jacques-eric gottenberg⁸, Benjamin A. Fisher⁹, Wolfgang Hueber¹⁰, Joel Van Roon¹¹, Valerie Devauchelle¹², Liseth de Wolff¹³, Peter Gergely¹⁴, Xavier Mariette¹⁵ and Raphaël Porcher¹⁶, ¹University Hospital Paris-Saclay, Le Kremlin Bicêtre, France, ²AP-HP Hôtel Dieu Hospital, Université Paris Descartes, Paris, France, ³CHRU Brest, Brest, France, ⁴Department of Rheumatology, Université Paris-Saclay, APHP Hôpital Bicêtre, Le Kremlin Bicêtre, France, ⁵University Hospitals Birmingham, Birmingham, United Kingdom, ⁶Experimental Medicine and Rheumatology, William Harvey Research Institute, Queen Mary University, London, United Kingdom, ⁷University Medical Center Groningen, Groningen, Netherlands, ⁸Strasbourg University Hospital, Strasbourg, France, ⁹University of Birmingham, Birmingham, United Kingdom, ¹⁰Novartis Pharmaceuticals, Basel, Switzerland, ¹¹Rheumatology & Clinical Immunology, University of Utrecht, Utrecht, Netherlands, ¹²Université de Bretagne Occidentale, Brest, France, ¹³UMCG, Zwolle, Netherlands, ¹⁴Novartis Pharma, Basel, Switzerland, ¹⁵Paris-Saclay University, Rueil Malmaison, Ile-de-France, France, ¹⁶Université Paris Cité, Hôtel-Dieu, Paris, France
Background/Purpose: The ESSDAI and ESSPRI, used alone, are not able to capture all features of primary Sjögren's syndrome (pSS). The NECESSITY consortium developed the Sjögren's…
Abstract Number: 2273 • ACR Convergence 2022
Waning Vaccine Response After Primary Vaccine Series: Results from the Covid19 Vaccine Response in Rheumatology Patients (COVER) Study
Amy Mudano¹, Gary Cutter², Ted Mikuls³, Geoffrey Thiele⁴, Mark Law⁴, Bart Hamilton⁴, Michael Zikry⁵, Kelly Y. Chun⁶, Monique Bastidas⁷, Michael George⁸, Lisa Williams⁹, Kevin Winthrop¹⁰, Mark Busch¹¹, Stanley Cohen¹², Roman Czubatyj¹³, Rajesh Kataria¹⁴, Reshma Khan¹⁵, Soha Mousa¹⁶, Jose Pando¹⁷, Elizabeth Perkins¹⁸, Shanmugapriya Reddy¹⁹, Delfin Santos²⁰, Joy Schechtman²¹, Frank Scott²², Sucharitha Shanmugam²³, Atul Singhal²⁴, John Tesser²⁵, John Tower²⁶, Swamy Venuturupalli²⁷, Sean Joseph Wollaston²⁸, Conrad Ziembinski²⁹ and Jeffrey Curtis³⁰, ¹Illumination Health, Hoover, AL, ²University of Alabama at Birmingham, Birmingham, AL, ³Division of Rheumatology, University of Nebraska Medical Center, Omaha, NE, ⁴University of Nebraska Medical Center, Omaha, NE, ⁵LabCorp, Burlington, NC, ⁶Labcorp, Calabasas, CA, ⁷LabCorp, Northridge, CA, ⁸University of Pennsylvania, Philadelphia, PA, ⁹Illumination Heath, Hoover, AL, ¹⁰Oregon Health & Science University, Portland, OR, ¹¹Family Arthritis Center-Jupiter, Jupiter, FL, ¹²Metroplex Clinical Research Center, Pittsburgh, PA, ¹³Arthritis Physicians LLC, Rochester Hills, MI, ¹⁴Southern Ohio, Wheelersburg, OH, ¹⁵Palm Beach Rheumatology and Wellness, Jupiter, FL, ¹⁶Arthritis and Rheumatology of Southwest Ohio, Liberty Township, OH, ¹⁷Rheumatology Consultants of DE, Lewes, DE, ¹⁸Rheumatology Care Center, Hoover, AL, ¹⁹Southwest Florida Rheumatology, Riverview, FL, ²⁰Rochester Rheumatology, Rochester Hills, MI, ²¹SunValley Arthritis Center, Peoria, AZ, ²²Arthritis Medical Center, Arroyo Grande, CA, ²³Rheumatology and Arthritis Care Center, Exton, PA, ²⁴Southwest Rheumatology Research, Mesquite, TX, ²⁵Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ²⁶Arthritis Physicians LLC, Rochester, MI, ²⁷Cedars-Sinai Medical Center, Los Angeles, CA, ²⁸Rheumatology Associates, North Hollywood, CA, ²⁹CZ Rheumatology, Coral Springs, FL, ³⁰Division of Clinical Immunology & Rheumatology, University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Given possible increased risk of COVID-19 in patients with autoimmune conditions, there is a need to better understand the immunogenicity and safety of SARS-CoV-2…
Abstract Number: 0544 • ACR Convergence 2022
Bimekizumab Improves Signs and Symptoms, Including Inflammation, in Patients with Active Non-Radiographic Axial Spondyloarthritis: 24-Week Efficacy & Safety from a Phase 3, Multicenter, Randomized, Placebo Controlled Study
Atul Deodhar¹, Désirée van der Heijde², Lianne Gensler³, Huji Xu⁴, Karl Gaffney⁵, Hiroaki Dobashi⁶, Walter P Maksymowych⁷, Martin Rudwaleit⁸, Marina Magrey⁹, Dirk Elewaut¹⁰, Marga Oortgiesen¹¹, Carmen Fleurinck¹², Natasha de Peyrecave¹³, Alicia Ellis¹⁴, Thomas Vaux¹⁵, Julie Shepherd-Smith¹⁵ and Xenofon Baraliakos¹⁶, ¹Oregon Health & Science University, Portland, OR, USA, Portland, OR, ²Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Leiden, Netherlands, ³Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, ⁴Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China, ⁵Norfolk and Norwich University Hospital NHS Trust, Norfolk, United Kingdom, ⁶Division of Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Faculty of Medicine, Kagawa, Kagawa, Japan, ⁷Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁸University of Bielefeld, Klinikum Bielefeld, Bielefeld; Germany Klinikum Bielefeld and Charité Berlin, Germany, and Gent University, Gent, Belgium, ⁹Case Western Reserve University, University Hospitals, Richfield, OH, ¹⁰Department of Rheumatology, Ghent University Hospital, Belgium, VIB-UGent Center for Inflammation Research, Ghent University, Heusden, Belgium, ¹¹UCB Pharma, Raleigh, NC, ¹²UCB Pharma, Brussels, Belgium, Oosterzele, Belgium, ¹³UCB Pharma, Brussels, Belgium, ¹⁴UCB Pharma, Raleigh, ¹⁵UCB Pharma, Slough, United Kingdom, ¹⁶Rheumazentrum Ruhrgebiet Herne, Herne, Germany
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. In patients (pts) with active ankylosing spondylitis (AS), BKZ…
Abstract Number: 1822 • ACR Convergence 2022
A Double-Blind, Placebo-Controlled, Ascending Dose Phase 2a Study of ABP-671, a Novel, Potent and Selective URAT1 Inhibitor, in Patients with Gout or Hyperuricemia
Marc Gurwith¹, Deon Smith², Paul Bird³, Jessica Leung⁴, Mark Bloch⁵, Joshua Kim⁶, Rahul Mohan⁷, Anthony Houston⁸, Oscar Cumming⁹, Ann Madrid¹⁰, Ullrich Schwertschlag¹¹, Jerry Liu¹², Roy Wu¹³, Jason Xu¹⁴, Adam Jin¹⁴ and William Dongfang Shi¹⁵, ¹Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Los Altos Hills, CA, ²Emeritus Research, Melbourne, Australia, ³Emeritus Research Sydney, Sydney, Australia, ⁴Austin Health, Preston, Victoria, Australia, ⁵Holdsworth House Medical Practice, Darlinghurst, Australia, ⁶Paratus Clinical Pty Ltd., New South Wales, Australia, ⁷Paratus Clinical Pty Ltd, Western Sydney, Australia, ⁸Peninsula Private Hospital, Kippa-Ring, Australia, ⁹Novatrials, Kotara, Australia, ¹⁰Novotech Australia, Sydney, Australia, ¹¹Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Palo Alto, ¹²Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., San Diego, ¹³Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., San Francisco, ¹⁴Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Suzhou, China, ¹⁵Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Fremont
Background/Purpose: ABP-671, a novel selective and potent URAT1 inhibitor reduces reabsorption of uric acid (UA) at the renal proximal tubule, and significantly decreases serum uric…
Abstract Number: 0545 • ACR Convergence 2022
Continuing (Full or Reduced Treatment) versus Withdrawing from Golimumab Treatment in Patients with Non-radiographic Spondylarthritis Who Achieved Inactive Disease: Efficacy and Safety Results from a Placebo-Controlled, Randomized Withdrawal and Retreatment Study (GO-BACK)
Cindy Weinstein¹, Paula Sliwinska-Stanczyk², Tomas Hala³, Marina Stanislav⁴, Anjela Tzontcheva⁵, Ruji Yao¹, Yuliya Berd¹, Sean Curtis¹ and George Philip¹, ¹Merck & Co., Inc., Rahway, NJ, ²Reumatika Centrum Reumatologii, Warsaw, Poland, ³Center for Clinical and Basic Research, Pardubice, Czech Republic, ⁴Vladimirsky Moscow Regional Scientific Institution, Moscow, Russia, ⁵MSD Switzerland, Zürich, Switzerland
Background/Purpose: Non-radiographic axial spondyloarthrits (nr-axSpA) is a rheumatic disease that is predominantly associated with chronic back pain and stiffness.1 Results from the Phase III GO-AHEAD…
Abstract Number: 1832 • ACR Convergence 2022
Efficacy and Safety Similarity of Biosimilar Adalimumab-aqvh to Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Phase III Study
Barbara Finck, Helen Tang, Kathy Jensen, Francesca Civoli and Suzanna Tatarewicz, Coherus BioSciences, Redwood City, CA
Background/Purpose: This study aimed to demonstrate that there were no clinically meaningful differences between adalimumab-aqvh, a US Food and Drug Administration–approved biosimilar, and adalimumab in…
Abstract Number: 0573 • ACR Convergence 2022
Telehealth versus Outpatients Clinic Follow up in Rheumatoid Arthritis Patients a Randomized Controlled Study
Anne Bull Haaversen¹, Inge Christoffer Olsen², Maiju Pesonen³, Andreas Diamantopoulos⁴ and jannicke Sundsby karlengen⁵, ¹Martina Hansens Hospital, Hosle, Norway, ²Oslo University Hospital, Oslo, Nepal, ³Oslo University, Oslo, Norway, ⁴Akershus University Hospital, Lørenskog, Norway, ⁵Martina Hansens Hospital, Baerum, Norway
Background/Purpose: Most Rheumatoid Arthritis (RA) patients are in remission or low disease activity. Yet, RA patients continue to be followed up by pre-scheduled visits, which…
Abstract Number: 1892 • ACR Convergence 2022
Genicular Nerve Block for Pain Management in Patients with Knee Osteoarthritis: A Randomised Double-blind Placebo Controlled Trial
Ernst Shanahan¹, Fin Cai², Frank Voyvodic², Suellen Lyne², Richard Woodman¹, Kokum Dissanayake², Kate Paddick², Giovanna Cheung² and Lucinda Robinson², ¹Flinders University, Adelaide, Australia, ²SALHN, Adelaide, Australia
Background/Purpose: To determine whether Genicular Nerve Block (GNB) is an efficacious treatment for patients with knee osteoarthritis (OA)Methods: Adults with symptomatic knee OA for greater than 3…
Abstract Number: 0763 • ACR Convergence 2022
Immunogenicity Analysis from the VOLTAIRE Trials in Patients with Rheumatoid Arthritis, Crohn’s Disease, and Chronic Plaque Psoriasis
Vibeke Strand¹, Shaun Bender² and Dorothy McCabe³, ¹Stanford University School of Medicine, Stanford, CA, ²Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, ³Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT
Background/Purpose: The VOLTAIRE trials program compared the safety, efficacy, and immunogenicity of biosimilar BI 695501 with adalimumab reference product (RP) for indications including moderate-severely active…
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: L19 • ACR Convergence 2021
Secukinumab in Giant Cell Arteritis: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial
Nils Venhoff¹, Wolfgang Schmidt², Raoul Bergner³, Jürgen Rech⁴, Leonore Unger⁵, Hans-Peter Tony⁶, Meryl Mendelson⁷, Christian Sieder⁸, Meron Maricos⁸ and Jens Thiel⁹, ¹Department of Rheumatology and Clinical Immunology, Vasculitis Center Freiburg, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany, ²Immanuel Krankenhaus Berlin, Medical Center for Rheumatology Berlin-Buch, Lindenberger Weg 19, 13125 Berlin, Germany, Berlin, Germany, ³Medizinische Klinik A, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany, ⁴Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054,, Erlangen, Germany, ⁵Medical Department 1, Städtisches Klinikum Dresden, Dresden, Germany, ⁶Department of Medicine 2, Rheumatology and Clinical Immunology Oberduerrbachertstr. 697080, Wuerzburg, Germany, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁸Novartis Pharma GmbH, Nuremberg, Germany, ⁹Department of Rheumatology and Clinical Immunology, Vasculitis Center Freiburg, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany; Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
Background/Purpose: Little is known about glucocorticoid-sparing agents in giant cell arteritis (GCA) except for IL-6 inhibition. Secukinumab (SEC) has shown significant improvements in the signs…
Abstract Number: L21 • ACR Convergence 2021
Rituximab versus Conventional Therapeutic Strategy for Remission Induction in Eosinophilic Granulomatosis with Polyangiitis: A Double-blind, Randomized, Controlled Trial
Benjamin Terrier¹, Gregory Pugnet², Claire de Moreuil³, Bernard Bonnotte⁴, Ygal Benhamou⁵, Elisabeth Diot⁶, Dominique Chauveau², Pierre Duffau⁷, Nicolas Limal⁸, Antoine Neel⁹, Geoffrey Urbanski¹⁰, Noemie Jourde-Chiche¹¹, Nicolas Martin-Silva¹², Francois Maurier¹³, Arsene Mekinian¹⁴, Nicolas Schleinitz¹¹, Felix Ackermann¹⁵, Anne-Laure Fauchais¹⁶, Antoine Froissart¹⁷, Thomas Le Gallou¹⁸, Yurdagul Uzunhan¹⁹, Jean-Francois Viallard⁷, Alice Berezne²⁰, Laurent Chiche²¹, Bruno Crestani¹⁴, Guillaume Direz²², Cecile-Audrey Durel²³, Pascal Godmer²⁴, Jean-Emmanuel Kahn²⁵, Marc Lambert²⁶, Thomas Quemeneur²⁷, Jacques Cadranel¹⁴, Pierre Charles²⁸, Antoine Dossier¹⁴, Lea Jilet²⁹, Loic Guillevin¹⁴, Hendy Abdoul²⁹ and Xavier Puechal¹⁴, ¹Cochin Hospital, Paris, France, ²CHU, Toulouse, France, ³CHU, Brest, France, ⁴CHU, Dijon, France, ⁵CHU, Rouen, France, ⁶CHU, Tours, France, ⁷CHU, Bordeaux, France, ⁸CHU, Creteil, France, ⁹CHU, Nantes, France, ¹⁰CHU, Angers, France, ¹¹CHU, Marseille, France, ¹²CHU, Caen, France, ¹³CH, Metz, France, ¹⁴CHU, Paris, France, ¹⁵Hopital Foch, Suresnes, France, ¹⁶CHU, Limoges, France, ¹⁷CHIC, Creteil, France, ¹⁸CHU, Rennes, France, ¹⁹CHU, Bobigny, France, ²⁰CH, Annecy, France, ²¹CH, Marseille, France, ²²CH, Le Mans, France, ²³CHU, Lyon, France, ²⁴CH, Vannes, France, ²⁵CHU, Boulogne, France, ²⁶CHRU, Lille, France, ²⁷CH, Valenciennes, France, ²⁸CH, Paris, France, ²⁹URC, Paris, France
Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is an eosinophilic ANCA-associated vasculitis.Glucocorticoids, alone or in combination with cyclophosphamide in severe forms, induce remission in most patients…
Abstract Number: L05 • ACR Convergence 2021
Phase 2 Study Results from a Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate Efficacy and Safety of Tigulixostat, a Novel Non-purine Selective Xanthine Oxidase Inhibitor, in Gout Patients with Hyperuricemia
Robert Terkeltaub¹, JuneSik Mune², Jieun Lee³ and Kenneth Saag⁴, ¹VA/UCSD, San Diego, CA, ²LG Chem, Ltd., Seoul, ³LG Chem, Ltd., Seoul, South Korea, ⁴The University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Gout can be effectively managed by inhibiting synthesis of uric acid. Tigulixostat is a novel non-purine selective xanthine oxidase inhibitor which lowers production of…
Abstract Number: L10 • ACR Convergence 2021
A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease
joshua solomon¹, Felix Woodhead², Sonye Danoff³, Shana Haynes-Harp⁴, Tanvi Naik⁵, Cathie Spino⁵, Shelley Hurwitz⁶, Rie Maurer⁶, Daniel Chambers⁷, Martin Kolb⁸, Hiliary Goldberg⁶ and Ivan Rosas⁴, ¹National Jewish Health, Denver, CO, ²University of Leicester, Leicester, United Kingdom, ³Johns Hopkins University, Baltimore, MD, ⁴Baylor College of Medicine, Houston, TX, ⁵University of Michigan, Ann Arbor, MI, ⁶Brigham and Womens Hospital, Boston, MA, ⁷University of Queensland, Brisbane, Australia, ⁸McMaster University, Hamilton, ON, Canada
Background/Purpose: Rheumatoid arthritis-associated interstitial lung disease (RA-ILD) is a prevalent and morbid condition leading to premature death in 10% of those affected. The TRAIL1 trial…

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