Abstracts tagged "Randomized Trial"

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: 1001 • ACR Convergence 2022
Effect of Atacicept on Renal Function in Patients with Systemic Lupus Erythematosus (SLE)
David Isenberg¹, Celia Lin², Amy Kao³, Aida Aydemir⁴ and Caroline Gordon⁵, ¹University College London, London, United Kingdom, ²Vera Therapeutics, Inc, Burlingame, CA, ³EMD Serono, Billerica, MA, ⁴EMD Serono Research & Development Institute, Inc, Billerica, MA, ⁵Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom
Background/Purpose: Atacicept is a fusion protein that blocks B-lymphocyte stimulator and a proliferation-inducing ligand, which are increased in patients with SLE. APRIL-SLE was a double-blind,…
Abstract Number: 1960 • ACR Convergence 2022
Impact of Delaying Initiation of Methotrexate by One Month on the Outcome of RA at One Year
Theresa Than¹, Emmanuelle Dernis², Olivier BROCQ³, Bruno Fautrel⁴, Helena HUGUET⁵, Liana Euller-Ziegler⁶, Lindsay BUSTAMENTE-CENCI⁶, Olivier Vittecoq⁷, Marie-christine PICOT⁵, Cédric Lukas⁸, Claire DAIEN⁹, Charlotte Hua¹⁰, Marlène Genty⁵, Helene Che⁵, Anouck REMY-MOULARD¹¹, Frederic LIOTE¹², Martin Soubrier¹³, Cécile GAUJOUX-VIALA¹⁴, Arnaud Constantin¹⁵, Alain Saraux¹⁶, Emilie Ducourau¹⁷, Stephanie RIST¹⁸, CARINE SALLIOT¹⁹, Nada IBRAHIM-NASSER¹⁸, Clara qUINTEN¹⁸, Vincent Goeb²⁰ and Jacques Morel¹, ¹University and CHU Montpellier, Montpellier, France, ²LE MANS general hospital, LE MANS, France, ³Centre hospitalier Princesse-Grace, Monaco, France, ⁴Sorbonne University Paris, France and Pierre Louis Institute of Epidemiology and Public Health, Paris, France, Paris, France, ⁵CHU Montpellier, Montpellier, France, ⁶CHRU Nice, Nice, France, ⁷CHU de Rouen, ROUEN, France, ⁸University Hospital Centre Montpellier, University of Montpellier, Montpellier, France, ⁹University Hospital, Saint-Gély-du-Fesc, France, ¹⁰La Lettre du Rhumatologue, Paris, France, ¹¹CHU Montpellier, Montpellier, Chad, ¹²University of Paris, Paris, France, ¹³Gabriel-Montpied Hospital, Clermont-Ferrand, France, ¹⁴CHU Nîmes, Univ Montpellier (IDESP), Nîmes, France, ¹⁵Toulouse University Hospital, Toulouse, France, ¹⁶CHU Brest, Brest, France, ¹⁷CH Orleans, Chambray Les Tours, France, ¹⁸CH orleans, Orleans, France, ¹⁹CHR orleans, Orleans, France, ²⁰CHU Amiens, Amiens, France
Background/Purpose: It is recommended that vaccinations should be performed prior to start methotrexate (MTX) knowing that delaying initiation of background therapy may have an impact…
Abstract Number: 0173 • ACR Convergence 2022
Cutaneous Manifestations, Clinical Trials, Safety Efficacy and Safety of Lenabasum in the Phase 3 DeterMine Trial in Dermatomyositis
Victoria Werth¹, Barbara White², Josef Concha³, Josh Dan¹, Nancy Dgetluck², Kathleen Hally², Scott Constantine², Rohit Aggarwal⁴, David Fiorentino⁵, Ingrid Lundberg⁶ and Chester Oddis⁷, ¹Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, ²Corbus Pharmaceuticals, Norwood, MA, ³Universiity of Pennsylvania/Dermatology, Philadelphia, PA, ⁴University of Pittsburgh, Division of Rheumatology, Pittsburgh, PA, ⁵Stanford university/Department of Dermatology, Palo Alto, CA, ⁶Karolinska Institute, Stockholm, Sweden, ⁷University of Pittsburgh, Pittsburgh, PA
Background/Purpose: Safe and effective treatments are of significant unmet need in DM. Lenabasum, a CB2 agonist that activates resolution of inflammation, improved skin disease, patient-reported…
Abstract Number: 1007 • ACR Convergence 2022
Metabolic Disorders and Abnormal Dietary Patterns and Their Association with Psoriatic Arthritis Activity: The Dietary Intervention in PsA (DIPSA) Study
Lihi Eder¹, Charlene Compher², Helen Emanoilidis³, Ryan F. Quinn², Dafna Gladman⁴, Vinod Chandran⁵, Jose Scher⁶ and Alexis Ogdie⁷, ¹Women’s College Research Institute, Department of Medicine, University of Toronto, Toronto, ON, Canada, ²University of Pennsylvania, Philadelphia, PA, ³Women's College Hospital, Toronto, ON, Canada, ⁴Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada, ⁵Departments of Medicine and Laboratory Medicine and Pathobiology, University of Toronto/ Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, ON, Canada, ⁶New York University School of Medicine, New York, NY, ⁷Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: Psoriatic Arthritis (PsA) is associated with obesity and its related metabolic abnormalities. The role of diet as an adjunct therapy in PsA remains unclear.…
Abstract Number: 1985 • ACR Convergence 2022
The BEGIN Study: A Double-blind, Multi-center, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks of Treatment with AP1189 in Early Rheumatoid Arthritis (RA) Patients with Active Joint Disease
Thomas Jonassen¹, Irene Sandholdt², Birgitte Telmer² and Ellen-Margrethe Hauge³, ¹SynAct Pharma, Holte, Denmark, ²CroxxMed, Hørsholm, Denmark, ³Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
Background/Purpose: Melanocortin (MC) type 1 and type 3 receptor stimulation is associated with anti-inflammatory activity and the promotion of inflammatory resolution. AP1189 is novel biased…
Abstract Number: 0199 • ACR Convergence 2022
Izokibep, a Novel IL-17A Inhibitor, Improves Patient-reported Outcomes – 16-Week Results from a Placebo-controlled Phase 2 Study in Patients with Active Psoriatic Arthritis
Peter Taylor¹, Frank Behrens², Philip J Mease³, Dieter Wetzel⁴, Paul Peloso⁵, Nicolai Brun⁴, Brian Wiens⁶, Jan Brandt-Juergens⁷, Edit Drescher⁸, Eva Dokoupilova⁹, Anna Rowińska-Osuch¹⁰, Nadia Abdel- Kader Martin¹¹ and Kurt de Vlam¹², ¹University of Oxford, Oxford, United Kingdom, ²Rheumatology University Hospital & Fraunhofer Institute Translational Medicine and Pharmacology, Goethe-University Frankfurt, Frankfurt Am Main, Germany, ³Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ⁴Affibody AB, Solna, Sweden, ⁵ACELYRIN, Naples, FL, ⁶ACELYRIN, Inc., Los Angeles, CA, ⁷Rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁸Veszprem Megyei Csolnoky Ferenc Korhaz, Budapest, Hungary, ⁹Medical Plus, s.r.o. & Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Brno, Prague, Czech Republic, ¹⁰ETG Network - Rheumatology, Warsaw, Poland, ¹¹Hospital Infanta Luisa Quiron, Rheumatology, Sevilla, Spain, ¹²University Hospitals Leuven, Leuven, Belgium
Background/Purpose: Izokibep is a unique IL-17A inhibitor with high potency and small molecular size designed to overcome the limitations of monoclonal antibodies. IL-17 is a…
Abstract Number: 1036 • ACR Convergence 2022
Efficacy and Safety of Tofacitinib in Patients with Psoriatic Arthritis or Ankylosing Spondylitis by History of Cigarette Smoking
Alexis Ogdie¹, Lars Erik Kristensen², Enrique R Soriano³, Servet Akar⁴, Yanhui Sun⁵, David Gruben⁶, Lara Fallon⁷, Cassandra D Kinch⁸ and Dafna Gladman⁹, ¹Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ²The Parker Institute, Copenhagen University Hospital, Copenhagen, Denmark, ³Rheumatology Unit and University Institute, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁴Izmir Katip Celebi University School of Medicine, Izmir, Turkey, ⁵Pfizer CRDC, Shanghai, China, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer Inc, Montréal, QC, Canada, ⁸Pfizer Canada ULC, Kirkland, Canada, ⁹Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada
Background/Purpose: In patients (pts) with PsA and AS, smoking may be associated with an increased comorbidity burden, and greater responses to TNF inhibitors (TNFi) are…
Abstract Number: 2002 • ACR Convergence 2022
Do SMS and Email Reminders Increase the Rate of Seasonal Influenza Vaccination in RA Patients Treated with Biologics: A Nested Randomized Controlled Trial Within the ART Registry?
Raphaèle Seror¹, Gabriel Baron², Sylvie Miconnet³, Rakiba Belkhir³, Martin Soubrier⁴, pascale thevenot⁵, andre basch⁶, Marie Truchetet⁷, Pascal Claudepierre⁸, Emmanuelle Dernis⁹, Hubert Marotte¹⁰, René-Marc Flipo¹¹, Olivier Brocq¹², Jacques Morel¹³, CARINE SALLIOT¹⁴, Bruno Fautrel¹⁵, Alain Saraux¹⁶, CHARLES LESKE¹⁷, Naïma Hamamouche¹⁸, Thierry schaeverbeke¹⁹, Xavier Mariette²⁰, Adeline Ruyssen-Witrand²¹ and Philippe Ravaud²², ¹University Hospital Paris-Saclay, Le Kremlin Bicêtre, France, ²AP-HP Hôtel Dieu Hospital, Université Paris Descartes, Paris, France, ³Rheumatology departement, Bicêtre, Paris-Saclay university, Le Kremlin Bicêtre, France, ⁴Gabriel-Montpied Hospital, Clermont-Ferrand, France, ⁵French Society of rheumatology, Paris, France, ⁶Infirmerie Protestante de Lyon, Caluire-et-Cuire, France, ⁷Bordeaux University Hospital, Bordeaux, France, ⁸Paris Est Creteil University, Creteil, France, ⁹LE MANS general hospital, LE MANS, France, ¹⁰INSERM 1059, Saint-Etienne, France, ¹¹CHU Lille, Boulogne-Billancourt, France, ¹²Rheumatology- CH Princesse Grace, Monaco, Monaco, ¹³University and CHU Montpellier, Montpellier, France, ¹⁴CHR orleans, Orleans, France, ¹⁵Sorbonne University Paris, France and Pierre Louis Institute of Epidemiology and Public Health, Paris, France, Paris, France, ¹⁶CHU Brest, Brest, France, ¹⁷Hospital, Cholet, France, ¹⁸e-health Services Sanoïa, Gémenos, France, ¹⁹CHU de Bordeaux, Bordeaux, France, ²⁰Paris-Saclay University, Rueil Malmaison, Ile-de-France, France, ²¹CHU de Toulouse, Toulouse, France, ²²Université Paris Cité, Hôtel-Dieu, Paris, France
Background/Purpose: In patients treated with biologics, vaccination against influenza is recommended. However, vaccination coverage remains very low. The use of automatic digital reminders is an…
Abstract Number: 0229 • ACR Convergence 2022
The Effect of Interactive E-learning on Resident’s Practical Performance in Musculoskeletal Ultrasound- a Randomized Study
Stine Maya Dreier Carstensen¹, Søren Just², Marie Velander³, Lars Konge⁴, Martin Slusarczyk Hubel⁵, Thiusius Rajeeth Savarimuthu⁵, Mogens Pfeiffer Jensen⁶, Mikkel Østergaard⁷ and Lene Terslev⁸, ¹Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Copenhagen University Hospital – Rigshospitalet Glostrup, Glostrup, Denmark, ²Medicinsk Afdeling Svendborg Sygehus OUH, Odense, Denmark, ³Section of Rheumatology, Department of Medicine, Svendborg Hospital - Odense University Hospital (OUH), Svendborg, Denmark, ⁴Copenhagen Academy for Medical Education and Simulation The Capital Region of Denmark, Copenhagen, Denmark, ⁵SDU Robotics, Mærsk Mc-Kinney Møller Instituttet, Syddansk Universitet, Odense, Odense, Denmark, ⁶Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Copenhagen University Hospital – Rigshospitalet Glostrup, Copenhagen, Denmark, ⁷Rigshospitalet, University of Copenhagen, Glostrup, Denmark, ⁸Copenhagen University Hospital Glostrup, Glostrup, Denmark
Background/Purpose: Musculoskeletal ultrasound (MSUS) is a complex procedure to master and requires both extensive theoretical knowledge and hands-on training. E-learning supplements hands-on training by providing…
Abstract Number: 1113 • ACR Convergence 2022
Remibrutinib (LOU064) in Sjögren’s Syndrome: Safety and Efficacy Results from a 24‑Week Placebo-controlled Proof-of-Concept Study
Thomas Dörner¹, Antónia Szántó², Jui-Cheng Tseng³, Martin Kaul⁴, Ilona Pylvaenaeinen⁵, Malika Hanser⁶, Nasri Abdallah⁶, Bruno Cenni⁶ and Richard Siegel⁶, ¹Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany, ²Debreceni Egyetem Klinikai Centrum, Debrecen, Hungary, ³Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ⁴Independent Consultant, Neustadt, Germany, ⁵Early Development Analytics, Novartis Pharmaceutical AG, Basel, Switzerland, ⁶Novartis Institutes for BioMedical Research, Basel, Switzerland
Background/Purpose: Sjögren's syndrome (SS) is a systemic autoimmune disease of unknown etiology characterized by B-cell hyperactivation, lymphoid infiltration, progressive destruction of exocrine glands, and various…
Abstract Number: 2008 • ACR Convergence 2022
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of Dazodalibep (VIB4920/HZN4920) in Patients with Rheumatoid Arthritis Having Inadequate Response to Conventional/Biological DMARDs
Alan Kivitz¹, Liangwei Wang², Ilias Alevizos², Michele Gunsior², Judith Falloon² and Gabor Illei³, ¹Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, ²Horizon Therapeutics, Gaithersburg, MD, ³Horizon Therapeutics, Rockville, MD
Background/Purpose: Dazodalibep (DAZ), a non-antibody biologic antagonist of CD40L, led to higher/durable response rates vs. placebo (PBO) in a double-blind, Phase 1b trial of patients…
Abstract Number: 0286 • ACR Convergence 2022
Efficacy and Safety of Upadacitinib in Patients Across Races with Rheumatoid Arthritis: A Post Hoc Analysis of Six Phase 3 Clinical Trials
Grace Wright¹, Eduardo Mysler², Iris Navarro-Millan³, Yoshiya Tanaka⁴, Samuel Anyanwu⁵, Jianzhong Liu⁵, Oishi Tanjinatus⁵, Andrew Garrison⁵ and Alvin Wells⁶, ¹Association of Women in Rheumatology, New York, NY, ²Department of Rheumatology, OMI (Medical Research Organization), Buenos Aires, Argentina, ³Weill Cornell Medicine, New York, NY, ⁴University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, ⁵AbbVie, Inc., North Chicago, IL, ⁶Aurora Rheumatology and Immunotherapy Center, Franklin, WI
Background/Purpose: RA affects diverse patient populations with varying disease severity and treatment responses. However, data on treatment response to advanced therapies by race are limited.1…
Abstract Number: 1229 • ACR Convergence 2022
Erosion Score and Erosive Joint Number Using Radiography: Clinical Implications in Patients with ACPA+ Early RA Treated with Abatacept
Chahin Pachai¹, Sean E Connolly², Yoshiya Tanaka³, Vivian Bykerk⁴, Tom Huizinga⁵, Gustavo Citera⁶, Clifton O. Bingham III⁷, Shuyan Du¹, Godehard Hoexter⁸, Paul Emery⁹, Subhashis Banerjee¹ and Roy Fleischmann¹⁰, ¹Bristol Myers Squibb, Princeton, NJ, ²Bristol-Myers Squibb, Morrisville, PA, ³University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, ⁴Hospital for Special Surgery, New York, NY, ⁵Leiden University Medical Center, Leiden, Netherlands, ⁶Instituto de Rehabilitación Psicofísica (IREP), Buenos Aires, Argentina, ⁷Johns Hopkins University, Baltimore, MD, ⁸Bristol Myers Squibb GmbH & Co. KGaA, Munich, Germany, ⁹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ¹⁰University of Texas Southwestern Medical Center and Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: Inhibition of structural joint damage progression is a key outcome measure in RA clinical trials. This can be assessed by progression of joint erosion…
Abstract Number: 2116 • ACR Convergence 2022
Assessment of the Ultrasound and Clinical Response to Apremilast Using a Joint-periarticular-nail Ultrasound Index and Clinical Evaluation in Patients with Active Psoriatic Arthritis
Juan Josè de Agustin¹, Gustavo Añez¹, delia reina², Sergi Heredia³, Felipe Julio Ramirez Garcia⁴, Andrea Cuervo⁵, Jesus Rodriguez⁶, Carmen Moragues⁶, Patricia Moya⁷, Mireia Moreno⁸, Marta Arévalo⁸, Manel Pujol⁹, Georgina Salvador⁹, Noemi Busquets¹⁰, andres Ponce¹⁰, Ana Maria Laiz Alonso⁷ and MAria Pascual Pastor¹¹, ¹Vall D'hebron University Hospital, Barcelona, Spain, ²Complex Hospitalari Moisès Broggi, Sant Joan Despí, Catalonia, Spain, ³Complex Hospitalari Moisès Broggi, Sant Joan Despi, Catalonia, Spain, ⁴Hospital Clínic, Barcelona, Spain, ⁵Hospital Clínico y Provincial de Barcelona, Barcelona, Spain, ⁶Hospital Bellvitge, Hospitalet de Llobregat, Spain, ⁷Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, ⁸Parc Tauli Hospital Universitari, Sabadell, Catalonia, Spain, ⁹Hospital Universitario MútuaTerrassa, Terrassa, Spain, ¹⁰Hospital General de Granollers, Granollers, Spain, ¹¹Hospital Universitari Vall d'Hebron, Barcelona, Spain
Background/Purpose: Psoriatic arthritis (PsA) is a chronic inflammatory disease involving joint and enthesis disease. Ultrasound (US) has demonstrated its useful tool for the diagnosis of…

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