Abstracts tagged "clinical trial"

Abstract Number: 0798 • ACR Convergence 2020
A Randomized, Double-blind Phase 3 Study Comparing the Efficacy, Safety and Immunogenicity of PF-06410293 (Abrilada™), an Adalimumab (ADL) Biosimilar, and Reference ADL (Humira®) in Patients with Moderate to Severe Active RA: Results from Weeks 52-92
Roy Fleischmann¹, Daniel Alvarez², Amy Bock³, Carol Cronenberger⁴, Ivana Vranic⁵, Wuyan Zhang⁶ and Rieke Alten⁷, ¹Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, ²Pfizer, Collegeville, PA, ³Pfizer, Cambridge, MA, ⁴Pfizer, Collegeville, ⁵Pfizer, Tadworth, United Kingdom, ⁶Pfizer, New York, ⁷Schlosspark-Klinik, Universitätsmedizin, Berlin, Germany
Background/Purpose: To evaluate the long-term safety, immunogenicity (IG), and efficacy of the adalimumab (ADL) biosimilar, PF-06410293 (ADL-PF), in patients (pts) with moderate to severe active…
Abstract Number: 0935 • ACR Convergence 2020
Efficacy and Safety Results from a Phase 2, Randomized, Double-Blind Trial of BIIB059, an Anti-Blood Dendritic Cell Antigen 2 Antibody, in SLE
Richard Furie¹, Ronald van Vollenhoven², Kenneth Kalunian³, Sandra Navarra⁴, Juanita Romero-Díaz⁵, Victoria Werth⁶, Xiaobi Huang⁷, Hua Carroll⁸, Adam Meyers⁷, Cristina Musselli⁷, Catherine Barbey⁹ and Nathalie Franchimont⁷, ¹Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ²Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, ³University of California San Diego, La Jolla, CA, ⁴University of Santo Tomas, Manila, Philippines, ⁵Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico, ⁶University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, ⁷Biogen, Cambridge, MA, ⁸Biogen, Cambridge, ⁹Biogen, Baar, Switzerland
Background/Purpose: Type I interferons (IFN-I), inflammatory mediators principally produced by plasmacytoid dendritic cells (pDCs), components of the innate immune system, have been implicated in the…
Abstract Number: 1233 • ACR Convergence 2020
Use of Multi-Biomarker Disease Activity Scores to Compare Biosimilar Adalimumab-afzb (PF-06410293) with EU-Sourced Reference Adalimumab in a Phase 3, Randomized, Double-Blind Trial in Patients with Active RA
Jonathan Kay¹, Amy Bock², Noriko Iikuni³, Wuyan Zhang⁴ and Daniel Alvarez⁵, ¹University of Massachusetts Medical School, Worcester, MA, ²Pfizer, Cambridge, MA, ³Pfizer, New York, NY, ⁴Pfizer, New York, ⁵Pfizer, Collegeville, PA
Background/Purpose: Traditional efficacy endpoints of disease activity (DA) in studies of anti-rheumatic drugs can be confounded by subjective (patient-/physician-reported) assessments, comorbidities, and pre-existing joint damage.…
Abstract Number: 1745 • ACR Convergence 2020
A Novel Method for Predicting 1-Year Retention of Abatacept Using Machine Learning Techniques
Rieke Alten¹, Claire Behar², Christine Boileau², Pierre Merckaert², Ebenezer Afari², Virginie Vannier-Moreau³, Sean Connolly³, Yedid Elbez², Pierre-Antoine Juge⁴ and Karissa Lozenski³, ¹Schlosspark-Klinik, Universitätsmedizin, Berlin, Germany, ²Excelya, Boulogne-Billancourt, France, ³Bristol-Myers Squibb Company, Princeton, NJ, ⁴Université de Paris, Service de Rhumatologie Hôpital Bichat-Claude Bernard, AP-HP, Paris, France
Background/Purpose: In the ACTION (NCT02109666) study, using multivariable Cox proportional hazards regression models, patient (pt) global assessment of pain, country, reason for stopping last biologic,…
Abstract Number: 2035 • ACR Convergence 2020
Exploring Stratification Strategies for Early Diffuse Systemic Sclerosis Clinical Trial Design
Robyn Domsic¹, Shiyao Gao², Maureen Laffoon², Steven Wisniewski³, Robert Lafyatis⁴, Virginia Steen⁵ and Thomas Medsger⁶, ¹University of Pittsburgh School of Medicine, Pittsburgh, PA, ²University of Pittsburgh, Pittsburgh, PA, ³University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, ⁴University of Pittsburgh, Arlington, MA, ⁵Division of Rheumatology, Department of Medicine, MedStar Georgetown University Hospital, Washington, DC, ⁶University of Pittsburgh School of Medicine, Verona, PA
Background/Purpose: Clinical trials in early diffuse systemic sclerosis (SSc) using the modified Rodnan skin score (mRSS) as the primary outcome have been largely negative. This…
Abstract Number: 0107 • ACR Convergence 2020
Effects of Abaloparatide on Modeling and Remodeling Based Bone Formation
David W Dempster¹, Hua Zhou¹, Sudhaker D Rao², Chris Recknor³, Paul D Miller⁴, Benjamin Z Leder⁵, Miriam Annett⁶, Michael S Ominsky⁶ and Bruce H Mitlak⁶, ¹Regional Bone Center, Helen Hayes Hospital, West Haverstraw, NY, West Haverstraw, NY, ²Bone & Mineral Research Laboratory, Henry Ford Health System, Detroit, MI, Detroit, MI, ³United Osteoporosis Centers, Gainesville, GA, Gainesville, GA, ⁴Colorado Center for Bone Research, Lakewood, CO, Lakewood, CO, ⁵Mass General Hospital, Harvard Medical School, Boston, MA, Boston, MA, ⁶Radius Health, Inc., Waltham, MA, Waltham, MA
Background/Purpose: To evaluate abaloparatide-induced changes in the bone formation indices of mineralizing surface (MS), bone formation rate (BFR) and mineral apposition rate (MAR); and to…
Abstract Number: 0215 • ACR Convergence 2020
Incidence and Risk of Venous Thromboembolic Events Among Patients with Rheumatoid Arthritis Enrolled in the Upadacitinib Clinical Trial Program
Ernest Choy¹, Iain McInnes², John Cush³, Jacob Aelion⁴, William Rigby⁵, Yanna Song⁶, Sebastian Meerwein⁷, John Liu⁸, Nasser Khan⁸, Jessica Suboticki⁸ and Alexander Cohen⁹, ¹CREATE Centre, Cardiff University, Cardiff, Wales, United Kingdom, ²Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, ³University of Texas Southwestern Medical School, Dallas, TX, ⁴Arthritis Clinic PLLC, Jackson, ⁵Dartmouth College, Norwichi, VT, ⁶AbbVie Inc., North Chicago,, IL, ⁷Pharmaceutical Development, AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany, ⁸AbbVie Inc., North Chicago, IL, ⁹Guy’s and St Thomas’ NHS FT Hospitals, King’s College, London, United Kingdom
Background/Purpose: Patients (pts) with rheumatoid arthritis (RA) are at an increased risk for the development of venous thromboembolism (VTE, including pulmonary embolism [PE] and deep…
Abstract Number: 0385 • ACR Convergence 2020
A Pilot Study to Evaluate the Safety and Efficacy of Treprostinil in the Treatment of Calcinosis in Patients with Systemic Sclerosis
Melody Chung¹, Antonia Maria Valenzuela Vergara², Benjamin Catanese¹, Shufeng Li¹, Kate Stevens¹ and Lorinda Chung³, ¹Stanford University, Stanford, CA, ²Pontificia Universidad Catolica de Chile, Santiago de Chile, Chile, ³Stanford University School of Medicine and Palo Alto VA Health Care System, Palo Alto, CA
Background/Purpose: Calcinosis is characterized by calcium deposition in skin and subcutaneous tissues and progresses over one year in the majority of systemic sclerosis (SSc) patients. Since…
Abstract Number: 0800 • ACR Convergence 2020
A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar (CT-P17) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis
Jonathan Kay¹, Janusz Jaworski², Rafal Wojciechowski³, Piotr Wiland⁴, Anna Dudek⁵, Marek Krogulec⁶, Slawomir Jeka⁷, Agnieszka Zielinska⁸, Jakub Trefler⁹, Katarzyna Bartnicka-Maslowska¹⁰, Magdalena Krajewska-Wlodarczyk¹¹, Piotr Klimiuk¹², Daniel Furst*¹³, SangJoon Lee¹⁴, YunJu Bae¹⁴, GoEun Yang¹⁴, JaeKyoung Yoo¹⁴, HyunJin Lee¹⁴ and Edward C Keystone¹⁵, ¹University of Massachusetts Medical School, Worcester, MA, ²Reumatika-Centrum Reumatologii, Warsaw, Poland, ³University Hospital No 2, Bydgoszcz, Poland, ⁴Medical Univeristy, Wroclaw, Poland, ⁵Centrum Medyczne AMED, Warsaw, Poland, ⁶Rheumatology Clinic NZOZ Lecznica MAK-MED, Nadarzyn, Poland, ⁷2nd Univ Hospital, CM UMK, Bydgoszcz, Poland, ⁸Medycyna Kliniczna Marzena Waszczak-Jeka, Warsaw, Poland, ⁹Reuma Centrum, Warsaw, Poland, ¹⁰Centrum Medyczne AMED oddzial w Łodzi, Łódź, Poland, ¹¹University of Warmia and Mazury, Olsztyn, Poland, ¹²Medical University of Białystok and Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk, Białystok, Poland, ¹³Department of Medicine, Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA, Los Angeles, CA, ¹⁴Celltrion, Inc., Incheon, Republic of Korea, ¹⁵Mount Sinai Hospital, Toronto, ON, Canada
Background/Purpose: CT-P17 (100 mg/mL) is the first proposed biosimilar of the high concentration and citrate-free formulation of reference adalimumab. The purpose of this study was…
Abstract Number: 0952 • ACR Convergence 2020
Reducing Immunogenicity of Pegloticase (RECIPE) with Concomitant Use of Mycophenolate Mofetil in Patients with Refractory Gout—a Phase II Double Blind Randomized Controlled Trial
Puja Khanna¹, Dinesh Khanna¹, Gary Cutter², Jeffrey Foster², Joshua Melnick³, Sara Jaafar¹, Stephanie Biggers², AKM Rahman², Hui-Chen Kuo², Michelle Feese² and Kenneth Saag⁴, ¹University of Michigan, Ann Arbor, MI, ²University of Alabama at Birmingham, Birmingham, AL, ³University of Alabama at Birmingham (UAB), Vestavia Hills, AL, ⁴University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, Birmingham, AL
Background/Purpose: Pegloticase, a recombinant, pegylated uricase, is used for treatment of gout in patients who fail oral urate lowering therapy (ULT). Despite successful reduction of…
Abstract Number: 1238 • ACR Convergence 2020
Associations Between Rheumatoid Arthritis Disease Activity and Patient-reported Outcomes in Sarilumab Clinical Trials
Gerd Burmester¹, Laure Gossec², Hubert van Hoogstraten³, Amy Praestgaard⁴, Gregory St John⁵, Thomas Huizinga⁶, Daniel Aletaha⁷ and Roy Fleischmann⁸, ¹Charité University Hospital Berlin, Berlin, Germany, ²Sorbonne Université and Hôpital Universitaire Pitié Salpêtrière, Paris, France, ³Sanofi, Bridgewater, NJ, ⁴Sanofi, Cambridge, MA, ⁵Regeneron Pharmaceuticals Inc, Tarrytown, NY, ⁶Leiden University Medical Center, Leiden, Netherlands, ⁷Division of Rheumatology, Department of Medicine III, Medical University of Vienna,, Vienna, Austria, ⁸Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: Sarilumab is a human IL-6 receptor inhibitor approved for the treatment of adults with moderately to severely active RA. The relationship between disease activity,…
Abstract Number: 1747 • ACR Convergence 2020
Brain fMRI Predicts Responses to Certolizumab Pegol in RA. an International, Multi-center, Randomized, Double-blind, Placebo-controlled Trial (PreCePRA)
Juergen Rech¹, Hannah Schenker², Koray Tascilar¹, Melanie Hagen², Arnd Kleyer¹, David Simon¹, Larissa Valor Mendez², Verena Schoenau³, Jutta Prade⁴, Marina Sergeeva⁴, Mageshvar Sulvakumar⁵, Sandra Strobelt⁴, Laura Konerth⁴, Frank Behrens⁶, Christoph Baerwald⁷, Stephanie Finzel⁸, Reinhard Voll⁹, Axel Hueber¹⁰, Julie Roesch¹¹, Eugen Feist¹², José A. P. da Silva¹³, Arnd Doerfler¹¹, Nemanja Damjanov¹⁴, Andreas Hess¹⁵ and Georg Schett¹⁶, ¹Department of Internal Medicine 3, Friedrich-Alexander University (FAU) Erlangen-Nuremberg and Universitätsklinikum Erlangen, Erlangen, Bayern, Germany, ²Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054, Erlangen, Germany, Erlangen, Germany, ³Department of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054, Erlangen, Germany, Erlangen, ⁴Institute for Experimental Pharmacology, Erlangen, Germany, ⁵Insitute for Experimental Pharmacology , Fau Erlangen-Nürnberg, Erlangen, Germany, ⁶CIRI/Rheumatology & Fraunhofer TMP, Goethe University, Frankfurt, Germany, ⁷Uniklinik Leipzig, Medizinische Klinik III - Bereich Rheumatologie, Leipzig, Germany, ⁸Universitätsklinikum Freiburg, Klinik für Rheumatologie und Klinische Immunologie, Freiburg, Germany, ⁹Universitätsklinikum Freiburg, Klinik für Rheumatologie und Klinische Immunologie, Freibrug, ¹⁰Section Rheumatology, Sozialstiftung Bamberg, Bamberg, Germany, ¹¹Abteilung für Neuroradiologie, Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054, Erlangen, Germany, Erlangen, Germany, ¹²Department of Rheumatology, Helios Vogelsang-Gommern, Vogelsang-Gommern, Germany, ¹³9.Centro Hospitalar e Universitário Coimbra (Rheumatology Department), Coimbra, Portugal, Coimbra, Portugal, ¹⁴University of Belgrade Medical School, Belgrade, Serbia, ¹⁵Institute for Experimental Pharmacology, Erlangen, ¹⁶Friedrich-Alexander-Universität Erlangen- Nuremberg, Erlangen, Germany
Background/Purpose: Personalization of RA treatment is not optimal due to lack of predictors. We previously demonstrated in RA patients that central nervous system (CNS) pain…
Abstract Number: 2052 • ACR Convergence 2020
Extended Follow-Up of Patients Recruited to a Randomized, Controlled Trial of Rituximab versus Azathioprine After Induction of Remission with Rituximab for Patients with ANCA-Associated Vasculitis and Relapsing Disease
Rona Smith¹, David Jayne² and Peter A. Merkel³, ¹University of Cambridge, Cambridge, United Kingdom, ²Department of Medicine, Vasculitis and Lupus Research Group, University of Cambridge, Cambridge, UK, Cambridge, United Kingdom, ³Division of Rheumatology University of Pennsylvania, Philadelphia, PA
Background/Purpose: Rituximab is an effective therapy for induction of remission in ANCA-associated vasculitis (AAV). However, the effect of rituximab is not sustained, and subsequent relapse…
Abstract Number: 0136 • ACR Convergence 2020
Filgotinib Significantly Improved Patient-reported Health-related Quality of Life for Patients with Active Rheumatoid Arthritis: A Post Hoc Analysis of SF-36 and HAQ-DI from Phase 3 Studies
Clifton Bingham III¹, David Walker², Peter Nash³, Susan Lee⁴, Lei Ye⁴, Hao Hu⁴, Javaria Mona Khalid⁵ and Bernard Combe⁶, ¹Johns Hopkins University, Baltimore, MD, ²Northumbria Healthcare NHS Foundation Trust, North Shields, United Kingdom, ³School of Medicine Griffith University, Brisbane, Queensland, Australia, ⁴Gilead Sciences, Inc., Foster City, CA, ⁵Galapagos BV, Leiden, Netherlands, ⁶University of Montpellier, Montpellier, France
Background/Purpose: Reduction in pain and fatigue, maintenance of physical functioning, and improvement in health-related quality of life (HRQoL) are vital aspects of successful treatment for…
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…

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