Abstracts tagged "Randomized Trial"

Abstract Number: 0584 • ACR Convergence 2021
High Number of Comorbidities and Concomitant Medications at Baseline in the Glucocorticoid Low-dose Outcome in Rheumatoid Arthritis (GLORIA) Study: An Older Population with Rheumatoid Arthritis
Maarten Boers¹, Linda Hartman¹, Daniela Opris-Belinski², Reinhard Bos³, Marc Kok⁴, Jose Pereira da Silva⁵, Eduard N Griep⁶, Ruth Klaasen⁷, Cornelia F. Allaart⁸, Paul Baudoin⁹, Hennie Raterman¹⁰, Zoltan Szekanecz¹¹, Frank Buttgereit¹², Pavol Masaryk¹³, L. Thomas Klausch¹, Sabrina Paolino¹⁴, Annemarie Schilder¹⁵, Willem Lems¹⁶ and Maurizio Cutolo¹⁴, ¹Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, ²Carol Davila University, Bucharest, Romania, ³Department of Rheumatology, Medical Centre Leeuwarden, Leeuwarden, Netherlands, ⁴Maasstad Hospital, Rotterdam, Netherlands, ⁵University of Coimbra | UC · Clínica Universitária de Reumatologia. Faculty of Medicine, Columbia, Portugal, ⁶Antonius Hospital, Leeuwarden, Netherlands, ⁷Meander Medical Center, Amersfoort, Netherlands, ⁸Leiden University Medical Center, Leiden, Netherlands, ⁹Reumazorg ZWN, Almere, Netherlands, ¹⁰Northwest Clinics, Alkmaar, Netherlands, ¹¹Division of Rheumatology, University of Debrecen, Faculty of Medicine, Debrecen, Hungary, ¹²Charité – Universitätsmedizin Berlin, Berlin, Germany, ¹³National Institute for the Rheumatic Diseases, Bratislava, Slovakia, ¹⁴Laboratory of Experimental Rheumatology and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, IRCCS Polyclinic San Martino Hospital, Genoa, Italy, ¹⁵Medical Centre Leeuwarden, Leeuwarden, Netherlands, ¹⁶VUmc, Amsterdam, Netherlands
Background/Purpose: Older people are often underrepresented in trials because the generally high number of comorbid conditions (1). The objective of this abstract is to document…
Abstract Number: 1692 • ACR Convergence 2021
Long-Term Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: 3-year Results from the SELECT-EARLY Study
Ronald F van Vollenhoven¹, Tsutomu Takeuchi², Jacob Aelion³, Nilmo Chavez⁴, Pablo Mannucci⁵, Atul Singhal⁶, Jerzy Swierkot⁷, Alan Friedman⁸, Nasser Khan⁸, Yihan Li⁹, Xianwei Bu⁹, Justin Klaff⁸ and Vibeke Strand¹⁰, ¹Amsterdam University Medical Centers, Department of Rheumatology and Clinical Immunology, Rheumatology and Immunology Center ARC, Amsterdam, Netherlands, ²Div. Rheumatology, Keio University, Tokyo, Japan, ³Arthritis Clinic and West Tennessee Research Institute, Jackson, TN, ⁴Instituto Guatemalteco de Seguridad Social, Ciudad de Guatemala, Guatemala, ⁵Aprillus Asistencia e Investigación, Buenos Aires, Argentina, ⁶Southwest Rheumatology Research LLC, Dallas, TX, ⁷Department of Rheumatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland, ⁸AbbVie Inc., North Chicago, IL, ⁹AbbVie Inc., North Chicago, ¹⁰Stanford University School of Medicine, Portola Valley, CA
Background/Purpose: Upadacitinib (UPA), an oral Janus kinase inhibitor, demonstrated significant improvements in signs, symptoms, and structural inhibition as monotherapy (mono) vs methotrexate (MTX) in MTX-naïve…
Abstract Number: 0674 • ACR Convergence 2021
A Behavioral Intervention to Improve Gout Outcomes in African Americans with Gout: A 12-month Multicenter, Randomized Controlled Trial
Jasvinder Singh¹, Kenneth Saag¹, Joshua Baker², Amy Joseph³, Seth Eisen⁴ and Terence Shaneyfelt¹, ¹University of Alabama at Birmingham, Birmingham, AL, ²University of Pennsylvania, Philadelphia, PA, ³Washington University / St. Louis VA, St Louis, MO, ⁴Washington University School of Medicine, St Louis, MO
Background/Purpose: Gout outcomes and severity are worst in African Americans compared to Caucasians with gout. Racial Disparities in gout are well-described. Few or no data…
Abstract Number: 1694 • ACR Convergence 2021
Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs
Ronald van Vollenhoven¹, Stephen Hall², Alvin Wells³, Sebastian Meerwein⁴, Yanna Song⁵, Jessica Suboticki⁵ and Roy Fleischmann⁶, ¹Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, ²Emeritus Research and Monash University, Melbourne, Australia, Melbourne, Australia, ³Rheumatology and Immunotherapy Center, Franklin, WI, ⁴AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, ⁵AbbVie Inc., North Chicago, IL, ⁶Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: Sustained clinical remission (REM) is the primary treatment goal for patients with rheumatoid arthritis (RA), with low disease activity (LDA) being an appropriate target…
Abstract Number: 0675 • ACR Convergence 2021
Urate-lowering Therapy for Prevention of Gout: Prespecified Analyses from the CKD-FIX Trial
Anushree Tiku¹, Neil Boudville², Fiona Brown³, Alan Cass⁴, Phiilip Clarke⁵, Richard Day⁶, Janak de Zoysa⁷, Bettina Douglas⁸, Randall Faull⁹, David Harris¹⁰, Carmel Hawley¹¹, Graham Jones⁶, John Kanellis³, Elaine Pascoe¹¹, Suetonia Palmer¹², Vlado Perkovic¹³, Gopala Rangan¹⁰, Donna Reidlinger¹¹, Laura Robison¹¹, Robert Walker¹⁴, Giles Walters¹⁵, David Johnson¹¹, Sunil Badve¹³ and Nicola Dalbeth⁷, ¹The George Institute of Australia, Sydney, Australia, ²University of Western Australia, Perth, Australia, ³Monash University, Melbourne, Australia, ⁴Menzies School of Health Research, Darwin, Australia, ⁵University of Oxford, Oxford, United Kingdom, ⁶University of New South Wales, Sydney, Australia, ⁷University of Auckland, Auckland, New Zealand, ⁸Princess Alexandra Hospital, Brisbane, Australia, ⁹University of Adelaide, Adelaide, Australia, ¹⁰University of Sydney, Sydney, Australia, ¹¹University of Queensland, Brisbane, Australia, ¹²University of Otago, Christchurch, New Zealand, ¹³The George Institute for Global Health, Sydney, Australia, ¹⁴University of Otago, Dunedin, New Zealand, ¹⁵The Canberra Hospital, Canberra, Australia
Background/Purpose: The CKD-FIX randomized controlled trial showed that allopurinol did not slow decline of estimated glomerular filtration rate (eGFR) over 104 weeks in patients with…
Abstract Number: 1703 • ACR Convergence 2021
AP1189: A Novel Oral Biased Melanocortin Agonist with Anti-inflammatory and Pro-resolving Effect for the Treatment of Rheumatoid Arthritis
Thomas Jonassen¹, Thierry Duvauchelle¹, Birgitte Telmer², Irene Sandholdt², Thomas Boesen¹ and Ellen-Margrethe Hauge³, ¹SynAct Pharma, Holte, Denmark, ²CroxxMed, Hørsholm, Denmark, ³Aarhus University Hospital, Aarhus, Denmark
Background/Purpose: Melanocortin (MC) type 1 and type 3 receptor stimulation is associated with anti-inflammation and promotion of inflammatory resolution. AP1189 is a biased MC type…
Abstract Number: 0695 • ACR Convergence 2021
Safety and Tolerability of IVIg (Octagam 10%) in Patients with Active Dermatomyositis. Results of a Randomized, Double-Blind, Placebo-Controlled Phase III Trial
Rohit Aggarwal¹, Christina Charles-Schoeman², Joachim Schessl³, Zsuzsanna Bata-Csorgo⁴, Mazen Dimachkie⁵, Zoltan Griger⁶, Sergey Moiseev⁷, Chester Oddis¹, Elena Schiopu⁸, Jiri Vencovsky⁹, Irene Beckmann¹⁰, Elisabeth Clodi¹⁰, Todd Levine¹¹ and and the ProDERM Investigators¹², ¹University of Pittsburgh, Pittsburgh, PA, ²Department of Medicine, University of California, Los Angeles, Los Angeles, CA, ³Friedrich-Baur-Institut/Medical University Munich, München, Germany, ⁴University of Szeged, Faculty of Medicine, Szeged, Hungary, ⁵University of Kansas Medical Center, Kansas City, KS, ⁶University of Debrecen, Debrecen, Hungary, ⁷First Moscow State Medical University, Moscow, Russia, ⁸University of Michigan, Ann Arbor, MI, ⁹Institute of Rheumatology, Prague, Czech Republic, ¹⁰Octapharma PPG, Vienna, Austria, ¹¹Phoenix Neurological Associates, LTD, Phoenix, AZ, ¹²Different Institutions in several countries, Vienna, Austria
Background/Purpose: Dermatomyositis (DM) is a chronic systemic autoimmune disease with characteristic skin rash and muscle weakness. Intravenous immunoglobulin (IVIg) has long been used as adjuvant…
Abstract Number: 1708 • ACR Convergence 2021
The Efficacy and Safety of Piclidenoson vs Methotrexate in Early Rheumatoid Arthritis: Phase 3 Randomized, Double-blind, Placebo-controlled Study
Tatiana Reitblat¹, Alexandra Gurman- Balbir², Zivit Harpaz³, Motti Farbstein³, Michael Silverman³, William Kerns³ and Pnina Fishman³, ¹Barzilai Medical Center, Ashkelon, Israel, ²Rambam Medical Center, Haifa, Israel, ³Can-Fite BioPharma, Petah Tikva, Israel
Background/Purpose: Piclidenoson, a highly selective A3 adenosine receptor (A3AR) agonist, demonstrated safety and efficacy in phase 2 clinical studies in rheumatoid arthritis (RA) and psoriasis.…
Abstract Number: 0733 • ACR Convergence 2021
A New Wearable Transcutaneous Electrical Nerve Stimulation Device (actiTENS®) Is More Efficient and Better Tolerated Than Weak Opioids in the Treatment of Knee Osteoarthritis Pain
Emmanuel Maheu¹, Sandrine Soriot-Thomas², Eric Noël³, Hervé Ganry⁴, Eric Lespessailles⁵ and Bernard Cortet⁶, ¹Saint-Antoine Hospital, Paris, France, ²CHU Amiens Picardie, Amiens, France, ³Santy Orthopaedic Center, Lyon, France, ⁴Hergan Consulting 4U, Amiens, France, ⁵CH Orléans, ORLEANS, France, ⁶CHU Lille, Lille, France
Background/Purpose: Knee osteoarthritis (KOA) is a frequent disease for which therapeutic possibilities are limited. In current recommendations, the first-line analgesic is acetaminophen. However, its low…
Abstract Number: 1786 • ACR Convergence 2021
Association of the Improvement of Synovitis and Enthesitis with Quality of Life/Patient Reported Outcomes in Patients with PsA Treated with Ixekizumab
Lars Erik Kristensen¹, Dennis McGonagle², Martin Rudwaleit³, Hideto Kameda⁴, Thorsten Holzkaemper⁵, Celine El Baou⁶ and Josef Smolen⁷, ¹Bispebjerg-Frederiksberg Hospital, Copenhagen,, Denmark, ²University of Leeds, Leeds, United Kingdom, ³Bielefeld University, Rheumatology, Klinikum Bielefeld, Berlin, Germany, ⁴Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan, ⁵Eli Lilly and Company, Bad Homburg, Germany, ⁶Eli Lilly and Company, Indianapolis, IN, ⁷Medical University of Vienna, Vienna, Austria
Background/Purpose: PsA is an inflammatory rheumatic disease with manifestations including synovitis and enthesitis. During extensive study programs, IXE has shown a treatment effect across domains…
Abstract Number: 0814 • ACR Convergence 2021
Patient Characteristics, Efficacy, and Treatment Patterns of Tofacitinib Monotherapy in Patients with RA: Contextualization of Randomized Controlled Trial Results with Real-world Data
Janet Pope¹, Axel Finckh², Lucia Silva-Fernández³, Peter Mandl⁴, Haiyun Fan⁵, Jose L Rivas⁶, Monica Valderrama⁶ and María Montoro⁶, ¹University of Western Ontario, London, ON, Canada, ²University Hospital of Geneva, Geneve - Vesenaz, Switzerland, ³Hospital Universitari Son Espases, Palma de Mallorca, Spain, ⁴Division of Rheumatology, Medical University of Vienna, Vienna, Austria, ⁵Pfizer Inc, Collegeville, PA, ⁶Pfizer SLU, Madrid, Spain
Background/Purpose: Randomized controlled trials (RCTs) have long been considered the gold standard for clinical research, but can be complemented with real-world data (RWD) to further…
Abstract Number: 1802 • ACR Convergence 2021
Comparison of Axial and Peripheral Manifestations in Patients with Psoriatic Arthritis and Ankylosing Spondylitis in Upadacitinib Clinical Trials
Xenofon Baraliakos¹, Atul Deodhar², Roberto Ranza³, Simona Rednic⁴, Francesco Ciccia⁵, Fabiana Ganz⁶, Tianming Gao⁶, Apinya Lertratanakul⁶, In-Ho Song⁶, Andrew Ostor⁷ and Laura Coates⁸, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, ²Oregon Health & Science University, Portland, OR, ³Hospital de Clinicas, Universidade Federal de Uberlândia, Uberlandia, MG, Brazil, ⁴Emergency Clinical County Hospital, Rheumatology and Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania, ⁵University of Campania “Luigi Vanvitelli", Naples, Italy, ⁶Abbvie Inc., North Chicago, IL, ⁷Monash University, Cabrini Hospital, and Emertius Research, Malvern, Australia, ⁸Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom
Background/Purpose: Axial, peripheral, and other disease manifestations often overlap between psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Upadacitinib (UPA) is an oral Janus kinase inhibitor…
Abstract Number: 0825 • ACR Convergence 2021
An Investigator-initiated Multicenter Randomized Study in Early Rheumatoid Arthritis of Active Conventional Therapy versus Three Biological Treatments: 48 Week Clinical and Radiographic Results of the NORD-STAR Trial
Mikkel Ostergaard¹, Ronald van Vollenhoven², Anna Rudin³, Merete Hetland⁴, Marte S Heiberg⁵, Dan Nordström⁶, Michael Nurmohamed⁷, Bjorn Gudbjornsson⁸, Lykke Ørnbjerg⁹, Pernille Bøyesen¹⁰, Inge Olsen¹¹, Kristina Lend¹², Kim Hørslev-Petersen¹³, Till Uhlig¹⁴, Tuulikki Sokka-Isler¹⁵, Gerdur Grondal⁸, Simon Krabbe¹⁶, Joakim Lindqvist¹⁷, Inger Gjertsson¹⁸, Daniel Glinatsi⁹, Meliha Kapetanovic¹⁹, Anna-Birgitte Aga¹⁰, Francesca Faustini²⁰, Pinja Parmanne²¹, Tove Lorenzen²², Cagnotto Giovanni²³, Johan Back²⁴, Oliver Hendricks²⁵, Daisy Vedder²⁶, Tuomas Rannio²⁷, Emma Grenholm²⁸, Maud Kristine Ljoså²⁹, Eli Brodin³⁰, Hanne Merete Lindegaard³¹, Annika Söderbergh³², Milad Rizk³³, Elsa Hermansson³⁴, Per Larsson³⁵, Line Uhrenholt³⁶, Søren Andreas Just³⁷, David John Stevens³⁸, Trine Bay Laurberg³⁹, Gunnstein Bakland⁴⁰, Espen Haavardsholm⁴¹ and Jon Lampa¹⁷, ¹Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, and Department of Clinical Medicine, University of Copenhagen, Glostrup, Denmark, ²Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, ³Rheumatology Clinic, Sahlgrenska University Hospital, Sahlgrenska Academy of University of Gothenburg, Gothenburg, Sweden, ⁴DANBIO and COPECARE, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, ⁵Diakonhjemmet Hospital, Oslo, Norway, ⁶Division of Internal Medicine and Rheumatology, Helsinki University Hospital, Helsinki, Finland, ⁷Reade and Amsterdam University Medical Center, location VUmc, Amsterdam, Netherlands, ⁸Landspitali University Hospital, University of Iceland, Reykjavik, Iceland, ⁹Copenhagen Center for Arthritis Research, COPECARE, Glostrup, Denmark, ¹⁰Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, ¹¹Oslo University Hospital, Oslo, Norway, ¹²Department of Medicine, Rheumatology Unit, The Karolinska Institute, Stockholm, Sweden, ¹³King Christian X's Hospital for Rheumatic Diseases, Gråsten, Denmark, ¹⁴Diakonhjemmet Hospital, University of Oslo, Oslo, Norway, ¹⁵University of Eastern Finland, Jyväskylä Central Hospital, Jyväskylä, Finland, ¹⁶Radiologisk Afdeling, Herlev Universitetshospital, Herlev, Denmark, ¹⁷Karolinska University Hospital, Stockholm, Sweden, ¹⁸Dept. of Rheumatology, Sahlgrenska University Hospital, Gothenborg, Sweden, ¹⁹Dept. of Clinical Sciences, Skåne University Hospital, Lund, Sweden, ²⁰Dept. of Medicine, Rheumatology, Karolinska University Hospital, Stockholm, Sweden, ²¹Division of Rheumatology, Helsinki University Hospital, Helsinki, Finland, ²²Dept. of Rheumatology, Silkeborg University Hospital, Silkeborg, Denmark, ²³Dept. of Clinical Sciences, Skåne University Hospital, Malmö, Sweden, ²⁴Dept. of Medical Sciences, Uppsala University Hospital, Uppsala, Sweden, ²⁵Danish Hospital for Rheumatic Diseases, Sønderborg, Denmark, ²⁶Dept. of Rheumatology, Reade, Amsterdam, Netherlands, ²⁷Finland Central Hospital, Jyväskylä, Finland, ²⁸Dept. of Rheumatology, Falunl, Falun, Sweden, ²⁹Dept. of Rheumatology, Ålesund Hospital, Ålesund, Norway, ³⁰Dept. of Rheumatology, Haukeland University Hospital, Haukeland, Norway, ³¹Rheumatology Research Unit, Odense University Hospital, Odense, Denmark, ³²Dept. of Rheumatology, Örebro University Hospital, Örebro, Sweden, ³³Rheumatology Clinic, Västmanlands Hospital Västerås, Västerås, Sweden, ³⁴Dept. of Rheumatology, Linköping University Hospital, Linköping, Sweden, ³⁵Academic Specialist Center, Stockholm, Sweden, ³⁶Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark, ³⁷Section of Rheumatology, Dept. of Medicine, Svendborg Hospital, Svendborg, Denmark, ³⁸Dept. of Rheumatology, University Hospital of Trondheim, Trondheim, Norway, ³⁹Dept. of Rheumatology, Aarhus University Hospital, Aarhus, Denmark, ⁴⁰Dept. of Rheumatology, University Hospital of North Norway, Tromsø, Norway, ⁴¹[email protected], Oslo, Norway
Background/Purpose: The optimal first-line treatment of patients (pts) with early rheumatoid arthritis (eRA) is yet to be established. The main objectives were to assess and…
Abstract Number: 1833 • ACR Convergence 2021
Risk of Major Adverse Cardiovascular Events (MACE) with Biologic and Targeted Synthetic Antirheumatic Agents in Psoriatic Arthritis: A Systematic Review and Network Meta-analysis
Muhammad Ajmal¹, Jawad Bilal¹, Syed Arsalan Ahmed Naqvi², Irbaz Bin Riaz³, Zaina Shahid⁴, Kaneez Zahra Rubab Khakwani¹, Yi-Shao Liu⁵, Sandipan Bhattacharjee⁵, Roxanne Bogucka⁵, Noureen Asghar⁶ and Kent Kwoh¹, ¹University of Arizona, Tucson, AZ, ²Dow University of Health Sciences, Karachi, Pakistan, ³Mayo Clinic, Phoenix, AZ, ⁴Lehigh Valley Health Network, Allentown, PA, ⁵University of Texas at Austin, Austin, TX, ⁶Dow University of Health Sciences, Karachi
Background/Purpose: The efficacy of biologics and targeted synthetic disease modifying antirheumatic agents approved for treatment of psoriatic arthritis (PsA) is well documented, but cardiovascular safety…
Abstract Number: 0831 • ACR Convergence 2021
Safety and Efficacy of Tofacitinib vs TNF Inhibitors in RA Patients Aged 50 Years or Older with One or More Cardiovascular Risks: Results from a Phase 3b/4 Randomized Safety Trial
Steven R Ytterberg¹, Deepak L Bhatt², Ted Mikuls³, Gary G Koch⁴, Jose L Rivas⁵, Rebecca Germino⁶, Sujatha Menon⁶, Yanhui Sun⁷, Cunshan Wang⁶, Andrea B Shapiro⁸, Keith S Kanik⁶, Carol A Connell⁶ and Roy Fleischmann⁹, ¹Division of Rheumatology, Mayo Clinic, Rochester, MN, ²Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, ³University of Nebraska Medical Center, Omaha, NE, ⁴Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁵Pfizer SLU, Madrid, Spain, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer CRDC, Shanghai, China (People's Republic), ⁸Pfizer Inc, Peapack, NJ, ⁹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: ORAL Surveillance (NCT02092467) was mandated by the US Food and Drug Administration to assess the relative risk of tofacitinib vs TNF inhibitors (TNFi), based…

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