Abstracts tagged "Randomized Trial"

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: 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: 0886 • ACR Convergence 2020
Achievement of Partial Remission and Inactive Disease in Upadacitinib-Treated Patients with Ankylosing Spondylitis
Atul Deodhar¹, Andrew Östör², Anna Maniccia³, Fabiana Ganz⁴, Tianming Gao³, Alvina D. Chu⁵ and Denis Poddubnyy⁶, ¹Oregon Health & Science University, Portland, OR, ²Cabrini Medical Center, Monash University, Malvern, Victoria, Australia, ³AbbVie Inc., North Chicago, IL, ⁴AbbVie Inc., Baar, Switzerland, ⁵AbbVie, North Chicago, IL, ⁶Charité – Universitätsmedizin Berlin, Berlin, Germany
Background/Purpose: Assessment of SpondyloArthritis international Society (ASAS) response criteria and AS Disease Activity Score (ASDAS) are both commonly used, rigorous composite indices consisting of components…
Abstract Number: 1372 • ACR Convergence 2020
Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis and Axial Involvement
Atul Deodhar¹, Roberto Ranza², Fabiana Ganz³, Tianming Gao⁴, Jaclyn K Anderson⁴ and Andrew Östör⁵, ¹Oregon Health & Science University, Portland, OR, ²Hospital de Clinicas, Universidade Federal de Uberlândia, Uberlândia, Brazil, ³AbbVie Inc., Baar, Switzerland, ⁴AbbVie Inc., North Chicago, IL, ⁵Cabrini Medical Center, Monash University, Malvern, Victoria, Australia
Background/Purpose: Upadacitinib (UPA) has demonstrated efficacy for the treatment of AS in patients (pts) who were NSAID inadequate responders (IR).1 Pts with psoriatic arthritis (PsA)…
Abstract Number: 2024 • ACR Convergence 2020
Effects of Filgotinib on Spinal Lesions in Patients with Ankylosing Spondylitis: Magnetic Resonance Imaging Data from the Placebo-Controlled, Double‑Blind, Randomized TORTUGA Trial
Walter Maksymowych¹, Mikkel Østergaard², Robert Landewé³, William Barchuk⁴, Ke Liu⁴, Chantal Tasset⁵, Leen Gilles⁵, Thijs Hendrikx⁶, Robin Besuyen⁶ and Xenofon Baraliakos⁷, ¹University of Alberta, Edmonton, AB, Canada, ²Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, ³Amsterdam University Medical Center & Zuyderland Hospital, Amsterdam, Netherlands, ⁴Gilead Sciences, Inc., Foster City, CA, ⁵Galapagos NV, Mechelen, Belgium, ⁶Galapagos BV, Leiden, Netherlands, ⁷Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany
Background/Purpose: The oral, selective Janus kinase 1 inhibitor filgotinib (FIL) significantly improved Spondyloarthritis Research Consortium of Canada (SPARCC) MRI inflammation scores (bone marrow edema) in…
Abstract Number: 0896 • ACR Convergence 2020
Impact of Upadacitinib on Reducing Pain in Patients with Active Psoriatic Arthritis: Results from Two Phase 3 Trials in Patients with Inadequate Response to Non-biologic or Biologic DMARDs
Iain McInnes¹, William Tillett², Philip Mease³, Kurt de Vlam⁴, Louis Bessette⁵, Ralph Lippe⁶, Anna Maniccia⁷, Patrick Zueger⁷, Dai Feng⁷, Koji Kato⁸ and Andrew Östör⁹, ¹Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, ²Royal National Hospital for Rheumatic Diseases, Bath, UK; Department of Pharmacy and Pharmacology, University of Bath, Bath, UK, Bath, United Kingdom, ³Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, ⁴Department of Rheumatology, University of Leuven, Belgium, Leuven, Belgium, ⁵Laval University, Quebec, Canada, ⁶AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, ⁷AbbVie Inc., North Chicago, IL, ⁸AbbVie Inc, North Chicago, IL, ⁹Cabrini Medical Center, Monash University, Malvern, Victoria, Australia
Background/Purpose: Pain is a dominant symptom of psoriatic arthritis (PsA), and pain reduction is a priority for patients (pts) that is often assessed in clinical…
Abstract Number: 1441 • ACR Convergence 2020
Effects of Belimumab on Renal Outcomes, Overall SLE Control and Biomarkers: Findings from a Phase 3, Randomized, Placebo-controlled 104-week Study in Patients with Active Lupus Nephritis
Richard Furie¹, Brad Rovin², Frédéric Houssiau³, Gabriel Contreras⁴, Ana Malvar⁵, Amit Saxena⁶, Xueqing Yu⁷, Y K Onno Teng⁸, Pieter van Paassen⁹, Ellen M Ginzler¹⁰, Diane Kamen¹¹, Mary Oldham¹², Damon Bass¹³, Andre van Maurik¹⁴, Mary Beth Welch¹³, Yulia Green¹⁵, Beulah Ji¹⁵, Christi Kleoudis¹⁶ and David Roth¹⁷, ¹Northwell Health, Great Neck, NY, ²The Ohio State University, Columbus, ³Cliniques Universitaires Saint-Luc, Brussels, Belgium, ⁴University of Miami Miller School of Medicine, Miami, ⁵Organizacion Medica de Investigacion, Buenos Aires, Argentina, ⁶NYU School of Medicine, New York, ⁷Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China (People's Republic), ⁸Leiden University Medical Center, Leiden, Netherlands, ⁹Maastricht University, Academisch Ziekenhuis Maastricht, Maastricht, Netherlands, ¹⁰SUNY Downstate Health Sciences University, Brooklyn, ¹¹Medical University of South Carolina, Charleston, SC, ¹²GlaxoSmithKline, Stevenage, United Kingdom, ¹³GlaxoSmithKline, Research Triangle Park, ¹⁴GlaxoSmithKline, Stevenage, ¹⁵GlaxoSmithKline, Uxbridge, ¹⁶Parexel (*At the time of study), Durham, ¹⁷GlaxoSmithKline, Collegeville
Background/Purpose: Belimumab (BEL) has demonstrated efficacy in systemic lupus erythematosus (SLE) in 4 positive pivotal trials. This study assessed the efficacy and safety of intravenous…
Abstract Number: 0897 • ACR Convergence 2020
Temporal Achievement of Clinical Response and Inactive Disease Status in Patients with Axial Spondyloarthritis Treated with Etanercept
Xenofon Baraliakos¹, Annette Szumski², Kenneth Kwok³ and Bonnie Vlahos⁴, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany, ²Syneos Health, Princeton, ³Pfizer, New York, NY, ⁴Pfizer, Collegeville, PA
Background/Purpose: Treatment with etanercept (ETN) is effective and well tolerated in patients with axial spondyloarthritis (AS), but the time frames within which patients tend to…
Abstract Number: 1444 • ACR Convergence 2020
Cluster-randomized Pragmatic Clinical Trial Evaluating the Potential Benefit of a Tight-control and Treat-to-target Strategy in Axial Spondyloarthritis: The Results of the TICOSPA Trial
Anna Molto¹, Clementina Lopez-Medina², Filip Van den Bosch³, Annelies Boonen⁴, Casper Webers⁴, Emmanuelle Dernis⁵, Floris van Gaalen⁶, Martin Soubrier⁷, Pascal Claudepierre⁸, Athan Baillet⁹, Mirian Starsman-Kool¹⁰, Anneke Spoorenberg¹¹, Désirée van der Heijde¹² and Maxime Dougados¹³, ¹Rheumatology Department, Cochin Hospital, APHP, Paris, France, Paris, France, ²INSERM U1153, Universtity of Paris, PAris, France, ³Ghent University Hospital, Ghent, Belgium, ⁴Maastricht University Medical Center, Maastricht, Netherlands, ⁵CH Le Mans, department of rheumatology, Le Mans, France, ⁶Leiden University Medical Center (LUMC), Leiden, Netherlands, ⁷CHU Gabriel Montpied, Clermont-Ferrand, France, ⁸Hôpital Henri Mondor, Université Paris Est Créteil, EA 7379 EpiDermE, department of rheumatology, Créteil, France, ⁹CHU Grenoble, Echirolles, France, ¹⁰ATRIUM Medical Center, Heerlen, ¹¹University Medical Centre Groningen and Medical centre Leeuwarden, Groningen, Netherlands, ¹²Leiden University Medical Center, Leiden, Netherlands, ¹³Université de Paris, Department of Rheumatology, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France
Background/Purpose: Recommendations for axial spondyloarthritis (axSpA) management include tight control and treat-to-target (TC), but no study has evaluated its potential benefit. The objective of this…
Abstract Number: 0907 • ACR Convergence 2020
Long-term Outcomes with Filgotinib, an Oral Selective Janus Kinase 1 Inhibitor: 100-week Data from an Open-label Extension (OLE) Study in Patients with Active Psoriatic Arthritis (PsA)
Laura Coates¹, Dafna Gladman², Filip Van den Bosch³, Philip Helliwell⁴, Anna Rychlewska-Hańczewska⁵, Mykola Stanislavchuk⁶, Leen Gilles⁷, Lien Gheyle⁷, Ke Liu⁸, Mona Trivedi⁸, Muhsen Alani⁹, Robin Besuyen¹⁰ and Philip Mease¹¹, ¹University of Oxford, Oxford, United Kingdom, ²Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ³Ghent University Hospital, Ghent, Belgium, ⁴Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁵Ai Centrum Medyczne, Poznań, Poland, ⁶National Pirogov Memorial Medical University, Vinnytsya, Ukraine, ⁷Galapagos NV, Mechelen, Belgium, ⁸Gilead Sciences, Inc., Foster City, CA, ⁹Gilead Sciences, Inc. and University of Washington, Foster City, CA, ¹⁰Galapagos BV, Leiden, Netherlands, ¹¹Seattle Rheumatology Associates, P.L.L.C., Seattle, WA
Background/Purpose: EQUATOR (NCT03101670) was a randomized, 16-week, Phase 2, multicenter, double-blind, placebo (PBO)‑controlled trial of filgotinib (FIL) in patients with active PsA ( Mease P,…

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