Abstracts tagged "Randomized Trial"

Abstract Number: 1585 • ACR Convergence 2021
Suprascapular Nerve Block for the Treatment of Adhesive Capsulitis
Ernst Shanahan¹, Elizabeth Briggs¹, Tiffany Gill², Catherine Hill³ and Tim Morris⁴, ¹SA Health, Adelaide, Australia, ²University of Adelaide, Adelaide, Australia, ³Queen Elizabeth Hospital, Woodville, Australia, ⁴Flinders University, Adelaide, Australia
Background/Purpose: To investigate the value of suprascapular nerve block (SSNB) as a treatment option for adhesive capsulitis.Methods: Patients with adhesive capsulitis confirmed by a rheumatologist…
Abstract Number: 0497 • ACR Convergence 2021
Efficacy in Patient Subgroups in the INCREASE Trial, a Phase III Trial to Evaluate Inhaled Treprostinil in Patients with Pulmonary Hypertension Due to Parenchymal Lung Disease
Victor Tapson¹, Steven Nathan², Reda Girgis³, James Runo⁴, Remzi Bag⁵, Arunabh Talwar⁶, Peter Smith⁷, Lisa Edwards⁷, Christine Park⁷ and Aaron Waxman⁸, ¹Cedars-Sinai, Los Angeles, CA, ²Inova Fairfax, Falls Church, VA, ³Michigan State University, Lansing, MI, ⁴University of Wisconsin, Madison, WI, ⁵University of Chicago, Chicago, IL, ⁶Hofstra Northwell School of Medicine, Hempstead, NY, ⁷United Therapeutics Corporation, Durham, NC, ⁸Brigham and Women's Hospital, Boston, MA
Background/Purpose: INCREASE was a 16-week trial evaluating the safety and efficacy of inhaled treprostinil (iTRE) in patients with pulmonary hypertension associated with interstitial lung disease…
Abstract Number: 1678 • ACR Convergence 2021
Favorable Balance of Benefit and Harm of Long-Term, Low Dose Prednisolone Added to Standard Treatment in Rheumatoid Arthritis Patients Aged 65+: The Pragmatic, Multicenter, Placebo-Controlled GLORIA Trial
Maarten Boers¹, Linda Hartman¹, Daniela Opris-Belinski², Reinhard Bos³, Marc Kok⁴, Jose Pereira da Silva⁵, Ed Griep⁶, Ruth Klaasen⁷, Cornelia F. Allaart⁸, Paul Baudoin⁹, Hennie Raterman¹⁰, Zoltan Szekanecz¹¹, Frank Buttgereit¹², Pavol Masaryk¹³, L. Thomas Klausch¹, Sabrina Paolino¹⁴, Annemarie Schilder³, Willem Lems¹⁵ and Maurizio Cutolo¹⁴, ¹Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, ²Carol Davila University, Bucharest, Romania, ³Medical Center Leeuwarden, Leeuwarden, Netherlands, ⁴Maasstad Hospital, Rotterdam, Netherlands, ⁵University of Coimbra | UC · Clínica Universitária de Reumatologia. Faculty of Medicine, Columbia, Portugal, ⁶Antonius Hospital, Sneek, Netherlands, ⁷Meander Medical Center, Amersfoort, Netherlands, ⁸Leiden University Medical Center, Leiden, Netherlands, ⁹Reumazorg Flevoland, Emmeloord, 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, ¹⁵VUmc, Amsterdam, Netherlands
Background/Purpose: Low-dose glucocorticoid (GC) therapy is widely used in rheumatoid arthritis (RA) but the balance of benefit and harm is still unclear. We studied the…
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: 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…

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