Abstracts tagged "Randomized Trial"

Abstract Number: 0496 • ACR Convergence 2021
Safety and Efficacy of Rituximab for Systemic Sclerosis: A Double-Blind, Parallel-Group Comparison, Investigators Initiated Confirmatory Randomized Clinical Trial (DESIRES Study)
Satoshi Ebata¹, Ayumi Yoshizaki¹, Koji Oba², Kosuke Kashiwabara³, Keiko Ueda³, Yukari Umemura⁴, Takeyuki Watadani⁵, Takemichi Fukasawa¹, Shunsuke Miura¹, Asako Yoshizaki-Ogawa¹, Yoshihide Asano¹, Naoko Okiyama⁶, Masanari Kodera⁷, Minoru Hasegawa⁸ and Shinichi Sato¹, ¹Department of Dermatology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan, ²Department of Biostatistics, School of Public Health, Graduate School of Medicine, and Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, Japan, ³Clinical Research Support Center, The Tokyo University Hospital, Tokyo, Japan, ⁴Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan, ⁵Department of Diagnostic Radiology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan., Tokyo, Japan, ⁶Department of Dermatology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan., Ibaraki, Japan, ⁷Department of Dermatology, Japan Community Health Care Organization Chukyo Hospital, Aichi, Japan., Aichi, Japan, ⁸Department of Dermatology, Division of Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan., Fukui, Japan
Background/Purpose: Systemic sclerosis (SSc) is a systemic autoimmune disease belonging to collagen diseases, characterized by fibrosis of various organs including the skin and lungs, and…
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: 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: 0690 • ACR Convergence 2020
AR882, a Potent and Selective Uricosuric Agent, Significantly Reduced Serum Urate in Patients with Gout in a Phase 2a Study
Li-Tain Yeh¹, Elizabeth Polvent¹, Zancong Shen², Vijay Hingorani¹, Andrea Clouser-Roche¹, Chris Mikelatis¹, Shunqi Yan¹ and Rongzi Yan¹, ¹Arthrosi Therapeutics Inc, Laguna Hills, CA, ²Arthrosi therapeutics, Laguna Hills, CA
Background/Purpose: AR882 is a potent and selective uric acid transporter 1 (URAT1) inhibitor under development for the treatment of hyperuricemia or gout. Phase 1 single…
Abstract Number: 1211 • ACR Convergence 2020
Relationship Between Changes in Lipid Levels and Improvement in Disease Activity Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib Treatment: Pooled Analysis of Data from Two Phase 3 Studies
Christina Charles-Schoeman¹, Jon Giles², Nancy Lane³, Ernest Choy⁴, Heidi Camp⁵, Yanna Song⁶, Samuel Anyanwu⁵ and Iain McInnes⁷, ¹University of California, Los Angeles, Los Angeles, CA, ²Columbia University, New York, NY, ³University of California, Davis, Sacramento, CA, ⁴CREATE Centre, Cardiff University, Cardiff, Wales, United Kingdom, ⁵AbbVie Inc., North Chicago, IL, ⁶AbbVie Inc., North Chicago,, IL, ⁷Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom
Background/Purpose: Upadacitinib (UPA) is an oral Janus kinase (JAK) inhibitor engineered to have greater selectivity for JAK1 vs JAK2, JAK3, and tyrosine kinase 2, and…
Abstract Number: 2009 • ACR Convergence 2020
Treat-to Target for Early RA Patients in Usual Clinical Practice, a Randomized Study with a Favorable Effect of a Second Oral Pulse of Prednisolone. the Amsterdam COBRA Treat-to-target Study
Linda Hartman¹, Linda Rasch², Samina Turk³, Marieke ter Wee¹, Pit Kerstens⁴, Conny van der Laken⁵, Mike Nurmohamed⁶, Dirkjan van Schaardenburg⁷, Lilian van Tuyl⁸, Alexandre Voskuyl¹, Maarten Boers⁷ and Willem Lems¹, ¹Amsterdam Rheumatology and Immunology Center, location Amsterdam UMC, VUmc, Amsterdam, Netherlands, ²Amsterdam Rheumatology and Immunology Center, location Amsterdam UMC, VUmc, Amsterdam, ³Amsterdam Rheumatology and Immunology Center, location Reade, Amsterdam, Netherlands, ⁴Westfriesgasthuis, Hoorn, Netherlands, ⁵Amsterdam Rheumatology and immunology Center, location Amsterdam UMC, VU medical center, Amsterdam, Netherlands, ⁶Amsterdam Rheumatology and immunology Center, location Reade and Amsterdam UMC, VU medical center, Amsterdam, Netherlands, ⁷Amsterdam Rheumatology and immunology Center | Reade and Amsterdam UMC, Amsterdam, Netherlands, ⁸Nivel, Utrecht, Netherlands
Background/Purpose: EULAR guidelines advise to start with methotrexate (MTX) for early rheumatoid arthritis (RA), either alone or combined with prednisolone. Since this strategy is not…
Abstract Number: 0799 • ACR Convergence 2020
Effectiveness of Electronic Drug Monitoring Feedback in Order to Increase Adherence in RA Patients Starting with a Biological DMARD
Renske Hebing¹, Wouter Bos¹, Mike Nurmohamed² and Bart van den Bemt³, ¹Amsterdam Rheumatology and Immunology Center | Reade, Amsterdam, Netherlands, ²Amsterdam Rheumatology and immunology Center, location Reade and Amsterdam UMC, VU medical center, Amsterdam, Netherlands, ³Sint Maartenskliniek, Nijmegen, Netherlands
Background/Purpose: Medication non-adherence in rheumatoid arthritis (RA) is associated with disease flares, increased disability and increased costs. Electronic Monitoring Feedback (EMF) to improve adherence has…
Abstract Number: 1213 • ACR Convergence 2020
Discrepancy Between the Multi-biomarker Disease Activity Score and Clinical Disease Activity Scores in a 2‑Part, Multicenter Study of Repository Corticotropin Injection (Acthar® Gel) for Patients with Persistently Active Rheumatoid Arthritis
Roy Fleischmann¹, Jingyu Liu², Julie Zhu², Oscar Segurado³ and Daniel Furst*⁴, ¹Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, ²Mallinckrodt Pharmaceuticals, Bedminster, NJ, ³SSI Strategy, San Jose, CA, ⁴Department of Medicine, Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA, Los Angeles, CA
Background/Purpose: Assessment of disease activity in RA with validated measures, such as the Disease Activity Score with 28 joint count and erythrocyte sedimentation rate (DAS28-ESR)…
Abstract Number: 2010 • ACR Convergence 2020
Stable versus Tapered and Withdrawn Treatment with Tumor Necrosis Factor Inhibitor in Rheumatoid Arthritis Remission: A Randomized, Open-Label, Phase 4, Non-Inferiority Trial
Siri Lillegraven¹, Nina Paulshus Sundlisæter¹, Anna-Birgitte Aga¹, Joseph Sexton¹, Inge C. Olsen², Åse Lexberg³, Tor Magne Madland⁴, Hallvard Fremstad⁵, Christian Høili⁶, Gunnstein Bakland⁷, Cristina Spada⁸, Hilde Haukeland⁹, Inger Myrnes Hansen¹⁰, Ellen Moholt¹, Till Uhlig¹, Daniel H. Solomon¹¹, Désirée van der Heijde¹², Tore K. Kvien¹ and Espen A. Haavardsholm¹, ¹Diakonhjemmet Hospital, Oslo, Norway, ²Oslo University Hospital, Oslo, Norway, ³Vestre Viken HF, Drammen, Norway, ⁴Haukeland University Hospital, Bergen, Norway, ⁵Ålesund Hospital, Ålesund, Norway, ⁶Hospital Øsftfold HF, Moss, Norway, ⁷University Hospital of North Norway, Tromsø, Norway, ⁸Revmatismesykehuset, Lillehammeer, Norway, ⁹Martina Hansens Hospital, Bærum, Norway, ¹⁰Helgelandssykehuset Mo i Rana, Mo i Rana, Norway, ¹¹Brigham & Women's Hospital and Harvard Medical School, Boston, MA, ¹²Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Remission is the preferred treatment target in rheumatoid arthritis (RA), and many patients require biologic disease-modifying antirheumatic drugs (DMARDs) to reach this state. It…
Abstract Number: 0865 • ACR Convergence 2020
Efficacy and Safety of Evobrutinib (M2951) in Adult Patients with Systemic Lupus Erythematosus Who Received Standard of Care Therapy: A Phase II, Randomized, Double-blind, Placebo-controlled Dose Ranging Study
Daniel J Wallace¹, Thomas Dörner², David Pisetsky³, F Jorge Sanchez-Guerrero⁴, Amy Kao⁵, Dana Parsons-Rich⁵, Anand Patel⁶, Yulia Zima⁵, Claire Le Bolay⁷, Karthinathan Thangavelu⁶ and Maria Dall'Era⁸, ¹Cedars-Sinai Medical Center, Beverly Hills, CA, ²DRFZ and Charité University Hospitals, Berlin, Germany, ³Duke University Medical Center, Durham, NC, ⁴University Health Network/Sinai Health system, Toronto, ON, Canada, ⁵EMD Serono (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, ⁶EMD Serono (a business of Merck KGaA, Darmstadt, Germany), Billerica, ⁷Merck KGaA, Darmstadt, Germany, ⁸Division of Rheumatology, University of California, San Francisco, CA
Background/Purpose: Bruton’s tyrosine kinase (BTK) is involved in signalling pathways known to be important to the pathogenesis of systemic lupus erythematosus (SLE). Evobrutinib is a…
Abstract Number: 1344 • ACR Convergence 2020
Guselkumab, an IL-23 Inhibitor That Specifically Binds to the IL23p19-Subunit, for Active Psoriatic Arthritis: One Year Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Patients Who Were Biologic-Naïve or TNFα Inhibitor-Experienced
Christopher Ritchlin¹, Philip Helliwell², Wolf-Henning Boehncke³, Elizabeth Hsia⁴, Alexa Kollmeier⁵, Ramanand Subramanian⁶, Xie Xu⁷, Shihong Sheng⁶, Yusang Jiang⁶, Bei Zhou⁶ and Atul Deodhar⁸, ¹Department of Medicine, University of Rochester Medical Center, Rochester, NY, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³Geneva University Hospitals, Geneva, Switzerland, ⁴Janssen Research & Development, LLC and University of Pennsylvania Medical Center, Spring House, PA, ⁵Janssen Research & Development, LLC, La Jolla, CA, ⁶Janssen Research & Development, LLC, Spring House, PA, ⁷Janssen Research & Development, LLC, San Marcos, CA, ⁸Oregon Health & Science University, Portland, OR
Background/Purpose: Guselkumab (GUS), a monoclonal antibody that specifically binds to the p19-subunit of IL-23, is approved to treat psoriasis (PsO). At Week 24 of the…

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