Abstracts tagged "Randomized Trial"

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…
Abstract Number: 1863 • ACR Convergence 2021
Consistent Efficacy with Apremilast in Men and Women to Treat Oral Ulcers Associated with Behçet’s Syndrome: Results from Phase 3 Researching Oral Apremilast Safety and Efficacy in Behçet’s Disease (RELIEF) Study
Gülen Hatemi¹, Alfred Mahr², Mitsuhiro Takeno³, Doyoung Kim⁴, Melike Melikoğlu⁵, Sue Cheng⁶, Sven Richter⁶, Shauna Jardon⁷, Maria Paris⁶, Mindy Chen⁶ and Yusuf Yazici⁸, ¹Istanbul University‒Cerrahpaşa, Cerrahpaşa Medical School and Behçet’s Disease Research Center, İstanbul, Turkey, ²Kantonsspital St. Gallen, St.Gallen, Switzerland, ³Musashi Kosugi Hospital, Kawasaki, Japan, ⁴Yonsei University College of Medicine and Severance Hospital, Seoul, Republic of Korea, ⁵Istanbul University‒Cerrahpaşa, İstanbul, Turkey, ⁶Amgen Inc., Thousand Oaks, CA, ⁷Amgen Inc., Gilbert, AZ, ⁸New York University School of Medicine, New York, NY
Background/Purpose: Painful, recurring oral ulcers (OU) associated with Behçet’s syndrome negatively affect quality of life (QoL). Differences across sexes were reported in the frequency of…
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: 0910 • ACR Convergence 2020
Effect of Filgotinib on the Complete Resolution of Enthesitis in Psoriatic Arthritis (PsA) Patients: 52-week Results from EQUATOR2
Philip Mease¹, Laura Coates², Filip Van den Bosch³, Philip Helliwell⁴, Dafna Gladman⁵, Leen Gilles⁶, Lien Gheyle⁶, Mona Trivedi⁷, Muhsen Alani⁸ and Robin Besuyen⁹, ¹Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, ²University of Oxford, Oxford, United Kingdom, ³Ghent University Hospital, Ghent, Belgium, ⁴Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁵Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ⁶Galapagos NV, Mechelen, Belgium, ⁷Gilead Sciences, Inc., Foster City, CA, ⁸Gilead Sciences, Inc. and University of Washington, Foster City, CA, ⁹Galapagos BV, Leiden, Netherlands
Background/Purpose: EQUATOR (NCT03101670) was a 16-week, Phase 2, double-blind, randomized placebo-controlled trial of filgotinib for PsA. At Week 16, placebo-treated patients could switch to filgotinib…
Abstract Number: 1483 • ACR Convergence 2020
A Randomised Controlled Trial Evaluating the Efficacy of Internet-based Exercises Aimed at Treating Knee Osteoarthritis (iBEAT-OA)
Sameer Gohir¹, Abhishek Abhishek², Anthony Kelly² and Ana M Valdes³, ¹NIHR Nottingham Biomedical Research Centre, GRAYS ESSEX, England, United Kingdom, ²University of Nottingham, Nottingham, United Kingdom, ³NIHR Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, England, United Kingdom
Background/Purpose: Osteoarthritis (OA) is the commonest cause of pain and disability in the general population and is usually managed by family doctors and physiotherapists. This…
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: 1484 • ACR Convergence 2020
Efficacy of Tocilizumab in Patients with Hand Osteoarthritis: Double Blind, Randomized, Placebo Controlled, Multicenter Trial
Pascal Richette¹, Augustin Latourte², Jeremie Sellam³, Daniel Wendling⁴, Muriel Piperno⁵, Philippe Goupille⁶, Yves-Marie Pers⁷, Florent Eymard⁸, Sebastien Ottaviani⁹, Paul Ornetti¹⁰, Rene-Marc Flipo¹¹, Bruno Fautrel¹², Jean-Pierre Bertola¹³, Eric Vicaut¹⁴ and Xavier Chevalier¹⁵, ¹Department of Rheumatology, Lariboisière Hospital, AP-HP Université de Paris, INSERM U1132, Paris, ²Department of Rheumatology, Lariboisière Hospital, AP-HP Université de Paris, INSERM U1132, Paris, France, ³AP-HP, Hôpital Saint-Antoine, Service de Rhumatologie, Centre de Recherche Saint-Antoine, INSERM UMR_S 938,Sorbonne Université, Paris, 75012, France, Paris, France, ⁴CHU Besançon, department of rheumatology, Besancon, France, ⁵Rheumatology Department, Lyon University Hospital, Lyon, France, ⁶CHU Tours, department of rheumatology, Tours, France, ⁷IRMB, University of Montpellier, Inserm U1183, University Hospital of Montpellier, Montpellier, France, ⁸APHP Henri Mondor Hospital, Creteil, France, ⁹Rheumatology Department, Bichat hospital, APHP, Paris, France, ¹⁰CHU Dijon, INSERM CAPS 1093, plateforme d’investigation technologique CIC1432, Dijon, France, ¹¹Lille University Hospital, Lille, France, ¹²Sorbonne University, INSERM, IPLES; Pitié-Salpêtrière Hospital, Paris, Ile-de-France, France, ¹³CHUGAI PHARMA FRANCE, Paris, France, ¹⁴Clinical Research Unit, Paris, ¹⁵AP-HP, UPEC, Créteil
Background/Purpose: To evaluate the efficacy of tocilizumab, an antibody against interleukin-6 receptor (IL-6R), in patients with hand osteoarthritis.Methods: This was a multicenter, 12-week, randomized, double-blind,…
Abstract Number: 0955 • ACR Convergence 2020
Efficacy and Safety of IVIg (Octagam 10%) in Patients with Active Dermatomyositis. Results of a Randomized, Double-Blind, Placebo-Controlled Phase III Trial (ProDERM Study)
Rohit Aggarwal¹, Christina Charles-Schoeman², Joachim Schessl³, Zsuzsanna Bata-Csorgo⁴, Mazen Dimachkie⁵, Zoltan Griger⁶, Sergey Moiseev⁷, Chester Oddis⁸, Elena Schiopu⁹, Jiří Vencovský¹⁰, Beckmann Irene¹¹, Clodi Elisabeth¹¹, Todd Levine¹² and and the ProDERM Investigators¹³, ¹University of Pittsburgh, Pittsburgh, PA, ²University of California, Los Angeles, Los Angeles, CA, ³Städtisches Klinikum Karlsruhe, Karlsruhe, Germany, ⁴University of Szeged, Faculty of Medicine, Szeged, Hungary, ⁵Univeristy of Kansas, Medical Center, Kansas City, KS, ⁶University of Debrecen, Debrecen, Hungary, ⁷First Moscow State Medical University, Moscow, Russia, ⁸Department of Medicine, Division of Rheumatology, University of Pittsburgh, Pittsburgh, PA, ⁹Michigan Medicine, Ann Arbor, MI, ¹⁰Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ¹¹Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria, ¹²Phoenix Neurological Associates, LTD, Phoenix, AZ, ¹³Different Institutions in several countries, Vienna, Austria
Background/Purpose: Dermatomyositis (DM) is a rare chronic systemic autoimmune disease with characteristic skin rash and progressive proximal muscle weakness. Intravenous immunoglobulin (IVIg) has long been…
Abstract Number: 1485 • ACR Convergence 2020
LNA043, a Novel Cartilage Regenerative Treatment for Osteoarthritis: Results from a First-In-Human Trial in Patients with Knee Osteoarthritis
Celeste Scotti¹, Joseph Gimbel², Didier Laurent¹, Aviv Madar³, Thomas Peters¹, Yunyu Zhang³, Florine Polus¹, Michael Beste³, Igor Vostiar¹, Subhajit Choudhury⁴, Nicole Gerwin¹, Jörg Goldhahn⁵, Matthias Schieker¹ and Ronenn Roubenoff¹, ¹Novartis Institutes for BioMedical Research, Basel, Switzerland, ²Arizona Research Center, Phoenix, ³Novartis Institutes for BioMedical Research, Cambridge, ⁴Biostatistics & Pharmacometrics, Novartis Healthcare Pvt. Ltd., Hyderabad, India, ⁵Department of Health Sciences and Technology, ETH Zürich, Zurich, Switzerland
Background/Purpose:LNA043 is a modified human angiopoietin-like 3 (ANGPTL3) protein identified in a phenotypic screen for inducers of chondrogenesis and cartilage repair. The primary objective of…
Abstract Number: 0200 • ACR Convergence 2020
Predictors of Durable Clinical Response to Tofacitinib 11 Mg Once Daily with or Without Methotrexate in Patients with Rheumatoid Arthritis: Post Hoc Analysis of Data from a Phase 3b/4 Methotrexate Withdrawal Study
Kunihiro Yamaoka¹, Stanley B Cohen², Naonobu Sugiyama³, Harry Shi⁴, Jose L Rivas⁵, Annette Diehl⁴ and Josef Smolen⁶, ¹Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan, ²Metroplex Clinical Research Center, Dallas, TX, ³Pfizer Japan Inc, Tokyo, Japan, ⁴Pfizer Inc, Collegeville, PA, ⁵Pfizer SLU, Madrid, Spain, ⁶Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria
Background/Purpose: ORAL Shift, a global Phase 3b/4 non-inferiority study, demonstrated sustained efficacy/safety of tofacitinib modified-release (MR) 11 mg QD following MTX withdrawal in patients (pts)…
Abstract Number: 0962 • ACR Convergence 2020
Efficacy of Clomipramine for Chronic Lumbar Radicular Pain a Randomized Clinical Trial
Saloua Afilal¹, Safaa Fellous¹, Ilham Aachari¹, Redouane Abouqal², Ihsane Hmamouchi³, Nada Alami¹, Latifa Tahiri¹, Hanan Rkain¹, Najia Hajjaj-Hassouni⁴ and Fadoua Allali¹, ¹Rheumatology B Department, El Ayachi Hospital, Faculty of Medicine and Pharmacy of Rabat, Mohammed V University, Rabat, Morocco., Rabat, Morocco, ²Laboratory of Biostatistics, Clinical Research and Epidemiology (LBRCE), Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco., Rabat, Morocco, ³Temara Hospital, Laboratory of Biostatistics, Clinical Research and Epidemiology (LBRCE), Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco, Rabat, Morocco, ⁴Health Sciences College, International University of Rabat (UIR), Rabat, Morocco
Background/Purpose: Lumbar radicular pain is the most common chronic neuropathic pain syndrome. Antidepressants are highly recommended for neuropathic pain, but there is no evidence for…

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