ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: 0139 • ACR Convergence 2022

    A Clinical Study Designed to Support a Demonstration of Interchangeability Between AVT02 and Reference Adalimumab (Humira®)

    Steven Feldman1, Heimo stroissnig2, Richard Kay3, Joanna Sobierska4, Roshan Dias4, Eric Guenzi5, Hendrik Otto2, Halimuniyazi Haliduola2, Abid Sattar6, Ruth Ruffieux4, Matjaz Steijger4 and Fausto Berti4, 1Wake Forest School of Medicine, Winston-Salem, NC, 2Alvotech, Jülich, Germany, 3RK Statistics, Bakewell, United Kingdom, 4Alvotech, Zürich, Switzerland, 5UGA Biopharma, Bonn, Germany, 6Alvotech, London, United Kingdom

    Background/Purpose: To support a demonstration of interchangeability of proposed biosimilar AVT02 and Humira® (reference adalimumab).Methods: Participants with chronic plaque psoriasis were selected for the study…
  • Abstract Number: 0312 • ACR Convergence 2022

    Dose-dependent Suppression of T Cell-Dependent Antibody Response in Healthy Volunteers by KPL-404, an Anti-CD40 Monoclonal Antibody, Supports Phase 2 Study in Patients with Rheumatoid Arthritis

    Lara Pupim1, Gerd Burmester2, Fang Fang1, Alan Kivitz3, Moses Njenga1, Costantino Pitzalis4, Jay Chatfield1, Anastassia Papandrikopoulou1, Manoj Samant1, Steve Schmitz1, Madeline Spiers1, Eben Tessari1, John Ziemniak1 and John F. Paolini5, 1Kiniksa, Lexington, MA, 2Charité University Medicine Berlin, Berlin, Germany, 3Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, 4Queen Mary University of London, London, United Kingdom, 5Kiniksa Pharmaceuticals, Lexington, MA

    Background/Purpose: An unmet need remains in patients with failure and/or inadequate response (IR) to biological disease-modifying antirheumatic drugs (bDMARD-IR) and/or Janus kinase inhibitors (JAKi-IR). The…
  • Abstract Number: 0480 • ACR Convergence 2022

    Treatment of Giant Cell Arteritis Patients with Ultra-short Glucocorticoids and Tocilizumab: Role of Imaging in a Prospective Study

    Francesco Muratore1, Giulia Cassone2, Chiara Marvisi3, ELENA GALLI1, Luigi Boiardi1, GIULIA BESUTTI1, Lucia Spaggiari1, MASSIMILIANO CASALI1, Pamela Mancuso1, Annibale Versari1, Paolo Giorgi Rossi1 and Carlo Salvarani4, 1Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy, 2Università di Modena e Reggio Emilia, Modena, Italy, 3Università di Modena e Reggio Emilia and National Institute of Arthritis & Musculoskeletal & Skin Diseases, National Institutes of Health, Bethesda, MD, 4Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Università di Modena e Reggio Emilia, Reggio Emilia, Italy

    Background/Purpose: To evaluate the clinical and functional/morphological imaging response in a series of active large vessel (LV)-GCA patients treated with tocilizumab (TCZ) monotherapy after ultra-short-term…
  • Abstract Number: 0935 • ACR Convergence 2022

    Targeted Synovial Tissue RNA-Seq Coupled with Artificial Intelligence Accurately Predicts Early Rheumatoid Arthritis Patients Likely to Respond to CsDMARDs, Enriching CsDMARDs Response Rates and Enabling Early Identification of Patients Requiring Subsequent Biological Therapy

    Giorgio CASABURI, Tyler O'Malley, Todd Holscher and Ming-Chou Lee, Exagen, Inc., Vista, CA

    Background/Purpose: Rheumatoid arthritis (RA) is a chronic, inflammatory, systemic autoimmune disease, affecting the joints with varying severity. RA affects approximately 0.5/1% of adults in the…
  • Abstract Number: 1359 • ACR Convergence 2022

    Usability and Acceptability of a Digital Behavioral Therapy for the Management of Fibromyalgia

    Nelson Mitchell1, Yifei Dai2, Michael Rosenbluth3, Allison Kraus1, Maggie Avila1, Aabha Morey1, Michael Gendreau4, Nicolette Vega1, Zunera Ghalib1 and Brian Keefe5, 1Swing Therapeutics, San Francisco, 2Swing Therapeutics, Gainesville, FL, 3Swing Therapeutics, San Francisco, CA, 4GENDREAU CONSULTING, LLC, Poway, CA, 5Swing Therapeutics, New York, NY

    Background/Purpose: Cognitive behavioral therapy (CBT) is considered a gold-standard treatment with demonstrated level 1A evidence for management of fibromyalgia (FM). Acceptance and Commitment Therapy (ACT),…
  • Abstract Number: 1599 • ACR Convergence 2022

    Bimekizumab Treatment in Patients with Active Psoriatic Arthritis and Inadequate Response to Tumor Necrosis Factor Inhibitors: 16-Week Efficacy and Safety from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study

    Joseph Merola1, Robert Landewé2, Iain B McInnes3, Philip J Mease4, Christopher Ritchlin5, Yoshiya Tanaka6, Akihiko Asahina7, Frank Behrens8, Dafna Gladman9, Laure Gossec10, Richard Warren11, Barbara Ink12, Deepak Assudani12, Rajan Bajracharya12, Jason Coarse13 and Laura Coates14, 1Harvard Medical School, Brigham and Women's Hospital, Boston, MA, 2Amsterdam University Medical Center, Meerssen, Netherlands, 3Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, United Kingdom, 4Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, 5Allergy, Immunology and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, 6University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, 7Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan, 8Rheumatology University Hospital & Fraunhofer Institute Translational Medicine and Pharmacology, Goethe-University Frankfurt, Frankfurt Am Main, Germany, 9Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada, 10Sorbonne Université, Paris, France, 11The University of Manchester, Manchester, United Kingdom, 12UCB Pharma, Slough, United Kingdom, 13UCB Pharma, Raleigh, NC, USA, Raleigh, NC, 14Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom

    Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. The phase 3 BE COMPLETE study assessed the efficacy…
  • Abstract Number: 1893 • ACR Convergence 2022

    Antihistamine Use and Structural Progression of Knee OA: A Post-Hoc Analysis of Two Phase 3 Clinical Trials

    Asger Bihlet1, Claire Miller1, Inger Byrjalsen1, Morten Karsdal2, Jeppe Andersen1, Tharaknath Rao3 and Matthew Baker4, 1NBCD, Copenhagen, Denmark, 2Nordic Bioscience, Herlev, Denmark, 3Mobility Bio, San Diego, CA, 4Mobility Bio, San Diego

    Background/Purpose: Prior studies indicate that mast cells are involved in chronic inflammation and that their activity in the synovium may contribute to structural progression of…
  • Abstract Number: 2054 • ACR Convergence 2022

    Towards a Novel Clinician-Reported Outcome Measure for SLE – Outcomes of an International Consensus Process

    Kathryn Connelly1, Laura Eades2, Rachel Koelmeyer3, Darshini Ayton3, Vera Golder2, Rangi Kandane-Rathnayake2, Kate Gregory-Wong3, Hussein Al-Mossawi4, Jeanette Andersen5, Cynthia Aranow6, Laurent Arnaud7, Anca Askanase8, Subhashis Banerjee9, Catherine Barbey10, Hermine Brunner11, Joy Buie12, Laurie Burke13, Alain Cornet14, Karen Costenbader15, Maria Dall'Era16, Khadija Dantata17, Nikolay Delev9, Ann Eldred18, Alan Friedman19, Richard Furie20, Sandra Garces21, Dennis Grasela22, Heath Guay23, Oliver Guenther24, Maria Juarez25, Shelly Kafka26, Kenneth Kalunian27, Elaine Karis28, Youmna Lahoud29, Catharina Lindholm30, Jeffrey Lockman31, Charlotte Lupton32, Justine Maller33, Ashley Marion34, Patrick Marquis35, Joan Merrill36, Thomas Morel37, Marta Mosca38, Yulia Pincus39, Samantha Pomponi40, Guillermo Pons-Estel41, Jorge Ross Terres33, Cailin Sibley42, Maria Silk43, Sanjeev Roy44, Lee S Simon45, Alessandro Sorrentino46, Christian Stach47, George Stojan48, Ying Sun24, Yoshiya Tanaka49, Erik Thomas50, Ronald van Vollenhoven51, Cristina Vazquez Mateo50, Edward M Vital52, Victoria Werth53, Eric Zollars28, Qing Zuraw54 and Eric Morand55, 1Monash Health, Camberwell, Australia, 2Monash University, Clayton, Australia, 3Monash University, Melbourne, Australia, 4AstraZeneca, Bucks, United Kingdom, 5Lupus Europe, Lupus DK, EULAR PARE, ERN ReCONNECT, Brussels, Belgium, 6Feinstein Institutes for Medical Research, Manhasset, NY, 7Hautepierre Hospital, University Hospital of Strasbourg, Rheumatology, Strasbourg, France, 8Columbia University Medical Center, New York, NY, 9Bristol Myers Squibb, Princeton, NJ, 10Biogen, Baar, Switzerland, 11Division of Rheumatology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Department of Pediatrics, Cincinnati, OH, 12Lupus Foundation of America, Charleston, SC, 13LORA Group, Royal Oak, MD, 14Lupus Europe, Brussels, Belgium, 15Brigham and Women's Hospital, Boston, MA, 16University of California, Division of Rheumatology, San Francisco, CA, 17Lupus Foundation of America, Richmond Hill, GA, 18AbbVie, Inc., Lake Bluff, IL, 19AbbVie, Inc., Libertyville, IL, 20Northwell Health, Great Neck, NY, 21Amgen, Inc., Almada, Portugal, 22Bristol Myers Squibb, Lawrencevile, NJ, 23AbbVie, Inc., Worcester, MA, 24Merck KGaA, Darmstadt, Germany, 25UCB Pharma, Slough, United Kingdom, 26AbbVie, Inc., Norristown, PA, 27University of California San Diego, La Jolla, CA, 28Amgen, Inc., Thousand Oaks, CA, 29Biogen International GmbH, Milton, MA, 30AstraZeneca, Gothenburg, Sweden, 31Bristol-Myers Squibb, New York, NY, 32AstraZeneca, Cambridge, United Kingdom, 33Genentech, San Francisco, CA, 34Lupus Foundation of America, Washington, DC, 35Modus Outcomes, Cambridge, MA, 36Oklahoma Medical Research Foundation, Oklahoma City, OK, 37UCB Pharma, Brussels, Belgium, 38University of Pisa, Pisa, Italy, 39Janssen, Flemington, NJ, 40Bristol Myers Squibb, Lawrence Township, NJ, 41Centro Regional de Enfermedades Autoinmunes y Reumáticas, Rosario, Argentina, 42Janssen Research & Development, San Diego, CA, 43Eli Lilly, Carmel, IN, 44Global Clinical Development, Ares Trading SA, an affiliate of Merck KGaA, Darmstadt, Germany,45SDG LLC, West Newton, MA,46AstraZeneca, Sollentuna, Sweden, 47UCB Pharma, Monheim, 48UCB Pharma, Baltimore, MD, 49University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, 50EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, 51Amsterdam University Medical Centers, Amsterdam, Netherlands, 52Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 53University of Pennsylvania and Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, 54Janssen Research and Development, LLC, Spring House, PA, 55Monash University, Victoria; Department of Rheumatology, Monash Health, Melbourne, Australia

    Background/Purpose: Most late-phase randomised controlled trials (RCTs) of novel drugs for systemic lupus erythematosus (SLE) have failed to meet their primary endpoint or shown contradictory…
  • Abstract Number: 2146 • ACR Convergence 2022

    Efficacy of Upadacitinib in Patients with Psoriatic Arthritis and Prior Exposure to Anti-TNF Therapy in the SELECT-PsA 2 Trial Through 2 Years

    Philip J Mease1, Rodrigo Luppino Assad2, Shigeyoshi Tsuji3, Pascal Richette4, Arathi Setty5, Erin McDearmon-Blondell6, Tianming Gao5, Sandra Ciecinski6 and Filip Van den bosch7, 1Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, 2Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil, 3Department of Orthopaedics and Rheumatology, Nippon Life Hospital, Osaka, Japan, 4Department of Rheumatology, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Paris, France, 5AbbVie, Inc., North Chicago, IL, 6AbbVie, Inc., Mettawa, IL, 7Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium

    Background/Purpose: Patients with psoriatic arthritis (PsA) who experience anti-TNF failure and switch to another TNF inhibitor as second- or third-line therapy typically show poorer responses…
  • Abstract Number: 0140 • ACR Convergence 2022

    Continued Treatment with Nintedanib in Patients with Progressive Fibrosing Autoimmune Disease-Related Interstitial Lung Diseases (ILDs): Data from INBUILD-ON

    Eric Matteson1, Danielle Antin-Ozerkis2, Francesco Bonella3, Nazia Chaudhuri4, Vincent Cottin5, Heiko Müller6, Carl Coeck7, Klaus Rohr8 and Wim Wuyts9, 1Mayo Clinic College of Medicine and Science, Rochester, MN, USA, Rochester, MN, 2Section of Pulmonary, Critical Care and Sleep Medicine, Yale University School of Medicine, New Haven, CT, 3Center for Interstitial and Rare Lung Diseases, Pneumology Department, Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany, 4North West Interstitial Lung Disease Unit, Manchester University Foundation Trust, Wythenshawe, Manchester, United Kingdom, 5Coordinating Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, University of Lyon, INRAE, Lyon, France, 6Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, Biberach, Germany, 7Boehringer Ingelheim SComm, Brussels, Brussels, Belgium, 8Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, 9Unit for Interstitial Lung Diseases, Department of Pulmonary Medicine, University Hospitals Leuven, Leuven, Belgium, Leuven, Belgium

    Background/Purpose: In the INBUILD trial in patients with progressive fibrosing ILDs other than idiopathic pulmonary fibrosis, nintedanib reduced the rate of decline in forced vital…
  • Abstract Number: 0355 • ACR Convergence 2022

    Long-term Use of Voclosporin in Patients with Class V Lupus Nephritis: Results from the AURORA 2 Continuation Study

    Amit Saxena1, Dawn Caster2, Salem Almaani3, Amber Rosales4 and Henry Leher5, 1NYU School of Medicine, New York, NY, 2University of Louisville, Louisville, KY, 3The Ohio State University Medical Center, Columbus, OH, 4Aurinia Pharmaceuticals Inc., Rockville, MD, 5Aurinia Pharmaceuticals Inc, Rockville, MD

    Background/Purpose: Persistent proteinuria increases the risk of comorbidities in lupus nephritis, and rapid reductions in protein have shown to be predictive of improved long-term renal…
  • Abstract Number: 0519 • ACR Convergence 2022

    Myeloablation Followed by Hematopoietic Stem Cell Transplantation Leads to Long-term Normalization of Systemic Sclerosis Molecular Signatures

    Nancy Wareing1, Xuan Wang2, Lynette Keyes-Elstein3, Ellen Goldmuntz4, Marka Lyons5, Peter McSweeney6, Daniel Furst7, Richard Nash6, Leslie Crofford8, Beverly Welch9, Ashley Pinckney10, Maureen Mayes11, Keith Sullivan12 and Shervin Assassi13, 1UTHealth Houston McGovern Medical School, Houston, TX, 2Baylor Institute for Immunology Research, Dallas, TX, 3Rho, Chapel Hill, NC, 4NIAID/ NIH, Washington, DC, 5University of Texas McGovern Medical School at Houston, Houston, TX, 6Colorado Blood Cancer Institute, Denver, CO, 7University of California Los Angeles, Los Angeles, CA, 8Vanderbilt University Medical Center, Nashville, TN, 9NIAID/NIH, Bethesda, MD, 10Rho, St. Louis Park, MN, 11Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, TX, 12Duke University, Durham, NC, 13McGovern Medical School, University of Texas, Houston, TX

    Background/Purpose: In the randomized Scleroderma: Cyclophosphamide Or Transplantation (SCOT trial), normalization of systemic sclerosis (SSc) peripheral blood gene expression signatures at the 26-month visit was…
  • Abstract Number: 0936 • ACR Convergence 2022

    Immediate and Long-term Effects of the MTX Discontinuation for 1 vs. 2 Weeks on Vaccine Response to Seasonal Influenza Vaccine: A Non-inferiority Randomized Controlled Trial

    Jin Kyun Park1, Yun Jong Lee2, Kichul Shin3, Eun Ha Kang2, You-Jung Ha2, Min Jung Kim4, Jun Won Park5, SE RIM CHOI5, Mi Hyeon Kim5, Ji In Jung5, Ju Yeon Kim5, Kevin Winthrop6 and Eun Bong Lee5, 1Seoul National University College of Medicine, Jongno-gu, Seoul, South Korea, 2Seoul National University Bundang Hospital, Seongnam, Republic of Korea, 3Seoul Metropolitan Government- Seoul National University Boramae Medical Center, Seoul, Republic of Korea, 4Seoul Metropolitan Government Boramae Medical center, Dongjak-gu, Seoul, Republic of Korea, 5Seoul National University Hospital, Seoul, Republic of Korea, 6Oregon Health & Science University, Portland, OR

    Background/Purpose: Methotrexate (MTX) significantly decreases the vaccine response to pneumococcal and seasonal influenza vaccines and temporarily discontinuing MTX for 2 weeks in patients with rheumatoid…
  • Abstract Number: 1362 • ACR Convergence 2022

    Validation of the 2016 ACR/EULAR Myositis Response Criteria in Juvenile Dermatomyositis (JDM) Clinical Trials and Consensus Profiles

    Hanna Kim1, Didem Saygin2, Christian Douglas3, john mcgrath3, Jesse Wilkerson3, angela Pistorio4, Ann Reed5, Chester Oddis6, Frederick Miller7, Jiří Vencovský8, Nicola Ruperto9, Rohit Aggarwal10 and Lisa G Rider7, 1Division of Rheumatology, Department of Medicine, George Washington University School of Medicine and Health Sciences; Juvenile Myositis Therapeutic and Translation Studies Unit, PTRB, NIAMS, NIH, Bethesda, MD, 2University of Chicago, Chicago, IL, 3Social and Scientific Systems, Inc., Durham, NC, 4IRCCS Istituto Giannina Gaslini, Genoa, Italy, 5Duke University School of Medicine, Durham, NC, 6University of Pittsburgh, Pittsburgh, PA, 7Environmental Autoimmunity Group, Clinical Research Branch, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, Bethesda, MD, 8Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, 9IRCCS Istituto Giannina Gaslini; PRINTO, Clinica Pediatrica e Reumatologia, Genova, Italy, 10Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA

    Background/Purpose: Juvenile dermatomyositis (JDM) ACR-EULAR myositis response criteria (MRC) were developed based on absolute % changes in 6 core set measures (CSM) differentially weighted to…
  • Abstract Number: 1604 • ACR Convergence 2022

    Hydroxychloroquine Does Not Prevent the Future Development of Rheumatoid Arthritis in a Population with Baseline High Levels of Antibodies to Citrullinated Protein Antigens and Absence of Inflammatory Arthritis: Interim Analysis of the StopRA Trial

    Kevin D Deane1, Christopher Striebich2, Marie Feser3, Kristen Demoruelle3, LauraKay Moss4, Elizabeth Bemis3, Ashley Frazer-Abel4, Chelsie Fleischer4, Jeffrey Sparks5, Elizabeth Solow6, Judith James7, Joel Guthridge7, John Davis8, Jonathan Graf9, Jonathan Kay10, Maria Danila11, S. Louis Bridges, Jr.12, Lindsy Forbess13, James O'Dell14, Maureen McMahon15, Jennifer Grossman15, Diane Horowitz16, Athan Tiliakos17, Elena Schiopu18, David Fox19, Jeffrey Carlin20, Cristina Arriens7, Vivian Bykerk12, Reem Jan21, Mathilde Pioro22, M. Elaine Husni23, Ana Fernandez-Pokorny24, Sarah Walker25, Susan Booher26, Melissa Greenleaf27, Margie Byron25, Lynette Keyes-Elstein25, Ellen Goldmuntz28 and V. Michael Holers29, 1University of Colorado Denver Anschutz Medical Campus, Denver, CO, 2University of Colorado, Aurora, CO, 3University of Colorado Anschutz Medical Campus, Aurora, CO, 4University of Colorado Denver, Denver, CO, 5Brigham and Women's Hospital and Harvard Medical School, Boston, MA, 6UT Southwestern Medical Center, Dallas, TX, 7Oklahoma Medical Research Foundation, Oklahoma City, OK, 8Mayo Clinic, Rochester, MN, 9Ucsf, San Francisco, CA, 10Division of Rheumatology, Department of Medicine, UMass Chan Medical School and UMass Memorial Medical Center, Worcester, MA, 11University of Alabama at Birmingham, Birmingham, AL, 12Hospital for Special Surgery, New York, NY, 13Cedars-Sinai Medical Center, Los Angeles, CA, 14University of Nebraska Medical Center, Omaha, NE, 15University of California Los Angeles, Los Angeles, CA, 16Northwell Health, Jericho, NY, 17Emory University, Roswell, GA, 18Michigan Medicine, Ann Arbor, MI, 19University of Michigan, Ann Arbor, MI, 20Virginia Mason Medical Center, Seattle, WA, 21University of Chicago, Chicago, IL, 22University of Washington, Seattle, WA, 23Cleveland Clinic, Cleveland, OH, 24Essentia Health, Duluth, MN, 25Rho, Chapel Hill, NC, 26NIH NIAID, Bethesda, MD, 27NIH, Rock Hill, SC, 28NIAID/ NIH, Washington, DC, 29University of Colorado, Denver, CO

    Background/Purpose: The Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis (StopRA) (ClinicalTrials.gov NCT02603146) is a randomized, double-masked, placebo-controlled, multi-center (20 sites) clinical trial evaluating…
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All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

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