ACR Meeting Abstracts

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Abstracts tagged "clinical trials"

  • Abstract Number: 1909 • 2017 ACR/ARHP Annual Meeting

    Long Term Safety of Filgotinib in the Treatment of Rheumatoid Arthritis: Week 84 Data from a Phase 2b Open-Label Extension Study

    Mark C. Genovese1, Arthur Kavanaugh2, Kevin Winthrop3, Maria Greenwald4, Lucia Ponce5, Favio Enriquez Sosa6, Mykola Stanislavchuk7, Minodora Mazur8, Alberto Spindler9, Regina Cseuz10, Natalya Nikulenkova11, Maria Glowacka-Kulesz12, Istvan Szombati13, Anna Dudek14, Neelufar Mozaffarian15, Joy Greer15, Xiao Ding15, Pille Harrison16, Annegret Van der Aa16, René Westhovens17 and Rieke Alten18, 1Stanford University Medical Center, Palo Alto, CA, 2Medicine, University of California, San Diego, La Jolla, CA, 3Oregon Health Sciences University, Portland, OR, 4Desert Medical Advances, Palm Desert, CA, 5Consulta Privada Dra. Lucia Ponce, Temuco, Chile, 6Clinstile SA de CV, Col., Mexico City, Mexico, 7Vinnitsa Regional Clinical Hospital, Vinnitsa, Ukraine, 8IMSP Inst. de Cardiologie, Chisinau, Moldova, The Republic of, 9Centro Médico Privado de Reumatología, Centro Médico Privado de Reumatología, Argentina, 10Revita Reumatologiai Rendelo, Budapest, Hungary, 11Vladimir Reg Clin Hosp, Vladimir, Russian Federation, 12Silesiana Centrum Medyczne, Wroclawska, Poland, 13QUALICLINIC Kft., Budapest, Hungary, 14Centrum Medyczne AMED Warszawa Targówek, Warszawa, Poland, 15Gilead Sciences, Inc, Foster City, CA, 16Galapagos NV, Mechelen, Belgium, 17KU Leuven Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, Leuven, Belgium, 18Internal Medicine, Rheumatology & Clinical Immunology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany

    Background/Purpose: Filgotinib is an orally administered, selective inhibitor of Janus Kinase 1 (JAK1) currently in Phase 3 development for the treatment of rheumatoid arthritis (RA).…
  • Abstract Number: 535 • 2017 ACR/ARHP Annual Meeting

    Effect of a Step-up or Step-Down in Tofacitinib Dose on Efficacy and Safety in Long-Term Extension Studies

    Ruediger Mueller1, Hendrik Schulze-Koops2, Daniel E Furst3, Stanley B Cohen4, Kenneth Kwok5, Anna Maniccia5, Lisy Wang6, Ermeg Akylbekova7 and Johannes von Kempis1, 1Kantonsspital St. Gallen, St. Gallen, Switzerland, 2Klinikum der Universität München, Munich, Germany, 3UCLA, Los Angeles, CA, 4Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, 5Pfizer Inc, New York, NY, 6Pfizer Inc, Groton, CT, 7QuintilesIMS, Durham, NC

    Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. Efficacy and safety of tofacitinib 5 and 10 mg BID have been…
  • Abstract Number: 2074 • 2017 ACR/ARHP Annual Meeting

    A Series of Double-Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Studies to Evaluate the Efficacy, Safety, and Dose-Response Relationship of Orally Administered URC102, a Novel URAT1 Inhibitor, in Korean Patients with Gout

    Jae-Bum Jun1, Howard Lee2, Chang-Hee Suh3, Chang Keun Lee4, Dong Wook Kim5, Jung-Yoon Choe6, Sang-Heon Lee7, Sang-Hyon Kim8, Seung-Jae Hong9, So-Young Bang10, Sung Jae Choi11, Yong-Beom Park12, Makoto Onohara13, Jeongeun Choi14, Jung Soo Song15 and Won Park16, 1Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), 2Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea, Republic of (South), 3Ajou University School of Medicine, Suwon, Korea, Republic of (South), 4Division of Rheumatology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea, Republic of (South), 5Division of Rheumatology, Department of Internal Medicine, Inje University College of Medicine, Busan, Korea, Republic of (South), 6Division of Rheumatology, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea, Republic of (South), 7Division of Rheumatology, Department of Internal Medicine,, Konkuk University School of Medicine, Seoul, Korea, Republic of (South), 8Division of Rheumatology, Department of Internal Medicine, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea, Daegu, Korea, Republic of (South), 9Department of Rheumatology, Kyung Hee University Medical Center, Seoul, Korea, Republic of (South), 10Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), 11Internal Medicine, Korea University Medical Center, Seoul, Korea, Republic of (South), 12Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea, Republic of (South), 13Science and Strategy, Translational Clinical Research, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan, 14JW Pharmaceutical Corporation, Seoul, Korea, Republic of (South), 15Rheumatology, Chung-Ang University College of Medicine, Seoul, Korea, Republic of (South), 16Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South)

    Background/Purpose: URC102 is a novel URAT1 inhibitor under clinical development for the treatment of hyperuricemia with gout. A series of double-blind, placebo-controlled, randomized, multicenter, phase…
  • Abstract Number: 41 • 2017 Pediatric Rheumatology Symposium

    Identification of Optimal Subcutaneous Doses of Tocilizumab in Children With Polyarticular-Course Juvenile Idiopathic Arthritis

    Hermine Brunner1, Nicola Ruperto2, Alberto Martini2, Athimalaipet Ramanan3, Rubén Cuttica4, Jennifer E. Weiss5, Michael Henrickson6, Heinrike Schmeling7, Jordi Anton8, Kirsten Minden9, Joy Hsu10, Kamal Bharucha11, Sunethra Wimalasundera12, Alysha K. Kadva13, Ruchi Upmanyu12, Navita L. Mallalieu10, Daniel Lovell6 and Fabrizio De Benedetti14, 1Rheumatology, PRCSG, Cincinnati, OH, 2PRINTO Coordinating Centre, Genoa, Italy, 3Bristol Royal Hospital for Children, Bristol, United Kingdom, 4Hospital Gral de Niños Pedro Elizalde, Buenos Aires, Argentina, 5Hackensack University Medical Center, Hackensack, NJ, 6PRCSG, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 7University of Calgary, Alberta Children's Hospital, Calgary, AB, Canada, 8Hospital Sant Joan de Deu, Barcelona, Spain, 9Charité – University of Medicine Berlin, Berlin, Germany, 10Roche Innovation Center, New York, NY, 11Genentech, South San Francisco, CA, 12Roche Products Ltd., Welwyn Garden City, United Kingdom, 13Genentech, San Francisco, CA, 14IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy

       Background/Purpose: The efficacy and safety of intravenous (IV) tocilizumab (TCZ), an interleukin-6 receptor-alpha inhibitor, have been demonstrated in patients (pts) with polyarticular-course juvenile idiopathic…
  • Abstract Number: 5L • 2016 ACR/ARHP Annual Meeting

    Speed of Remission with the Use of Voclosporin, MMF and Low Dose Steroids: Results of a Global Lupus Nephritis Study

    Mary Anne Dooley1, William Pendergraft III2, Ellen M. Ginzler3, Nancy J. Olsen4, James Tumlin5, Brad H. Rovin6, Frédéric A. Houssiau7, David Wofsy8, David A. Isenberg9, Neil Solomons10, Robert Huizinga11 and AURA Study Group, 1Dooley Rheumatology, Chapel Hill Doctors, Chapel Hill, NC, 2Kidney Center, University of North Carolina, Chapel Hill, NC, 3Rheumatology, SUNY Downstate Medical Center, Brooklyn, NY, 4Medicine/Rheumatology, Penn State Hershey Medical Center, Hershey, PA, 5Nephrology, University of Tennessee College of Medicine, Chattanooga, TN, 6Ohio State University Medical Center, Columbus, OH, 7Rheumatology, Pôle de Maladies Rhumatismales, Université catholique de Louvain, Brussels, Belgium, 8Rheumatology, University of California, San Francisco, San Francisco, CA, 9Centre for Rheumatology Research, University College Hospital London, UK, London, United Kingdom, 10Aurinia Pharmaceuticals Inc., Victoria, BC, Canada, 11Clinical Affairs, Aurinia Pharmaceuticals Inc., Victoria, BC, Canada

    Background/Purpose: Voclosporin (VCS) is a novel CNI intended for use in the treatment of autoimmune diseases such as lupus nephritis. VCS’s unique structure allows for…
  • Abstract Number: 6L • 2016 ACR/ARHP Annual Meeting

    Myeloablative Autologous Transplantation of CD34+ -Selected Hematopoietic Stem Cells (HSCT) Vs Monthly Intravenous Cyclophosphamide (CYC) for Severe Scleroderma with Internal Organ Involvement: Outcomes of a Randomized North American Clinical Trial

    Keith Sullivan1, Lynette Keyes-Elstein2, Peter McSweeney3, Ashley Pinckney2, Beverly Welch4, Maureen D Mayes5, Richard Nash3, Leslie J. Crofford6, Sharon Castina2, Linda Griffith7, Ellen Goldmuntz8 and Daniel E. Furst9, 1Duke University, Durham, NC, 2Rho, Inc, Chapel Hill, NC, 3Colorado Blood Cancer Institute, Denver, CO, 46610 Rockledge Dr., NIAID/NIH, Bethesda, MD, 5Department of Internal Medicine - Rheumatology, University of Texas-McGovern Medical School, Houston, TX, 6Medicine, Vanderbilt University Medical Center, Nasville, TN, 7NIAID, NIH, Bethesda, MD, 8NIAID, National Institutes of Health, Bethesda, MD, 9David Geffen School of Medicine at UCLA, Los Angeles, CA

      Background/Purpose: Therapeutic options for diffuse cutaneous systemic sclerosis (dcSSc) are limited. The Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial was a multicenter study designed to…
  • Abstract Number: 7L • 2016 ACR/ARHP Annual Meeting

    Overall Reduction in Acute Flares during Treatment with Febuxostat Compared with Placebo over 2 Years in Patients with Early Gout

    Nicola Dalbeth1, Kenneth G. Saag2, William Palmer3, Hyon K. Choi3, Barbara Hunt4, Patricia MacDonald4, Ulrich Thienel5 and Lhanoo Gunawardhana4, 1University of Auckland, Auckland, New Zealand, 2University of Alabama at Birmingham, Birmingham, AL, 3Massachusetts General Hospital/Harvard Medical School, Boston, MA, 4Takeda Pharmaceuticals International, Deerfield, IL, 5RRD International, Rockville, MD

    Background/Purpose: No clinical trials have previously investigated the frequency of acute flares in early gout or the benefit of instituting urate-lowering therapy (ULT) earlier in…
  • Abstract Number: 643 • 2016 ACR/ARHP Annual Meeting

    Exposure-Response Analyses of Efficacy of ABT-122, a Dual-Variable Domain Immunoglobulin (DVD-Ig™) Targeting TNF-α and IL-17A, Compared with Adalimumab in Subjects with Rheumatoid Arthritis and Background MTX

    Amit Khatri1, Ben Klunder2, Mukul Minocha3, Heikki T. Mansikka1 and Ahmed A. Othman1, 1AbbVie Inc., North Chicago, IL, 2AbbVie, Ludwigshafen am Rhein, Germany, 3Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL

    Background/Purpose: ABT-122 is a novel dual-variable domain immunoglobulin (DVD-IgTM), which specifically neutralizes both TNF alpha (TNFα) and interleukin-17A (IL-17). Both cytokines are expressed at increased…
  • Abstract Number: 1709 • 2016 ACR/ARHP Annual Meeting

    Randomized, Double-Blind Study Comparing Chs-0214 with Etanercept (Enbrel) in Patients with Psoriasis and Psoriatic Arthritis

    Alan J. Kivitz1, Kim Papp2, Alim Devani3, Andreas Pinter4, Rodney Sinclair5,6,7, Michael Ziv8, John Caminis9, Cass Kelleher10, Helen Tang11, Barbara Finck10 and RaPsOdy study group , 1Altoona Center for Clinical Research, Duncansville, PA, 2K Papp Clinical Research, Inc. and Probity Medical Research, Waterloo, ON, Canada, 3Institute for Skin Advancement, Surgical and Cosmetic Dermatology, Calgary, AB, Canada, 4Dept. of Dermatology, Venereology and Allergology, Theodor-Stern-Kai 7, Frankfurt, Germany, 5University of Melbourne, E. Melbourne, Australia, 6Epworth Healthcare, E. Melbourne, Australia, 7Sinclair Dermatology Investigational Research, Education and Clinical Trials, E. Melbourne, Australia, 8Dept of Dermatology, Emek Medical Center, Afula, Israel, 9Shire, cambridge, MA, 10Clinical Science, Coherus BioSciences, Redwood City, CA, 11Coherus BioSciences, Redwood City, CA

    Background/Purpose:  CHS-0214 is a proposed biosimilar of etanercept, a fusion protein inhibiting tumor necrosis factor. This Phase III multi-center study compared the efficacy and safety…
  • Abstract Number: 649 • 2016 ACR/ARHP Annual Meeting

    Clinical Evaluation Usefulness of Standardized Protocol Strategies of Dose Reduction in Patients with Rheumatoid Arthritis in Clinical Remission Treated with Biologic Therapies. the Optibio Study

    Carmen Bejerano1, Natividad Oreiro1, Carlos Fernandez-Lopez2, Jose A Pinto-Tasende1, Antonio Atanes1, Bruno De Aspe1, Genaro Graña Gil1, Mercedes Freire1, Manuel Acasuso3, Sonia Pertega4, Francisco J. de Toro1 and Francisco J Blanco1, 1Rheumatology Division, INIBIC-Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruna, Spain, 2Rheumatology Division, INIBIC-Complejo Hospitalario Universitario A Coruña (CHUAC), La Coruña, Spain, 3Centro de Salud San Jose, XAP Coruna, A Coruna, Spain, 4Epidemiology Unit, INIBIC - Complejo Hospitalario Universitario A Coruña, A Coruña, Spain

    Background/Purpose: The OPTIBIO study is a clinical trial whose primary endpoint is to evaluate the proportion of patients that after one year are maintained in…
  • Abstract Number: 2012 • 2016 ACR/ARHP Annual Meeting

    Utility of the Lupus Low Disease Activity State Definition in Discriminating Responders in the Phase IIb Muse Trial of Anifrolumab in Systemic Lupus Erythematosus

    E. Morand1, A. Berglind2, T. Sheytanova2, R. Tummala3 and G. Illei3, 1Monash University, Melbourne, Australia, 2AstraZeneca, Mölndal, Sweden, 3MedImmune, Gaithersburg, MD

    Background/Purpose: Preliminary validation of a Lupus Low Disease Activity State (LLDAS) definition has demonstrated that LLDAS attainment is associated with reduced damage accrual in patients…
  • Abstract Number: 650 • 2016 ACR/ARHP Annual Meeting

    ABT-122, a Tnf– and IL-17–Targeted Dual Variable Domain (DVD)–Ig™ in Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate: Results from a Phase 2 Trial

    Mark C. Genovese1, Michael Weinblatt2, Jacob A Aelion3, Heikki T. Mansikka4, Paul M. Peloso4, Kun Chen4, Yihan Li4, Ahmed A. Othman4, Amit Khatri4, Nasser S. Khan4 and Robert J. Padley4, 1Stanford University Medical Center, Palo Alto, CA, 2Brigham and Women’s Hospital, Boston, MA, 3West Tennessee Research Institute, Jackson, TN, 4AbbVie Inc., North Chicago, IL

    Background/Purpose: Tumor necrosis factor (TNF) and interleukin 17 (IL-17) appear to independently contribute to the pathophysiology of rheumatoid arthritis (RA), synergistically inducing inflammatory mediators leading…
  • Abstract Number: 2222 • 2016 ACR/ARHP Annual Meeting

    Tai Chi Is More Effective Than Aerobic Exercise in Treating Fibromyalgia: A Randomized Controlled Trial

    Chenchen Wang1, Christopher Schmid2, Roger A. Fielding3, William F. Harvey1, Lori Lyn Price4, Jeffrey B. Driban1, Kieran Reid3, Robert A. Kalish5, Ramel Rones6 and Timothy E. McAlindon7, 1Rheumatology, Tufts Medical Center, Boston, MA, 2Brown University School of Public Health, Providence, RI, 3Nutrition, Exercise Physiology and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, 4Clinical Care Research, Tufts Medical Center, Boston, MA, 5Div of Rheumatology, Tufts Medical Center, Boston, MA, 6Center for Mind–Body Therapies, Boston, MA, 7Division of Rheumatology, Tufts Medical Center, Boston, MA

    Background/Purpose:  Fibromyalgia is a complex disorder with strong psychological and pain components and is best managed with multidisciplinary therapies. Previous studies have suggested that Tai…
  • Abstract Number: 911 • 2016 ACR/ARHP Annual Meeting

    Efficacy and Safety of Tocilizumab in Patients with Giant Cell Arteritis: Primary and Secondary Outcomes from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial

    John H. Stone1, Katie Tuckwell2, Sophie Dimonaco2, Micki Klearman3, Martin Aringer4, Daniel Blockmans5, Elisabeth Brouwer6, Maria C. Cid7, Bhaskar Dasgupta8, Juergen Rech9, Carlo Salvarani10, Robert F. Spiera11, Sebastian H. Unizony1, Neil Collinson2 and the GiACTA Investigators, 1Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, MA, 2Roche Products Ltd., Welwyn Garden City, United Kingdom, 3Genentech, South San Francisco, CA, 4Abteilung für Rheumatologie, Dresden, Germany, 5General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium, 6Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands, 7Vasculitis Research Unit. Department of Autoimmune Diseases, Hospital Clínic. University of Barcelona. IDIBAPS, Barcelona, Spain, 8Rheumatology, Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea, United Kingdom, 9Friedrich-Alexander-University Erlangen-Nürnberg, Universitätsklinikum Erlangen, Erlangen, Germany, 10Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy, 11Hospital for Special Surgery, Cornell, New York, NY

    Background/Purpose: The efficacy and safety of tocilizumab (TCZ), an IL-6 receptor-alpha inhibitor, was evaluated in patients with giant cell arteritis (GCA) in GiACTA, a randomized,…
  • Abstract Number: 2373 • 2016 ACR/ARHP Annual Meeting

    Patient Preference for Display of Electronic Patient-Reported Outcomes in Osteoarthritis Clinical Trials: Wording Emphasis, Question Format, and Navigation Button Placement

    Laura Khurana1, Ellen Durand1, Sarah Gary1, Tony Otero1, Chris Hall1, Aisling Ryan2, Christopher J. Evans2 and Susan Dallabrida1, 1ERT, Boston, MA, 2Endpoint Outcomes, Boston, MA

    Background/Purpose:  Electronic patient-reported outcomes (ePROs) are a reliable method for collecting patient data in osteoarthritis clinical trials and offer many advantages over paper collection; however,…
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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.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

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Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. Academic institutions, private organizations and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part a scientific presentation or presentation of additional new information that will be available at the time of the meeting) is under embargo until Saturday, November 11, 2023.

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying financial and other sponsors about this policy. If you have questions about the abstract embargo policy, please contact the public relations department at [email protected].

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