ACR Meeting Abstracts

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Abstracts tagged "clinical trials"

  • Abstract Number: 702 • 2013 ACR/ARHP Annual Meeting

    Prediction Of Worsening Of Skin Fibrosis In Patients With Diffuse Systemic Sclerosis Using The EULAR Scleroderma Trials and Research (EUSTAR) Registry

    Britta Maurer1, Nicole Graf2, Beat A. Michel3, Carola Metzig4, Vivian Lanius4, Dinesh Khanna5 and Oliver Distler1, 1Division of Rheumatology, University Hospital Zurich, Zurich, Switzerland, 2graf biostatistics, Winterthur, Switzerland, 3Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland, 4Bayer Pharma AG, Berlin, Germany, 5University of Michigan Health System, Ann Arbor, MI

    Background/Purpose: To identify predictive parameters for the progression of skin fibrosis in patients with diffuse cutaneous SSc (dcSSc) to enable 1) risk-stratification in clinical practice…
  • Abstract Number: 281 • 2013 ACR/ARHP Annual Meeting

    GO-Kids Imaging Substudy: MRI Treatment Response To 30 Mg/m2 4-Weekly Subcutaneous  injections Of Golimumab In Children With Polyarticular JIA – Preliminary Results Of The Open Label Portion

    Nikolay Tzaribachev1, Catrin Tzaribachev1 and Bernd Koos2, 1Pediatric Rheumatology, PRI - Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany, 2Clinic of Orthodontics, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany

    GO-KIDS Imaging Substudy: MRI treatment response to 30 mg/m2 4-weekly subcutaneous injections of Golimumab in children with polyarticular JIA– preliminary results of the open label…
  • Abstract Number: 278 • 2013 ACR/ARHP Annual Meeting

    Results Of a 24 Month Extension Study In Patients Who Participated In The Trial Of Early Aggressive Therapy In Polyarticular Juvenile Idiopathic Arthritis

    Carol A. Wallace1, John Bonsack2, Steven J. Spalding3, Hermine Brunner4, Kathleen M. O'Neil5, Diana Milojevic6, Sarah Ringold7, Laura E. Schanberg8, Gloria C. Higgins9, Beth S. Gottlieb10, Joyce J. Hsu11, Marilynn G. Punaro12, Yukiko Kimura13 and Audrey F. Hendrickson14, 1University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA, 2Pediatrics, University of Utah Health Sciences Center, Salt Lake City, UT, 3Pediatric Institute, Department of Pediatric Rheumatology, The Cleveland Clinic, Cleveland, OH, 4Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 5Pediatric Rheumatology, Riley Hospital for Children, Indianapolis, IN, 6Dept of Pediatric Rheumatology, University of California, San Francisco, San Francisco, CA, 7Pediatrics, Seattle Children's Hospital/Univ of Washington, Seattle, WA, 8Pediatrics, Duke University Medical Center, Durham, NC, 9Pediatric Rheumatology Ohio State University, Nationwide Childrens Hosp, Columbus, OH, 10Pediatric Rheumatology, Cohen Children's Medical Center of New York, New Hyde Park, NY, 11Pediatric Rheumatology, Stanford University, Palo Alto, CA, 12Pediatric Rheumatology, Texas Scottish Rite Hospital, Dallas, TX, 13Pediatric Rheumatology, Joseph M Sanzari Children’s Hospital, Hackensack University Medical Center, Hackensack, NJ, 14Rheumatology, Seattle Children's Research Institute, Seattle, WA

    Background/Purpose: The Trial of Early Aggressive Therapy in Polyarticular Juvenile Idiopathic Arthritis (TREAT-JIA) was a double-blind, randomized, placebo-controlled trial in 85 patients with onset of…
  • Abstract Number: 2830 • 2013 ACR/ARHP Annual Meeting

    First Stage Of a Simon’s Two-Stage Optimal Approach Supports Placental Transfer Of Hydroxychloroquine and a Reduced Recurrence Rate Of The Cardiac Manifestations Of Neonatal Lupus

    Peter M. Izmirly1, Nathalie Costedoat-Chalumeau2, Amit Saxena3, Amanda Zink4, Zoey Smith3, Deborah Friedman5 and Jill P. Buyon1, 1Medicine, Division of Rheumatology, New York University School of Medicine, New York, NY, 2Internal Medicine, Hopital Cochin, Paris, France, 3Rheumatology, New York University School of Medicine, New York, NY, 4NYU Hospital for Joint Diseases, New York University School of Medicine, New York, NY, 5Division of Pediatric Cardiology, New York Medical College, Valhalla, NY

    Background/Purpose: A previous case control study suggested that hydroxychloroquine (HCQ) might prevent the development of cardiac Neonatal Lupus (cardiac NL) in anti-SSA/Ro antibody (ab) exposed…
  • Abstract Number: L6 • 2013 ACR/ARHP Annual Meeting

    Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Co-Morbid Depression Receiving Concurrent Antidepressant Therapy: A Randomized, 2-Way Crossover, Double-Blind, Placebo-Controlled Study

    Lesley M. Arnold1, Piercarlo Sarzi-Puttini2, Pierre Arsenault3, Tahira Khan4, Pritha Bhadra Brown5, Andrew Clair5, Joseph Driscoll4, Jaren Landen4 and Lynne Pauer4, 1Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, 2Azienda Ospedaliera Polo Universitario L. Sacco, Milano, Italy, 3Département de Médecine de Famille, Université de Sherbrooke, Sherbrooke, QC, Canada, 4Pfizer Inc, Groton, CT, 5Pfizer Inc, New York, NY

    Background/Purpose: Fibromyalgia (FM) is characterized by chronic widespread pain and often associated with mood disorders including depression. Approximately 50–70% of FM patients have a lifetime…
  • Abstract Number: 2765 • 2013 ACR/ARHP Annual Meeting

    A Double-Blind Randomized Placebo-Controlled Trial Of Lovastatin in Patients with Rheumatoid Arthritis

    Cynthia Aranow1, John J. Cush2, Marcy B. Bolster3, Christopher C. Striebich4, Maria Dall'era5, Meggan Mackay6, Ewa Olech7, Tracy M. Frech8, J. Box9, Richard M. Keating10, Mary Chester M. Wasko11, E. William St Clair12, Alan Kivitz13, Betty Diamond14, Anne Davidson15, Meagan Spychala16, Ellen A. Goldmuntz17 and Autoimmunity Centers of Excellence18, 1Feinstein Institute for Medical Research, Manhasset, NY, 2Baylor Research Institute and Baylor University Medical Center, Dallas, TX, 3Medicine, Medical University of South Carolina, Charleston, SC, 4University of Colorado Denver, Aurora, CO, 5Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, 6Autoimmune & Musculoskeletal Disease, Feinstein Institute for Medical Research, Manhasset, NY, 7Clinical Pharmacology, Oklahoma Medical Research Foundation, Oklahoma City, OK, 8Internal Medicine-Division of Rheumatology, University of Utah School of Medicine, SLC, UT, 9Carolina Bone and Joint, Charlotte, NC, 10Rheumatology Section, The University of Chicago, Chicago, IL, 11West Penn Allegheny Health System, Temple University School of Medicine, Pittsburgh, PA, 12Medicine, Duke Unversity Medical Center, Durham, NC, 13Altoona Center for Clinical Research, Duncansville, PA, 14Autoimmune & Musculoskeletal, Feinstein Institute for Medical Research, Manhasset, NY, 15Autoimmunity and Musculoskeletal Diseases, Feinstein Institute for Medical Research, Manhasset, NY, 16Rho, Inc., Chapel Hill, NC, 17DAIT, NIAID/NIH, Bethesda, MD, 18NIAID, National Institutes of Health, Bethesda, MD

    Background/Purpose: HMG -CoA reductase inhibitors (statins) are standard treatment for hyperlipidemia. In addition to lipid lowering abilities, statins exhibit multiple anti-inflammatory effects.   The objectives of…
  • Abstract Number: 2675 • 2013 ACR/ARHP Annual Meeting

    Phase 2 Trial On Triptorelin For Ovary Protection In Childhood-Onset Systemic Lupus Erythematosus

    Rina Mina1, Andreas Reiff2, Clovis A. Silva3, Patricia Vega Fernandez4, Gloria C. Higgins5, Lisa F. Imundo6, Marisa S. Klein-Gitelman7, Calvin Williams8, Carol A. Wallace9, Nadia E. Aikawa10, Shannen L. Nelson11, Jun Ying12, Susan R. Rose13 and Hermine Brunner14, 1Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 2Division of Rheumatology, Children's Hospital Los Angeles, Los Angeles, CA, 3Children's Institute, Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, Brazil, 4Cincinnati Children's Hospital Medica Center, CINCINNATI, OH, 5Pediatric Rheumatology Ohio State University, Nationwide Childrens Hosp, Columbus, OH, 6Pediatric and Adult Rheumatology Columbia University Medical Center, New York, NY, 7Division of Rheumatology, Children's Memorial Hospital, Chicago, IL, 8Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, 9University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA, 10Reumatologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil, 11Rheumatology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 12Medicine-Internal Medicine-General Medicine, University of Cincinnati, Cincinnati, OH, 13Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 14PRCSG, Cincinnati, OH

    Background/Purpose: Gonadotoxicity is a known side effect of cyclophosphamide (CYC) therapy in childhood-onset systemic lupus erythematosus (cSLE).  Gonadotropin releasing hormone (GnRH) agonists, such as triptorelin,…
  • Abstract Number: 2392 • 2013 ACR/ARHP Annual Meeting

    Impact Of CT-P13 and Originator Infliximab Treatment On Quality Of Life Derived From The Health Assessment Questionnaire (HAQ) and Short-Form 36 (SF-36) From a Randomized, Double-Blind Trial In Patients With Active RA

    Dae-Hyun Yoo1, Andriy Yagensky2, Antoaneta Toncheva3, Osca Ruiz Santacruz4, Fidencio Cons Molina5, Yunju Bae6, Taek Kwon6, SinHye Kim6, Peter Lacouture7, Teresa Kok8 and Won Park9, 1Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 2Lutsk City Hospital, Lutsk, Ukraine, 3National Multiprofile Transport Hospital, Sofia, Bulgaria, 4Centro Integral de Reumatología e Inmunología - CIREI S.A.S, Bogotá, Colombia, 5Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, 6Celltrion Inc., Incheon, South Korea, 7Hospira Inc, Lake forest, IL, 8Hospira Inc., Lake Forest, IL, 9Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea

    Background/Purpose: Quality of life and functionality are important outcome metrics in understanding the value of therapeutic interventions in RA. Biological products have become an established…
  • Abstract Number: 2355 • 2013 ACR/ARHP Annual Meeting

    Sarilumab, a Subcutaneously-Administered, Fully-Human Monoclonal Antibody Against The IL-6 Receptor Alpha: Using Acute Phase Reactants, Efficacy and Safety Parameters To Inform Phase 3 Dose Selection

    Janet van Adelsberg1, Steven P. Weinstein2, Neil Graham3, Tanya Momtahen4, Chunpeng Fan5 and Stefano Fiore6, 1Clinical Science, Regeneron Pharmaceutials, Inc., Tarrytown, NY, 2Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, NY, 3Program Direction, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 4Program Direction, Sanofi, Bridgewater, NJ, 5Biostatistics, Sanofi, Bridgewater, NJ, 6Clinical Science, Sanofi, Bridgewater, NJ

    Background/Purpose: Sarilumab (SAR) is a fully human mAb directed against IL-6Rα. In phase 2 MOBILITY Part A (NCT01061736), SAR administered SC plus MTX (methotrexate 10-25…
  • Abstract Number: 2258 • 2013 ACR/ARHP Annual Meeting

    Less Than 5% Of Ethnic Minority Rheumatoid Arthritis Patients Meet Inclusion Criteria For Randomized Controlled Clinical Trials

    Gail S. Kerr1, Yusuf Yazici2, Christopher Swearingen3, Chunqiao Luo4, Yvonne R. S. Sherrer5, Edward L. Treadwell6, Angelia D. Mosley-Williams7, Luis R. Espinoza8, Rodolfo Perez Alamino9, Sharon Dowell10, Ignacio Garcia-Vallardes11, Theresa Lawrence-Ford12, Adrian Godoy10, Akgun Ince13 and Cindy Flower14, 1Rheumatology, Washington DC VAMC, Georgetown and Howard University, Washington, DC, 2New York University Hospital for Joint Diseases, New York, NY, 3Pediatrics and Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, 4Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, 5Rheum/Immunology, Centre Rheum Immunol Arthritis, Fort Lauderdale, FL, 6Dept Medicine Div of Rheum, East Carolina University, Greenville, NC, 7John Dingell VAMC, Detroit, MI, 8Medicine-Section of Rheum, LSU Medical Center, New Orleans, LA, 9Rheumatology, Lousiana State University and LSU Medical Center, New Orleans, LA, 10Division of Rheumatology, Howard University, Washington, DC, 11Rheumatology Clinical Practice, Guadalajara, Gaudalajara, Mexico, 12North Georgia Rheumatology Group, PC, Lawrenceville, GA, 13Arthitis Consultants Inc, Saint Louis University, St. Louis, MO, 14Medicine, University of the West Indies, Bridgetown, Barbados

    Background/Purpose:  RCT are the gold standard for therapeutic efficacy, yet many studies indicate most patients seen in routine clinical care do not meet inclusion criteria.…
  • Abstract Number: 1809 • 2013 ACR/ARHP Annual Meeting

    Topline Results Of The Biomarkers Of Lupus Disease (BOLD) Study: Clinical and Mechanistic Perplexities Of Lupus Treatment Trials Can Be Mitigated By Eliminating Background Immune Suppressants

    Joan T. Merrill1, Frederick W. Immermann2, Tianhui Zhou3, Margot O'Toole4, Maryann Whitley5, Andrew A. Hill5, Ying Zhang5, David von Schack5, Padmalatha S. Reddy5, Jaime L. Masferrer4, Stan Kamp1, Joel M. Guthridge6, Aikaterini Thanou7, Paul Wu5, Theresa Paradis5, William M. Mounts5, Judith A. James8 and Sudhakar T. Sridharan2, 1Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, 2BioTherapeutics R&D, Pfizer Inc, Collegeville, PA, 3BioTherapeutics R&D, Bristol Myers Squibb, Princeton, NJ, 4independent consultant, Cambridge, MA, 5Pfizer Inc, Cambridge, MA, 6Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, 7Arthritis and Clinical Immmunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, 8Oklahoma Medical Research Foundation, Oklahoma City, OK

    Background/Purpose: The BOLD study was designed to test the discriminatory capacity and safety of a trial design eliminating background immune suppressants (IS) in SLE patients…
  • Abstract Number: 1780 • 2013 ACR/ARHP Annual Meeting

    The Randomized Placebo Phase Study of Rilonacept in the Treatment of Systemic Juvenile Idiopathic Arthritis

    Norman T. Ilowite1, Kristi Prather2, Yuliya Lokhnygina3, Laura E. Schanberg4, Melissa Elder5, Diana Milojevic6, James W. Verbsky7, Steven J. Spalding8, Yukiko Kimura9, Lisa F. Imundo10, Marilynn G. Punaro11, David D. Sherry12, Stacey E. Tarvin13, Lawrence S. Zemel14, James D. Birmingham15, Beth S. Gottlieb16, Michael L. Miller17, Kathleen M. O'Neil18, Natasha M. Ruth19, Carol A. Wallace20, Nora G. Singer21 and Christy I. Sandborg22, 1Pediatrics, The Children's Hospital at Montefiore, Bronx, NY, 2Statistics, Duke Clinical Research Institute, Durham, NC, 3Duke Clinical Research Institute, Durham, NC, 4Pediatrics, Duke University Medical Center, Durham, NC, 5Pediatrics, University of Florida, Gainesville, HI, 6Dept of Pediatric Rheumatology, University of California, San Francisco, San Francisco, CA, 7Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, 8Pediatric Institute, Department of Pediatric Rheumatology, The Cleveland Clinic, Cleveland, OH, 9Pediatric Rheumatology, Joseph M Sanzari Children’s Hospital, Hackensack University Medical Center, Hackensack, NJ, 10Pediatric and Adult Rheumatology Columbia University Medical Center, New York, NY, 11Pediatric Rheumatology, Texas Scottish Rite Hospital, Dallas, TX, 12Pediatric Rheumatology, Children's Hospital of Philadelphia, Philadelphia, PA, 13Pediatric Rheumatology, Riley Hospital for Children, Indianapolis, IN, 14Pediatric Rheumatology Collaborative Study Group, Cincinnati, OH, 15Medicine & Pediatrics, Rheumatology, Michigan State University College of Human Medicine, Grand Rapids, MI, 16Pediatric Rheumatology, Cohen Children's Medical Center of New York, New Hyde Park, NY, 17Rheumatology, Childrens Memorial Hospital, Chicago, IL, 18Division of Pediatric Rheumatology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, 19Pediatric Rheumatology, Medical University of South Carolina, Charleston, SC, 20University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA, 21Rheumatology, MetroHealth Medical Center, Cleveland, OH, 22Pediatric Rheumatology, Stanford University, Palo Alto, CA

    Background/Purpose:   The RAndomized Placebo Phase Study Of Rilonacept in the Treatment of Systemic Juvenile Idiopathic Arthritis (RAPPORT) is a multicenter controlled trial using a…
  • Abstract Number: 1609 • 2013 ACR/ARHP Annual Meeting

    AMG 811 (anti-IFN-gamma) Treatment Leads To a Reduction In The Whole Blood IFN-Signature and Serum CXCL10 In Subjects With Systemic Lupus Erythematosus:   Results Of Two Phase I Studies

    David A. Martin1, Andrew Welcher2, Michael Boedigheimer2, Zahir Amoura3, Alan Kivitz4, Jill P. Buyon5, Jorge Sanchez-Guerrero6, Juanita Romero-Diaz7, Alla Rudinskaya8, Kevin M. Latinis9, S Cohen10, Cynthia Aranow11, Mike Damore2, Winnie Sohn2, Kit Chiu2, Christine Wang12, Naren Chirmule2, Barbara Sullivan2 and James Chung2, 1Medical Sciences, Amgen, Seattle, WA, 2Amgen, Thousand Oaks, CA, 3Department of Internal Medicine 2. Referal center for SLE/APS, CHU Pitié-Salpêtrière, Paris, France, 4Altoona Center for Clinical Research, Duncansville, PA, 5Medicine, Division of Rheumatology, NYU School of Medicine, New York, NY, 6UHN Toronto Western Hospital, Toronto, ON, Canada, 7Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico, 8Danbury Hospital, Danbury, CT, 9Latinis Rheumatology, Leawood, KS, 10Metroplex Clinical Research Center, Dallas, TX, 11The Feinstein Institute, Manhasset, NY, 12Biostatistics, Amgen, Thousand Oaks, CA

    Background/Purpose: Interferon-gamma (IFN-g) is a major pro-inflammatory cytokine that modulates the function of several important populations of immune cells including B cells, T cells, and…
  • Abstract Number: 1857 • 2012 ACR/ARHP Annual Meeting

    Identifying Core Symptom Domains in the Fibromyalgia Impact Questionnaire: Principal Component Analysis of Data From Milnacipran Clinical Studies

    Philip J. Mease1, Robert M. Bennett2, Robert H. Palmer3 and Yong Wang4, 1Swedish Medical Center and University of Washington, Seattle, WA, 2Medicine & Nursing, Oregon Health & Science Univ, Portland, OR, 3Forest Research Institute, Inc., Jersey City, NJ, 4Forest Research Institute, Jersey City, NJ

    Background/Purpose: The Fibromyalgia Impact Questionnaire (FIQ) is a multidimensional instrument that encompasses many of the core domains recommended by OMERACT for evaluation in fibromyalgia (FM)…
  • Abstract Number: 755 • 2012 ACR/ARHP Annual Meeting

    Sifalimumab, an Anti-IFN-Alpha Monoclonal Antibody Shows Target Suppression of a Type I IFN Signature in Blood and Muscle of Dermatomyositis and Polymyositis Patients

    Brandon W. Higgs1, Wei Zhu2, Chris Morehouse1, Wendy White3, Philip Brohawn1, Charles Le4, Anthony A Amato5, David Fiorentino6, Steven A. Greenberg5, Laura Richman1, Warren Greth4, Bahija Jallal1 and Yihong Yao3, 1Translational Sciences, MedImmune, LLC, Gaithersburg, MD, 2Translational Science, MedImmune, LLC, Gaithersburg, MD, 3Translational Sciences, MedImmune, Gaithersburg, MD, 4Clinical Development, MedImmune, LLC, Gaithersburg, MD, 5Brigham and Women's Hospital and Harvard Medical School, Boston, MA, 6Dermatology, Stanford University School of Medicine, Redwood City, CA

    Background/Purpose: To assess the pharmacodynamic effects of sifalimumab, an investigational anti-IFN-alpha monoclonal antibody, in the blood and muscle of adult dermatomyositis and polymyositis patients by…
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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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