ACR Meeting Abstracts

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Abstracts tagged "monoclonal antibodies"

  • Abstract Number: 1163 • 2017 ACR/ARHP Annual Meeting

    A First-in-Human Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Novel Anti-Interleukin 1 Biologic Agent, Rph-104, in Healthy Subjects

    Ahmet Gul1, Sibel Ulker2, Recep Selim Senturk2, Ugur Onsel Turk2, Cemil Gurgun2, Yan Lavrovsky3, Mikhail Samsonov4, Sebnem Ozen5 and Serdar Altinel6, 1Department of Internal Medicine, Division of Rheumatology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey, 2Ege University Drug Development and Pharmacokinetics Research and Application Centre (ARGEFAR), Izmir, Turkey, 3R-Pharm Overseas, Inc.,, San Diego, CA, 4Medical Department, R-Pharm JSC, Moscow, Russian Federation, 5Clinical Trial Department, TRPHARM İlac A.S., Istanbul, Turkey, 6linical Trial Department, TRPHARM İlac A.S., Istanbul, Turkey

    Background/Purpose: Interleukin-1 (IL-1) is highly active pro-inflammatory cytokine, which is responsible for clinical and laboratory findings in hereditary and acquired auto-inflammatory disorders. Blocking IL-1 activity…
  • Abstract Number: 1195 • 2017 ACR/ARHP Annual Meeting

    Efficacy and Safety of Subcutaneous Tanezumab in Patients with Knee or Hip Osteoarthritis (NCT01089725)

    Charles A. Birbara1, Eugene J. Dabezies2, Aimee M. Burr3, Robert J. Fountaine4, Michael D. Smith3, Mark T. Brown3, Christine R. West3, Rosalinda H. Arends3 and Kenneth M. Verburg3, 1University of Massachusetts Medical School, Worcester, MA, 2Pensacola Research Consultants, Pensacola, FL, 3Pfizer, Inc., Groton, CT, 4Pfizer, Inc., Grotoon, CT

    Background/Purpose : Tanezumab (TNZ) is a monoclonal antibody that inhibits nerve growth factor and reduces hip or knee osteoarthritis (OA) pain. A placebo-controlled phase 3…
  • Abstract Number: 2445 • 2017 ACR/ARHP Annual Meeting

    Efficacy and Safety of Rituximab Biosimilar, CT-P10, after a Single Switch from Innovator Rituximabs in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 72 Weeks

    Seung-Cheol Shim1, Ljubinka Bozic Majstorovic2, Alfredo Berrocal Kasay3, Elias Chalouhi El-Khouri4, Fedra Irazoque-Palazuelos5, Francisco Cons Molina6, Francisco G. Medina-Rodriguez7, Pedro Miranda8, Pavel Shesternya9, Jose Chavez Corrales10, Piotr Wiland11, Slawomir Jeka12, Olena Garmish13, Pawel Hrycaj14, Natalia Fomina15, Won Park16, Chang-Hee Suh17, Sang-Joon Lee18, Sung Young Lee19 and Dae-Hyun Yoo20, 1Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), 2Clinical Centre Banja Luka, Bonja Luka, Bosnia and Herzegovina, 3ABK Reuma SRL – Medicentro Biociencias, Lima, Peru, 4Clinica Internacional, Lima, Peru, 5Centro de Invstigacion y Tratamiento Reumatologico S.C, Mexico City, Mexico, 6Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, 7Rheumatology, LaSalle University, Mexico City, Mexico, 8Centro De Estudios Reumatológicos, Santiago, Chile, 9Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, 10Clinica San Borja, Lima, Peru, 11Department and Clinic of Rheumatology and Internal Medicine, Medical University, Wroclaw, Poland, 122nd University Hospital, CM UMK, Department of Rheumatology and Connective Tissue Diseases,, Bydgoszcz, Poland, 13Institute of Cardiology named by M.D. Strazhesko NAMS of Ukraine, Kyiv, Ukraine, 14Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, 15Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation, 16Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), 17Ajou University School of Medicine, Suwon, Korea, Republic of (South), 18CELLTRION, Inc., Incheon, Korea, Republic of (South), 19Clinical Planning Department, CELLTRION, Inc., Incheon, Korea, Republic of (South), 20Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South)

    Background/Purpose: Similarity of pharmacokinetic, efficacy and safety between CT-P10 and reference rituximab (RTX) were shown in the phase 3 randomized controlled trial (NCT02149121) up to…
  • Abstract Number: 2461 • 2017 ACR/ARHP Annual Meeting

    Rituximab Is Effective in the Treatment of Rheumatoid Arthritis Irrespective of Body Mass Index; Up to 48 Weeks Results from Phase 3 Study

    Dae-Hyun Yoo1, Won Park2, Chang-Hee Suh3, Seung-Cheol Shim4, Sang-Joon Lee5, Yun Ju Bae5, Chan Park5 and Noo Ri Han5, 1Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), 2Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), 3Ajou University School of Medicine, Suwon, Korea, Republic of (South), 4Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), 5CELLTRION, Inc., Incheon, Korea, Republic of (South)

    Background/Purpose: High body mass index (BMI) is known to be associated with inadequate clinical response to anti-TNF agents in RA patients.1 However, there are limited…
  • Abstract Number: 2490 • 2017 ACR/ARHP Annual Meeting

    Sustained Clinical Response in Refractory Rheumatoid Arthritis Patients with a Low-Dose Rituximab Retreatment Regimen. a Single Center Experience

    Sebastian C Rodriguez-Garcia, Raul Castellanos-Moreira Sr., M. Victoria Hernández, Andrea Cuervo, Virginia Ruiz-Esquide, Julio Ramírez, Juan Cañete and Raimon Sanmartí, Rheumatology Service, Hospital Clínic de Barcelona, Barcelona, Spain

    Background/Purpose: : The standard dose of rituximab (RTX) in rheumatoid arthritis (RA) is two intravenous (iv) 1 g infusions, separated by two weeks. Recently, the…
  • Abstract Number: 1686 • 2016 ACR/ARHP Annual Meeting

    Association of Early Skin Improvement with ACR Responses Among Biologic DMARD-Naive Psoriatic Arthritic Patients Treated with Ixekizumab

    Diamant Thaci1, Akimichi Morita2, Julie Birt3, Chen-Yen Lin3, Catherine L. Shuler3 and Alice B. Gottlieb4, 1Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany, 2Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, 3Eli Lilly and Company, Indianapolis, IN, 4Tufts University School of Medicine, Boston, MA

    Background/Purpose: Ixekizumab (IXE) is a high-affinity monoclonal antibody that selectively targets interleukin-17A. In a phase 3 study, IXE was superior to placebo (PBO) in achieving…
  • Abstract Number: 2757 • 2016 ACR/ARHP Annual Meeting

    Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Psoriatic Arthritis: 104 Weeks Results from a Phase 3 Trial

    Iain B McInnes1, Philip J Mease2, Christopher T. Ritchlin3, Proton Rahman4, Alice B Gottlieb5, Bruce Kirkham6, Radhika Kajekar7, Evie Maria Delicha8, Luminita Pricop9 and Shephard Mpofu8, 1University of Glasgow, Glasgow, Great Britain, 2Swedish Medical Center and University of Washington, Seattle, WA, 3Allergy Immunology & Rheumatology, University of Rochester Medical Center, Rochester, NY, 4Rheumatology, St Claires Mercy Hospital, St Johns, NF, Canada, 5Tufts University School of Medicine, Boston, MA, 6Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom, 7One Health Plaza, Novartis Pharmaceuticals Corporation, East Hanover, NJ, 8Novartis Pharma AG, Basel, Switzerland, 9Novartis Pharmaceuticals Corporation, East Hanover, NJ

    Background/Purpose:  Secukinumab, a fully human anti–IL-17A monoclonal antibody, significantly improved signs and symptoms of psoriatic arthritis (PsA) over 52 weeks (wks) in FUTURE 2 study (NCT01752634).1,2 Here…
  • Abstract Number: 295 • 2016 ACR/ARHP Annual Meeting

    Efficacy and Safety of Fasinumab for Osteoarthritic Pain in Patients with Moderate to Severe Osteoarthritis of the Knees or Hips

    Jennifer Maloney1, Alan Kivitz2, Thomas J. Schnitzer3, Paula Dakin1, Catherine Stehman-Breen1 and Greg Geba1, 1Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 2Altoona Center for Clinical Research, Duncansville, PA, 3Northwestern University, Chicago, IL

    Background/Purpose:  Osteoarthritis (OA) is an important cause of chronic pain in older adults. Fasinumab is a fully-human, high-affinity monoclonal antibody directed against the nerve growth…
  • Abstract Number: 961 • 2016 ACR/ARHP Annual Meeting

    Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Psoriatic Arthritis through 3 Years: Efficacy and Safety Results from a Phase 3 Trial

    Philip J Mease1, Arthur Kavanaugh2, Andreas Reimold3, Hasan Tahir4, Juergen Rech5, Stephen Hall6, Piet Geusens7,8, Pellet Pascale9, Evie Maria Delicha10, Luminita Pricop11 and Shephard Mpofu10, 1Swedish Medical Center and University of Washington, Seattle, WA, 2UC San Diego School of Medicine, La Jolla, CA, 3Dallas VA Medical Center and University of Texas Southwestern Medical Center, Dallas, TX, 4Barts Health NHS Trust, London, United Kingdom, 5Department of Internal Medicine 3 – Rheumatology and Immunology, Universitätsklinikum Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany, 6Monash University, Melbourne, Australia, 7University of Hasselt, Hasselt, Belgium, 8Maastricht University Hospital, Maastricht, Netherlands, 9Novartis Pharma AG, basel, Switzerland, 10Novartis Pharma AG, Basel, Switzerland, 11Novartis Pharmaceuticals Corporation, East Hanover, NJ

    Background/Purpose:  Secukinumab, an anti–interleukin-17A monoclonal antibody, provided rapid and significant improvements in the key clinical domains of psoriatic arthritis (PsA) in the FUTURE 1 study…
  • Abstract Number: 1634 • 2016 ACR/ARHP Annual Meeting

    Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks

    Chang-Hee Suh1, Alfredo Berrocal Kasay2, Elias Chalouhi El-Khouri3, Pedro Miranda4, Ljubinka Bozic Majstorovic5, Slawomir Jeka6, Pawel Hrycaj7, Dmytro Rekalov8, Piotr Wiland9, Andreas Krause10, Istvan Szombati11, Anna Mihailova12, Ihor Hospodarskyy13, Mariusz Piotrowski14, Seong-Ryul Kwon15, Eun-Young Lee16, Dae-Hyun Yoo17, Won Park18, Seung-Cheol Shim19, Sang-Joon Lee20 and Taek S. Kwon20, 1Department of Rheumatology, Ajou University School of Medicine, Suwon, Korea, The Republic of, 2ABK Reuma SRL – Medicentro Biociencias, Lima, Peru, 3Clinica Internacional, Lima, Peru, 4Centro De Estudios Reumatológicos, Santiago, Chile, 5Clinical Centre Banja Luka, Bonja Luka, Bosnia and Herzegovina, 6Department of Rheumatology and Connective Tissue Diseases, 2nd University Hospital, CM UMK, Bydgoszcz, Poland, 7Rheumatology and Clinical Immunology, Poznañ University of Medical Sciences, Poznan, Poland, 8Department of Internal Diseases, Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine, 9Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckigo, Wroclaw, Poland, 10Medical Centre for Rheumatology Berlin-Buch, Immanuel Krankenhaus Berlin, Berlin, Germany, 11QUALICLINIC Kft., Budapest, Hungary, 12Orto clinic Ltd., Riga, Latvia, 13Ternopil State Medical University, Ternopil, Ukraine, 14Rheumatology and Connective Tissue Diseases, Medical University of Lublin, Poland, Lublin, Poland, 15Internal Medicine/Rheumatology, Inha University Hospital, Incheon, South Korea, 16Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea, The Republic of, 17Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 18Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, 19Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, 20CELLTRION, Inc., Incheon, South Korea

    Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Result from Phase 3…
  • Abstract Number: 1635 • 2016 ACR/ARHP Annual Meeting

    Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks

    Dae-Hyun Yoo1, Ljubinka Bozic Majstorovic2, Alfredo Berrocal Kasay3, Elias Chalouhi El-Khouri4, Fedra Irazoque-Palazuelos5, Francisco Cons Molina6, Pedro Miranda7, Pavel Shesternya8, Francisco G. Medina-Rodriguez9, Piotr Wiland10, Slawomir Jeka11, Olena Garmish12, Pawel Hrycaj13, Dmytro Rekalov14, Natalia Fomina15, Devy Zisman16, Yong-Beom Park17, Young Mo Kang18, Chang-Hee Suh19, Seung Cheol Shim20, Sang Joon Lee21, Sung Young Lee22 and Won Park23, 1Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 2Clinical Centre Banja Luka, Bonja Luka, Bosnia and Herzegovina, 3ABK Reuma SRL – Medicentro Biociencias, Lima, Peru, 4Clinica Internacional, Lima, Peru, 5Centro de Invstigacion y Tratamiento Reumatologico S.C, Mexico City, Mexico, 6Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, 7Centro De Estudios Reumatológicos, Santiago, Chile, 8State Budgetary Educational Institution of High Professional Education "Krasnoyarsk state medical university n.a. professor V.F.Voino-Yasenetsky" Ministry of Health of Russian Federation, Krasnoyarsk, Russian Federation, 9Biologics Especializados SA, Mexico City, Mexico, 10Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckigo, Wroclaw, Poland, 11Department of Rheumatology and Connective Tissue Diseases, 2nd University Hospital, CM UMK, Bydgoszcz, Poland, 12Institute of Cardiology named by M.D. Strazhesko NAMS of Ukraine, Kyiv, Ukraine, 13Rheumatology and Clinical Immunology, Poznañ University of Medical Sciences, Poznan, Poland, 14Department of Internal Diseases, Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine, 15Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation, 16The Lady Davis, Haifa, Israel, 17Dept of Internal Medicine, Severance Hospital, Seoul, Korea, The Republic of, 18Division of Rheumatology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea, Republic of, 19Department of Rheumatology, Ajou University School of Medicine, Suwon, Korea, The Republic of, 20Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, 21CELLTRION, Inc., Incheon, South Korea, 22Clinical Planning Department, CELLTRION, Inc., Incheon, South Korea, 23Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea

    Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Result from Phase 3 Randomized Controlled Trial over 24…
  • Abstract Number: 1645 • 2016 ACR/ARHP Annual Meeting

    Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of ASP5094, an Anti-Alpha-9-Integrin Monoclonal Antibody, Following Single Intravenous Doses in Healthy Subjects

    Tianli Wang1, Christopher Lademacher2, Paul Blahunka2, Corrie Howieson2, Txheng Yang2, Tomasz Wojtkowski2, Mina Kikuchi2 and Robert Townsend2, 1Clinical Pharmacology and Exploratory Development, Astellas Pharma Global Development, Inc., Northbrook, IL, 2Astellas Pharma Global Development, Inc., Northbrook, IL

    Background/Purpose:  ASP5094 is a recombinant humanized anti-alpha-9 integrin IgG1 monoclonal antibody (mAb) under development for the treatment of rheumatoid arthritis. This first-in-human placebo‑controlled single ascending‑dose…
  • Abstract Number: 570 • 2015 ACR/ARHP Annual Meeting

    Dose Selection of Namilumab, an Anti-GM-CSF Monoclonal Antibody: An Integrated Pharmacokinetic and Pharmacodynamic Approach for Phase II Studies in Patients with Rheumatoid Arthritis

    Thomas Wagner1, Ulrich Thienel2, Eva-Maria Vieser3, Bernard Souberbielle4 and Gezim Lahu1, 1Takeda Pharmaceuticals, Zurich, Switzerland, 2Takeda Pharmaceuticals, Deerfield, IL, 3AMGEN Research (Munich) GmbH, Munich, Germany, 4Takeda Pharmaceuticals, London, United Kingdom

    Background/Purpose: Granulocyte macrophage-colony stimulating factor (GM-CSF) mediates a range of immunological and inflammatory processes, and plays a role in a variety of inflammatory diseases. Namilumab…
  • Abstract Number: 972 • 2015 ACR/ARHP Annual Meeting

    A Phase 2b Study Evaluating the Efficacy and Safety of Subcutaneously Administered Tregalizumab in Subjects with Active Rheumatoid Arthritis (RA) Despite Treatment with Methotrexate (MTX)

    Ronald F. van Vollenhoven1, Edward C. Keystone2, Vibeke Strand3, Cesar Pacheco-Tena4, Jiri Vencovsky5, Frank Behrens6, Daniela Zipp7, Faiza Rharbaoui8, Ralf Wolter9, Rolf-Dietrich Tiemann10, Luise Knierim11, Rainer Schmeidl11, Xuefei Zhou12, Silke Aigner8,13, Benjamin Daelken14 and Andrea Wartenberg-Demand8,12, 1Department of Medicine, Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), The Karolinska Institute, Stockholm, Sweden, 2Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, 3Biopharmaceutical Consultant, Portola Valley, CA, 4Universidad Autónoma de Chihuahua, Chihuahua, Mexico, 5Institute of Rheumatology, Prague, Czech Republic, 6CIRI/Rheumatology & Fraunhofer TMP, Goethe University, Frankfurt, Germany, 7Landseinerstr 5, Biotest AG, Dreieich, Germany, 8Biotest AG, Dreieich, Germany, 9Corporate Clinical Research, L, Biotest AG, Dreieich, Germany, 10Data Management and Outsourcing, Biotest AG, Dreieich, Germany, 11Cooperate Drug Safety, Biotest AG, Dreieich, Germany, 12Cooperate Clinical Research, Biotest AG, Dreieich, Germany, 13Landsteinerstrasse 5, Biotest AG, Dreieich, Germany, 14Project Managerment Office, Biotest Pharmaceuticals Corporation, Boca Raton, FL

    Background/Purpose: In autoimmune diseases reduced numbers and functional impairment of regulatory T cells (Tregs) have been observed (1). Tregalizumab (BT-061) is a humanized, anti-CD4 mAb,…
  • Abstract Number: 1112 • 2015 ACR/ARHP Annual Meeting

    Obinutuzumab Outperforms Rituximab at Inducing B-Cell Cytotoxicity in Vitro through Fc-Mediated Effector Mechanisms in Rheumatoid Arthritis and Systemic Lupus Erythematosus

    Venkat Reddy1, Christian Klein2, David A. Isenberg3, Geraldine Cambridge4, Martin Glennie5, Mark Cragg6 and Maria J. Leandro1, 1Rheumatology, University College London, London, United Kingdom, 2Roche Pharmaceutical Research & Early Development Oncology Discovery & Translational Area, Roche Glycart AG, Schlieren, Switzerland, 3Centre for Rheumatology, Division of Medicine, University College London, London, United Kingdom, 4Rheumatology, Centre for Rheumatology and Bloomsbury Rheumatology Unit, University College London, London, United Kingdom, 5Antibody and Vaccine group, Southampton University, Southampton, United Kingdom, 6Antibody and Vaccine group, Cancer Sciences Unit, Faculty of Medicine, Southampton University, Southampton, United Kingdom

    Background/Purpose: Obinutuzumab (OBZ, a Type II anti-CD20 monoclonal antibody [mAb] with afucosylated Fc portion and enhanced affinity for Fcγ receptor III) is more efficient than…
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