ACR Meeting Abstracts

ACR Meeting Abstracts

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Abstracts tagged "pharmacokinetics and safety"

  • Abstract Number: 1371 • 2018 ACR/ARHP Annual Meeting

    Systemic Exposure of Triamcinolone Acetonide Following Bilateral Injection of Extended-Release Triamcinolone Acetonide and Standard Triamcinolone in Patients with Bilateral Knee Osteoarthritis

    Alan J. Kivitz1, Louis Kwong2, Tammi Shlotzhauer3, Joelle Lufkin4, Teresa Curto5 and Scott Kelley4, 1Altoona Center for Clinical Research, Duncansville, PA, 2Department of Orthopaedic Surgery, Harbor-UCLA Medical Center, Torrance, CA, 3Rochester Clinical Research, Inc., Rochester, NY, 4Flexion Therapeutics, Inc., Burlington, MA, 5Cytel Inc., Waltham, MA

    Background/Purpose: Current ACR guidelines recommend the use of IACS for short-term acute pain relief in patients (pts) with knee OA.1 Bilateral knee OA can occur…
  • Abstract Number: 544 • 2017 ACR/ARHP Annual Meeting

    Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF-06650833, a Novel, Potentially First-in-Class Inhibitor of Interleukin-1 Receptor Associated Kinase-4 (IRAK-4) in Healthy Subjects

    Spencer Danto1, Negin Shojaee1, Cheryl Li1, Steven A. Gilbert2, Ravi Shankar Singh1, Zorayr Manukyan1 and Iain Kilty1, 1Worldwide Research and Development, Pfizer, Inc., Cambridge, MA, 2Pfizer, Inc., Cambridge, MA

    Background/Purpose: IRAK‑4 is a key node in innate immune signaling and is activated by the interleukin (IL)‑1 family receptors (IL‑1R, IL‑18R, and IL‑33R), in addition…
  • 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: 638 • 2016 ACR/ARHP Annual Meeting

    A Randomized, Open-Label, Single-Dose, Parallel-Group Trial to Determine the Pharmacokinetics, Safety and Immunogenicity of GP2017, a Proposed Adalimumab Biosimilar, Following a Single Subcutaneous Injection By an Autoinjector or Prefilled Syringe in Healthy Male Subjects

    Ellen Schuck1, Julia Jauch1, Alison Balfour1, Jennifer Storck1, Martin Rieger1, Paul Martin1, Andrej Skerjanec1 and Maria Velinova2, 1Hexal AG, Holzkirchen, Germany, 2PRA Health Sciences, Zuidlaren, Netherlands

    Background/Purpose:  The purpose of this study was to describe the pharmacokinetics (PK), safety and immunogenicity of GP2017, a proposed adalimumab biosimilar, administered as a single…
  • Abstract Number: 947 • 2016 ACR/ARHP Annual Meeting

    A Multi-Center, Open-Label Study to Assess the Pharmacokinetics, Efficacy and Safety of Certolizumab Pegol in Children and Adolescents with Moderately to Severely Active Polyarticular-Course Juvenile Idiopathic Arthritis: Week 24 Results

    Hermine I. Brunner1, Nicolino Ruperto2, Vladimir Keltsev3, Ekaterina Alexeeva4, Carlos Abud-Mendoza5, Heinrike Schmeling6, María del Rocío Maldonado-Velázquez7, Nadina Rubio-Pérez8, Marina Stanislav9, Vyacheslav Chasnyk10, Diane Brown11, Michael Henrickson1, Daniel Kingsbury12, C. Egla Rabinovich13, Andrew Zeft14, Earl Silverman15, Maggie Wang16, Philippa Charlton16, Rocio Lledo-Garcia17, Laura Shaughnessy16, Daniel J. Lovell1 and Alberto Martini2, 1PRCSG, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 2PRINTO, Istituto Gaslini, Genoa, Italy, 3Togliatti City Clinical Hospital №5, Togliatti, Russian Federation, 4Children's Health of RAMS and IM Sechenov First Moscow State Medical University, Moscow, Russian Federation, 5Hospital Central & Facultad de Medicina, Universidad Autónoma de San Luis Potosí, San Luis Potosí, Mexico, 6Alberta Children's Hospital, University of Calgary, Calgary, AB, Canada, 7Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico, 8Universidad Autónoma de Nuevo León, Nuevo León, Mexico, 9Research Rheumatology Institute V.A. Nassonova, Moscow, Russia, 10St Petersburg State Pediatric Medical Academy, St Petersburg, Russian Federation, 11Division of Rheumatology, Children's Hospital of Los Angeles and University of Southern California, Los Angeles, CA, 12Pediatric Rheumatology, Randall Children's Hospital at Legacy Emanuel, Portland, OR, 13Duke University Medical Center, Durham, NC, 14Cleveland Clinic, Pediatric Rheumatology, Cleveland, OH, 15Hospital for Sick Children, Toronto, ON, Canada, 16UCB Pharma, Raleigh, NC, 17UCB Pharma, Slough, United Kingdom

    Background/Purpose: Juvenile idiopathic arthritis (JIA) often requires biologic medication to control polyarticular disease courses. This study assesses the pharmacokinetics (PK), efficacy and safety of certolizumab…
  • 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: 2754 • 2015 ACR/ARHP Annual Meeting

    Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics of BI 655064, an Antagonistic Anti-CD40 Antibody Following Single-Dose Administration in Chinese and Japanese Healthy Volunteers

    Jiyoon Kim1, Yasuhiro Tsuda2, Kazuhiko Yamamoto3, Ralf Thiedmann4, Corinna Schoelch4, Stephen Norris5, Steven Padula6, Juergen Steffgen4 and In-Jin Jang7, 1Boehringer Ingelheim Korea Ltd., Seoul, South Korea, 2Clinical PK/PD department, Nippon Boehringer-Ingelheim.Co.,Ltd., Kobe, Japan, 3Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan, 4Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, 5Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, 6Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany, 7Seoul National University Hospital, Seoul, South Korea

    Background/Purpose: The CD40-CD40L pathway may play a major role in autoimmune disorders like rheumatoid arthritis or SLE. Blocking this pathway may be a promising new…
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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.).

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