Abstracts tagged "clinical trials"

Abstract Number: 2244 • 2014 ACR/ARHP Annual Meeting
Multimedia Patient Education Tool for Patients with Osteoarthritis
Aparna Ingleshwar¹, Maria A. Lopez-Olivo², Robert Volk¹, Andrea Barbo³, Maria Jibaja-Weiss⁴, Heather Lin⁵ and Maria E. Suarez-Almazor⁶, ¹General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ²Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁴Office of Outreach and Health Disparities, Baylor College of Medicine, Houston, TX, ⁵Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁶The Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX
Background/Purpose: The use of video modelling in patient education can result in positive patient outcomes including informed decision-making and improved self-management. The purpose of our…
Abstract Number: 2080 • 2014 ACR/ARHP Annual Meeting
Carryover Effects in Crossover Design Studies in Fibromyalgia and Other Pain Conditions
Lynne Pauer¹, Birol Emir², Ed Whalen³, Joseph Scavone⁴ and Andrew Clair², ¹445 Eastern Point Road, Pfizer Inc, Groton, CT, ²Pfizer Inc, New York, NY, ³Pfizer Inc., New York, NY, ⁴Pfizer Inc, Groton, CT
Background/Purpose: Explore carryover effects and their influence on crossover and randomized withdrawal design (RWD) studies.Methods: We examine pregabalin crossover and RWD studies in fibromyalgia (FM),…
Abstract Number: 2005 • 2014 ACR/ARHP Annual Meeting
Multimedia Patient Education Tool for Patients with Osteoporosis
Maria A. Lopez-Olivo¹, Aparna Ingleshwar², Robert Volk², Andrea Barbo³, Maria Jibaja-Weiss⁴, Heather Lin⁵ and Maria E. Suarez-Almazor⁶, ¹Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ²General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁴Office of Outreach and Health Disparities, Baylor College of Medicine, Houston, TX, ⁵Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁶The Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX
Background/Purpose: Patient education materials incorporating video modelling can be effective in improving patients’ outcomes. We conducted a randomized control trial to test the efficacy of…
Abstract Number: 1891 • 2014 ACR/ARHP Annual Meeting
Early MRI Endpoints Provide a Valid Measure of Structural Damage While Reducing Study Duration and Participant Numbers in Rheumatoid Arthritis Clinical Trials
Joshua Baker¹, Philip G. Conaghan², Paul Emery³, Daniel Baker⁴ and Mikkel Østergaard⁵, ¹Medicine/Rheumatology, Philadelphia VA Medical Center, Philadelphia, PA, ²University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, United Kingdom, ³NIHR-Leeds Musculoskeletal Biomedical Research Unit and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁴Janseen R&D, Spring House, PA, ⁵Copenhagen Center for Arthritis Research, Copenhagen University Hospital at Glostrup, Glostrup, Denmark
Background/Purpose We used data from a large randomized controlled clinical trial of an effective biologic (golimumab, GO-BEFORE study) to compare the associations of disease activity…
Abstract Number: 1863 • 2014 ACR/ARHP Annual Meeting
CCX168, an Orally Administered C5aR Inhibitor for Treatment of Patients with Antineutrophil Cytoplasmic Antibody-Associated Vasculitis
Pirow Bekker¹, David Jayne², Annette Bruchfeld³, Matthias Schaier⁴, Kazimierz Ciechanowski⁵, Lorraine Harper⁶, Michel Jadoul⁷, Mårten Segelmark⁸, Daina Selga⁹, Istvan Szombati¹⁰, Michael Venning¹¹, Christian Hugo¹², Paul L. van Daele¹³, Ondrej Viklicky¹⁴, Antonia Potarca¹⁵ and Thomas J. Schall¹⁵, ¹Medical & Clinical Affairs, Chemocentryx, Inc., Mountain View, CA, ²Vasculitis and Lupus Clinic, Addenbrookes Hospital University of Cambridge, Cambridge, United Kingdom, ³Karolinska Institute, Stockholm, Sweden, ⁴University of Heidelberg, Heidelberg, Germany, ⁵Pomeranian Medical University, Szczecin, Poland, ⁶Nephrology, University of Birmingham, Birmingham, United Kingdom, ⁷Cliniques Saint-Luc, Brussels, Belgium, ⁸Nephrology, Linkobing University, Linkoping University, Linkoping, Sweden, ⁹Lund University, Lund, Sweden, ¹⁰Budaclinic, Budapest, Hungary, ¹¹Manchester University, Manchester, United Kingdom, ¹²Dresden University, Dresden, Germany, ¹³Erasmus Medical Center, Immunology, Rotterdam, Netherlands, ¹⁴Instit of Clin and Exp Med, Prague, Czech Republic, ¹⁵ChemoCentryx, Inc., Mountain View, CA
Background/Purpose: CCX168 is a potent, specific C5aR inhibitor in clinical development for ANCA-associated vasculitis. The initial focus of this randomized, double-blind, placebo-controlled clinical trial was…
Abstract Number: 1557 • 2014 ACR/ARHP Annual Meeting
Clinical Response in Subjects with Psoriatic Arthritis Following One Year of Treatment with Brodalumab, an Anti-Interleukin-17 Receptor Antibody
Mark C Genovese¹, Philip J. Mease², Maria W. Greenwald³, Christopher T. Ritchlin⁴, A Beaulieu⁵, Atul A. Deodhar⁶, Richard Newmark⁷, JingYuan Feng⁸, Ngozi Erondu⁹ and Ajay Nirula¹⁰, ¹Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, CA, ²Swedish Medical Center and University of Washington, Seattle, WA, ³Desert Medical Advances, Palm Desert, CA, ⁴Allergy Immunology & Rheumatology, University of Rochester Medical Center, Rochester, NY, ⁵Bureau 360, Centre de Rhumatologie, St-Louis, QC, Canada, ⁶Oregon Health and Sciences University, Portland, OR, ⁷Clinical Affairs, Amgen, Thousand Oaks, CA, ⁸Amgen Inc, Thousand Oaks, CA, ⁹Inflammation, Amgen, Inc., Thousand Oaks, CA, ¹⁰Amgen, Thousand Oaks, CA
Background/Purpose: Interleukin-17 (IL-17) plays a role in the pathogenesis of psoriatic disease of both skin and joint. We sought to assess long-term efficacy and safety…
Abstract Number: 1509 • 2014 ACR/ARHP Annual Meeting
A Randomized, Double-Blind, Three-Arm, Parallel Group, Single-Dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of Three Formulations of Infliximab (CT-P13, EU-sourced Infliximab and US-sourced Infliximab) in Healthy Volunteers
Dae-Hyun Yoo¹, Won Park², Seung-Cheol Shim³, Chang-Hee Suh⁴, Jihye Yun⁵ and Tina Pyo⁵, ¹Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ²Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, ³Chungnam National University Hospital, Daejeon, South Korea, ⁴Allergy-Rheumatology, Ajou University Hospital, Suwon, South Korea, ⁵CELLTRION, Inc, Incheon, South Korea
Background/Purpose CT-P13 has been approved as the first biosimilar to innovator infliximab sourced from European Union (EU‑INX) in Sep 2013. Even if it has been…
Abstract Number: 1522 • 2014 ACR/ARHP Annual Meeting
Impact of Sarilumab on Health Related Quality of Life (HRQoL), Fatigue, and Sleep in Rheumatoid Arthritis Patients at Week 24 – Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study
Vibeke Strand¹, George Joseph², Hubert van Hoogstraten², Chieh-I Chen³, Chungpeng Fan², Paulo Carita⁴, Neil Graham³, Tanya Momtahen² and Mark C Genovese⁵, ¹Biopharmaceutical Consultant, Portola Valley, CA, ²Sanofi, Bridgewater, NJ, ³Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁴Sanofi, Chilly-Mazarin, France, ⁵Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, CA
Background/Purpose: Sarilumab, a fully human monoclonal antibody directed against the IL-6 receptor, demonstrated efficacy in the phase 3 part of the RA-MOBILITY study (NCT01061736) in…
Abstract Number: 1487 • 2014 ACR/ARHP Annual Meeting
A Phase 1 Dose-Ranging Repeated-Dose Trial of Parenteral Staphylococcal Protein A (PRTX-100) in Patients with Active Rheumatoid Arthritis on Methotrexate or Leflunamide Therapy
Craig Wiesenhutter^1,2, Rakesh Patel³, John Lavery⁴, Nighat Tahir^5,6, Lydie Hazan⁷, Alan Kivitz⁸, Elizabeth Bretton⁹ and Jeffrey Kaine¹⁰, ¹University of Washington School of Medicine, Seattle, WA, ²Coeur d’Alene Arthritis Clinic, Coeur d’Alene, ID, ³PMG Research of Salisbury, Salisbury, NC, ⁴Allen Arthritis and Allergy, Allen, TX, ⁵Community Hospital of Anderson and Madison County, Inc., Anderson, IN, ⁶Community Rheumatology of Anderson, Anderson, IN, ⁷Axis Clinical Trials, Los Angeles, CA, ⁸Altoona Center for Clinical Research, Duncansville, PA, ⁹Albuquerque Clinical Trials, Albuquerque, NM, ¹⁰Sarasota Arthritis Center, Sarasota, FL
Background/Purpose Staphylococcal protein A (SpA) binds with high affinity to the Fc region of human immunoglobulin G and also to the Fab framework region of…
Abstract Number: 977 • 2014 ACR/ARHP Annual Meeting
Randomized Clinical Trial of a Patient and Provider Intervention for Managing Osteoarthritis in Veterans
Kelli D. Allen^1,2, Hayden B. Bosworth^3,4, Amy Jeffreys¹, Cynthia Coffman^3,5, Santanu Datta^4,6, Jennifer McDuffie^1,7, Eugene Oddone^3,4, Jennifer Strauss^1,8 and William S. Yancy Jr.^1,4, ¹Health Services Research, Durham VA Medical Center, Durham, NC, ²Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, ³Health Services Research, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁴Department of Medicine, Division of General Internal Medicine, Duke University Medical Center, Durham, NC, ⁵Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, ⁶Health Services Reserach, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁷Medicine, Duke University Medical Center, Durham, NC, ⁸Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC
Background/Purpose: Adequate management of osteoarthritis (OA) requires both medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and there is low…
Abstract Number: 950 • 2014 ACR/ARHP Annual Meeting
Multiple Mechanisms of Tolerance Characterize the Immune Response to Autologous Modified Dendritic Cells Exposed to Citrullinated Peptides in Patients with Rheumatoid Arthritis
Soi-Cheng Law¹, Hendrik Nel², Ahmed Mehdi², Kim-Anh Le Cao² and Ranjeny Thomas³, ¹Diamantina Institute, Univ of Queensland, Brisbane, Australia, ²Diamantina Institute, University of Queensland, Brisbane, Australia, ³Diamantina Institute, Univ of Queensland, Brisbane, QLD, Australia
Background/Purpose We carried out a phase I clinical trial of tolerising autologous peripheral blood DCs exposed to 4 citrullinated self-peptides (“Rheumavax”) in 29 HLA-DR shared…
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…

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