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…

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 CT on October 25. 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].