Abstracts tagged "clinical trials"

Abstract Number: 2730 • 2015 ACR/ARHP Annual Meeting
Patient-Reported Outcomes from a Phase 3 Study of Baricitinib in Patients with Rheumatoid Arthritis with Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs
Paul Emery¹, Carol L. Gaich², Amy M. DeLozier³, Stephanie de Bono^2,4, Jiajun Liu², Cecile Chang² and Maxime Dougados⁵, ¹Division of Rheumatic and Musculoskeletal Disease, University of Leeds, Leeds Institute of Molecular Medicine and LMBRU, Leeds, United Kingdom, ²Eli Lilly and Company, Indianapolis, IN, ³Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, ⁴Eli Lilly and Company, Cookham, United Kingdom, ⁵Paris-Descartes University, Paris, France
Background/Purpose: Baricitinib (bari) is an oral Janus kinase (JAK) 1 /JAK2 selective inhibitor, representing a potentially effective treatment for patients with moderately to severely active rheumatoid…
Abstract Number: 3079 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Riociguat in Patients with Pulmonary Arterial Hypertension (PAH) Associated with Connective Tissue Disease (CTD)
Christopher P. Denton¹, J. Gerry Coghlan², Hossein-Ardeschir Ghofrani³, Friedrich Grimminger³, Jianguo He⁴, Gabriela Riemekasten⁵, Dario Vizza⁶, Annette Boeckenhoff⁷, Christian Meier⁸, Janethe de Oliveira Pena⁹ and Marc Humbert¹⁰, ¹Centre for Rheumatology and Connective Tissue Disease, UCL Medical School Royal Free Campus, London, United Kingdom, ²Royal Free London NHS Foundation Trust, London, England, ³University of Giessen and Marburg Lung Center, Giessen, Germany, ⁴Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, ⁵Clinic of Rheumatology and Clinical Immunology, Berlin, Germany, ⁶La Sapienza University of Rome, Rome, Italy, ⁷Bayer Pharma AG, Wuppertal, Germany, ⁸Bayer Pharma AG, Berlin, Germany, ⁹Bayer HealthCare Pharma, Whippany, NJ, ¹⁰Université Paris-Sud, Laboratoire d’Excellence en Recherche sur le Médicament et Innovation Thérapeutique, and INSERM Unité 999, Le Kremlin–Bicêtre, France
Background/Purpose: PAH associated with CTD (PAH-CTD) has a worse prognosis than idiopathic/familial PAH. Here we report a prospective subgroup analysis of patients with PAH-CTD from…
Abstract Number: 851 • 2015 ACR/ARHP Annual Meeting
Does the Clinical Context Improve the Reliability of Rheumatologists Grading Digital Ulcers in Systemic Sclerosis?
Michael Hughes¹, Chris Roberts², Andrew Tracey¹, Graham Dinsdale¹, Andrea Murray¹ and Ariane L. Herrick¹, ¹Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom, ²Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester, United Kingdom
Background/Purpose: Digital ulcers (DUs) are often a primary end point in SSc clinical trials, although the reliability of rheumatologists grading DUs is poor to moderate…
Abstract Number: 1047 • 2015 ACR/ARHP Annual Meeting
Characterization of Changes in Lymphocyte Subsets in Baricitinib-Treated Patients with Rheumatoid Arthritis in Two Phase 3 Studies
Paul Emery¹, Iain McInnes², Mark C. Genovese³, Josef S. Smolen⁴, Joel Kremer⁵, Maxime Dougados⁶, Douglas E. Schlichting⁷, Terence Rooney⁷, Maher Issa⁷, Stephanie de Bono⁷, William L. Macias⁷, Veronica Rogai⁷, Steven H. Zuckerman⁷ and Peter C. Taylor⁸, ¹Division of Rheumatic and Musculoskeletal Disease, University of Leeds, Leeds, United Kingdom, ²Glasgow Biomedical Research Centre, Glasgow, United Kingdom, ³Division of Rheumatology, Stanford University Medical Center, Palo Alto, CA, ⁴Department of Rheumatology, Medical University of Vienna, Vienna, Austria, ⁵Albany Medical College, Albany, NY, ⁶Paris-Descartes University, Paris, France, ⁷Eli Lilly and Company, Indianapolis, IN, ⁸Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford Botnar Research Centre, Oxford, United Kingdom
Background/Purpose: Baricitinib (bari) is an oral, reversible inhibitor of Janus kinase (JAK)1/JAK2 being developed as QD treatment for patients (pts) with RA. In phase (ph)…
Abstract Number: 1048 • 2015 ACR/ARHP Annual Meeting
Filgotinib (GLPG0634), an Oral JAK1 Selective Inhibitor Is Effective in Combination with Methotrexate in Patients with Active Rheumatoid Arthritis: Results from a Phase 2B Dose Ranging Study
R Westhovens¹, Rieke Alten², Dace Pavlova³, Favio Enríquez-Sosa⁴, Minodora Mazur⁵, Maria Greenwald⁶, Annegret Van der Aa⁷, Frédéric Vanhoutte⁷, Chantal Tasset⁷ and Pille Harrison⁷, ¹Skeletal Biology and Engineering Research Center, Department of Development and Regeneration, KU Leuven, Leuven, Belgium, KU Leuven, Leuven, Belgium, ²Internal Medicine, Rheumatology & Clinical Immunology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany, ³LTD M & M Centrs, Carnikava, Latvia, ⁴CLINSTILE, S.A. DE C.V, Mexico, Mexico, ⁵IMSP Institul de Cardiologie, Chisinau, Moldova, ⁶Desert Medical Advances, Palm Desert, CA, ⁷Galapagos NV, Mechelen, Belgium
Background/Purpose: Filgotinib (GLPG0634) is a novel oral, potent and selective JAK1 inhibitor that has previously demonstrated efficacy in combination with methotrexate (MTX) in treating rheumatoid…
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: 2503 • 2014 ACR/ARHP Annual Meeting
Early Response to Full-Dose Etanercept-Plus-Methotrexate Induction Therapy Predicts Sustained Remission with Reduced-Dose Combination Therapy in Early Rheumatoid Arthritis Patients
Paul Emery¹, Ronald Pedersen², Jack Bukowski³ and Lisa Marshall⁴, ¹NIHR-Leeds Musculoskeletal Biomedical Research Unit and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds., United Kingdom, Leeds, United Kingdom, ²Specialty Care, Pfizer Inc, Collegeville, PA, ³Department of Specialty Care, Pfizer Inc, Collegeville, PA, ⁴Inflammation Immunology Disease Group, Pfizer Inc., Collegeville, PA
Background/Purpose: In early rheumatoid arthritis (RA), achievement of clinical remission and low disease activity (LDA) limits joint damage and disability.1 Anti-TNF agents are effective in…
Abstract Number: 891 • 2014 ACR/ARHP Annual Meeting
Randomized Clinical Trial of Group Vs. Individual Physical Therapy for Knee Osteoarthritis
Kelli D. Allen¹, Dennis Bongiorni², Hayden B. Bosworth³, Cynthia Coffman³, Santanu Datta⁴, David Edelman³, Jennifer H. Lindquist⁵, Eugene Oddone³ and Helen Hoenig⁶, ¹Health Services Research, Durham VA Medical Center and University of North Carolina at Chapel Hill, Durham, NC, ²Durham VA Medical Center, Durham, NC, ³Health Services Research, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁴Health Services Reserach, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁵Health Services Research, Durham VA Medical Center, Durham, NC, ⁶Durham VA Medical Center and Duke University Medical Center, Durham, NC
Background/Purpose: Physical therapy (PT) is a key component of treatment for knee osteoarthritis (OA). There is a high demand for PT services in many healthcare…

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