Abstracts tagged "clinical trials"

Abstract Number: 2313 • 2015 ACR/ARHP Annual Meeting
Responder Rates and Numbers Needed to Treat Based on Clinically Meaningful Improvements in Patient Reported Outcomes (PROs) Including Health-Related Quality of Life (HRQoL) after Sarilumab Treatment during a Phase III Randomized Controlled Trial (RCT)
Vibeke Strand¹, Regina Rendas-Baum², George J. Joseph³, Chieh-I Chen⁴, Hubert van Hoogstraten⁵, T. W. J. Huizinga⁶ and Mark C. Genovese⁷, ¹Biopharmaceutical Consultant, Portola Valley, CA, ²QualityMetric Inc, Lincoln, RI, ³Global Health Economics & Outcomes Research (HEOR), Sanofi, Bridgewater, NJ, ⁴Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁵Sanofi, Bridgewater, NJ, ⁶Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁷Division of Rheumatology, Stanford University Medical Center, Palo Alto, CA
Background/Purpose: Sarilumab is a human monoclonal antibody (mAb) directed against the soluble IL-6 receptor (sIL-6R), administered subcutaneously (SC) every 2 weeks (q2w). In the phase…
Abstract Number: 2363 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Adrenocorticotropic Hormone Gel (Acthar Gel ®) in Refractory Dermatomyositis or Polymyositis
Rohit Aggarwal¹, Galina Marder², Priyadarshini Loganathan³, Diane Koontz⁴, Preeya Nandkumar⁵, Zengbiao Qi⁶ and Chester V. Oddis⁷, ¹Rheumtology, University of Pittsburgh Medical Center, Pittsburgh, PA, ²Medicine, North Shore Long Island Health System, Great Neck, NY, ³University of Pittsburgh Medical Center, Pittsburgh, PA, ⁴University of Pittsburgh, Pittsburgh, PA, ⁵North Shore Long Island Health System, Great Neck, NY, ⁶Division of Rheumatology, University of Pittsburgh, Pittsburgh, PA, ⁷Rheum/Clinical Immunology, University of Pittsburgh, Pittsburgh, PA
Background/Purpose: Adrenocorticotropic hormone (ACTH) gel (repository corticotropin injection) is a long-acting full sequence ACTH that may include other pro-opiomelanocortin peptides thought to have anti-inflammatory and…
Abstract Number: 2727 • 2015 ACR/ARHP Annual Meeting
BI 695501, a Proposed Biosimilar for Adalimumab, Shows Bioequivalence to Adalimumab Reference Products in a Randomized, Double-Blind Phase I Trial in Healthy Subjects
Christopher Wynne¹, Magdalena Petkova², Ferdinand Rombout³, Niklas Czeloth³, Mario Altendorfer³, Benjamin Lang⁴, Francois-Xavier Frapaise³ and Rod Ellis-Pegler⁵, ¹Christchurch Clinical Studies Trust, Christchurch, New Zealand, ²SGS, CPU Antwerpen, Antwerp, Belgium, ³Boehringer Ingelheim, Ingelheim, Germany, ⁴Boehringer Ingelheim, Biberach an der Riss, Germany, ⁵Auckland Clinical Studies Limited, Auckland, New Zealand
Background/Purpose: BI 695501 is a proposed adalimumab biosimilar currently in development and was evaluated for pharmacokinetic (PK) similarity to both US-licensed and EU-approved reference products.…
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: 2231 • 2014 ACR/ARHP Annual Meeting
Combined Chondroitin Sulfate and Glucosamine Is Comparable to Celecoxib for Painful Knee Osteoarthritis. Results from a Multicenter, Randomized, Double-Blind, PHASE IV NON-Inferiority TRIAL
Marc Hochberg¹, Johanne Martel-Pelletier², Jordi Monfort³, Ingrid Moller⁴, Juan Ramon Castillo⁵, Nigel K. Arden^6,7,8, Francis Berenbaum^9,10, Jean-Pierre Pelletier¹¹, Francisco J. Blanco¹², Philip G. Conaghan¹³, Yves Henrotin^14,15, Thomas Pap¹⁶, Pascal Richette^17,18,19, Allen Sawitzke²⁰, Patrick du Souich²¹ and Moves Investigation Group²², ¹University of Maryland School of Medicine, Baltimore, MD, ²Osteoarthritis Research Unit CR-CHUM, Notre-Dame Hospital 1560 Sherbrooke St East, Montreal, QC, Canada, ³Department of Rheumatology, Grup de recerca cel•lular en inflamació i cartílag. IMIM (Institut de Recerca Hospital del Mar), Barcelona, Spain, ⁴Instituto Poal, Barcelona, Spain, ⁵Head of Clinical Pharmacology Unit Hospital Universitario Virgen del Rocío, Sevilla, Spain;, Sevilla, Spain, ⁶NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, United Kingdom, ⁷Arthritis Research UK (ARUK), Center for Sports, Exercise and Osteoarthritis, University of Oxford, Nuffield Orthopaedic Centre, Oxford, United Kingdom, ⁸MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, United Kingdom, ⁹Sorbonne University, INSERM UMR S938, UPMC, University of Paris 06, DHU i2B, Paris, France, ¹⁰Department of Rheumatology, Assistance Publique – Hôpitaux de Paris, Saint-Antoine Hospital, Paris, France, ¹¹Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, QC, Canada, ¹²Rheumatology Service, INIBIC-Hospital Universitario A Coruña, A Coruña, Spain, ¹³University of Leeds, Leeds, United Kingdom, ¹⁴Physical Therapy and Rehabilitation Department, Princess Paola Hospital, Marche-en-Famenne, Belgium, ¹⁵Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, Institute of Pathology, CHU Sart-Tilman, Liege, Belgium, ¹⁶Institute of Experimental Muskuloskeletal Medicine University Hospital Münster, Münster, Germany, ¹⁷Université Paris Diderot, UFR médicale, Paris, France, ¹⁸INSERM 1132, Université Paris-Diderot, Hôpital Lariboisière, Paris, France, ¹⁹2 Rue Ambroise Pare, Hopital Lariboisiere, Paris, France, ²⁰Rheumatology, University of Utah Medical Center, Salt Lake City, UT, ²¹Department of Pharmacology, Faculty of Medicine, University of Montreal, Montreal, QC, Canada, ²²Spain, Germany, France and Poland, Barcelona, Spain
Background/Purpose The Multicentre Osteoarthritis interVEntion trial with Sysadoa (MOVES) compared efficacy and safety of Chondroitin sulfate (CS) and Glucosamine Hydrochloride (GH) with that of Celecoxib…
Abstract Number: 254 • 2014 ACR/ARHP Annual Meeting
The Effect of Milnacipran on Pain in Rheumatoid Arthritis Patients with Widespread Pain: a Randomized Blinded Crossover Trial
Yvonne C. Lee¹, Elena Massarotti², Robert R. Edwards³, Bing Lu⁴, Chih-Chin Liu⁵, Yuanyu Lo⁴, Alyssa Wohlfahrt⁴, Nancy Kim⁶, Daniel J. Clauw⁷ and Daniel H. Solomon⁸, ¹Department of Medicine, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ²Rheumatology/PBB-3, Brigham & Women's Hosp, Boston, MA, ³Anesthesiology, Brigham & Womens Hospital, Chestnut Hill, MA, ⁴Brigham and Women's Hospital, Boston, MA, ⁵Rheumatology & Immunology, Brigham & Women's Hospital, Boston, MA, ⁶Div of Rheumatology, Massachusetts General Hospital, Charlestown, MA, ⁷Anesthesiology/Internal Medicine (Rheum), University of Michigan, Ann Arbor, MI, ⁸Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA
Background/Purpose: Clinical trials have shown that serotonin norepinephrine reuptake inhibitors, such as milnacipran, decrease pain in chronic non-inflammatory pain conditions like fibromyalgia and osteoarthritis. We…
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…

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