Abstracts tagged "clinical trials"

Abstract Number: 650 • 2016 ACR/ARHP Annual Meeting
ABT-122, a Tnf– and IL-17–Targeted Dual Variable Domain (DVD)–Ig™ in Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate: Results from a Phase 2 Trial
Mark C. Genovese¹, Michael Weinblatt², Jacob A Aelion³, Heikki T. Mansikka⁴, Paul M. Peloso⁴, Kun Chen⁴, Yihan Li⁴, Ahmed A. Othman⁴, Amit Khatri⁴, Nasser S. Khan⁴ and Robert J. Padley⁴, ¹Stanford University Medical Center, Palo Alto, CA, ²Brigham and Women’s Hospital, Boston, MA, ³West Tennessee Research Institute, Jackson, TN, ⁴AbbVie Inc., North Chicago, IL
Background/Purpose: Tumor necrosis factor (TNF) and interleukin 17 (IL-17) appear to independently contribute to the pathophysiology of rheumatoid arthritis (RA), synergistically inducing inflammatory mediators leading…
Abstract Number: 2222 • 2016 ACR/ARHP Annual Meeting
Tai Chi Is More Effective Than Aerobic Exercise in Treating Fibromyalgia: A Randomized Controlled Trial
Chenchen Wang¹, Christopher Schmid², Roger A. Fielding³, William F. Harvey¹, Lori Lyn Price⁴, Jeffrey B. Driban¹, Kieran Reid³, Robert A. Kalish⁵, Ramel Rones⁶ and Timothy E. McAlindon⁷, ¹Rheumatology, Tufts Medical Center, Boston, MA, ²Brown University School of Public Health, Providence, RI, ³Nutrition, Exercise Physiology and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, ⁴Clinical Care Research, Tufts Medical Center, Boston, MA, ⁵Div of Rheumatology, Tufts Medical Center, Boston, MA, ⁶Center for Mind–Body Therapies, Boston, MA, ⁷Division of Rheumatology, Tufts Medical Center, Boston, MA
Background/Purpose: Fibromyalgia is a complex disorder with strong psychological and pain components and is best managed with multidisciplinary therapies. Previous studies have suggested that Tai…
Abstract Number: 911 • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of Tocilizumab in Patients with Giant Cell Arteritis: Primary and Secondary Outcomes from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial
John H. Stone¹, Katie Tuckwell², Sophie Dimonaco², Micki Klearman³, Martin Aringer⁴, Daniel Blockmans⁵, Elisabeth Brouwer⁶, Maria C. Cid⁷, Bhaskar Dasgupta⁸, Juergen Rech⁹, Carlo Salvarani¹⁰, Robert F. Spiera¹¹, Sebastian H. Unizony¹, Neil Collinson² and the GiACTA Investigators, ¹Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, MA, ²Roche Products Ltd., Welwyn Garden City, United Kingdom, ³Genentech, South San Francisco, CA, ⁴Abteilung für Rheumatologie, Dresden, Germany, ⁵General Internal Medicine, University Hospitals Gasthuisberg, Leuven, Belgium, ⁶Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands, ⁷Vasculitis Research Unit. Department of Autoimmune Diseases, Hospital Clínic. University of Barcelona. IDIBAPS, Barcelona, Spain, ⁸Rheumatology, Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea, United Kingdom, ⁹Friedrich-Alexander-University Erlangen-Nürnberg, Universitätsklinikum Erlangen, Erlangen, Germany, ¹⁰Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy, ¹¹Hospital for Special Surgery, Cornell, New York, NY
Background/Purpose: The efficacy and safety of tocilizumab (TCZ), an IL-6 receptor-alpha inhibitor, was evaluated in patients with giant cell arteritis (GCA) in GiACTA, a randomized,…
Abstract Number: 2373 • 2016 ACR/ARHP Annual Meeting
Patient Preference for Display of Electronic Patient-Reported Outcomes in Osteoarthritis Clinical Trials: Wording Emphasis, Question Format, and Navigation Button Placement
Laura Khurana¹, Ellen Durand¹, Sarah Gary¹, Tony Otero¹, Chris Hall¹, Aisling Ryan², Christopher J. Evans² and Susan Dallabrida¹, ¹ERT, Boston, MA, ²Endpoint Outcomes, Boston, MA
Background/Purpose: Electronic patient-reported outcomes (ePROs) are a reliable method for collecting patient data in osteoarthritis clinical trials and offer many advantages over paper collection; however,…
Abstract Number: 14L • 2015 ACR/ARHP Annual Meeting
Safety and Efficacy of ABT-494, a Novel Selective JAK1 Inhibitor, in Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Anti-TNF Biologic Therapy
Joel M. Kremer¹, Edward C. Keystone², Paul Emery³, Heidi S. Camp⁴, Alan Friedman⁴, Li Wang⁴, Ahmed A. Othman⁴, Nasser Khan⁴ and Steven Jungerwirth⁴, ¹Albany Medical College, Albany, NY, ²Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ³NIHR-Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, United Kingdom, ⁴AbbVie Inc., North Chicago, IL
Background/Purpose: The safety, efficacy, and dose response of ABT-494, a novel selective JAK1 inhibitor, were characterized vs placebo (PBO) in patients (pts) with moderately to…
Abstract Number: 1782 • 2015 ACR/ARHP Annual Meeting
a Double-Blind, Randomized, Parallel-Group Study of Hydroxychloroquine on Cutaneous Lupus Erythematosus in Japan
Naoto Yokogawa¹, Toshiya Takahashi², Toshiaki Sato³ and Naohisa Yokota⁴, ¹on behalf of Japanese Hydroxychloroquine Study Group, Japan, Japan, ²Sanofi K.K., Tokyo, Japan, ³Sanofi.KK, Tokyo, Japan, ⁴Sanofi KK, Tokyo, Japan
Background/Purpose: In Japan hydroxychloroquine (HCQ) is still unavailable due to the banning of chloroquine in 1974 following allegations that it caused severe retinopathy. Therefore, a…
Abstract Number: 1786 • 2015 ACR/ARHP Annual Meeting
Improvements in Health-Related Quality of Life and Fatigue Following Administration of an IL-6 Monoclonal Antibody (PF-04236921) in an Enriched Population of Subjects with Active SLE
Vibeke Strand¹, Annette Diehl², Jared Christensen², Joseph Wajdula², Sudhakar Sridharan³ and Paul J Healey², ¹Biopharmaceutical Consultant, Portola Valley, CA, ²Pfizer Inc, New York City, NY, ³PPD Inc, Rockville, MA
Background/Purpose: The 10 mg dose of PF-04236921 showed evidence of efficacy in a phase 2 randomized controlled trial (RCT) in SLE.1,2 Here patient-reported outcomes (PROs)…
Abstract Number: 2144 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Different Dose Regimens of a Selective IL-23p19 Inhibitor (BI 655066) Compared with Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis with and without Psoriatic Arthritis
Kim Papp¹, Alan Menter², Howard Sofen³, Stephen Tyring⁴, Jean-Philippe Lacour⁵, Beate Berner⁶, Nathan Bennett⁷, Stella Aslanyan⁷, Mary Flack⁷ and Paul Scholl⁷, ¹Probity Clinical Research, Waterloo, ON, Canada, ²Baylor Research Institute, Dallas, TX, ³Dermatology Research Associates, Los Angeles, CA, ⁴Center for Clinical Studies, Houston, TX, ⁵Dermatology Department, Hôpital de L’Archet, Nice, France, ⁶Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, ⁷Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT
Background/Purpose: IL-23 is essential for the differentiation and maintenance of Th17 cells in psoriasis and psoriatic arthritis (PsA). We assessed the efficacy and safety of…
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: 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)…

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