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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Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. 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 a scientific presentation or presentation of additional new information that will be available at the time of the meeting) is under embargo until Saturday, November 11, 2023.

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