Abstracts tagged "clinical trials"

Abstract Number: 976 • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of Tocilizumab in Patients with Refractory Takayasu Arteritis: Results from a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial in Japan
Yoshikazu Nakaoka¹, Mitsuaki Isobe², Syuji Takei³, Yoshiya Tanaka⁴, Tomonori Ishii⁵, Shumpei Yokota⁶, Akira Nomura⁷, Seitaro Yoshida⁷ and Norihiro Nishimoto⁸, ¹Department of Vascular Physiology, National Cerebral and Cardiovascular Center Research Institute, Osaka, Japan, ²Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan, ³School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima, Japan, ⁴University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan, ⁶Laboratory of Pediatric Research, Medical Research Institute of Tokyo Medical School, Tokyo, Japan, ⁷Chugai Pharmaceutical Co., Ltd., Tokyo, Japan, ⁸Osaka Rheumatology Clinic, Osaka, Japan
Background/Purpose: Glucocorticoids (GC) are the mainstay of treatment options for patients (pts) with Takayasu arteritis (TAK); however, long-term GC therapy is associated with adverse events…
Abstract Number: 3131 • 2016 ACR/ARHP Annual Meeting
Pregabalin Is More Effective in Treating Hand Osteoarthritis Pain Than Duloxetine or Placebo: A Double-Blind Randomized Controlled Trial
Nidhi Sofat¹, Abiola Harrison², Salma Ayis³, Patrick Kiely⁴, Thomas Richard Barrick⁵ and Franklyn Howe⁶, ¹Basic Medical Sciences, St. George's, University of London, London, United Kingdom, ²Rheumatology, Mailpoint J1A, St George's, University of London, London, United Kingdom, ³Department if Statistics, Division of Health & Social Care Research, Guy's Campus, King's College London, London, United Kingdom, ⁴Rheumatology Dept, St Georges Hospital, London, Great Britain, ⁵Clinical Sciences, St George's, University of London, London, United Kingdom, ⁶Cardiovascular and Cell Sciences, St George's, University of London, London, United Kingdom
Background/Purpose: A prospective, randomized, double-blind, placebo-controlled trial from 42 primary care and rheumatology clinics in the UK. We recruited 85 participants: 65 with hand OA…
Abstract Number: 978 • 2016 ACR/ARHP Annual Meeting
A Randomized Clinical Trial of CCX168, an Orally Administered C5aR Inhibitor for Treatment of Patients with ANCA-Associated Vasculitis
Peter A. Merkel¹, John Niles², Richard Jimenez³, Robert F. Spiera⁴, Brad H. Rovin⁵, Andrew Bomback⁶, Christian Pagnoux⁷, Antonia Potarca⁸, Thomas J. Schall⁹ and Pirow Bekker⁹, ¹Division of Rheumatology, Univ of Pennsylvania; Perelman School of Med, Philadelphia, PA, ²Massachusetts General Hospital, Boston, MA, ³Rheumatology, The Seattle Arthritis Clinic, University of Washington Medicine, Northwest Hospital and Medical Center, Seattle, WA, ⁴Hospital for Special Surgery, Cornell, New York, NY, ⁵Ohio State University Medical Center, Columbus, OH, ⁶Columbia University Medical Center, New York, NY, ⁷Division of Rheumatology, Mount Sinai Hospital, University Health Network, University of Toronto, Toronto, Canada, Toronto, ON, Canada, ⁸ChemoCentryx, Inc., Mountain View, CA, ⁹ChemoCentryx, Mountain View, CA
Background/Purpose: Complement 5a (C5a) is involved in the pathogenesis of anti-neutrophil cytoplasm antibody (ANCA)-associated vasculitis (AAV). CCX168 is an orally administered, small molecule selective inhibitor of…
Abstract Number: 3225 • 2016 ACR/ARHP Annual Meeting
Dual Cytokine Inhibition with ABT-122, a Tnf– and IL-17–Targeted Dual Variable Domain Immunoglobulin (DVD-Ig™): Results from a 24-Week Open-Label Extension Study in Patients with Rheumatoid Arthritis
Mark C. Genovese¹, Michael Weinblatt², Heikki T. Mansikka³, Paul M. Peloso³, Kun Chen³, Yihan Li³, John Liu³ and Robert J. Padley³, ¹Stanford University Medical Center, Palo Alto, CA, ²Brigham and Women’s Hospital, Boston, MA, ³AbbVie Inc., North Chicago, IL
Background/Purpose: ABT-122 is a dual variable domain immunoglobulin (DVD-Ig™) that targets human tumor necrosis factor-α (TNF-α) and interleukin-17A (IL-17A). The object was to investigate the…
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: 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)…
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: 1049 • 2015 ACR/ARHP Annual Meeting
Filgotinib (GLPG0634), an Oral JAK1 Selective Inhibitor Is Effective As Monotherapy in Patients with Active Rheumatoid Arthritis: Results from a Phase 2B Dose Ranging Study
Arthur Kavanaugh¹, Lucia Ponce², Regina Cseuz³, Olga Reshetko⁴, Mykola A Stanislavchuk⁵, Maria Greenwald⁶, Annegret Van der Aa⁷, Frédéric Vanhoutte⁷, Chantal Tasset⁷ and Pille Harrison⁷, ¹University of California San Diego, La Jolla, CA, ²Consulta Privada Dra. Lucia Ponce, Temuco, Chile, ³Revita Reumatologiai Rendelo, Budapest, Indonesia, ⁴Regional Clinical Hospital, Saratov, Russia, ⁵Vinnitsa Regional Clinical Hospital n.a. Pirogov, Vinnitsa, Ukraine, 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: 1079 • 2015 ACR/ARHP Annual Meeting
The Potential Effect on Recruitment of Restricting Skin Scores Eligibility Criteria in Early Diffuse Scleroderma Trials
Robyn T. Domsic¹, Dinesh Khanna², Mary Lucas³, Virginia D. Steen⁴, Daniel E. Furst⁵, Robert Lafyatis⁶ and Thomas A. Medsger Jr.⁷, ¹Medicine - Rheumatology, University of Pittsburgh, Pittsburgh, PA, ²Division of Rheumatology, University of Michigan, Ann Arbor, MI, ³Medicine, University of Pittsburgh Scleroderma Center, Pittsburgh, PA, ⁴Rheumatology, Georgetown University Medical Center, Washington, DC, ⁵Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, ⁶Boston University School of Medicine, Boston, MA, ⁷Department of Medicine/Rheumatology, University of Pittsburgh, Pittsburgh, PA
Background/Purpose: There is increasing interest in cohort enrichment for clinical trials of early diffuse SSc (dcSSc). Recent EUSTAR database analysis (Maurer et al. 2015)…
Abstract Number: 1080 • 2015 ACR/ARHP Annual Meeting
Modified Rodnan Skin Score Thresholds for the Optimization of Cohort Enrichment in Clinical Trials in Skin Fibrosis in Patients with Diffuse Cutaneous Systemic Sclerosis
Rucsandra Dobrota¹, Britta Maurer¹, Nicole Graf², Suzana Jordan³, Carmen Marina Mihai⁴, Otylia Kowal-Bielecka⁵, Yannick Allanore⁶, Oliver Distler¹ and EUSTAR co-authors, ¹Division of Rheumatology, University Hospital Zurich, Zurich, Switzerland, ²graf biostatistics, Winterthur, Switzerland, ³Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland, ⁴Department of Internal Medicine and Rheumatology, Cantacuzino Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, ⁵Department of Rheumatology and Internal Medicine, Medical University of Bialystok, Bialystok, Poland, ⁶Department of Rheumatology, University Paris Descartes and Cochin Hospital, Paris, France
Background/Purpose: The modified Rodnan skin score (mRSS) is the major outcome measure for skin fibrosis in clinical trials (CT) in diffuse cutaneous scleroderma (dcSSc). Traditionally,…

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