Abstracts tagged "Clinical trials and rheumatoid arthritis"

Abstract Number: 2878 • ACR/ARHP Annual Meeting 2018
Phase II Clinical Trials Systematically Overestimate Treatment Effects of Subsequent Phase III Trials in Rheumatoid Arthritis
Andreas Kerschbaumer¹, Harald Herkner², Josef S. Smolen³ and Daniel Aletaha⁴, ¹Department of Internal Medicine III, Division of Rheumatology, Medical University of Vienna, Vienna, Austria, ²Department for Emergency Medicine, Medical University of Vienna, Vienna, Austria, ³Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria, ⁴Medical University of Vienna, Vienna, Austria
Background/Purpose: Phase 3 (P3) clinical trials are the mainstay of drug development in all areas of medicine, including rheumatology, allowing to determine safety and efficacy…
Abstract Number: 2799 • ACR/ARHP Annual Meeting 2017
Efficacy, Safety and Immunogenicity in Randomized, Double-Blind (DB) and Open-Label Extension (OLE) Studies Comparing FKB327, an Adalimumab Biosimilar, with the Adalimumab Reference Product (Humira®; RP) in Patients (pts) with Active Rheumatoid Arthritis (RA)
Mark C. Genovese¹, Josephine Glover², Nobuhito Matsunaga³, Diane Chisholm⁴ and Rieke Alten⁵, ¹Stanford University Medical Center, Palo Alto, CA, ²Coephycient Pharmaceutical Consultancy, Guildford, United Kingdom, ³Fujifilm Kyowa Kirin Biologics, Chiyoda-ku, Tokyo, Japan, ⁴Fujifilm Kyowa Kirin Biologics, Galashiels, United Kingdom, ⁵University Medicine Berlin, Berlin, Germany
Background/Purpose: FKB327 is a proposed biosimilar of the adalimumab RP. A randomized, DB, Phase 3 study (NCT02260791) compared the efficacy, safety, pharmacokinetics (PK) and immunogenicity…
Abstract Number: 970 • ACR/ARHP Annual Meeting 2015
Efficacy and Safety of Sarilumab in Combination with Csdmards in Patients with Active Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant of Anti–TNF-Î± Therapy: Results from a Phase 3 Study
Roy Fleischmann¹, Geraldo Castelar-Pinheiro², Jan Brzezicki³, Pawel Hrycaj⁴, Yong Lin⁵, Janet van Adelsberg⁶, Neil Graham⁷, Hubert van Hoogstraten⁵, Deborah Bauer⁵ and Gerd Burmester⁸, ¹University of Texas Southwestern Medical Center, Dallas, TX, ²Discipline of Rheumatology, Rio de Janeiro State University, Rio de Janeiro, Brazil, ³Centrum Kliniczno-Badawcze, Elblag, Poland, ⁴Poznan University of Medical Sciences, Poznan, Poland, ⁵Sanofi, Bridgewater, NJ, ⁶Clinical Science, Regeneron Pharmaceutials, Inc., Tarrytown, NY, ⁷Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁸Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany
Background/Purpose: The investigational agent sarilumab is a human mAb directed against the IL-6 receptor. The phase 3 MOBILITY study (NCT01061736) evaluated the efficacy and safety…
Abstract Number: 1486 • ACR/ARHP Annual Meeting 2014
Rapid Onset of Clinical Benefit Is Associated with a Reduction in Validated Biomarkers of Disease in Patients with Rheumatoid Arthritis Treated with Mavrilimumab, a Human Monoclonal Antibody Targeting GM-CSFRÃ¡
Iain B. McInnes¹, Gerd Burmester², Joel M. Kremer³, Pedro Miranda⁴, Mariusz Korkosz⁵, Jiri Vencovsky⁶, Andrea Rubbert-Roth⁷, Eduardo Mysler⁸, David Close⁹, Matthew A. Sleeman¹⁰, Alex Godwood¹¹, Sara Sandbach¹², Patricia C. Ryan¹³, Dominic Sinibaldi¹⁴, Wendy White¹³, Nadine A. Defranoux¹⁵ and Michael Weinblatt¹⁶, ¹Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, ²Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Berlin, Germany, ³Medicine, Albany Medical College and the Center for Rheumatology, Albany, NY, ⁴Centro de Estudios Reumatologicos, Santiago, Chile, ⁵Inernal Medicine and Gerontology, Malopolskie Centrum Medyczne, Krakow, Poland, ⁶Rheumatology, Charles University Institute of Rheumatology, Prague, Czech Republic, ⁷Med Clinic I, University of Cologne, koln, Germany, ⁸Rheumatology, OMI, Buenos Aires, Argentina, ⁹Clinical Development, MedImmune Ltd, Cambridge, United Kingdom, ¹⁰Respiratory, Inflammation and Autoimmunity, MedImmune Ltd, Cambridge, United Kingdom, ¹¹Clinical Biostatics and Data Management, MedImmune Ltd, Cambridge, United Kingdom, ¹²Clinical biologics, MedImmune Ltd, Cambridge, United Kingdom, ¹³Translational Sciences, MedImmune, Gaithersburg, MD, ¹⁴R&D IS Translational & Clinical Informatics, MedImmune, Gaithersburg, MD, ¹⁵Crescendo Bioscience Inc., South San Francisco, CA, ¹⁶Rheumatology, Brigham & Women's Hospital, Harvard Medical School, Boston, MA
Background/Purpose Macrophages are pivotal to rheumatoid pathogenesis and their inflammatory products drive many of the signs and symptoms of disease. Mavrilimumab inhibits macrophage activation and…
Abstract Number: 1793 • ACR/ARHP Annual Meeting 2013
Oskira-1: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study Of 2 Dosing Regimens Of Fostamatinib In Rheumatoid Arthritis Patients With An Inadequate Response To Methotrexate
Michael Weinblatt¹, Mark C. Genovese², Meilien Ho³, Sally Hollis³, Krystyna Rosiak-Jedrychowicz⁴, Arthur Kavanaugh⁵, David Millson³, Gustavo Leon⁶, Millie Wang³ and Désiréé van der Heijde⁷, ¹Division of Rheumatology, Brigham & Women's Hospital, Boston, MA, ²Division of Immunology and Rheumatology, Stanford University, Palo Alto, CA, ³AstraZeneca R&D Alderley Park, Macclesfield, United Kingdom, ⁴Przychodnia Neuromedyka, Zyrardów, Poland, ⁵University of California, San Diego, La Jolla, CA, ⁶Instituto de Ginecología y Reproducción-Cirugía Mínimamente Invasiva, Surco, Peru, ⁷Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Fostamatinib (Fosta) is an oral SYK inhibitor. This 52-wk study (NCT01197521) compared Fosta vs placebo (PBO) + methotrexate (MTX) in patients (pts) with active…