Abstracts tagged "clinical trials and rheumatoid arthritis (RA)"

Abstract Number: 1936 • 2018 ACR/ARHP Annual Meeting
A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Efficacy, Safety and Immunogenicity of a Proposed Adalimumab Biosimilar (GP2017) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis
Piotr Wiland¹, Sławomir Jeka², Eva Dokoupilová^3,4, Juan Manuel Miranda Limón⁵, Julia Jauch-Lembach⁶, Anjali Thakur⁶, Halimuniyazi Haliduola⁶ and Norman B Gaylis⁷, ¹Wrocław Medical University, Wrocław, Poland, ²Collegium Medicum UMK, 2nd University Hospital, Bydgoszcz, Poland, ³MEDICAL PLUS s.r.o., Uherské Hradiště, Czech Republic, ⁴Faculty of Pharmacy, University of Veterinary and Pharmaceutical sciences, Brno, Czech Republic, ⁵RM Pharma Specialists, Mexico City, Mexico, ⁶Hexal AG, Holzkirchen, Germany, ⁷Arthritis & Rheumatic Disease Specialties, Aventura, FL
Background/Purpose: GP2017, a proposed adalimumab biosimilar, matched reference adalimumab (refADL) in preclinical and pharmacokinetics studies.1,2 The confirmatory efficacy and safety study in patients with plaque-type…
Abstract Number: 485 • 2015 ACR/ARHP Annual Meeting
Evaluate the Dose Efficacy Response Relationship of Baricitinib in Patients with Rheumatoid Arthritis
Xin Zhang, Laiyi Chua, C. Steven Ernest II, William Macias, Terence Rooney and Lai San Tham, Eli Lilly and Company, Indianapolis, IN
Background/Purpose: Baricitinib (Bari) is an oral inhibitor of Janus kinases (JAK) selective for JAK 1 and 2. It has demonstrated dose-dependent efficacy in patients with…
Abstract Number: 971 • 2015 ACR/ARHP Annual Meeting
Safety and Tolerability of Subcutaneous Sarilumab Compared to Intravenous Tocilizumab in Patients with RA
Paul Emery¹, Juan Rondon², Anju Garg³, Hubert van Hoogstraten³, Neil Graham⁴, Ming Liu⁵, Janie Parrino⁶, Alberto J. Spindler⁷ and Nancy Liu⁵, ¹Division of Rheumatic and Musculoskeletal Disease, University of Leeds, Leeds, United Kingdom, ²Elite Research Institute, Miami, FL, ³Sanofi, Bridgewater, NJ, ⁴Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁵Regeneron Pharmaceuticals, Tarrytown, NY, ⁶Merck & Co., Inc., Whitehouse Station, NJ, ⁷Rheumatology, Hospital Padilla, Tucuman, Argentina
Background/Purpose: The investigational drug sarilumab is a human mAb directed against the IL-6 receptor. In previous studies, sarilumab + MTX demonstrated efficacy in patients (pts)…
Abstract Number: 1050 • 2015 ACR/ARHP Annual Meeting
Response to Baricitinib at 4 Weeks Predicts Response at 12 and 24 Weeks in Patients with Rheumatoid Arthritis: Results from Two Phase 3 Studies
Joel Kremer¹, Maxime Dougados², Mark C. Genovese³, Paul Emery⁴, Lili Yang⁵, Stephanie de Bono⁵, Thorsten Holzkaemper⁵, Noriko Iikuni⁵, Douglas E. Schlichting⁵ and Josef S. Smolen⁶, ¹The Center for Rheumatology, Center for Rheumatology, Albany Medical College, Albany, NY, ²Service de Rhumatologie B, GHU Cochin, F-75014 France, PARIS, France, ³Division of Rheumatology, Stanford University Medical Center, Palo Alto, CA, ⁴Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁵Eli Lilly and Company, Indianapolis, IN, ⁶Department of Rheumatology, Medical University of Vienna, Vienna, Austria
Background/Purpose: Baricitinib (bari), an oral, reversible inhibitor of Janus kinase (JAK)1/JAK2, improved signs and symptoms in phase 3, placebo (PBO)-controlled studies in patients (pts) with…
Abstract Number: 376 • 2014 ACR/ARHP Annual Meeting
Using the Multi-Biomarker Disease Activity Score As a Complementary Inclusion Criterion for Clinical Trials in Rheumatoid Arthritis May Enhance Recruitment
Ronald F. van Vollenhoven¹, Rebecca J. Bolce², Karen Hambardzumyan³, Saedis Saevarsdottir⁴, Kristina Forslind⁴, Ingemar Petersson⁵, Eric H. Sasso², CC Hwang⁶, Oscar Segurado² and Pierre Geborek⁷, ¹Unit for clinical therapy research (ClinTrid), Karolinska Institute, Stockholm, Sweden, ²Crescendo Bioscience Inc., South San Francisco, CA, ³ClinTRID, the Karolinska Institute, Stockholm, Sweden, ⁴Department of Medicine, Karolinska Institute, Stockholm, Sweden, ⁵Lund University, Department of Orthopedics, Clinical Sciences Lund, Lund, Sweden, ⁶Biostatistics, Crescendo Bioscience Inc., South San Francisco, CA, ⁷Section of Rheumatology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden
Background/Purpose Clinical trials in rheumatoid arthritis (RA) often require elevated C-reactive protein (CRP) as an inclusion criterion, which may limit recruitment by excluding some patients…
Abstract Number: 1695 • 2012 ACR/ARHP Annual Meeting
Prolonged Exposure to Subcutaneous and Intravenous Abatacept in Patients with Rheumatoid Arthritis Does Not Affect Rates of Infection, Malignancy and Autoimmune Events: Results From Pooled Clinical Trial Data
M. C. Genovese¹, M C. Hochberg², R. B. Cohen³, M. E. Weinblatt⁴, J. Kaine⁵, Edward Keystone⁶, P. Nash⁷, I. Delaet⁸ and R. Alten⁹, ¹Stanford University, Palo Alto, CA, ²Department of Medicine, University of Maryland, Baltimore, MD, ³Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, ⁴Rheumatology & Immunology, Brigham & Women's Hospital, Boston, MA, ⁵Sarasota Arthritis Research Center, Sarasota, FL, ⁶Mount Sinai Hospital, Toronto, ON, Canada, ⁷University of Queensland, Brisbane, Australia, ⁸Bristol-Myers Squibb, Princeton, NJ and Bristol-Myers Squibb, Hopewell, VA, ⁹Schlosspark-Klinik, University Medicine, Berlin, Germany
Background/Purpose: Disease-modifying therapies for RA have proven efficacy, but these drugs may have selective toxicities, such as malignancy, that may increase with duration of treatment.…
Abstract Number: 460 • 2012 ACR/ARHP Annual Meeting
Real-World Efficacy and Safety of Abatacept Treatment for Rheumatoid Arthritis: 12-Month Interim Analysis of the Action Study
H. Nüßlein¹, R. Alten², M. Galeazzi³, H. M. Lorenz⁴, Dimitrios Boumpas⁵, M. T. Nurmohamed⁶, W. Bensen⁷, Gerd Burmester⁸, H.-H. Peter⁹, F. Rainer¹⁰, Karel Pavelka¹¹, M. Chartier¹², C. Poncet¹³, C. Rauch¹⁴ and M. Le Bars¹⁵, ¹University Erlangen, Nürnberg, Germany, ²Schlosspark-Klinik, University Medicine, Berlin, Germany, ³University of Siena, Siena, Italy, ⁴University Hospital Heidelberg, Heidelberg, Germany, ⁵Panepistimio Kritis, Rethymnon, Greece, ⁶VU University Medical Center/Jan van Bremen Research Institute, Amsterdam, Netherlands, ⁷St. Joseph's Hospital and McMaster University, Hamilton, ON, Canada, ⁸Charité-Universitätsmedizin, Berlin, Germany, ⁹University Medical Center Freiburg, Freiburg, Germany, ¹⁰Hospital Barmherzige Brueder, Graz, Austria, ¹¹Institute of Rheumatology, Prague, Czech Republic, ¹²Chiltern International, Neuilly, France, ¹³Docs International, Sévres, France, ¹⁴Bristol-Myers Squibb, Munich, Germany, ¹⁵Bristol-Myers Squibb, Rueil Malmaison, France
Background/Purpose: Randomized controlled trials (RCTs) of abatacept (ABA) in patients (pts) with RA have demonstrated sustained, long-term efficacy, high pt retention, and consistent safety.1 Data…
Abstract Number: 462 • 2012 ACR/ARHP Annual Meeting
Subcutaneous Abatacept: Long-Term Data From the Acquire Trial
M. C. Genovese¹, C. Pacheco-Tena², A. Covarrubias³, Gustavo Leon⁴, E. Mysler⁵, M. Keiserman⁶, R. Valente⁷, P. Nash⁸, J. A. Simon-Campos⁹, J. Box¹⁰, C. Legerton III¹¹, E. Nasonov¹², P. Durez¹³, I. Delaet¹⁴ and R. Alten¹⁵, ¹Stanford University, Palo Alto, CA, ²Universidad Autónoma de Chihuahua, Chihuahua, Mexico, ³Centro Medico De Las Americas, Merida, Mexico, ⁴Instituto De Ginecologia Y Reproduccion, Lima, Peru, ⁵Organización Médica de Investigación, Buenos Aires, Argentina, ⁶Pontificial Catholic University School of Medicine, Porto Alegre, Brazil, ⁷Arthritis Center of Nebraska, Lincoln, NE, ⁸Rheumatology Research Unit, Nambour Hospital, Sunshine Coast and Department of Medicine, University of Queensland, Queensland, Australia, ⁹Centro De Especialidades Médicas/Universidad Marista, Merida, Mexico, ¹⁰Carolina Bone and Joint, Charlotte, NC, ¹¹Low Country Rheumatology, Charleston, SC, ¹²Institute of Rheumatology, Moscow, Russia, ¹³Université Catholique de Louvain, Brussels, Belgium, ¹⁴Bristol-Myers Squibb, Princeton, NJ, ¹⁵Schlosspark-Klinik, University Medicine, Berlin, Germany
Background/Purpose: The Abatacept (ABA) Comparison of Sub[QU]cutaneous (SC) versus Intravenous (IV) in Inadequate Responders to MethotrexatE (MTX) (ACQUIRE) study showed comparable efficacy and safety of…

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