Abstracts tagged "clinical trials"

Abstract Number: 965 • 2016 ACR/ARHP Annual Meeting
Clinical and Serologic Variables Associated with Renal Response Among Lupus Nephritis Phase III Trial Patients Treated with Standard of Care Immunosuppression
Matthew D. Cascino¹, Peter Lambert², Anna Decker², Tamiko Katsumoto², Jay Garg², Paul Brunetta², Maria Dall'Era¹ and Leonard L. Dragone², ¹Division of Rheumatology, University of California, San Francisco, San Francisco, CA, ²Genentech, Inc., South San Francisco, CA
Background/Purpose: Lupus nephritis (LN) is associated with high treatment failure rates and the development of new therapies for LN is limited by the lack of…
Abstract Number: 2622 • 2016 ACR/ARHP Annual Meeting
Safety, Pharmacokinetics, and Biomarker Profile from Phase 1 Clinical Trials of Healthy Volunteers Treated with GDC-0853, a Highly Selective Reversible Oral Bruton’s Tyrosine Kinase (BTK) Inhibitor
Tamiko Katsumoto, Helen Winter, Shweta Kotwal, Elaine Murray, Rui Zhao, Marilyn Florero, Alyse Lin, Anita Moein, Rena Wang, Meire Bremer, Serika Kokubu, Adrian Serone, Alyssa Morimoto, Leslie Chinn and Ann Herman, Genentech, Inc., South San Francisco, CA
Background/Purpose: B cell depletion therapy has provided evidence of the importance of B cells in the pathogenesis of rheumatoid arthritis and other inflammatory diseases. Consequently,…
Abstract Number: 969 • 2016 ACR/ARHP Annual Meeting
Safety and Efficacy of Subcutaneous Tocilizumab in Early Systemic Sclerosis: Results from the Open-Label Period of a Phase 2 Randomized, Controlled Trial
Dinesh Khanna¹, Christopher Denton², Helen Spotswood³, Angelika Jahreis⁴, Jacob M. van Laar⁵, Laura Burke⁶, Celia J. F. Lin⁴, Janet E. Pope⁷, Yannick Allanore⁸, Ulf Müller-Ladner⁹, Jeffrey Siegel⁶, Daniel E. Furst¹⁰ and faSScinate Clinical Trial Investigators, ¹University of Michigan, Ann Arbor, MI, ²Division of Medicine, Centre for Rheumatology and Connective Tissue Disease, University College London, London, United Kingdom, ³Roche Products Ltd., Welwyn Garden City, CA, United Kingdom, ⁴Genentech, South San Francisco, CA, ⁵University Medical Center Utrecht, Utrecht, Netherlands, ⁶Roche Products Ltd., Welwyn Garden City, United Kingdom, ⁷University of Western Ontario, St Joseph's Health Care, London, ON, Canada, ⁸Rheumatology, Paris Descartes University, Paris, France, ⁹Justus-Liebig-University Giessen, Department of Internal Medicine and Rheumatology, Kerckhoff-Klinik, Bad Nauheim, Germany, Bad-Nauheim, Germany, ¹⁰University of California, Los Angeles, Los Angeles, CA
Background/Purpose: Systemic sclerosis (SSc) is a debilitating disease with few treatment options. Interleukin-6 (IL-6) appears to play a role in SSc pathogenesis (J Rheumatol 1998;25:308;…
Abstract Number: 2623 • 2016 ACR/ARHP Annual Meeting
Intravenous Infusion of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in Rheumatoid Arthritis: A Phase 1, Proof-of-Concept Clinical Trial
Dong Jin Go¹, Hee-suk Lim², Ahrmi Cho³, Kyounghwan Roh³, Kwang-Won Seo³, Kyung-Sun Kang^3,4 and Kichul Shin⁵, ¹Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea, The Republic of, ²Division of Rheumatology, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, South Korea, ³Institute for Stem cell Regenerative Medicine, Kangstem Biotech, Seoul, Korea, The Republic of, ⁴Adult Stem Cell Research Center, College of Veterinary Medicine, Seoul National University, Seoul, Korea, The Republic of, ⁵Kyungnam villa #102, Division of Rheumatology, Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea, Republic of
Background/Purpose: The immunomodulatory actions of human umbilical cord blood (hUCB)-derived mesenchymal stem cells (MSCs) in rheumatoid arthritis (RA) have been studied extensively via in vitro…
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: 989 • 2016 ACR/ARHP Annual Meeting
A Randomized Controlled Trial of Rheumatoid Arthritis Risk Disclosure Personalized to Genetics, Autoantibodies, and Lifestyle Among Unaffected First-Degree Relatives: The Personalized Risk Estimator for RA (PRE-RA) Family Study
Jeffrey A. Sparks¹, Maura D. Iversen², Zhi Yu³, Nellie A. Triedman³, Maria G. Prado³, Rachel Miller Kroouze⁴, Sarah S. Kalia⁵, Elinor A. Mody³, Simon M. Helfgott³, Derrick J. Todd³, Paul F. Dellaripa³, Bonnie L. Bermas³, Kevin D. Deane⁶, Karen H. Costenbader³, Bing Lu³, Robert C. Green⁵ and Elizabeth W. Karlson³, ¹Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ²Physical Therapy, Movement and Rehabilitation Sciences, Northeastern University, Boston, MA, ³Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ⁴Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ⁵Division of Genetics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ⁶Division of Rheumatology, University of Colorado School of Medicine, Aurora, CO
Background/Purpose : Disclosure of genetic risk information alone has had limited impact on changing health behaviors in research trials. Prior studies have not evaluated whether…
Abstract Number: 1023 • 2016 ACR/ARHP Annual Meeting
Fracture Risk Reduction with Romosozumab: Results of a Phase 3 Study in Postmenopausal Women with Osteoporosis
F Cosman¹, DB Crittenden², JD Adachi³, N Binkley⁴, E Czerwinski⁵, S Ferrari⁶, LC Hofbauer⁷, E Lau⁸, EM Lewiecki⁹, A Miyauchi¹⁰, CAF Zerbini¹¹, CE Milmont², L Chen², J Maddox², PD Meisner¹², C Libanati¹² and A Grauer², ¹Helen Hayes Hospital, West Haverstraw, and Columbia University, New York, NY, ²Amgen Inc., Thousand Oaks, CA, ³McMaster University, Hamilton, ON, Canada, ⁴University of Wisconsin–Madison Osteoporosis Clinical Center and Research Program, Madison, WI, ⁵Krakow Medical Center, Krakow, Poland, ⁶Geneva University Hospital, Geneva, Switzerland, ⁷Division of Endocrinology, Diabetes, and Bone Diseases, TU Dresden Medical Center, Dresden, Germany, ⁸Center for Clinical and Basic Research, Hong Kong, China, ⁹New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, ¹⁰Miyauchi Medical Center, Osaka, Japan, ¹¹Centro Paulista de Investigação Clinica, São Paulo, Brazil, ¹²UCB Pharma, Brussels, Belgium
Background/Purpose: Romosozumab (Romo) is an investigational bone-forming monoclonal antibody that binds sclerostin and has a dual effect, increasing bone formation and decreasing bone resorption. Here,…
Abstract Number: 1024 • 2016 ACR/ARHP Annual Meeting
Superior Gains in Bone Mineral Density and Estimated Strength at the Hip for Romosozumab Compared with Teriparatide in Women with Postmenopausal Osteoporosis Transitioning from Bisphosphonate Therapy: Results of a Phase 3, Open-Label Clinical Trial
B Langdahl¹, C Libanati², DB Crittenden³, MA Bolognese⁴, JP Brown⁵, NS Daizadeh³, K Engelke⁶, HK Genant⁷, S Goemaere⁸, Lars Hyldstrup⁹, E Jodar-Gimeno¹⁰, TM Keaveny¹¹, D Kendler¹², P Lakatos¹³, J Maddox³, J Malouf¹⁴, FE Massari¹⁵, JF Molina¹⁶, MR Ulla¹⁷ and A Grauer³, ¹Aarhus University Hospital, Aarhus, Denmark, ²UCB Pharma, Brussels, Belgium, ³Amgen Inc., Thousand Oaks, CA, ⁴Bethesda Health Research Center, Bethesda, MD, ⁵Laval University and CHU de Québec (CHUL) Research Centre, Quebec City, QC, Canada, ⁶BioClinica Inc., Hamburg, Germany, ⁷Department of Radiology, University of California San Francisco, San Francisco, CA, ⁸Ghent University Hospital, Gent, Belgium, ⁹Hvidovre University Hospital, Hvidovre, Denmark, ¹⁰Servicio de Endocrinología, Hospital Universitario Quirón, Madrid, Spain, ¹¹University of California at Berkeley, Berkeley, CA, ¹²University of British Columbia, Vancouver, BC, Canada, ¹³Department of Medicine, Semmelweis University, Budapest, Hungary, ¹⁴Universitat Autònoma de Barcelona, Barcelona, Spain, ¹⁵Instituto de Investigaciones Metabólicas, Buenos Aires, Argentina, ¹⁶Reumalab Centro Integral de Reumatologia, Medellin, Colombia, ¹⁷Instituto Latinoamericano de Investigaciones Médicas, Córdoba, Argentina
Background/Purpose: STRUCTURE was a phase 3, open-label study evaluating the effect of romosozumab or teriparatide for 12 months in women with postmenopausal osteoporosis transitioning from…
Abstract Number: 1028 • 2016 ACR/ARHP Annual Meeting
Discontinuation of Denosumab and Associated Vertebral Fracture Incidence: Analysis from a Phase 3 Placebo-Controlled Study of Denosumab and Its Open-Label Extension
Jacques P Brown¹, S Ferrari², N Gilchrist³, Jens-Erik Beck Jensen⁴, N Pannacciulli⁵, Chris Recknor⁶, Christian Roux⁷, Shawna Smith⁵, Ove Törring⁸, Ivo Valter⁹, Rachel B Wagman⁵, A Wang⁵ and SR Cummings¹⁰, ¹Centre Hospitalier de l'Université Laval (CHUL), Quebec City, QC, Canada, ²Geneva University Hospital, Geneva, Switzerland, ³The Princess Margaret Hospital, Christchurch, New Zealand, ⁴Hvidovre University Hospital, Hvidovre, Denmark, ⁵Amgen Inc., Thousand Oaks, CA, ⁶United Osteoporosis Centers, Gainesville, GA, ⁷Paris Descartes University, Paris, France, ⁸Karolinska Institutet Sodersjukhuset, Stockholm, Sweden, ⁹Center for Clinical and Basic Research, Tallinn, Estonia, ¹⁰SFCC, CPMC Research Institute & UCSF, San Francisco, CA
Background/Purpose: Denosumab (DMAb) treatment has been shown to decrease fracture (Fx) risk. Unlike bisphosphonates, DMAb is a monoclonal antibody against RANKL. Discontinuation is characterized by…
Abstract Number: 1052 • 2016 ACR/ARHP Annual Meeting
Longitudinal Patterns in SLE Response to Standard of Care Therapy: Implications for SLE Clinical Trial Design
Mimi Kim¹, Joan T Merrill², Kenneth Kalunian³, Bevra H. Hahn⁴, Anita Roach⁵, Peter M. Izmirly⁶ and the Lupus Foundation of America Collective Data Analysis Initiative Group., ¹Biostatistics and Research Design Resource, Albert Einstein Coll Med, Bronx, NY, ²OMRF, Oklahoma, OK, ³Center for Innovative Therapy, UCSD School of Medicine, La Jolla, CA, ⁴Division of Rheumatology, UCLA David Geffen School of Medicine, Los Angeles, CA, ⁵Education & Research, Lupus Foundation of America, Washington, DC, ⁶New York University School of Medicine, New York, NY
Background/Purpose: Most clinical trials of new treatments for systemic lupus erythematosus (SLE) have shown weak discrimination between investigational agents and placebo when added to standard…
Abstract Number: 321 • 2016 ACR/ARHP Annual Meeting
Results of a Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Romosozumab in Men with Osteoporosis
EM Lewiecki¹, S Horlait², T Blicharski³, S Goemaere⁴, K Lippuner⁵, P Meisner⁶, PD Miller⁷, A Miyauchi⁸, J Maddox⁹, NS Daizadeh⁹ and A Grauer⁹, ¹New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, ²Amgen Ltd., Uxbridge, United Kingdom, ³Medical University of Lublin, Lublin, Poland, ⁴Ghent University Hospital, Gent, Belgium, ⁵Bern University Hospital, Bern, Switzerland, ⁶UCB Pharma, Brussels, Belgium, ⁷Colorado Center for Bone Research, Lakewood, CO, ⁸Miyauchi Medical Center, Osaka, Japan, ⁹Amgen Inc., Thousand Oaks, CA
Background/Purpose: Treatment with romosozumab (Romo) has been shown to rapidly increase BMD in postmenopausal women with low BMD through a dual effect on bone, increasing…
Abstract Number: 1588 • 2016 ACR/ARHP Annual Meeting
Treatment with BI 655064 (Antagonistic Anti-CD40 Antibody) Modulates Clinical and Biomarker Parameters Associated with Rheumatoid Arthritis (RA)
Sudha Visvanathan¹, Meera Ramanujam¹, Corinna Schoelch², Patrick Baum², Richard Vinisko¹, Ralf Thiedmann², Ulf Müller-Ladner³, Stefan Daniluk⁴, Rafal Ptaszyński⁵, Steven Padula⁶, Jay S. Fine¹ and Jürgen Steffgen², ¹Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, ²Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, ³Giessen University, Kerckhoff-Klinik, Bad-Nauheim, Germany, ⁴ClinicMed Badurski and Partners, Bialystok, Poland, ⁵Rheumatica, Warsaw, Poland, ⁶Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
Background/Purpose: Costimulation through the CD40–CD40L axis is implicated in the pathogenesis of RA including T cell-mediated responses, B cell-driven autoantibodies, adhesion molecule expression, synovial hyperplasia…

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