Abstracts tagged "clinical trials"

Abstract Number: 1709 • 2016 ACR/ARHP Annual Meeting
Randomized, Double-Blind Study Comparing Chs-0214 with Etanercept (Enbrel) in Patients with Psoriasis and Psoriatic Arthritis
Alan J. Kivitz¹, Kim Papp², Alim Devani³, Andreas Pinter⁴, Rodney Sinclair^5,6,7, Michael Ziv⁸, John Caminis⁹, Cass Kelleher¹⁰, Helen Tang¹¹, Barbara Finck¹⁰ and RaPsOdy study group , ¹Altoona Center for Clinical Research, Duncansville, PA, ²K Papp Clinical Research, Inc. and Probity Medical Research, Waterloo, ON, Canada, ³Institute for Skin Advancement, Surgical and Cosmetic Dermatology, Calgary, AB, Canada, ⁴Dept. of Dermatology, Venereology and Allergology, Theodor-Stern-Kai 7, Frankfurt, Germany, ⁵University of Melbourne, E. Melbourne, Australia, ⁶Epworth Healthcare, E. Melbourne, Australia, ⁷Sinclair Dermatology Investigational Research, Education and Clinical Trials, E. Melbourne, Australia, ⁸Dept of Dermatology, Emek Medical Center, Afula, Israel, ⁹Shire, cambridge, MA, ¹⁰Clinical Science, Coherus BioSciences, Redwood City, CA, ¹¹Coherus BioSciences, Redwood City, CA
Background/Purpose: CHS-0214 is a proposed biosimilar of etanercept, a fusion protein inhibiting tumor necrosis factor. This Phase III multi-center study compared the efficacy and safety…
Abstract Number: 649 • 2016 ACR/ARHP Annual Meeting
Clinical Evaluation Usefulness of Standardized Protocol Strategies of Dose Reduction in Patients with Rheumatoid Arthritis in Clinical Remission Treated with Biologic Therapies. the Optibio Study
Carmen Bejerano¹, Natividad Oreiro¹, Carlos Fernandez-Lopez², Jose A Pinto-Tasende¹, Antonio Atanes¹, Bruno De Aspe¹, Genaro Graña Gil¹, Mercedes Freire¹, Manuel Acasuso³, Sonia Pertega⁴, Francisco J. de Toro¹ and Francisco J Blanco¹, ¹Rheumatology Division, INIBIC-Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruna, Spain, ²Rheumatology Division, INIBIC-Complejo Hospitalario Universitario A Coruña (CHUAC), La Coruña, Spain, ³Centro de Salud San Jose, XAP Coruna, A Coruna, Spain, ⁴Epidemiology Unit, INIBIC - Complejo Hospitalario Universitario A Coruña, A Coruña, Spain
Background/Purpose: The OPTIBIO study is a clinical trial whose primary endpoint is to evaluate the proportion of patients that after one year are maintained in…
Abstract Number: 2012 • 2016 ACR/ARHP Annual Meeting
Utility of the Lupus Low Disease Activity State Definition in Discriminating Responders in the Phase IIb Muse Trial of Anifrolumab in Systemic Lupus Erythematosus
E. Morand¹, A. Berglind², T. Sheytanova², R. Tummala³ and G. Illei³, ¹Monash University, Melbourne, Australia, ²AstraZeneca, Mölndal, Sweden, ³MedImmune, Gaithersburg, MD
Background/Purpose: Preliminary validation of a Lupus Low Disease Activity State (LLDAS) definition has demonstrated that LLDAS attainment is associated with reduced damage accrual in patients…
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: 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…

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