Abstracts tagged "clinical trials"

Abstract Number: 1653 • 2016 ACR/ARHP Annual Meeting
Delineating the Effects of Rheumatoid Arthritis Pharmacotherapies on Vascular Inflammation: Rationale and Design of a Clinical Trial
Jon T. Giles¹, Katherine Liao², Nina Paynter³, Alyssa Wohlfahrt⁴, Afshin Zartoshti⁵, Rachel Broderick⁶, Daniel H. Solomon⁷ and Joan Bathon⁶, ¹Division of Rheumatology, Columbia University, College of Physicians & Surgeons, New York, NY, ²Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, Boston, MA, ³Medicine, Harvard University, Boston, MA, ⁴Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ⁵Rheumatology, Columbia University, College of Physicians & Surgeons, New York city, NY, ⁶Rheumatology, Columbia University, College of Physicians & Surgeons, New York, NY, ⁷Division of Rheumatology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
Background/Purpose: Rheumatoid arthritis is associated with an excess cardiovascular disease (CVD) burden. Fewer CVD events associated with specific DMARD therapies have been reported; however, causal…
Abstract Number: 642 • 2016 ACR/ARHP Annual Meeting
Quality of Life Outcomes Following Therapy with Chs-0214 and Etanercept (Enbrel): Randomized, Double-Blind Study in Subjects with Rheumatoid Arthritis
Alan J. Kivitz^1,2, James R. O'Dell³, Tsutomu Takeuchi⁴, Yoshiya Tanaka⁵, Satoshi Nakashima⁶, Cass Kelleher⁷, Jennifer Hodge⁸, Barbara Finck⁷ and RApsody Study Group, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Altoona Arthritis & Osteoporosis Center, Duncansville, PA, ³Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, ⁴Division of Rheumatology, Department of Internal Medicine,, Keio University School of Medicine, Tokyo, Japan, ⁵The First Department of Internal Medicine,, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁶Daiishi Sankyo, Shinagawa-Ku Tokyo, Japan, ⁷Clinical Science, Coherus BioSciences, Redwood City, CA, ⁸Coherus BioSciences, Redwood City, CA
Background/Purpose: CHS-0214 is in development as a proposed biosimilar of etanercept. This Phase III confirmatory, safety and efficacy study randomized and dosed 644 subjects with…
Abstract Number: 1704 • 2016 ACR/ARHP Annual Meeting
Consistent Safety and Tolerability of Secukinumab over Long-Term Exposure in Patients with Active Psoriatic Arthritis and Moderate to Severe Plaque Psoriasis: Updated Pooled Safety Analyses
Philip J Mease¹, Iain B McInnes², Kristian Reich³, Mats Andersson⁴, Aiyang Tao⁵, Todd Fox⁴ and Chetan Karyekar⁵, ¹Swedish Medical Center and University of Washington, Seattle, WA, ²University of Glasgow, Glasgow, Great Britain, ³Dermatologikum Hamburg and Georg-August-University Göttingen, Hamburg, Germany, ⁴Novartis Pharma AG, Basel, Switzerland, ⁵Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: Pooled safety data from the psoriasis (PsO) and psoriatic arthritis (PsA) clinical trial programs of secukinumab (SEC), through approximately 1 year, have been reported…
Abstract Number: 643 • 2016 ACR/ARHP Annual Meeting
Exposure-Response Analyses of Efficacy of ABT-122, a Dual-Variable Domain Immunoglobulin (DVD-Ig™) Targeting TNF-α and IL-17A, Compared with Adalimumab in Subjects with Rheumatoid Arthritis and Background MTX
Amit Khatri¹, Ben Klunder², Mukul Minocha³, Heikki T. Mansikka¹ and Ahmed A. Othman¹, ¹AbbVie Inc., North Chicago, IL, ²AbbVie, Ludwigshafen am Rhein, Germany, ³Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL
Background/Purpose: ABT-122 is a novel dual-variable domain immunoglobulin (DVD-IgTM), which specifically neutralizes both TNF alpha (TNFα) and interleukin-17A (IL-17). Both cytokines are expressed at increased…
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…

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Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. Academic institutions, private organizations and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part a scientific presentation or presentation of additional new information that will be available at the time of the meeting) is under embargo until Saturday, November 11, 2023.

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