Abstracts tagged "clinical trials"

Abstract Number: 2610 • 2017 ACR/ARHP Annual Meeting
Quantiferon Testing in a Clinical Trial of Systemic Lupus Erythematosus
Niti Goel¹, Stephen Wax², Amy Kao², Russell Reeve³ and Marsha Mackey⁴, ¹QuintilesIMS, Duke University School of Medicine, Durham, NC, ²EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA), Billerica, MA, ³QuintilesIMS, Durham, NC, ⁴QuintilesIMS, Rockville, MD
Background/Purpose: Tuberculosis (TB) has been reported to occur at a higher rate in SLE patients than in the general population. As a result, most clinical…
Abstract Number: 874 • 2017 ACR/ARHP Annual Meeting
Effect of Rituximab on a Salivary Gland Ultrasound Score in Primary Sjögren’s Syndrome: Results of Multicentre Double-Blind Randomised Controlled Trial Sub-Study
Benjamin Fisher¹, Colin Everett², John Rout³, John O'Dwyer², Paul Emery⁴, Costantino Pitzalis⁵, Wan-Fai Ng⁶, Andrew Carr⁷, Colin Pease², Elizabeth Price⁸, Nurhan Sutcliffe⁹, Jimmy Makdissi¹⁰, Anwar Tappuni¹⁰, Nagui Gendi¹¹, Frances Hall¹², Sharon Ruddock², Catherine Fernandez², Claire Hulme², Kevin Davies¹³, Christopher J. Edwards¹⁴, Peter Lanyon¹⁵, Robert J. Moots¹⁶, Euthalia Roussou¹⁷, Linda Sharples¹⁸, Michele Bombardieri¹⁹ and Simon Bowman²⁰, ¹Rheumatology Research Group, University of Birmingham, Birmingham, United Kingdom, ²University of Leeds, Leeds, United Kingdom, ³Birmingham Dental Hospital, Birmingham, United Kingdom, ⁴NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁵Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London, School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom, ⁶Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom, ⁷Newcastle Dental Hospital, Newcastle, United Kingdom, ⁸Great Western Hospital, Swindon, United Kingdom, ⁹Royal London Hospital, London, UK, London, United Kingdom, ¹⁰Barts Health NHS Trust, London, United Kingdom, ¹¹Basildon and Thurrock University Hospital, Basildon, UK, Basildon, United Kingdom, ¹²School of Clinical Medicine, University of Cambridge, Cambridge, United Kingdom, ¹³University of Sussex, Brighton, United Kingdom, ¹⁴University of Southampton, Southampton, United Kingdom, ¹⁵University of Nottingham, Nottingham, United Kingdom, ¹⁶University of Liverpool, Liverpool, United Kingdom, ¹⁷Barking Havering and Redbridge University hospitals NHS Trust, London, United Kingdom, ¹⁸London School of Hygiene and Tropical Medicine, London, United Kingdom, ¹⁹Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Queen Mary University of London, UK, London, United Kingdom, ²⁰Department of Rheumatology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK, Birmingham, United Kingdom
Background/Purpose: B lymphocytes are important in the pathogenesis of primary Sjögren’s syndrome (PSS), but two phase III trials (TEARS and TRACTISS) of the B cell…
Abstract Number: 2766 • 2017 ACR/ARHP Annual Meeting
Physical Therapy Vs. Internet-Based Exercise Training for Patients with Knee Osteoarthritis: Results of a Randomized Controlled Trial
Kelli Allen¹, Liubov Arbeeva², Leigh F. Callahan³, Yvonne M. Golightly⁴, Adam P. Goode⁵, Bryan Heiderscheit⁶, Carla Hill⁷, Kim Huffman⁸, Herbert Seversen⁹ and Todd A. Schwartz¹⁰, ¹Rheumatology, University of North Carolina at Chapel Hill and Durham VA Medical Center, Durham, NC, ²Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, ³Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC, ⁴Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁵O, Duke University, Durham, NC, ⁶Department of Orthopedics and Rehabilitation, University of Wisconsin, Madison, WI, ⁷University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁸School of Medicine, Division of Rheumatology, Immunology and Molecular Physiology and Durham VA Medical Center, Duke University, Durham, NC, ⁹Oregon Research Institute, Durham, OR, ¹⁰Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC
Background/Purpose: The majority of adults with osteoarthritis (OA) are inactive, highlighting the need for continued efforts to promote regular engagement in exercise. Few studies have…
Abstract Number: 41 • 2017 Pediatric Rheumatology Symposium
Identification of Optimal Subcutaneous Doses of Tocilizumab in Children With Polyarticular-Course Juvenile Idiopathic Arthritis
Hermine Brunner¹, Nicola Ruperto², Alberto Martini², Athimalaipet Ramanan³, Rubén Cuttica⁴, Jennifer E. Weiss⁵, Michael Henrickson⁶, Heinrike Schmeling⁷, Jordi Anton⁸, Kirsten Minden⁹, Joy Hsu¹⁰, Kamal Bharucha¹¹, Sunethra Wimalasundera¹², Alysha K. Kadva¹³, Ruchi Upmanyu¹², Navita L. Mallalieu¹⁰, Daniel Lovell⁶ and Fabrizio De Benedetti¹⁴, ¹Rheumatology, PRCSG, Cincinnati, OH, ²PRINTO Coordinating Centre, Genoa, Italy, ³Bristol Royal Hospital for Children, Bristol, United Kingdom, ⁴Hospital Gral de Niños Pedro Elizalde, Buenos Aires, Argentina, ⁵Hackensack University Medical Center, Hackensack, NJ, ⁶PRCSG, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ⁷University of Calgary, Alberta Children's Hospital, Calgary, AB, Canada, ⁸Hospital Sant Joan de Deu, Barcelona, Spain, ⁹Charité – University of Medicine Berlin, Berlin, Germany, ¹⁰Roche Innovation Center, New York, NY, ¹¹Genentech, South San Francisco, CA, ¹²Roche Products Ltd., Welwyn Garden City, United Kingdom, ¹³Genentech, San Francisco, CA, ¹⁴IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy
Background/Purpose: The efficacy and safety of intravenous (IV) tocilizumab (TCZ), an interleukin-6 receptor-alpha inhibitor, have been demonstrated in patients (pts) with polyarticular-course juvenile idiopathic…
Abstract Number: 5L • 2016 ACR/ARHP Annual Meeting
Speed of Remission with the Use of Voclosporin, MMF and Low Dose Steroids: Results of a Global Lupus Nephritis Study
Mary Anne Dooley¹, William Pendergraft III², Ellen M. Ginzler³, Nancy J. Olsen⁴, James Tumlin⁵, Brad H. Rovin⁶, Frédéric A. Houssiau⁷, David Wofsy⁸, David A. Isenberg⁹, Neil Solomons¹⁰, Robert Huizinga¹¹ and AURA Study Group, ¹Dooley Rheumatology, Chapel Hill Doctors, Chapel Hill, NC, ²Kidney Center, University of North Carolina, Chapel Hill, NC, ³Rheumatology, SUNY Downstate Medical Center, Brooklyn, NY, ⁴Medicine/Rheumatology, Penn State Hershey Medical Center, Hershey, PA, ⁵Nephrology, University of Tennessee College of Medicine, Chattanooga, TN, ⁶Ohio State University Medical Center, Columbus, OH, ⁷Rheumatology, Pôle de Maladies Rhumatismales, Université catholique de Louvain, Brussels, Belgium, ⁸Rheumatology, University of California, San Francisco, San Francisco, CA, ⁹Centre for Rheumatology Research, University College Hospital London, UK, London, United Kingdom, ¹⁰Aurinia Pharmaceuticals Inc., Victoria, BC, Canada, ¹¹Clinical Affairs, Aurinia Pharmaceuticals Inc., Victoria, BC, Canada
Background/Purpose: Voclosporin (VCS) is a novel CNI intended for use in the treatment of autoimmune diseases such as lupus nephritis. VCS’s unique structure allows for…
Abstract Number: 6L • 2016 ACR/ARHP Annual Meeting
Myeloablative Autologous Transplantation of CD34+ -Selected Hematopoietic Stem Cells (HSCT) Vs Monthly Intravenous Cyclophosphamide (CYC) for Severe Scleroderma with Internal Organ Involvement: Outcomes of a Randomized North American Clinical Trial
Keith Sullivan¹, Lynette Keyes-Elstein², Peter McSweeney³, Ashley Pinckney², Beverly Welch⁴, Maureen D Mayes⁵, Richard Nash³, Leslie J. Crofford⁶, Sharon Castina², Linda Griffith⁷, Ellen Goldmuntz⁸ and Daniel E. Furst⁹, ¹Duke University, Durham, NC, ²Rho, Inc, Chapel Hill, NC, ³Colorado Blood Cancer Institute, Denver, CO, ⁴6610 Rockledge Dr., NIAID/NIH, Bethesda, MD, ⁵Department of Internal Medicine - Rheumatology, University of Texas-McGovern Medical School, Houston, TX, ⁶Medicine, Vanderbilt University Medical Center, Nasville, TN, ⁷NIAID, NIH, Bethesda, MD, ⁸NIAID, National Institutes of Health, Bethesda, MD, ⁹David Geffen School of Medicine at UCLA, Los Angeles, CA
Background/Purpose: Therapeutic options for diffuse cutaneous systemic sclerosis (dcSSc) are limited. The Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial was a multicenter study designed to…
Abstract Number: 7L • 2016 ACR/ARHP Annual Meeting
Overall Reduction in Acute Flares during Treatment with Febuxostat Compared with Placebo over 2 Years in Patients with Early Gout
Nicola Dalbeth¹, Kenneth G. Saag², William Palmer³, Hyon K. Choi³, Barbara Hunt⁴, Patricia MacDonald⁴, Ulrich Thienel⁵ and Lhanoo Gunawardhana⁴, ¹University of Auckland, Auckland, New Zealand, ²University of Alabama at Birmingham, Birmingham, AL, ³Massachusetts General Hospital/Harvard Medical School, Boston, MA, ⁴Takeda Pharmaceuticals International, Deerfield, IL, ⁵RRD International, Rockville, MD

Background/Purpose: No clinical trials have previously investigated the frequency of acute flares in early gout or the benefit of instituting urate-lowering therapy (ULT) earlier in…
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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