Abstracts tagged "clinical trials"

Abstract Number: 1909 • 2017 ACR/ARHP Annual Meeting
Long Term Safety of Filgotinib in the Treatment of Rheumatoid Arthritis: Week 84 Data from a Phase 2b Open-Label Extension Study
Mark C. Genovese¹, Arthur Kavanaugh², Kevin Winthrop³, Maria Greenwald⁴, Lucia Ponce⁵, Favio Enriquez Sosa⁶, Mykola Stanislavchuk⁷, Minodora Mazur⁸, Alberto Spindler⁹, Regina Cseuz¹⁰, Natalya Nikulenkova¹¹, Maria Glowacka-Kulesz¹², Istvan Szombati¹³, Anna Dudek¹⁴, Neelufar Mozaffarian¹⁵, Joy Greer¹⁵, Xiao Ding¹⁵, Pille Harrison¹⁶, Annegret Van der Aa¹⁶, René Westhovens¹⁷ and Rieke Alten¹⁸, ¹Stanford University Medical Center, Palo Alto, CA, ²Medicine, University of California, San Diego, La Jolla, CA, ³Oregon Health Sciences University, Portland, OR, ⁴Desert Medical Advances, Palm Desert, CA, ⁵Consulta Privada Dra. Lucia Ponce, Temuco, Chile, ⁶Clinstile SA de CV, Col., Mexico City, Mexico, ⁷Vinnitsa Regional Clinical Hospital, Vinnitsa, Ukraine, ⁸IMSP Inst. de Cardiologie, Chisinau, Moldova, The Republic of, ⁹Centro Médico Privado de Reumatología, Centro Médico Privado de Reumatología, Argentina, ¹⁰Revita Reumatologiai Rendelo, Budapest, Hungary, ¹¹Vladimir Reg Clin Hosp, Vladimir, Russian Federation, ¹²Silesiana Centrum Medyczne, Wroclawska, Poland, ¹³QUALICLINIC Kft., Budapest, Hungary, ¹⁴Centrum Medyczne AMED Warszawa Targówek, Warszawa, Poland, ¹⁵Gilead Sciences, Inc, Foster City, CA, ¹⁶Galapagos NV, Mechelen, Belgium, ¹⁷KU Leuven Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, Leuven, Belgium, ¹⁸Internal Medicine, Rheumatology & Clinical Immunology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany
Background/Purpose: Filgotinib is an orally administered, selective inhibitor of Janus Kinase 1 (JAK1) currently in Phase 3 development for the treatment of rheumatoid arthritis (RA).…
Abstract Number: 535 • 2017 ACR/ARHP Annual Meeting
Effect of a Step-up or Step-Down in Tofacitinib Dose on Efficacy and Safety in Long-Term Extension Studies
Ruediger Mueller¹, Hendrik Schulze-Koops², Daniel E Furst³, Stanley B Cohen⁴, Kenneth Kwok⁵, Anna Maniccia⁵, Lisy Wang⁶, Ermeg Akylbekova⁷ and Johannes von Kempis¹, ¹Kantonsspital St. Gallen, St. Gallen, Switzerland, ²Klinikum der Universität München, Munich, Germany, ³UCLA, Los Angeles, CA, ⁴Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ⁵Pfizer Inc, New York, NY, ⁶Pfizer Inc, Groton, CT, ⁷QuintilesIMS, Durham, NC
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. Efficacy and safety of tofacitinib 5 and 10 mg BID have been…
Abstract Number: 2074 • 2017 ACR/ARHP Annual Meeting
A Series of Double-Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Studies to Evaluate the Efficacy, Safety, and Dose-Response Relationship of Orally Administered URC102, a Novel URAT1 Inhibitor, in Korean Patients with Gout
Jae-Bum Jun¹, Howard Lee², Chang-Hee Suh³, Chang Keun Lee⁴, Dong Wook Kim⁵, Jung-Yoon Choe⁶, Sang-Heon Lee⁷, Sang-Hyon Kim⁸, Seung-Jae Hong⁹, So-Young Bang¹⁰, Sung Jae Choi¹¹, Yong-Beom Park¹², Makoto Onohara¹³, Jeongeun Choi¹⁴, Jung Soo Song¹⁵ and Won Park¹⁶, ¹Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), ²Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea, Republic of (South), ³Ajou University School of Medicine, Suwon, Korea, Republic of (South), ⁴Division of Rheumatology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea, Republic of (South), ⁵Division of Rheumatology, Department of Internal Medicine, Inje University College of Medicine, Busan, Korea, Republic of (South), ⁶Division of Rheumatology, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea, Republic of (South), ⁷Division of Rheumatology, Department of Internal Medicine,, Konkuk University School of Medicine, Seoul, Korea, Republic of (South), ⁸Division of Rheumatology, Department of Internal Medicine, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea, Daegu, Korea, Republic of (South), ⁹Department of Rheumatology, Kyung Hee University Medical Center, Seoul, Korea, Republic of (South), ¹⁰Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), ¹¹Internal Medicine, Korea University Medical Center, Seoul, Korea, Republic of (South), ¹²Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea, Republic of (South), ¹³Science and Strategy, Translational Clinical Research, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan, ¹⁴JW Pharmaceutical Corporation, Seoul, Korea, Republic of (South), ¹⁵Rheumatology, Chung-Ang University College of Medicine, Seoul, Korea, Republic of (South), ¹⁶Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South)
Background/Purpose: URC102 is a novel URAT1 inhibitor under clinical development for the treatment of hyperuricemia with gout. A series of double-blind, placebo-controlled, randomized, multicenter, phase…
Abstract Number: 725 • 2017 ACR/ARHP Annual Meeting
Safety and Efficacy of Anabasum (JBT-101) in Diffuse Cutaneous Systemic Sclerosis (dcSSc) Subjects Treated in an Open-Label Extension of Trial JBT101-SSc-001
Robert F. Spiera¹, Laura K. Hummers², Lorinda Chung³, Tracy M. Frech⁴, Robyn T. Domsic⁵, Vivien Hsu⁶, Daniel E. Furst⁷, Jessica K. Gordon¹, Maureen D. Mayes⁸, Robert W. Simms⁹, Scott Constantine¹⁰ and Barbara White¹⁰, ¹Rheumatology, Hospital for Special Surgery, New York, NY, ²Medical and Rheumatology, Johns Hopkins University, Baltimore, MD, ³Rheumatology, Stanford University Medical Center, Palo Alto, CA, ⁴Division of Rheumatology, University of Utah, Salt Lake City, UT, ⁵Medicine - Rheumatology, University of Pittsburgh, Pittsburgh, PA, ⁶Rheumatology, Robert Wood Johnson University Scleroderma Program, New Brunswick, NJ, ⁷David Geffen School of Medicine at UCLA, Los Angeles, CA, ⁸Internal Medicine/Rheumatology, University of Texas Health Science Center at Houston, Houston, TX, ⁹Rheumatology, Boston University School of Medicine, Boston, MA, ¹⁰Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: Anabasum (JBT-101) is a selective cannabinoid receptor type 2 agonist that activates resolution of innate immune responses and limits fibrosis in animal models of…
Abstract Number: 2092 • 2017 ACR/ARHP Annual Meeting
Pilot Clinical Study of a Novel Unobtrusive Carpal Tunnel Tissue Manipulation Device in Reducing Symptoms of Carpal Tunnel Syndrome
Pauline Luong^1,2, Frank King³, Zong-Ming Li^2,4, Matt Dickason⁵, Matthew Diamond⁶ and Jae Son^1,2, ¹Pressure Profile Systems, Los Angeles, CA, ²Sohn Inc, Los Angeles, CA, ³Mission Pain and Spine Institute, Mission Viejo, CA, ⁴Biomedical Engineering, Orthopaedic Surgery, and Physical Medicine & Rehabilitatio, Cleveland Clinic, Cleveland, OH, ⁵Renaissance Associates, Newport Beach, CA, ⁶Rusk Institute of Rehabilitation Medicine, NYU School of Medicine, San Francisco, CA
Background/Purpose: Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and has been associated with systemic conditions such as rheumatoid arthritis, hypothyroidism, and…
Abstract Number: 726 • 2017 ACR/ARHP Annual Meeting
Performance of the American College of Rheumatology Provisional Composite Response Index in Systemic Sclerosis (CRISS) in the Scleroderma Lung Study-I
Dinesh Khanna¹, Donald P. Tashkin², Holly Wilhalme² and Chi-hong Tseng³, ¹University of Michigan, Ann Arbor, MI, ²University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, ³Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA
Background/Purpose: The CRISS has been proposed as a composite outcome measure for trials in systemic sclerosis1. CRISS is a 2-step process that assigns a probability…
Abstract Number: 2156 • 2017 ACR/ARHP Annual Meeting
Comparison of Patients with Dermatomyositis in a Specialty Clinic Versus Clinical Trial with Anabasum (JBT-101), a Cannabinoid Receptor Type 2 Agonist
Victoria P Werth¹, Emily Hejazi², Sandra M. Pena³, Jessica S. Haber⁴, Joyce Okawa³, Rui Feng⁵, Kirubel Gabre², Josef Concha², Scott Constantine⁶ and Barbara White⁶, ¹University of Pennsylvania and the VA Medical Center, Philadelphia, PA, ²University of Pennsylvania, Philadelphia, PA, ³Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁴Department of Dermatology, University of Pennsylvania, Philadelphia, PA, ⁵Department of Biostatistics and Epidemiology at the Hospital of the University of Pennsylvania, Philadelphia, PA, ⁶Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: There are limited treatment options and no published double-blind randomized placebo-controlled trials for the treatment of skin manifestations of dermatomyositis (DM). There is no…
Abstract Number: 738 • 2017 ACR/ARHP Annual Meeting
Prospective Validation of the Systemic Sclerosis Skin Symptoms Patient-Reported Outcome (SSPRO) in a Phase 2 Trial of Anabasum (JBT-101) in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Ada Man¹, Nancy Dgetluck² and Barbara White³, ¹Rheumatology, University of Manitoba, Winnipeg, MB, Canada, ²Biostatistics, Corbus Pharmaceuticals, Norwood, MA, ³Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: Skin thickening is the defining manifestation of dcSSc. A dcSSc patient’s assessment of their skin involvement can provide information about how that patient feels…
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: 885 • 2017 ACR/ARHP Annual Meeting
48-Week Complete Remission By Ethnic, Sex and Age Subgroups in Patients with Active Lupus Nephritis Treated with Voclosporin
David Wofsy¹, David A. Isenberg², Frédéric A. Houssiau³, Mary Anne Dooley⁴, Neil Solomons⁵ and Simrat Randhawa⁶, ¹Rheumatology, UCSF, San Francisco, CA, ²Centre for Rheumatology Research, Division of Medicine, University College London, London, United Kingdom, ³Rheumatology, Pôle de Maladies Rhumatismales, Université catholique de Louvain, Brussels, Belgium, ⁴UNC Kidney Centre, Chapel Hill, NC, ⁵Aurinia Pharmaceuticals Inc., Victoria, BC, Canada, ⁶Medical Affairs, Aurinia Pharmaceuticals, Victoria, BC, Canada
Background/Purpose: Voclosporin (VCS) is a novel CNI with a favorable metabolic profile, no observed effect on electrolytes, and a predictable dose response potentially eliminating the…
Abstract Number: 2884 • 2017 ACR/ARHP Annual Meeting
A Phase 2 Study of Safety and Efficacy of Anabasum (JBT-101), a Cannabinoid Receptor Type 2 Agonist, in Diffuse Cutaneous Systemic Sclerosis
Robert F. Spiera¹, Laura K. Hummers², Lorinda Chung³, Tracy M. Frech⁴, Robyn T. Domsic⁵, Vivien Hsu⁶, Daniel E. Furst⁷, Jessica K. Gordon¹, Maureen D. Mayes⁸, Robert W. Simms⁹, Scott Constantine¹⁰ and Barbara White¹⁰, ¹Rheumatology, Hospital for Special Surgery, New York, NY, ²Medical and Rheumatology, Johns Hopkins University, Baltimore, MD, ³Rheumatology, Stanford University Medical Center, Palo Alto, CA, ⁴Division of Rheumatology, University of Utah, Salt Lake City, UT, ⁵Rheumatology, University of Pittsburgh, Pittsburgh, PA, ⁶Rheumatology, Robert Wood Johnson University Scleroderma Program, New Brunswick, NJ, ⁷David Geffen School of Medicine at UCLA, Los Angeles, CA, ⁸University of Texas McGovern Medical School, Houston, TX, ⁹Rheumatology, Boston University School of Medicine, Boston, MA, ¹⁰Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: Systemic sclerosis (SSc) is characterized in part by chronic activation of the innate immune system with fibrosis. Anabasum is a non-immunosuppressive, synthetic, orally administered…
Abstract Number: 891 • 2017 ACR/ARHP Annual Meeting
Long-Term Efficacy and Safety of Tocilizumab in Patients with Refractory Takayasu Arteritis Treated Continuously over 52 Weeks: Results from Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial and Open-Label Extension 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, ²Sakakibara Heart Institute, Tokyo, Japan, ³Pediatrics of Developmental Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan, ⁴The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Japan, ⁶Laboratory of Pediatric Research, Institute of Medical Science, Tokyo Medical University, Tokyo, Japan, ⁷Chugai Pharmaceutical Co., Ltd., Tokyo, Japan, ⁸Department of Molecular Regulation for Intractable Disease, Institute of Medical Science, Tokyo Medical University, Tokyo, Japan
Background/Purpose: Tocilizumab (TCZ), a humanized anti–IL-6 receptor antibody, showed a favorable trend toward relapse suppression in patients (pts) with refractory Takayasu arteritis (TAK) in a…
Abstract Number: 2981 • 2017 ACR/ARHP Annual Meeting
Evaluation of American College of Rheumatology Provisional Composite Response Index in Systemic Sclerosis (CRISS) in the Fasscinate Trial
Dinesh Khanna¹, Veronica J. Berrocal², Christopher Denton³, Angelika Jahreis⁴, Helen Spotswood⁵, Celia J. F. Lin⁴, Jeffrey Siegel⁶ and Daniel E. Furst⁷, ¹University of Michigan, Ann Arbor, MI, ²Div of Rheumatology, University of Michigan, Ann Arbor, MI, ³Department of Rheumatology, University College London, Royal Free Hospital, London, United Kingdom, ⁴Genentech, South San Francisco, CA, ⁵Roche Products Ltd., Welwyn Garden City, CA, United Kingdom, ⁶Roche Products Ltd., Welwyn Garden City, United Kingdom, ⁷University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA
Background/Purpose: Treatment with Interleukin-6R inhibitor, tocilizumab (TCZ), in early progressive systemic sclerosis (SSc; the faSScinate trial) resulted in consistent, but not statistically significant, improvements in…

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