Abstracts tagged "clinical trials"

Abstract Number: 1827 • 2017 ACR/ARHP Annual Meeting
Comparison of Ixekizumab and Ustekinumab Efficacy in the Treatment of Nail Lesions of Patients with Moderate-to-Severe Plaque Psoriasis: 24-Week Data from a Phase 3 Trial
Pierre-Dominique Ghislain¹, Curdin Conrad², Yves Dutronc³, Carsten Henneges³, David Sandoval Calderon³, Myriam Vincent³, Liesbet Ghys³, Jolien de Gruijter³ and Peter C M van de Kerkhof⁴, ¹Cliniques Universitaires Saint-Luc, Brussels, Belgium, ²Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, ³Eli Lilly and Company, Indianapolis, IN, ⁴Department of Dermatology, Radboud University Nijmegen Medical Center, Nijmegen, Netherlands
Background/Purpose: Nails are frequently involved in psoriasis and represent one of the most difficult to treat manifestations of the disease. This study evaluated the comparative…
Abstract Number: 1839 • 2017 ACR/ARHP Annual Meeting
Development and Validation of a Novel Evidence-Based Lupus Multivariable Outcome Score for Clinical Trials
Michal Abrahamowicz¹, John M. Esdaile², Rosalind Ramsey-Goldman³, Lee S. Simon⁴, Vibeke Strand⁵ and Peter E. Lipsky⁶, ¹Departmernt of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada, ²Arthritis Research Canada, Richmond, BC, Canada, ³FSM, Northwestern University, Chicago, IL, ⁴SDG LLC Consulting, West Newton, MA, ⁵Stanford University, Palo Alto, CA, ⁶AMPEL BioSolutions, LLC, Charlottesville, VA
Background/Purpose: Randomized controlled trials (RCTs) of new SLE treatments are hampered by the lack of effective outcome measures that are responsive to change and clinically…
Abstract Number: 318 • 2017 ACR/ARHP Annual Meeting
A Randomized Alendronate-Controlled Trial of Romosozumab: Results of the Phase 3 Active-Controlled Fracture Study in Postmenopausal Women with Osteoporosis at High Risk
Kenneth Saag¹, Jeffrey Petersen², Maria Luisa Brandi³, Andrew Karaplis⁴, Mattias Lorentzon⁵, Thierry Thomas⁶, Judy Maddox², Michelle Fan², Paul D. Meisner⁷ and Andreas Grauer², ¹University of Alabama, Birmingham, AL, ²Amgen Inc., Thousand Oaks, CA, ³University of Florence, Florence, Italy, ⁴McGill University, Montreal, QC, Canada, ⁵University of Gothenburg and Sahlgrenska University Hospital, Mölndal, Sweden, ⁶CHU de Saint-Étienne, Saint-Étienne, France, ⁷UCB Pharma, Brussels, Belgium
Background/Purpose: The bone forming agent romosozumab (Romo) was previously shown to reduce vertebral and clinical fractures in postmenopausal women with osteoporosis. Here we report the…
Abstract Number: 1886 • 2017 ACR/ARHP Annual Meeting
Continued Fracture Risk Reduction after 12 Months of Romosozumab Followed By Denosumab through 36 Months in the Extension of the Phase 3 Fracture Study in Postmenopausal Women with Osteoporosis
E Michael Lewiecki¹, Rajani V Dinavahi², Marise Lazaretti-Castro³, Peter R Ebeling⁴, J Adachi⁵, Akimitsu Miyauchi⁶, Evelien Gielen⁷, Cassandra E Milmont², Cesar Libanati⁸ and Andreas Grauer², ¹New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, ²Amgen Inc., Thousand Oaks, CA, ³Federal University of São Paulo, São Paulo, Brazil, ⁴Monash University, Melbourne, Australia, ⁵McMaster University, Hamilton, ON, Canada, ⁶Miyauchi Medical Center, Osaka, Japan, ⁷University Hospitals Leuven, Leuven, Belgium, ⁸UCB Pharma, Brussels, Belgium
Background/Purpose: Romosozumab (Romo) is a monoclonal antibody that binds sclerostin with a dual effect, increasing bone formation and decreasing bone resorption. In the primary analysis…
Abstract Number: 437 • 2017 ACR/ARHP Annual Meeting
Recruitment of RA Trials in the Modern Era: Are United States-Based Trials Still Feasible?
Carla Maldini^1,2, Alfred Mahr³, David T. Felson^4,5 and Michael P. LaValley⁶, ¹Internal Medicine, Hospital Saint-Louis, Paris, France, ²Rheumatology, Hospital Córdoba, Cordoba, Argentina, ³Internal Medicine, University Hospital Saint-Louis, Paris, France, ⁴Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston, MA, ⁵Arthritis Research UK Centre for Epidemiology, Institute of Inflammation and Repair, University of Manchester, Manchester, United Kingdom, ⁶Biostatistics, Boston University School of Public Health, Boston, MA
Background/Purpose: Timely recruitment of patients into interventional trials is necessary for their successful completion. The aim of this study was to evaluate recruitment rates of…
Abstract Number: 1904 • 2017 ACR/ARHP Annual Meeting
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Upadacitinib (ABT-494), a Selective JAK-1 Inhibitor, in Patients with Active Rheumatoid Arthritis with Inadequate Response to Conventional Synthetic Dmards
Gerd R. Burmester¹, Joel Kremer², Filip van Den Bosch³, Yihan Li⁴, Yijie Zhou⁴, Ahmed A. Othman⁵, Aileen L. Pangan⁴ and Heidi S. Camp⁵, ¹Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany, ²Albany Medical College, Albany, NY, ³Rheumatology, Ghent University Hospital, Gent, Belgium, ⁴AbbVie Inc., North Chicago, IL, ⁵AbbVie, North Chicago, IL
Background/Purpose: Upadacitinib (UPA) is an oral, selective JAK-1 inhibitor in development for the treatment of patients (pts) with moderate to severe rheumatoid arthritis (RA) and…
Abstract Number: 509 • 2017 ACR/ARHP Annual Meeting
Long-Term Safety and Efficacy of Upadacitinib (ABT-494), an Oral JAK-1 Inhibitor in Patients with Rheumatoid Arthritis in an Open Label Extension Study
Mark C. Genovese¹, Joel Kremer², Sheng Zhong³ and Alan Friedman³, ¹Stanford University Medical Center, Palo Alto, CA, ²Albany Medical College, Albany, NY, ³AbbVie Inc., North Chicago, IL
Background/Purpose: Upadacitinib (UPA, ABT-494) is a selective, oral JAK-1 inhibitor studied in two phase 2 randomized controlled trials (RCTs) in patients (pts) with rheumatoid arthritis…
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…

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