Abstracts tagged "clinical trials"

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…
Abstract Number: 935 • 2017 ACR/ARHP Annual Meeting
Results from a 52 Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of a Novel, Intra-Articular, Wnt Pathway Inhibitor (SM04690) for the Treatment of Knee Osteoarthritis
Yusuf Yazici¹, Timothy E. McAlindon², Allan Gibofsky³, Nancy E. Lane⁴, Daniel J. Clauw⁵, Eddie Armas⁶, Nebojsa Skrepnik⁷, Christopher J. Swearingen¹, Anita DiFrancesco¹, Jeymi Tambiah¹ and Marc Hochberg⁸, ¹Samumed, LLC, San Diego, CA, ²Division of Rheumatology, Tufts Medical Center, Boston, MA, ³Rheumatology, Weill Cornell Medicine, and Hospital for Special Surgery, New York, NY, ⁴Center for Musculoskeletal Health, University of California at Davis, Hillsborough, CA, ⁵Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, MI, ⁶Well Pharma Medical Research, Miami, FL, ⁷Tuscon Orthopedics Institute, Tuscon, AZ, ⁸Head, Division of Rheumatology & Clinical Immunology; Vice Chair, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD
Background/Purpose: Knee osteoarthritis (OA) is characterized by pain, disability and joint deformity due to articular cartilage degradation and bone remodeling. Wnt signaling is involved in…
Abstract Number: 2983 • 2017 ACR/ARHP Annual Meeting
Predictors for Disease Worsening Defined By Organ Failure in Diffuse Systemic Sclerosis: A European Scleroderma Trials and Research (EUSTAR) Analysis
Mike Oliver Becker¹, Nicole Graf², Rafael Sauter³, Yannick Allanore⁴, John Curram⁵, Christopher Denton⁶, Dinesh Khanna⁷, Marco Matucci-Cerinic⁸, Janethe Pena⁹, Janet E. Pope¹⁰ and Oliver Distler¹, ¹Department of Rheumatology, Center of Experimental Rheumatology, University Hospital Zurich, Zurich, Switzerland, ²Graf Biostatistics, Winterthur, Switzerland, ³Big Data Institute, Li Ka Shing Centre for Health Information and Discovery, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom, ⁴Department of Rheumatology, Cochin Hospital, Paris Descartes University, Paris, France, ⁵Bayer Plc, Newbury, United Kingdom, ⁶Department of Rheumatology, University College London, Royal Free Hospital, London, United Kingdom, ⁷University of Michigan, Ann Arbor, MI, ⁸Dept of Medicine/Div of Rheum, University of Florence, Florence, Italy, ⁹Bayer HealthCare Pharmaceuticals Inc, Whippany, NJ, ¹⁰Department of Medicine, Division of Rheumatology, University of Western Ontario, St Joseph's Health Care, London, ON, Canada
Background/Purpose: Mortality and worsening of organ function would be desirable endpoints for clinical trials in systemic sclerosis (SSc). However, these events are relatively rare, making…
Abstract Number: 1201 • 2017 ACR/ARHP Annual Meeting
Reducing Heterogeneity in OA Clinical Trials: Data from a Phase 2 Study of SM04690, a Novel, Intra-Articular, Wnt Pathway Inhibitor in Knee Osteoarthritis
Philip G. Conaghan¹, Anita DiFrancesco², Christopher J. Swearingen², Sarah Kennedy², Ismail Simsek², Jeymi Tambiah² and Yusuf Yazici², ¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ²Samumed, LLC, San Diego, CA
Background/Purpose: Kellgren-Lawrence [KL] radiographic grading is used to classify knee osteoarthritis (OA), but may not accurately reflect disease progression. Classifying subjects by baseline medial joint…
Abstract Number: 1204 • 2017 ACR/ARHP Annual Meeting
Radiographic Outcomes Were Associated with Pain and Function Responses: Post-Hoc Analysis of Results from a Phase 2 Study of a Small Molecule Wnt Pathway Inhibitor, SM04690, for Knee Osteoarthritis Treatment
Yusuf Yazici¹, Timothy E. McAlindon², Allan Gibofsky³, Nancy E. Lane⁴, Nebojsa Skrepnik⁵, Eddie Armas⁶, Christopher J. Swearingen¹, Anita DiFrancesco¹, Jeymi Tambiah¹ and Marc Hochberg⁷, ¹Samumed, LLC, San Diego, CA, ²Division of Rheumatology, Tufts Medical Center, Boston, MA, ³Rheumatology, Weill Cornell Medicine, and Hospital for Special Surgery, New York, NY, ⁴Center for Musculoskeletal Health, University of California, Davis School of Medicine, Sacramento, CA, ⁵Tuscon Orthopedics Institute, Tuscon, AZ, ⁶Well Pharma Medical Research, Miami, FL, ⁷Head, Division of Rheumatology & Clinical Immunology; Vice Chair, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD
Background/Purpose: Knee osteoarthritis (OA) is characterized by pain, disability and joint deformity due to articular cartilage degradation and bone remodeling. Wnt signaling is involved in…
Abstract Number: 1676 • 2017 ACR/ARHP Annual Meeting
Improving Sensitivity to Change of the Modified Rodnan Skin Score over Time
Annel M. Fernandez¹, Robert F. Spiera², Jackie Szymonifka² and Jessica K. Gordon², ¹Medicine- Rheumatology/ Research, Hospital For Special Surgery, New York, NY, ²Rheumatology, Hospital for Special Surgery, New York, NY
Background/Purpose: The Modified Rodnan Skin Score (MRSS) assesses global dermal thickness through the examination of 17 body areas scored by clinical palpation using a 4…
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…

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