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Abstracts tagged "clinical trials"

  • Abstract Number: 478 • 2018 ACR/ARHP Annual Meeting

    Evidence Based Recommendations for Corticosteroid Tapering/Discontinuation in New Onset Juvenile Dermatomyositis Patients: Results from the Paediatric Rheumatology International Trials Organisation

    Gabriella Giancane1, Claudio Lavarello2, Angela Pistorio2, Francesco Zulian2, Bo Magnusson3, Tadej Avcin2, Fabrizia Corona2, Valeria Gerloni2, Serena Pastore2, Roberto Marini2, Silvana Martino2, Anne Pagnier4, Michel Rodiere2, Christine Soler2, Valda Stanevicha2, Rebecca ten Cate2, Yosef Uziel2, Jelena Vojinovic2, Elena Fueri2, Angelo Ravelli5, Alberto Martini6 and Nicola Ruperto7, 1Clinica Pediatrica - Reumatologia, Istituto Giannina Gaslini, Genoa, Italy, 2Istituto Giannina Gaslini - Clinica Pediatrica e Reumatologia - PRINTO, Genoa, Italy, 3Karolinska University Hospital, Stockholm, Sweden, 4Istituto Giannina Gaslini - Clinica Pediatrica e Reumatologia - PRINTO, Genova, Italy, 5Clinica Pediatrica - Reumatologia, Istituto Giannina Gaslini, Genova, Italy, 6Universita di Genova Pediatria II, Genova, Italy, 7Istituto Giannina Gaslini - Clinica Pediatrica e Reumatologia, Genoa, Italy

    Background/Purpose: At present no clear evidence based guidelines exist to standardize the tapering and discontinuation of corticosteroids (CS) in juvenile dermatomyositis (JDM). Aim of our…
  • Abstract Number: 2284 • 2018 ACR/ARHP Annual Meeting

    Safety and Efficacy of Lenabasum in Refractory Skin-Predominant Dermatomyositis Subjects Treated on an Open-Label Extension of Trial JBT101-DM-001

    Victoria P. Werth1,2, David Pearson1,2, Joyce Okawa1,2, Rui Feng3, Josef Concha1,2, Basil Patel1,2, Emily Hejazi1,2, Caitlin Cornwall4, Scott Constantine4 and Barbara White4, 1University of Pennsylvania, Philadelphia, PA, 2Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, 3University of Pennsylvania, Philadelphia', PA, 4Corbus Pharmaceuticals, Inc., Norwood, MA

    Background/Purpose: Lenabasum is a synthetic, non-immunosuppressive, selective cannabinoid receptor type 2 agonist that activates resolution of innate immune responses. Lenabasum had acceptable safety and tolerability…
  • Abstract Number: 662 • 2018 ACR/ARHP Annual Meeting

    Radiographic Progression of Structural Joint Damage in Patients with Active Psoriatic Arthritis Treated with Ixekizumab for up to 3 Years

    Désirée van der Heijde1, Vinod Chandran2, Roy Fleischmann3, Olivier Benichou4, Suchitrita Rathmann4 and Catherine Shuler4, 1Leiden University Medical Centre, Leiden, Netherlands, 2Krembil Research Institute & University of Toronto, Toronto, ON, Canada, 3University of Texas Southwestern Medical Center, Dallas, TX, 4Eli Lilly and Company, Indianapolis, IN

    Background/Purpose: Ixekizumab (IXE), an IL-17A antagonist, was shown to be superior to placebo (PBO) in inhibiting the progression of structural joint damage in patients (pts)…
  • Abstract Number: 2356 • 2018 ACR/ARHP Annual Meeting

    Perceptions, Incentives, and Barriers to Clinical Trial Participation: Qualitative Evaluation of Lupus Patients, Enriched for Minority Participants

    Cristina Arriens1, Fredonna Carthen2, D'Angelo Grant2, Paul Kamp1, Stan Kamp1, Katherine Thanou1, Teresa Aberle1, Eliza Chakravarty1, Judith A. James3, Joan T. Merrill1 and Motolani E. Ogunsanya4, 1Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, 2Arthritis & Clinical Immunology, Oklahoma Medical Research Foundation, OKLAHOMA CITY, OK, 3Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, 4College of Pharmacy, University of Oklahoma Health Sciences Center, Oklahoma City, OK

    Background/Purpose: Although SLE disproportionately affects minority racial groups, they are significantly under-represented in clinical trials. This may lead to false, underpowered conclusions in race-based sub-group…
  • Abstract Number: 7L • 2017 ACR/ARHP Annual Meeting

    A Phase 2 Study of Safety and Efficacy of Anabasum (JBT-101), a Cannabinoid Receptor Type 2 Agonist, in Refractory Skin-Predominant Dermatomyositis

    Victoria P. Werth1, Emily Hejazi2, Sandra M. Pena1, Jessica S. Haber3, Joyce Okawa1, Rui Feng4, Kirubel Gabre2, Josef Concha2, Caitlin Cornwall5, Nancy Dgetluck6, Scott Constantine5 and Barbara White5, 1Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, 2University of Pennsylvania, Philadelphia, PA, 3Department of Dermatology, University of Pennsylvania, Philadelphia, PA, 4Department of Biostatistics and Epidemiology at the Hospital of the University of Pennsylvania, Philadelphia, PA, 5Corbus Pharmaceuticals, Inc., Norwood, MA, 6Biostatistics, Corbus Pharmaceuticals, Inc., Norwood, MA

    Background/Purpose: Effective treatment options are limited for refractory skin disease in dermatomyositis (DM). Anabasum is a non-immunosuppressive, synthetic, oral preferential CB2 agonist that triggers resolution…
  • Abstract Number: 13L • 2017 ACR/ARHP Annual Meeting

    Significant, Sustained Improvement in Knee Function after Intra-Articular TPX-100: A Double-Blind, Randomized, Multi-Center, Placebo-Controlled Phase 2 Trial

    Dawn McGuire1, Nancy E Lane2, Neil Segal3, Samy Metyas4, Hans Richard Barthel5, Meghan Miller1, David Rosen1 and Yoshi Kumagai1, 1OrthoTrophix, Inc, Oakland, CA, 2UC Davis Medical Center, Sacramento, CA, 3University of Kansas, Shawnee, KS, 4Medvin Clinical Research, Covina, CA, 5Barthel Clinic, Santa Barbara, CA

    Background/Purpose: The current Phase 2 study was designed to evaluate safety, tolerability and preliminary efficacy of TPX-100 by IA administration in subjects with mild to…
  • 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 Maldini1,2, Alfred Mahr3, David T. Felson4,5 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…
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