Abstracts tagged "clinical trials"

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: 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: 1052 • 2016 ACR/ARHP Annual Meeting
Longitudinal Patterns in SLE Response to Standard of Care Therapy: Implications for SLE Clinical Trial Design
Mimi Kim¹, Joan T Merrill², Kenneth Kalunian³, Bevra H. Hahn⁴, Anita Roach⁵, Peter M. Izmirly⁶ and the Lupus Foundation of America Collective Data Analysis Initiative Group., ¹Biostatistics and Research Design Resource, Albert Einstein Coll Med, Bronx, NY, ²OMRF, Oklahoma, OK, ³Center for Innovative Therapy, UCSD School of Medicine, La Jolla, CA, ⁴Division of Rheumatology, UCLA David Geffen School of Medicine, Los Angeles, CA, ⁵Education & Research, Lupus Foundation of America, Washington, DC, ⁶New York University School of Medicine, New York, NY
Background/Purpose: Most clinical trials of new treatments for systemic lupus erythematosus (SLE) have shown weak discrimination between investigational agents and placebo when added to standard…
Abstract Number: 321 • 2016 ACR/ARHP Annual Meeting
Results of a Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Romosozumab in Men with Osteoporosis
EM Lewiecki¹, S Horlait², T Blicharski³, S Goemaere⁴, K Lippuner⁵, P Meisner⁶, PD Miller⁷, A Miyauchi⁸, J Maddox⁹, NS Daizadeh⁹ and A Grauer⁹, ¹New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, ²Amgen Ltd., Uxbridge, United Kingdom, ³Medical University of Lublin, Lublin, Poland, ⁴Ghent University Hospital, Gent, Belgium, ⁵Bern University Hospital, Bern, Switzerland, ⁶UCB Pharma, Brussels, Belgium, ⁷Colorado Center for Bone Research, Lakewood, CO, ⁸Miyauchi Medical Center, Osaka, Japan, ⁹Amgen Inc., Thousand Oaks, CA
Background/Purpose: Treatment with romosozumab (Romo) has been shown to rapidly increase BMD in postmenopausal women with low BMD through a dual effect on bone, increasing…
Abstract Number: 1588 • 2016 ACR/ARHP Annual Meeting
Treatment with BI 655064 (Antagonistic Anti-CD40 Antibody) Modulates Clinical and Biomarker Parameters Associated with Rheumatoid Arthritis (RA)
Sudha Visvanathan¹, Meera Ramanujam¹, Corinna Schoelch², Patrick Baum², Richard Vinisko¹, Ralf Thiedmann², Ulf Müller-Ladner³, Stefan Daniluk⁴, Rafal Ptaszyński⁵, Steven Padula⁶, Jay S. Fine¹ and Jürgen Steffgen², ¹Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, ²Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, ³Giessen University, Kerckhoff-Klinik, Bad-Nauheim, Germany, ⁴ClinicMed Badurski and Partners, Bialystok, Poland, ⁵Rheumatica, Warsaw, Poland, ⁶Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
Background/Purpose: Costimulation through the CD40–CD40L axis is implicated in the pathogenesis of RA including T cell-mediated responses, B cell-driven autoantibodies, adhesion molecule expression, synovial hyperplasia…
Abstract Number: 323 • 2016 ACR/ARHP Annual Meeting
Effect of 10 Years of Denosumab Treatment on Bone Histology and Histomorphometry in the Freedom Extension Study
David W Dempster^1,2, NS Daizadeh³, A Fahrleitner-Pammer⁴, Jens-Erik Beck Jensen⁵, DL Kendler⁶, Ivo Valter⁷, Rachel B Wagman³, Susan Yue³ and Jacques P Brown⁸, ¹Columbia University, New York, NY, ²Helen Hayes Hospital, West Haverstraw, NY, ³Amgen Inc., Thousand Oaks, CA, ⁴Medical University, Graz, Austria, ⁵Hvidovre University Hospital, Hvidovre, Denmark, ⁶University of British Columbia, Vancouver, BC, Canada, ⁷Center for Clinical and Basic Research, Tallinn, Estonia, ⁸Centre Hospitalier de l'Université Laval (CHUL), Quebec City, QC, Canada
Background/Purpose: Denosumab (DMAb) has been associated with low incidence of spine and non-spine, including hip, fractures through 10 years of treatment (Bone ASBMR 2015). Questions…
Abstract Number: 1653 • 2016 ACR/ARHP Annual Meeting
Delineating the Effects of Rheumatoid Arthritis Pharmacotherapies on Vascular Inflammation: Rationale and Design of a Clinical Trial
Jon T. Giles¹, Katherine Liao², Nina Paynter³, Alyssa Wohlfahrt⁴, Afshin Zartoshti⁵, Rachel Broderick⁶, Daniel H. Solomon⁷ and Joan Bathon⁶, ¹Division of Rheumatology, Columbia University, College of Physicians & Surgeons, New York, NY, ²Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, Boston, MA, ³Medicine, Harvard University, Boston, MA, ⁴Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ⁵Rheumatology, Columbia University, College of Physicians & Surgeons, New York city, NY, ⁶Rheumatology, Columbia University, College of Physicians & Surgeons, New York, NY, ⁷Division of Rheumatology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
Background/Purpose: Rheumatoid arthritis is associated with an excess cardiovascular disease (CVD) burden. Fewer CVD events associated with specific DMARD therapies have been reported; however, causal…
Abstract Number: 642 • 2016 ACR/ARHP Annual Meeting
Quality of Life Outcomes Following Therapy with Chs-0214 and Etanercept (Enbrel): Randomized, Double-Blind Study in Subjects with Rheumatoid Arthritis
Alan J. Kivitz^1,2, James R. O'Dell³, Tsutomu Takeuchi⁴, Yoshiya Tanaka⁵, Satoshi Nakashima⁶, Cass Kelleher⁷, Jennifer Hodge⁸, Barbara Finck⁷ and RApsody Study Group, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Altoona Arthritis & Osteoporosis Center, Duncansville, PA, ³Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, ⁴Division of Rheumatology, Department of Internal Medicine,, Keio University School of Medicine, Tokyo, Japan, ⁵The First Department of Internal Medicine,, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁶Daiishi Sankyo, Shinagawa-Ku Tokyo, Japan, ⁷Clinical Science, Coherus BioSciences, Redwood City, CA, ⁸Coherus BioSciences, Redwood City, CA
Background/Purpose: CHS-0214 is in development as a proposed biosimilar of etanercept. This Phase III confirmatory, safety and efficacy study randomized and dosed 644 subjects with…
Abstract Number: 1704 • 2016 ACR/ARHP Annual Meeting
Consistent Safety and Tolerability of Secukinumab over Long-Term Exposure in Patients with Active Psoriatic Arthritis and Moderate to Severe Plaque Psoriasis: Updated Pooled Safety Analyses
Philip J Mease¹, Iain B McInnes², Kristian Reich³, Mats Andersson⁴, Aiyang Tao⁵, Todd Fox⁴ and Chetan Karyekar⁵, ¹Swedish Medical Center and University of Washington, Seattle, WA, ²University of Glasgow, Glasgow, Great Britain, ³Dermatologikum Hamburg and Georg-August-University Göttingen, Hamburg, Germany, ⁴Novartis Pharma AG, Basel, Switzerland, ⁵Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: Pooled safety data from the psoriasis (PsO) and psoriatic arthritis (PsA) clinical trial programs of secukinumab (SEC), through approximately 1 year, have been reported…
Abstract Number: 643 • 2016 ACR/ARHP Annual Meeting
Exposure-Response Analyses of Efficacy of ABT-122, a Dual-Variable Domain Immunoglobulin (DVD-Ig™) Targeting TNF-α and IL-17A, Compared with Adalimumab in Subjects with Rheumatoid Arthritis and Background MTX
Amit Khatri¹, Ben Klunder², Mukul Minocha³, Heikki T. Mansikka¹ and Ahmed A. Othman¹, ¹AbbVie Inc., North Chicago, IL, ²AbbVie, Ludwigshafen am Rhein, Germany, ³Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL
Background/Purpose: ABT-122 is a novel dual-variable domain immunoglobulin (DVD-IgTM), which specifically neutralizes both TNF alpha (TNFα) and interleukin-17A (IL-17). Both cytokines are expressed at increased…

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