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Abstracts tagged "clinical trials"

  • 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: 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: 989 • 2016 ACR/ARHP Annual Meeting

    A Randomized Controlled Trial of Rheumatoid Arthritis Risk Disclosure Personalized to Genetics, Autoantibodies, and Lifestyle Among Unaffected First-Degree Relatives: The Personalized Risk Estimator for RA (PRE-RA) Family Study

    Jeffrey A. Sparks1, Maura D. Iversen2, Zhi Yu3, Nellie A. Triedman3, Maria G. Prado3, Rachel Miller Kroouze4, Sarah S. Kalia5, Elinor A. Mody3, Simon M. Helfgott3, Derrick J. Todd3, Paul F. Dellaripa3, Bonnie L. Bermas3, Kevin D. Deane6, Karen H. Costenbader3, Bing Lu3, Robert C. Green5 and Elizabeth W. Karlson3, 1Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, 2Physical Therapy, Movement and Rehabilitation Sciences, Northeastern University, Boston, MA, 3Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, 4Brigham and Women's Hospital and Harvard Medical School, Boston, MA, 5Division of Genetics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, 6Division of Rheumatology, University of Colorado School of Medicine, Aurora, CO

    Background/Purpose : Disclosure of genetic risk information alone has had limited impact on changing health behaviors in research trials. Prior studies have not evaluated whether…
  • Abstract Number: 1023 • 2016 ACR/ARHP Annual Meeting

    Fracture Risk Reduction with Romosozumab: Results of a Phase 3 Study in Postmenopausal Women with Osteoporosis

    F Cosman1, DB Crittenden2, JD Adachi3, N Binkley4, E Czerwinski5, S Ferrari6, LC Hofbauer7, E Lau8, EM Lewiecki9, A Miyauchi10, CAF Zerbini11, CE Milmont2, L Chen2, J Maddox2, PD Meisner12, C Libanati12 and A Grauer2, 1Helen Hayes Hospital, West Haverstraw, and Columbia University, New York, NY, 2Amgen Inc., Thousand Oaks, CA, 3McMaster University, Hamilton, ON, Canada, 4University of Wisconsin–Madison Osteoporosis Clinical Center and Research Program, Madison, WI, 5Krakow Medical Center, Krakow, Poland, 6Geneva University Hospital, Geneva, Switzerland, 7Division of Endocrinology, Diabetes, and Bone Diseases, TU Dresden Medical Center, Dresden, Germany, 8Center for Clinical and Basic Research, Hong Kong, China, 9New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, 10Miyauchi Medical Center, Osaka, Japan, 11Centro Paulista de Investigação Clinica, São Paulo, Brazil, 12UCB Pharma, Brussels, Belgium

    Background/Purpose:  Romosozumab (Romo) is an investigational bone-forming monoclonal antibody that binds sclerostin and has a dual effect, increasing bone formation and decreasing bone resorption. Here,…
  • Abstract Number: 1024 • 2016 ACR/ARHP Annual Meeting

    Superior Gains in Bone Mineral Density and Estimated Strength at the Hip for Romosozumab Compared with Teriparatide in Women with Postmenopausal Osteoporosis Transitioning from Bisphosphonate Therapy: Results of a Phase 3, Open-Label Clinical Trial

    B Langdahl1, C Libanati2, DB Crittenden3, MA Bolognese4, JP Brown5, NS Daizadeh3, K Engelke6, HK Genant7, S Goemaere8, Lars Hyldstrup9, E Jodar-Gimeno10, TM Keaveny11, D Kendler12, P Lakatos13, J Maddox3, J Malouf14, FE Massari15, JF Molina16, MR Ulla17 and A Grauer3, 1Aarhus University Hospital, Aarhus, Denmark, 2UCB Pharma, Brussels, Belgium, 3Amgen Inc., Thousand Oaks, CA, 4Bethesda Health Research Center, Bethesda, MD, 5Laval University and CHU de Québec (CHUL) Research Centre, Quebec City, QC, Canada, 6BioClinica Inc., Hamburg, Germany, 7Department of Radiology, University of California San Francisco, San Francisco, CA, 8Ghent University Hospital, Gent, Belgium, 9Hvidovre University Hospital, Hvidovre, Denmark, 10Servicio de Endocrinología, Hospital Universitario Quirón, Madrid, Spain, 11University of California at Berkeley, Berkeley, CA, 12University of British Columbia, Vancouver, BC, Canada, 13Department of Medicine, Semmelweis University, Budapest, Hungary, 14Universitat Autònoma de Barcelona, Barcelona, Spain, 15Instituto de Investigaciones Metabólicas, Buenos Aires, Argentina, 16Reumalab Centro Integral de Reumatologia, Medellin, Colombia, 17Instituto Latinoamericano de Investigaciones Médicas, Córdoba, Argentina

    Background/Purpose:  STRUCTURE was a phase 3, open-label study evaluating the effect of romosozumab or teriparatide for 12 months in women with postmenopausal osteoporosis transitioning from…
  • Abstract Number: 1028 • 2016 ACR/ARHP Annual Meeting

    Discontinuation of Denosumab and Associated Vertebral Fracture Incidence: Analysis from a Phase 3 Placebo-Controlled Study of Denosumab and Its Open-Label Extension

    Jacques P Brown1, S Ferrari2, N Gilchrist3, Jens-Erik Beck Jensen4, N Pannacciulli5, Chris Recknor6, Christian Roux7, Shawna Smith5, Ove Törring8, Ivo Valter9, Rachel B Wagman5, A Wang5 and SR Cummings10, 1Centre Hospitalier de l'Université Laval (CHUL), Quebec City, QC, Canada, 2Geneva University Hospital, Geneva, Switzerland, 3The Princess Margaret Hospital, Christchurch, New Zealand, 4Hvidovre University Hospital, Hvidovre, Denmark, 5Amgen Inc., Thousand Oaks, CA, 6United Osteoporosis Centers, Gainesville, GA, 7Paris Descartes University, Paris, France, 8Karolinska Institutet Sodersjukhuset, Stockholm, Sweden, 9Center for Clinical and Basic Research, Tallinn, Estonia, 10SFCC, CPMC Research Institute & UCSF, San Francisco, CA

    Background/Purpose: Denosumab (DMAb) treatment has been shown to decrease fracture (Fx) risk. Unlike bisphosphonates, DMAb is a monoclonal antibody against RANKL. Discontinuation is characterized by…
  • 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 Dempster1,2, 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…
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All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM CT on October 25. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

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