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 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…

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