Abstracts tagged "clinical trials"

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: 14L • 2015 ACR/ARHP Annual Meeting
Safety and Efficacy of ABT-494, a Novel Selective JAK1 Inhibitor, in Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Anti-TNF Biologic Therapy
Joel M. Kremer¹, Edward C. Keystone², Paul Emery³, Heidi S. Camp⁴, Alan Friedman⁴, Li Wang⁴, Ahmed A. Othman⁴, Nasser Khan⁴ and Steven Jungerwirth⁴, ¹Albany Medical College, Albany, NY, ²Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ³NIHR-Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, United Kingdom, ⁴AbbVie Inc., North Chicago, IL
Background/Purpose: The safety, efficacy, and dose response of ABT-494, a novel selective JAK1 inhibitor, were characterized vs placebo (PBO) in patients (pts) with moderately to…
Abstract Number: 851 • 2015 ACR/ARHP Annual Meeting
Does the Clinical Context Improve the Reliability of Rheumatologists Grading Digital Ulcers in Systemic Sclerosis?
Michael Hughes¹, Chris Roberts², Andrew Tracey¹, Graham Dinsdale¹, Andrea Murray¹ and Ariane L. Herrick¹, ¹Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom, ²Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester, United Kingdom
Background/Purpose: Digital ulcers (DUs) are often a primary end point in SSc clinical trials, although the reliability of rheumatologists grading DUs is poor to moderate…
Abstract Number: 1047 • 2015 ACR/ARHP Annual Meeting
Characterization of Changes in Lymphocyte Subsets in Baricitinib-Treated Patients with Rheumatoid Arthritis in Two Phase 3 Studies
Paul Emery¹, Iain McInnes², Mark C. Genovese³, Josef S. Smolen⁴, Joel Kremer⁵, Maxime Dougados⁶, Douglas E. Schlichting⁷, Terence Rooney⁷, Maher Issa⁷, Stephanie de Bono⁷, William L. Macias⁷, Veronica Rogai⁷, Steven H. Zuckerman⁷ and Peter C. Taylor⁸, ¹Division of Rheumatic and Musculoskeletal Disease, University of Leeds, Leeds, United Kingdom, ²Glasgow Biomedical Research Centre, Glasgow, United Kingdom, ³Division of Rheumatology, Stanford University Medical Center, Palo Alto, CA, ⁴Department of Rheumatology, Medical University of Vienna, Vienna, Austria, ⁵Albany Medical College, Albany, NY, ⁶Paris-Descartes University, Paris, France, ⁷Eli Lilly and Company, Indianapolis, IN, ⁸Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford Botnar Research Centre, Oxford, United Kingdom
Background/Purpose: Baricitinib (bari) is an oral, reversible inhibitor of Janus kinase (JAK)1/JAK2 being developed as QD treatment for patients (pts) with RA. In phase (ph)…
Abstract Number: 1048 • 2015 ACR/ARHP Annual Meeting
Filgotinib (GLPG0634), an Oral JAK1 Selective Inhibitor Is Effective in Combination with Methotrexate in Patients with Active Rheumatoid Arthritis: Results from a Phase 2B Dose Ranging Study
R Westhovens¹, Rieke Alten², Dace Pavlova³, Favio Enríquez-Sosa⁴, Minodora Mazur⁵, Maria Greenwald⁶, Annegret Van der Aa⁷, Frédéric Vanhoutte⁷, Chantal Tasset⁷ and Pille Harrison⁷, ¹Skeletal Biology and Engineering Research Center, Department of Development and Regeneration, KU Leuven, Leuven, Belgium, KU Leuven, Leuven, Belgium, ²Internal Medicine, Rheumatology & Clinical Immunology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany, ³LTD M & M Centrs, Carnikava, Latvia, ⁴CLINSTILE, S.A. DE C.V, Mexico, Mexico, ⁵IMSP Institul de Cardiologie, Chisinau, Moldova, ⁶Desert Medical Advances, Palm Desert, CA, ⁷Galapagos NV, Mechelen, Belgium
Background/Purpose: Filgotinib (GLPG0634) is a novel oral, potent and selective JAK1 inhibitor that has previously demonstrated efficacy in combination with methotrexate (MTX) in treating rheumatoid…
Abstract Number: 1049 • 2015 ACR/ARHP Annual Meeting
Filgotinib (GLPG0634), an Oral JAK1 Selective Inhibitor Is Effective As Monotherapy in Patients with Active Rheumatoid Arthritis: Results from a Phase 2B Dose Ranging Study
Arthur Kavanaugh¹, Lucia Ponce², Regina Cseuz³, Olga Reshetko⁴, Mykola A Stanislavchuk⁵, Maria Greenwald⁶, Annegret Van der Aa⁷, Frédéric Vanhoutte⁷, Chantal Tasset⁷ and Pille Harrison⁷, ¹University of California San Diego, La Jolla, CA, ²Consulta Privada Dra. Lucia Ponce, Temuco, Chile, ³Revita Reumatologiai Rendelo, Budapest, Indonesia, ⁴Regional Clinical Hospital, Saratov, Russia, ⁵Vinnitsa Regional Clinical Hospital n.a. Pirogov, Vinnitsa, Ukraine, ⁶Desert Medical Advances, Palm Desert, CA, ⁷Galapagos NV, Mechelen, Belgium
Background/Purpose: Filgotinib (GLPG0634) is a novel oral, potent and selective JAK1 inhibitor that has previously demonstrated efficacy in combination with methotrexate (MTX) in treating rheumatoid…
Abstract Number: 1079 • 2015 ACR/ARHP Annual Meeting
The Potential Effect on Recruitment of Restricting Skin Scores Eligibility Criteria in Early Diffuse Scleroderma Trials
Robyn T. Domsic¹, Dinesh Khanna², Mary Lucas³, Virginia D. Steen⁴, Daniel E. Furst⁵, Robert Lafyatis⁶ and Thomas A. Medsger Jr.⁷, ¹Medicine - Rheumatology, University of Pittsburgh, Pittsburgh, PA, ²Division of Rheumatology, University of Michigan, Ann Arbor, MI, ³Medicine, University of Pittsburgh Scleroderma Center, Pittsburgh, PA, ⁴Rheumatology, Georgetown University Medical Center, Washington, DC, ⁵Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, ⁶Boston University School of Medicine, Boston, MA, ⁷Department of Medicine/Rheumatology, University of Pittsburgh, Pittsburgh, PA
Background/Purpose: There is increasing interest in cohort enrichment for clinical trials of early diffuse SSc (dcSSc). Recent EUSTAR database analysis (Maurer et al. 2015)…
Abstract Number: 1080 • 2015 ACR/ARHP Annual Meeting
Modified Rodnan Skin Score Thresholds for the Optimization of Cohort Enrichment in Clinical Trials in Skin Fibrosis in Patients with Diffuse Cutaneous Systemic Sclerosis
Rucsandra Dobrota¹, Britta Maurer¹, Nicole Graf², Suzana Jordan³, Carmen Marina Mihai⁴, Otylia Kowal-Bielecka⁵, Yannick Allanore⁶, Oliver Distler¹ and EUSTAR co-authors, ¹Division of Rheumatology, University Hospital Zurich, Zurich, Switzerland, ²graf biostatistics, Winterthur, Switzerland, ³Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland, ⁴Department of Internal Medicine and Rheumatology, Cantacuzino Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, ⁵Department of Rheumatology and Internal Medicine, Medical University of Bialystok, Bialystok, Poland, ⁶Department of Rheumatology, University Paris Descartes and Cochin Hospital, Paris, France
Background/Purpose: The modified Rodnan skin score (mRSS) is the major outcome measure for skin fibrosis in clinical trials (CT) in diffuse cutaneous scleroderma (dcSSc). Traditionally,…
Abstract Number: 1647 • 2015 ACR/ARHP Annual Meeting
A Randomized, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of Etoricoxib in Patients with Rheumatoid Arthritis
Kara Bickham¹, Désirée van der Heijde², Narinder Rawal³, Joachim Sieper⁴, Boyd Scott⁵, Nancy Frontera¹, Sandhya Shah¹, Paul Stryszak¹, Dimitris Papanicolaou¹, Zoran Popmihajlov¹ and Paul Peloso¹, ¹Merck & Co., Inc., Kenilworth, NJ, ²University Hospital, Maastricht, Netherlands, ³Orebro University Hospital, Orebro, Sweden, ⁴Rheumatology, Charite - Campus Benjamin Franklin, Berlin, Germany, ⁵Merck Sharp & Dohme Corp., Whitehouse Station, NJ
Background/Purpose: Etoricoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, provides symptom modification in RA patients. Previous dose-ranging studies in RA demonstrated the clinical efficacy of etoricoxib 90…
Abstract Number: 1782 • 2015 ACR/ARHP Annual Meeting
a Double-Blind, Randomized, Parallel-Group Study of Hydroxychloroquine on Cutaneous Lupus Erythematosus in Japan
Naoto Yokogawa¹, Toshiya Takahashi², Toshiaki Sato³ and Naohisa Yokota⁴, ¹on behalf of Japanese Hydroxychloroquine Study Group, Japan, Japan, ²Sanofi K.K., Tokyo, Japan, ³Sanofi.KK, Tokyo, Japan, ⁴Sanofi KK, Tokyo, Japan
Background/Purpose: In Japan hydroxychloroquine (HCQ) is still unavailable due to the banning of chloroquine in 1974 following allegations that it caused severe retinopathy. Therefore, a…
Abstract Number: 1786 • 2015 ACR/ARHP Annual Meeting
Improvements in Health-Related Quality of Life and Fatigue Following Administration of an IL-6 Monoclonal Antibody (PF-04236921) in an Enriched Population of Subjects with Active SLE
Vibeke Strand¹, Annette Diehl², Jared Christensen², Joseph Wajdula², Sudhakar Sridharan³ and Paul J Healey², ¹Biopharmaceutical Consultant, Portola Valley, CA, ²Pfizer Inc, New York City, NY, ³PPD Inc, Rockville, MA
Background/Purpose: The 10 mg dose of PF-04236921 showed evidence of efficacy in a phase 2 randomized controlled trial (RCT) in SLE.1,2 Here patient-reported outcomes (PROs)…
Abstract Number: 2144 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Different Dose Regimens of a Selective IL-23p19 Inhibitor (BI 655066) Compared with Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis with and without Psoriatic Arthritis
Kim Papp¹, Alan Menter², Howard Sofen³, Stephen Tyring⁴, Jean-Philippe Lacour⁵, Beate Berner⁶, Nathan Bennett⁷, Stella Aslanyan⁷, Mary Flack⁷ and Paul Scholl⁷, ¹Probity Clinical Research, Waterloo, ON, Canada, ²Baylor Research Institute, Dallas, TX, ³Dermatology Research Associates, Los Angeles, CA, ⁴Center for Clinical Studies, Houston, TX, ⁵Dermatology Department, Hôpital de L’Archet, Nice, France, ⁶Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, ⁷Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT
Background/Purpose: IL-23 is essential for the differentiation and maintenance of Th17 cells in psoriasis and psoriatic arthritis (PsA). We assessed the efficacy and safety of…

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