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: 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…
Abstract Number: 1709 • 2016 ACR/ARHP Annual Meeting
Randomized, Double-Blind Study Comparing Chs-0214 with Etanercept (Enbrel) in Patients with Psoriasis and Psoriatic Arthritis
Alan J. Kivitz¹, Kim Papp², Alim Devani³, Andreas Pinter⁴, Rodney Sinclair^5,6,7, Michael Ziv⁸, John Caminis⁹, Cass Kelleher¹⁰, Helen Tang¹¹, Barbara Finck¹⁰ and RaPsOdy study group , ¹Altoona Center for Clinical Research, Duncansville, PA, ²K Papp Clinical Research, Inc. and Probity Medical Research, Waterloo, ON, Canada, ³Institute for Skin Advancement, Surgical and Cosmetic Dermatology, Calgary, AB, Canada, ⁴Dept. of Dermatology, Venereology and Allergology, Theodor-Stern-Kai 7, Frankfurt, Germany, ⁵University of Melbourne, E. Melbourne, Australia, ⁶Epworth Healthcare, E. Melbourne, Australia, ⁷Sinclair Dermatology Investigational Research, Education and Clinical Trials, E. Melbourne, Australia, ⁸Dept of Dermatology, Emek Medical Center, Afula, Israel, ⁹Shire, cambridge, MA, ¹⁰Clinical Science, Coherus BioSciences, Redwood City, CA, ¹¹Coherus BioSciences, Redwood City, CA
Background/Purpose: CHS-0214 is a proposed biosimilar of etanercept, a fusion protein inhibiting tumor necrosis factor. This Phase III multi-center study compared the efficacy and safety…
Abstract Number: 649 • 2016 ACR/ARHP Annual Meeting
Clinical Evaluation Usefulness of Standardized Protocol Strategies of Dose Reduction in Patients with Rheumatoid Arthritis in Clinical Remission Treated with Biologic Therapies. the Optibio Study
Carmen Bejerano¹, Natividad Oreiro¹, Carlos Fernandez-Lopez², Jose A Pinto-Tasende¹, Antonio Atanes¹, Bruno De Aspe¹, Genaro Graña Gil¹, Mercedes Freire¹, Manuel Acasuso³, Sonia Pertega⁴, Francisco J. de Toro¹ and Francisco J Blanco¹, ¹Rheumatology Division, INIBIC-Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruna, Spain, ²Rheumatology Division, INIBIC-Complejo Hospitalario Universitario A Coruña (CHUAC), La Coruña, Spain, ³Centro de Salud San Jose, XAP Coruna, A Coruna, Spain, ⁴Epidemiology Unit, INIBIC - Complejo Hospitalario Universitario A Coruña, A Coruña, Spain
Background/Purpose: The OPTIBIO study is a clinical trial whose primary endpoint is to evaluate the proportion of patients that after one year are maintained in…
Abstract Number: 2012 • 2016 ACR/ARHP Annual Meeting
Utility of the Lupus Low Disease Activity State Definition in Discriminating Responders in the Phase IIb Muse Trial of Anifrolumab in Systemic Lupus Erythematosus
E. Morand¹, A. Berglind², T. Sheytanova², R. Tummala³ and G. Illei³, ¹Monash University, Melbourne, Australia, ²AstraZeneca, Mölndal, Sweden, ³MedImmune, Gaithersburg, MD
Background/Purpose: Preliminary validation of a Lupus Low Disease Activity State (LLDAS) definition has demonstrated that LLDAS attainment is associated with reduced damage accrual in patients…

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