Abstracts tagged "clinical trials"

Abstract Number: 2420 • 2014 ACR/ARHP Annual Meeting
Quality Assessment of Controlled Trials Evaluating Chinese Herbal Medicine in Patients with Rheumatoid Arthritis: a Systematic Review
Xin Pan^1,2, Maria A. Lopez-Olivo², Pratibha Nayak³ and Maria E. Suarez-Almazor⁴, ¹Department of Rheumatology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China, ²Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁴The Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX
Background/Purpose: Chinese herbal medicine (CHM) is a mainstay in the treatment of rheumatoid arthritis (RA) in China. We conducted a systematic review to appraise the…
Abstract Number: 875 • 2014 ACR/ARHP Annual Meeting
Treatment-Related Outcomes in Connective Tissue Disease-Associated Pulmonary Arterial Hypertension: A Pooled Analysis of 12 Randomized Controlled Trials
Rennie L. Rhee¹, Nicole B. Gabler², Amy Praestgaard², Peter A. Merkel³ and Steven M. Kawut⁴, ¹Rheumatology, University of Pennsylvania, Philadelphia, PA, ²Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, ³University of Pennsylvania, Philadelphia, PA, ⁴Pulmonary and Critical Care, University of Pennsylvania, Philadelphia, PA
Background/Purpose: Recent studies have shown that therapies for pulmonary arterial hypertension (PAH) improve exercise capacity, but subgroup analyses suggest that these therapies may be less…
Abstract Number: 2254 • 2014 ACR/ARHP Annual Meeting
Changes in Subject Characteristics in the Denosumab Pivotal Fracture Trial and Its Extension for up to 8 Years
JD Adachi¹, CJF Lin², PR Ho², MA Bolognese³, HG Bone⁴, P Hadji⁵, S Papapoulos⁶, C Recknor⁷, NS Daizadeh², P Dakin², RB Wagman² and S Ferrari⁸, ¹McMaster University, Hamilton, ON, Canada, ²Amgen Inc., Thousand Oaks, CA, ³Bethesda Health Research Center, Bethesda, MD, ⁴Michigan Bone and Mineral Clinic, Detroit, MI, ⁵Philipps-University of Marburg, Marburg, Germany, ⁶Leiden University Medical Center, Leiden, Netherlands, ⁷United Osteoporosis Centers, Gainesville, GA, ⁸Geneva University Hospital, Geneva, Switzerland
Background/Purpose: Changes in demographics of study population enrolled in long-term osteoporosis clinical trials may affect interpretation of efficacy/safety outcomes. Denosumab is being evaluated for up…
Abstract Number: 581 • 2014 ACR/ARHP Annual Meeting
Evaluation of the Nonsteroidal Anti-Inflammatory Drug-Sparing Effect of Etanercept in Axial Spondyloarthritis: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Maxime Dougados¹, Emily Wood², Bernard Combe³, Corinne Miceli-Richard⁴, Francis Berenbaum⁵, Nandan Koppiker⁶, Arnaud Dubanchet⁷ and Isabelle Logeart⁷, ¹Université Paris René Descartes and Hôpital Cochin, Paris, France, ²Biostatistics, Quanticate, Hitchin, England, ³Immuno-Rhumatologie, Hôpital Lapeyronie, Montpellier, France, ⁴Rheumatology Department, Université Paris-Sud 11, Bicêtre Hospital,, Kremlin Bicêtre, France, ⁵Service de Rhumatologie, Saint-Antoine Hospital, Paris, France, ⁶Pfizer PGRD, Sandwich, United Kingdom, ⁷Pfizer, Paris, France
Background/Purpose Nonsteroidal anti-inflammatory drugs (NSAIDs) are first-line pharmacotherapy in axial spondyloarthritis (axSpA) but are recommended for use at the lowest effective dose for the shortest…
Abstract Number: 2255 • 2014 ACR/ARHP Annual Meeting
Vertebral Cortical Bone Mass and Structure Significantly Improved with Romosozumab Compared with Teriparatide: HR-QCT Analyses of Postmenopausal Women with Low BMD from a Phase 2 Study
T Damm¹, C Libanati², J Peña¹, G Campbell¹, R Barkmann¹, DA Hanley³, S Goemaere⁴, MA Bolognese⁵, C Recknor⁶, C Mautalen⁷, YC Yang² and CC Glüer¹, ¹Christian-Albrechts-Universität zu Kiel, Kiel, Germany, ²Amgen Inc., Thousand Oaks, CA, ³University of Calgary, Calgary, AB, Canada, ⁴Ghent University Hospital, Ghent, Belgium, ⁵Bethesda Health Research Center, Bethesda, MD, ⁶United Osteoporosis Centers, Gainesville, GA, ⁷Centro de Osteopatias Medicas, Buenos Aires, Argentina
Background/Purpose : Understanding the effect of therapies in the vertebral compartments is relevant to bone biology and clinical practice. We developed an improved technique using…
Abstract Number: 427 • 2014 ACR/ARHP Annual Meeting
Multimedia Patient Education Tool for Patients with Rheumatoid Arthritis
Maria A. Lopez-Olivo¹, Aparna Ingleshwar², Robert Volk², Andrea Barbo³, Maria Jibaja-Weiss⁴, Heather Lin⁵ and Maria E. Suarez-Almazor⁶, ¹Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ²General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁴Office of Outreach and Health Disparities, Baylor College of Medicine, Houston, TX, ⁵Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁶The Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX
Background/Purpose: Effective patient education provides individuals with essential information about their disease and treatment alternatives, and aids informed decision-making. The purpose of our study was…
Abstract Number: 2231 • 2014 ACR/ARHP Annual Meeting
Combined Chondroitin Sulfate and Glucosamine Is Comparable to Celecoxib for Painful Knee Osteoarthritis. Results from a Multicenter, Randomized, Double-Blind, PHASE IV NON-Inferiority TRIAL
Marc Hochberg¹, Johanne Martel-Pelletier², Jordi Monfort³, Ingrid Moller⁴, Juan Ramon Castillo⁵, Nigel K. Arden^6,7,8, Francis Berenbaum^9,10, Jean-Pierre Pelletier¹¹, Francisco J. Blanco¹², Philip G. Conaghan¹³, Yves Henrotin^14,15, Thomas Pap¹⁶, Pascal Richette^17,18,19, Allen Sawitzke²⁰, Patrick du Souich²¹ and Moves Investigation Group²², ¹University of Maryland School of Medicine, Baltimore, MD, ²Osteoarthritis Research Unit CR-CHUM, Notre-Dame Hospital 1560 Sherbrooke St East, Montreal, QC, Canada, ³Department of Rheumatology, Grup de recerca cel•lular en inflamació i cartílag. IMIM (Institut de Recerca Hospital del Mar), Barcelona, Spain, ⁴Instituto Poal, Barcelona, Spain, ⁵Head of Clinical Pharmacology Unit Hospital Universitario Virgen del Rocío, Sevilla, Spain;, Sevilla, Spain, ⁶NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, United Kingdom, ⁷Arthritis Research UK (ARUK), Center for Sports, Exercise and Osteoarthritis, University of Oxford, Nuffield Orthopaedic Centre, Oxford, United Kingdom, ⁸MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, United Kingdom, ⁹Sorbonne University, INSERM UMR S938, UPMC, University of Paris 06, DHU i2B, Paris, France, ¹⁰Department of Rheumatology, Assistance Publique – Hôpitaux de Paris, Saint-Antoine Hospital, Paris, France, ¹¹Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, QC, Canada, ¹²Rheumatology Service, INIBIC-Hospital Universitario A Coruña, A Coruña, Spain, ¹³University of Leeds, Leeds, United Kingdom, ¹⁴Physical Therapy and Rehabilitation Department, Princess Paola Hospital, Marche-en-Famenne, Belgium, ¹⁵Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, Institute of Pathology, CHU Sart-Tilman, Liege, Belgium, ¹⁶Institute of Experimental Muskuloskeletal Medicine University Hospital Münster, Münster, Germany, ¹⁷Université Paris Diderot, UFR médicale, Paris, France, ¹⁸INSERM 1132, Université Paris-Diderot, Hôpital Lariboisière, Paris, France, ¹⁹2 Rue Ambroise Pare, Hopital Lariboisiere, Paris, France, ²⁰Rheumatology, University of Utah Medical Center, Salt Lake City, UT, ²¹Department of Pharmacology, Faculty of Medicine, University of Montreal, Montreal, QC, Canada, ²²Spain, Germany, France and Poland, Barcelona, Spain
Background/Purpose The Multicentre Osteoarthritis interVEntion trial with Sysadoa (MOVES) compared efficacy and safety of Chondroitin sulfate (CS) and Glucosamine Hydrochloride (GH) with that of Celecoxib…
Abstract Number: 254 • 2014 ACR/ARHP Annual Meeting
The Effect of Milnacipran on Pain in Rheumatoid Arthritis Patients with Widespread Pain: a Randomized Blinded Crossover Trial
Yvonne C. Lee¹, Elena Massarotti², Robert R. Edwards³, Bing Lu⁴, Chih-Chin Liu⁵, Yuanyu Lo⁴, Alyssa Wohlfahrt⁴, Nancy Kim⁶, Daniel J. Clauw⁷ and Daniel H. Solomon⁸, ¹Department of Medicine, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ²Rheumatology/PBB-3, Brigham & Women's Hosp, Boston, MA, ³Anesthesiology, Brigham & Womens Hospital, Chestnut Hill, MA, ⁴Brigham and Women's Hospital, Boston, MA, ⁵Rheumatology & Immunology, Brigham & Women's Hospital, Boston, MA, ⁶Div of Rheumatology, Massachusetts General Hospital, Charlestown, MA, ⁷Anesthesiology/Internal Medicine (Rheum), University of Michigan, Ann Arbor, MI, ⁸Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA
Background/Purpose: Clinical trials have shown that serotonin norepinephrine reuptake inhibitors, such as milnacipran, decrease pain in chronic non-inflammatory pain conditions like fibromyalgia and osteoarthritis. We…
Abstract Number: 2244 • 2014 ACR/ARHP Annual Meeting
Multimedia Patient Education Tool for Patients with Osteoarthritis
Aparna Ingleshwar¹, Maria A. Lopez-Olivo², Robert Volk¹, Andrea Barbo³, Maria Jibaja-Weiss⁴, Heather Lin⁵ and Maria E. Suarez-Almazor⁶, ¹General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ²Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁴Office of Outreach and Health Disparities, Baylor College of Medicine, Houston, TX, ⁵Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁶The Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX
Background/Purpose: The use of video modelling in patient education can result in positive patient outcomes including informed decision-making and improved self-management. The purpose of our…
Abstract Number: 2080 • 2014 ACR/ARHP Annual Meeting
Carryover Effects in Crossover Design Studies in Fibromyalgia and Other Pain Conditions
Lynne Pauer¹, Birol Emir², Ed Whalen³, Joseph Scavone⁴ and Andrew Clair², ¹445 Eastern Point Road, Pfizer Inc, Groton, CT, ²Pfizer Inc, New York, NY, ³Pfizer Inc., New York, NY, ⁴Pfizer Inc, Groton, CT
Background/Purpose: Explore carryover effects and their influence on crossover and randomized withdrawal design (RWD) studies.Methods: We examine pregabalin crossover and RWD studies in fibromyalgia (FM),…
Abstract Number: 2005 • 2014 ACR/ARHP Annual Meeting
Multimedia Patient Education Tool for Patients with Osteoporosis
Maria A. Lopez-Olivo¹, Aparna Ingleshwar², Robert Volk², Andrea Barbo³, Maria Jibaja-Weiss⁴, Heather Lin⁵ and Maria E. Suarez-Almazor⁶, ¹Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ²General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁴Office of Outreach and Health Disparities, Baylor College of Medicine, Houston, TX, ⁵Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁶The Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX
Background/Purpose: Patient education materials incorporating video modelling can be effective in improving patients’ outcomes. We conducted a randomized control trial to test the efficacy of…
Abstract Number: 1412 • 2013 ACR/ARHP Annual Meeting
Use Of a Biologic Marker For An Integrated Pharmacodynamic and Clinical Analysis To Inform Further Clinical Development, Including Dose Selection For The Phase 2b Trial – Treat 2b – Of Tregalizumab In Rheumatoid Arthritis
Eva Dokoupilova¹, Slawomir Jeka², Jiri Vencovsky³, Janusz Badurski⁴, Klaas Prins⁵, Vibeke Strand⁶, Edward C. Keystone⁷, Ronald F van Vollenhoven⁸, Jurgen Wollenhaupt⁹, Andrea Wartenberg-Demand¹⁰, Gabriele Niemann¹⁰, Ahmed Abufarag¹⁰, Silke Aigner¹⁰, Sibylle Kaiser¹⁰, Faiza Rharbaoui¹⁰, Niklas Czeloth¹¹, Ralf Wolter¹⁰, Benjamin Dälken¹⁰ and Thorsten Holzkämper¹⁰, ¹Medical Plus s.r.o, Uherske Hradiste, Czech Republic, ²Clinic of Rheumatology and Connective Tissue Diseases University Hospital No 2 in Bydgoszcz Collegium Medicum UMK in Torun, Bydgoszcz, Poland, ³Institute of Rheumatology, Department of Clinical and Experimental Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic, ⁴Center of Osteoporosis and Osteo-articular Diseases, Bialystock, Poland, ⁵qPharmetra, Nijmegen, Netherlands, ⁶Adjunct, Division of Immunology / Rheumatology, Stanford University, Portola Valley, CA, ⁷Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ⁸ClinTRID, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, ⁹Schoen-Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, ¹⁰Biotest AG, Dreieich, Germany, ¹¹Global Research Immunology, Biotest AG, Dreieich, Germany
Background/Purpose: In patients with rheumatoid arthritis (RA) reduced numbers and functional impairment of regulatory T cells (Tregs) have been observed. Tregalizumab is a humanized, agonistic…
Abstract Number: 1237 • 2013 ACR/ARHP Annual Meeting
Denosumab Leads To Significantly Greater Increases In Bone Mineral Density Than Ibandronate and Risedronate In Postmenopausal Women At High Risk For Fracture Who Were Previously Treated With An Oral Bisphosphonate
Jacques P. Brown¹, Michael A. Bolognese², Pei-Ran Ho³, Jesse Hall³, Christian Roux⁴, Henry G. Bone⁵, Sydney Bonnick⁶, Joop van den Bergh⁷, Irene Ferreira⁸, Prayashi Ghelani⁹, Paula Dakin³, Rachel B. Wagman³ and Chris Recknor¹⁰, ¹CHU de Québec Research Centre and Laval University, Quebec City, QC, Canada, ²Bethesda Health Research Center, Bethesda, MD, ³Amgen Inc., Thousand Oaks, CA, ⁴Paris Descartes University, Paris, France, ⁵Michigan Bone and Mineral Clinic, Detroit, MI, ⁶Clinical Research Center of North Texas, Denton, TX, ⁷VieCuri Medical Centre and Maastricht University, Venlo, Netherlands, ⁸Amgen Inc., Cambridge, United Kingdom, ⁹Ovatech Solutions, London, United Kingdom, ¹⁰United Osteoporosis Centers, Gainesville, GA
Denosumab Leads to Significantly Greater Increases in Bone Mineral Density Than Ibandronate and Risedronate in Postmenopausal Women at High Risk for Fracture Who Were Previously…
Abstract Number: 884 • 2013 ACR/ARHP Annual Meeting
Treatment Of Lupus Nephritis With Abatacept Plus Low-Dose Pulse Cyclophosphamide Followed By Azathioprine (the Euro-Lupus Regimen): Twenty-Four Week Data From a Double-Blind Controlled Trial
David Wofsy¹, Anca Askanase², Patricia C. Cagnoli³, W. Winn Chatham⁴, Gabriel Contreras⁵, Maria Dall'era⁶, Mary Anne Dooley⁷, Hilda Fragoso-Loyo⁸, David R. Karp⁹, Meenakshi Jolly¹⁰, Kenneth Kalunian¹¹, Diane L. Kamen¹², Iris Lee¹³, Marc C. Levesque¹⁴, S. Sam Lim¹⁵, Meggan Mackay¹⁶, Cesar Ramos-Remus¹⁷, Brad H. Rovin¹⁸, Tammy O. Utset¹⁹, Swamy Venuturupalli²⁰, Robert Winchester²¹, Linna Ding²², Wendy Gao²², Lynette Keyes-Elstein²³ and Patti Tosta²⁴, ¹Rheumatology/Immunology, University of California San Francisco and NIAID Autoimmunity Centers of Excellence, San Francisco, CA, ²NYU School of Medicine, New York, NY, ³Int Med/Div of Rheum, University of Michigan Health, Ann Arbor, MI, ⁴University of Alabama at Birmingham, Birmingham, AL, ⁵University of Miami, Miami, FL, ⁶Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁷University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁸Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, Mexico, ⁹Rheumatic Diseases Division, UT Southwestern Medical Center, Dallas, TX, ¹⁰Rheumatology, Rush University Medical Center, Chicago, IL, ¹¹UCSD School of Medicine, La Jolla, CA, ¹²Department of Medicine, Division of Rheumatology, Medical University of South Carolina, Charleston, SC, ¹³Nephrology, Temple University, Philadelphia, PA, ¹⁴Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, ¹⁵Emory University School of Medicine, Division of Rheumatology, Atlanta, GA, ¹⁶Autoimmune & Musculoskeletal Disease, Feinstein Institute for Medical Research, Manhasset, NY, ¹⁷Unidad de Investigacion en Enfermedades Cronico-Degenerativas, Guadalajara, Mexico, ¹⁸Division of Nephrology, Ohio State University Medical Center, Columbus, OH, ¹⁹Rheumatology, University of Chicago Medical Center, Chicago, IL, ²⁰Cedars-Sinai Medical Center, West Hollywood, CA, ²¹Dept of Medicine & Pathology, Columbia University, New York, NY, ²²NIAID, Bethesda, MD, ²³Rho Federal Systems, Inc., Chapel Hill, NC, ²⁴Immune Tolerance Network, San Francisco, CA
Background/Purpose: Studies in murine models for SLE have shown that CTLA4Ig can ameliorate murine lupus nephritis. Moreover, the combination of CTLA4Ig plus intravenous cyclophosphamide (IVC)…
Abstract Number: 817 • 2013 ACR/ARHP Annual Meeting
Clinical Response To Brodalumab, An Anti-Interleukin-17 Receptor Antibody, In Subjects With Psoriatic Arthritis
MC Genovese¹, Philip J. Mease², Maria W. Greenwald³, Christopher T. Ritchlin⁴, André Beaulieu⁵, Atul A. Deodhar⁶, Richard Newmark⁷, JingYuan Feng⁸, Ngozi Erondu⁸ and Ajay Nirula⁸, ¹Division of Rheumatology, Stanford University, Palo Alto, CA, ²Swedish Medical Center and University of Washington School of Medicine, Seattle, WA, ³Desert Medical Advances, Palm Desert, CA, ⁴Allergy, Immunology and Rheumatology, University of Rochester, Rochester, NY, ⁵Faculty of Medicine, Laval University, Quebec, QC, Canada, ⁶Oregon Health and Science University, Portland, OR, ⁷Clinical Development, Amgen Inc, Thousand Oaks, CA, ⁸Amgen Inc, Thousand Oaks, CA
Background/Purpose: Psoriasis-associated skin and joint disorders are characterized by ongoing inflammation mediated by similar molecular pathways. IL-17 plays a potential role in the pathogenesis and…

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