Abstracts tagged "clinical trials"

Abstract Number: 1487 • 2014 ACR/ARHP Annual Meeting
A Phase 1 Dose-Ranging Repeated-Dose Trial of Parenteral Staphylococcal Protein A (PRTX-100) in Patients with Active Rheumatoid Arthritis on Methotrexate or Leflunamide Therapy
Craig Wiesenhutter^1,2, Rakesh Patel³, John Lavery⁴, Nighat Tahir^5,6, Lydie Hazan⁷, Alan Kivitz⁸, Elizabeth Bretton⁹ and Jeffrey Kaine¹⁰, ¹University of Washington School of Medicine, Seattle, WA, ²Coeur d’Alene Arthritis Clinic, Coeur d’Alene, ID, ³PMG Research of Salisbury, Salisbury, NC, ⁴Allen Arthritis and Allergy, Allen, TX, ⁵Community Hospital of Anderson and Madison County, Inc., Anderson, IN, ⁶Community Rheumatology of Anderson, Anderson, IN, ⁷Axis Clinical Trials, Los Angeles, CA, ⁸Altoona Center for Clinical Research, Duncansville, PA, ⁹Albuquerque Clinical Trials, Albuquerque, NM, ¹⁰Sarasota Arthritis Center, Sarasota, FL
Background/Purpose Staphylococcal protein A (SpA) binds with high affinity to the Fc region of human immunoglobulin G and also to the Fab framework region of…
Abstract Number: 977 • 2014 ACR/ARHP Annual Meeting
Randomized Clinical Trial of a Patient and Provider Intervention for Managing Osteoarthritis in Veterans
Kelli D. Allen^1,2, Hayden B. Bosworth^3,4, Amy Jeffreys¹, Cynthia Coffman^3,5, Santanu Datta^4,6, Jennifer McDuffie^1,7, Eugene Oddone^3,4, Jennifer Strauss^1,8 and William S. Yancy Jr.^1,4, ¹Health Services Research, Durham VA Medical Center, Durham, NC, ²Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, ³Health Services Research, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁴Department of Medicine, Division of General Internal Medicine, Duke University Medical Center, Durham, NC, ⁵Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, ⁶Health Services Reserach, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁷Medicine, Duke University Medical Center, Durham, NC, ⁸Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC
Background/Purpose: Adequate management of osteoarthritis (OA) requires both medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and there is low…
Abstract Number: 950 • 2014 ACR/ARHP Annual Meeting
Multiple Mechanisms of Tolerance Characterize the Immune Response to Autologous Modified Dendritic Cells Exposed to Citrullinated Peptides in Patients with Rheumatoid Arthritis
Soi-Cheng Law¹, Hendrik Nel², Ahmed Mehdi², Kim-Anh Le Cao² and Ranjeny Thomas³, ¹Diamantina Institute, Univ of Queensland, Brisbane, Australia, ²Diamantina Institute, University of Queensland, Brisbane, Australia, ³Diamantina Institute, Univ of Queensland, Brisbane, QLD, Australia
Background/Purpose We carried out a phase I clinical trial of tolerising autologous peripheral blood DCs exposed to 4 citrullinated self-peptides (“Rheumavax”) in 29 HLA-DR shared…
Abstract Number: 2503 • 2014 ACR/ARHP Annual Meeting
Early Response to Full-Dose Etanercept-Plus-Methotrexate Induction Therapy Predicts Sustained Remission with Reduced-Dose Combination Therapy in Early Rheumatoid Arthritis Patients
Paul Emery¹, Ronald Pedersen², Jack Bukowski³ and Lisa Marshall⁴, ¹NIHR-Leeds Musculoskeletal Biomedical Research Unit and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds., United Kingdom, Leeds, United Kingdom, ²Specialty Care, Pfizer Inc, Collegeville, PA, ³Department of Specialty Care, Pfizer Inc, Collegeville, PA, ⁴Inflammation Immunology Disease Group, Pfizer Inc., Collegeville, PA
Background/Purpose: In early rheumatoid arthritis (RA), achievement of clinical remission and low disease activity (LDA) limits joint damage and disability.1 Anti-TNF agents are effective in…
Abstract Number: 891 • 2014 ACR/ARHP Annual Meeting
Randomized Clinical Trial of Group Vs. Individual Physical Therapy for Knee Osteoarthritis
Kelli D. Allen¹, Dennis Bongiorni², Hayden B. Bosworth³, Cynthia Coffman³, Santanu Datta⁴, David Edelman³, Jennifer H. Lindquist⁵, Eugene Oddone³ and Helen Hoenig⁶, ¹Health Services Research, Durham VA Medical Center and University of North Carolina at Chapel Hill, Durham, NC, ²Durham VA Medical Center, Durham, NC, ³Health Services Research, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁴Health Services Reserach, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁵Health Services Research, Durham VA Medical Center, Durham, NC, ⁶Durham VA Medical Center and Duke University Medical Center, Durham, NC
Background/Purpose: Physical therapy (PT) is a key component of treatment for knee osteoarthritis (OA). There is a high demand for PT services in many healthcare…
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: 2258 • 2013 ACR/ARHP Annual Meeting
Less Than 5% Of Ethnic Minority Rheumatoid Arthritis Patients Meet Inclusion Criteria For Randomized Controlled Clinical Trials
Gail S. Kerr¹, Yusuf Yazici², Christopher Swearingen³, Chunqiao Luo⁴, Yvonne R. S. Sherrer⁵, Edward L. Treadwell⁶, Angelia D. Mosley-Williams⁷, Luis R. Espinoza⁸, Rodolfo Perez Alamino⁹, Sharon Dowell¹⁰, Ignacio Garcia-Vallardes¹¹, Theresa Lawrence-Ford¹², Adrian Godoy¹⁰, Akgun Ince¹³ and Cindy Flower¹⁴, ¹Rheumatology, Washington DC VAMC, Georgetown and Howard University, Washington, DC, ²New York University Hospital for Joint Diseases, New York, NY, ³Pediatrics and Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, ⁴Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, ⁵Rheum/Immunology, Centre Rheum Immunol Arthritis, Fort Lauderdale, FL, ⁶Dept Medicine Div of Rheum, East Carolina University, Greenville, NC, ⁷John Dingell VAMC, Detroit, MI, ⁸Medicine-Section of Rheum, LSU Medical Center, New Orleans, LA, ⁹Rheumatology, Lousiana State University and LSU Medical Center, New Orleans, LA, ¹⁰Division of Rheumatology, Howard University, Washington, DC, ¹¹Rheumatology Clinical Practice, Guadalajara, Gaudalajara, Mexico, ¹²North Georgia Rheumatology Group, PC, Lawrenceville, GA, ¹³Arthitis Consultants Inc, Saint Louis University, St. Louis, MO, ¹⁴Medicine, University of the West Indies, Bridgetown, Barbados
Background/Purpose: RCT are the gold standard for therapeutic efficacy, yet many studies indicate most patients seen in routine clinical care do not meet inclusion criteria.…
Abstract Number: 1809 • 2013 ACR/ARHP Annual Meeting
Topline Results Of The Biomarkers Of Lupus Disease (BOLD) Study: Clinical and Mechanistic Perplexities Of Lupus Treatment Trials Can Be Mitigated By Eliminating Background Immune Suppressants
Joan T. Merrill¹, Frederick W. Immermann², Tianhui Zhou³, Margot O'Toole⁴, Maryann Whitley⁵, Andrew A. Hill⁵, Ying Zhang⁵, David von Schack⁵, Padmalatha S. Reddy⁵, Jaime L. Masferrer⁴, Stan Kamp¹, Joel M. Guthridge⁶, Aikaterini Thanou⁷, Paul Wu⁵, Theresa Paradis⁵, William M. Mounts⁵, Judith A. James⁸ and Sudhakar T. Sridharan², ¹Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, ²BioTherapeutics R&D, Pfizer Inc, Collegeville, PA, ³BioTherapeutics R&D, Bristol Myers Squibb, Princeton, NJ, ⁴independent consultant, Cambridge, MA, ⁵Pfizer Inc, Cambridge, MA, ⁶Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁷Arthritis and Clinical Immmunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁸Oklahoma Medical Research Foundation, Oklahoma City, OK
Background/Purpose: The BOLD study was designed to test the discriminatory capacity and safety of a trial design eliminating background immune suppressants (IS) in SLE patients…
Abstract Number: 1780 • 2013 ACR/ARHP Annual Meeting
The Randomized Placebo Phase Study of Rilonacept in the Treatment of Systemic Juvenile Idiopathic Arthritis
Norman T. Ilowite¹, Kristi Prather², Yuliya Lokhnygina³, Laura E. Schanberg⁴, Melissa Elder⁵, Diana Milojevic⁶, James W. Verbsky⁷, Steven J. Spalding⁸, Yukiko Kimura⁹, Lisa F. Imundo¹⁰, Marilynn G. Punaro¹¹, David D. Sherry¹², Stacey E. Tarvin¹³, Lawrence S. Zemel¹⁴, James D. Birmingham¹⁵, Beth S. Gottlieb¹⁶, Michael L. Miller¹⁷, Kathleen M. O'Neil¹⁸, Natasha M. Ruth¹⁹, Carol A. Wallace²⁰, Nora G. Singer²¹ and Christy I. Sandborg²², ¹Pediatrics, The Children's Hospital at Montefiore, Bronx, NY, ²Statistics, Duke Clinical Research Institute, Durham, NC, ³Duke Clinical Research Institute, Durham, NC, ⁴Pediatrics, Duke University Medical Center, Durham, NC, ⁵Pediatrics, University of Florida, Gainesville, HI, ⁶Dept of Pediatric Rheumatology, University of California, San Francisco, San Francisco, CA, ⁷Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, ⁸Pediatric Institute, Department of Pediatric Rheumatology, The Cleveland Clinic, Cleveland, OH, ⁹Pediatric Rheumatology, Joseph M Sanzari Children’s Hospital, Hackensack University Medical Center, Hackensack, NJ, ¹⁰Pediatric and Adult Rheumatology Columbia University Medical Center, New York, NY, ¹¹Pediatric Rheumatology, Texas Scottish Rite Hospital, Dallas, TX, ¹²Pediatric Rheumatology, Children's Hospital of Philadelphia, Philadelphia, PA, ¹³Pediatric Rheumatology, Riley Hospital for Children, Indianapolis, IN, ¹⁴Pediatric Rheumatology Collaborative Study Group, Cincinnati, OH, ¹⁵Medicine & Pediatrics, Rheumatology, Michigan State University College of Human Medicine, Grand Rapids, MI, ¹⁶Pediatric Rheumatology, Cohen Children's Medical Center of New York, New Hyde Park, NY, ¹⁷Rheumatology, Childrens Memorial Hospital, Chicago, IL, ¹⁸Division of Pediatric Rheumatology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, ¹⁹Pediatric Rheumatology, Medical University of South Carolina, Charleston, SC, ²⁰University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA, ²¹Rheumatology, MetroHealth Medical Center, Cleveland, OH, ²²Pediatric Rheumatology, Stanford University, Palo Alto, CA
Background/Purpose: The RAndomized Placebo Phase Study Of Rilonacept in the Treatment of Systemic Juvenile Idiopathic Arthritis (RAPPORT) is a multicenter controlled trial using a…
Abstract Number: 1609 • 2013 ACR/ARHP Annual Meeting
AMG 811 (anti-IFN-gamma) Treatment Leads To a Reduction In The Whole Blood IFN-Signature and Serum CXCL10 In Subjects With Systemic Lupus Erythematosus: Results Of Two Phase I Studies
David A. Martin¹, Andrew Welcher², Michael Boedigheimer², Zahir Amoura³, Alan Kivitz⁴, Jill P. Buyon⁵, Jorge Sanchez-Guerrero⁶, Juanita Romero-Diaz⁷, Alla Rudinskaya⁸, Kevin M. Latinis⁹, S Cohen¹⁰, Cynthia Aranow¹¹, Mike Damore², Winnie Sohn², Kit Chiu², Christine Wang¹², Naren Chirmule², Barbara Sullivan² and James Chung², ¹Medical Sciences, Amgen, Seattle, WA, ²Amgen, Thousand Oaks, CA, ³Department of Internal Medicine 2. Referal center for SLE/APS, CHU Pitié-Salpêtrière, Paris, France, ⁴Altoona Center for Clinical Research, Duncansville, PA, ⁵Medicine, Division of Rheumatology, NYU School of Medicine, New York, NY, ⁶UHN Toronto Western Hospital, Toronto, ON, Canada, ⁷Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico, ⁸Danbury Hospital, Danbury, CT, ⁹Latinis Rheumatology, Leawood, KS, ¹⁰Metroplex Clinical Research Center, Dallas, TX, ¹¹The Feinstein Institute, Manhasset, NY, ¹²Biostatistics, Amgen, Thousand Oaks, CA
Background/Purpose: Interferon-gamma (IFN-g) is a major pro-inflammatory cytokine that modulates the function of several important populations of immune cells including B cells, T cells, and…

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