Abstracts tagged "clinical trials"

Abstract Number: 2470 • 2012 ACR/ARHP Annual Meeting
Does Structural Progression of Knee Osteoarthritis Measured with Magnetic Resonance Imaging or Radiography Predict Knee Replacement? – Data From the Osteoarthritis Initiative
Felix Eckstein¹, C. Kent Kwoh², Robert M. Boudreau³, Zhijie Wang⁴, Michael J. Hannon⁴, Wolfgang Wirth¹, Ali Guermazi⁵, Frank Roemer⁶, Michael C. Nevitt⁷, Markus R. John⁸, Leena Sharma⁹, Jeffrey W. Duryea¹⁰, David J. Hunter¹¹ and Osteoarthritis Initiative Investigators¹², ¹Anatomy & Musculoskeletal Research, Paracelsus Medical University, Salzburg, Austria, ²School of Medicine, Department of Medicine, Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, ³Epidemiology, University of Pittsburgh, Pittsburgh, PA, ⁴Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, ⁵Radiology, Boston University, Boston, MA, ⁶Klinikum Augsburg, Augsburg, Germany, ⁷Epidemiology & Biostatistics, UCSF (University of California, San Francisco), San Francisco, CA, ⁸Novartis Pharma AG, Basel, Switzerland, ⁹Northwestern University, Chicago, IL, ¹⁰Dept of Radiology, Brigham & Women, Boston, MA, ¹¹Rheumatology, Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, Australia, ¹²San Francisco
Background/Purpose: Imaging biomarkers that predict relevant clinical endpoints, such as knee replacement (KR), are valuable tools for knee osteoarthritis prognosis. Currently, measurement of minimum radiographic…
Abstract Number: 963 • 2012 ACR/ARHP Annual Meeting
Efficacy of Long-Term Milnacipran Treatment in Patients Meeting Different Thresholds of Clinically Relevant Pain Relief: Subgroup Analysis of a Double-Blind, Placebo-Controlled Discontinuation Study
Daniel J. Clauw¹, Philip J. Mease², Robert H. Palmer³, Joel M. Trugman⁴ and Yimin Ma⁴, ¹Anesthesiology/Internal Medicine (Rheum), University of Michigan, Ann Arbor, MI, ²Swedish Medical Center and University of Washington, Seattle, WA, ³Forest Research Institute, Inc., Jersey City, NJ, ⁴Forest Research Institute, Jersey City, NJ
Background/Purpose: Patients with fibromyalgia (FM) who received up to 3.25 years of milnacipran (MLN) in a flexible-dose (≤200 mg/d) open-label (OL) study were eligible to…
Abstract Number: 2439 • 2012 ACR/ARHP Annual Meeting
A Brief Exercise and Self Management Programme Improves Upper Limb Disability in People with Early Rheumatoid Arthritis
Lindsay M. Bearne¹, Victoria L. Manning², David L. Scott³, Ernest Choy⁴ and Michael V. Hurley⁵, ¹Academic Department of Physiotherapy, Health and Social Care Research Division,, Kings College London, London, United Kingdom, ²Academic Department of Physiotherapy, Health and Social Care Research Division, Kings College London, London, United Kingdom, ³King's College London, Department of Rheumatology, London, United Kingdom, ⁴Section of Rheumatology, Cardiff University School of Medicine, Cardiff, United Kingdom, ⁵School of Rehabilitation Sciences, St George's University of London and Kingston University, London, United Kingdom
Background/Purpose: Upper limb dysfunction occurs early in people with rheumatoid arthritis (RA) and deteriorates as the disease progresses, impacting on independence and work capacity. Exercise is…
Abstract Number: 952 • 2012 ACR/ARHP Annual Meeting
Cognitive Behavioral Therapy and Milnacipran in Combination Appears to Be More Efficacious Than Either Therapy Alone
Dennis C. Ang¹, Mark P. Jensen², Jennifer L. Steiner³, Janna Hilligoss¹, Richard Gracely⁴ and Chandan Saha⁵, ¹Indiana University, Indianapolis, IN, ²Rehabilitation, University of Washington, Seattle, WA, ³Psychology, Indiana University Purdue University Indianapolis, Indianapolis, IN, ⁴Dentistry, University of North Carolina, Chapel Hill, NC, ⁵Biostatistics, Indiana University
Background/Purpose: The two treatment options that have received the significant attention in fibromyalgia (FM) management are cognitive behavioral therapy (CBT) and medications. Given the fact…
Abstract Number: 1997 • 2012 ACR/ARHP Annual Meeting
Safety and Efficacy of Denosumab Vs Ibandronate in Postmenopausal Women Sub-Optimally Treated with Daily or Weekly Bisphosphonates: A Randomized, Open-Label Study
Michael A. Bolognese¹, Edward Czerwinski², Henry G. Bone³, Sydney Bonnick⁴, Neil Binkley⁵, Alfred Moffett Jr.⁶, Suresh Siddhanti⁷, Irene Ferreira⁸, Prayashi Ghelani⁹, Rachel Wagman⁷, Jesse W. Hall⁷ and Chris Recknor¹⁰, ¹Bethesda Health Research Center, Bethesda, MD, ²Krakow Medical Center, Krakow, Poland, ³Michigan Bone and Mineral Clinic, Detroit, MI, ⁴Clinical Research Center of North Texas, Denton, TX, ⁵University of Wisconsin, Madison, WI, ⁶OB-GYN Associates of Mid Florida, PA, Leesburg, FL, ⁷Amgen Inc., Thousand Oaks, CA, ⁸Amgen Inc., Cambridge, United Kingdom, ⁹Ovatech Solutions, London, United Kingdom, ¹⁰United Osteoporosis Centers, Gainesville, GA
Background/Purpose: Denosumab, a fully human monoclonal antibody that specifically targets RANKL to inhibit osteoclast formation, function, and survival, reduces risk for vertebral, non-vertebral, and hip…
Abstract Number: 833 • 2012 ACR/ARHP Annual Meeting
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study of Intravenous Staphylococcal Protein A in Patients with Active Rheumatoid Arthritis On Methotrexate: Safety, Pharmacokinetics and Efficacy
Edward Bernton¹, Eduard Krantz² and William Gannon Jr.³, ¹Protalex Inc., Summit, NJ, ²Parexel Clinical Pharmacology, Bloemfontein, South Africa, ³Capital City Technical Consulting, Inc., Washington, DC
Background/Purpose: PRTX-100 is highly-purified GMP staphylococcal protein A (SpA) that binds with extremely high affinity to the Vh antibody framework region of Clade Vh3 immunoglobulins. …
Abstract Number: 1977 • 2012 ACR/ARHP Annual Meeting
Relationship Between Baseline Bone Turnover Marker Levels and Bone Mineral Density Changes in Men with Low Bone Mineral Density Receiving Denosumab or Placebo
Eric Orwoll¹, Ugis Gruntmanis², Steven Boonen³, Yu-Ching Yang⁴, Rachel B. Wagman⁴, Jesse W. Hall⁴ and Paul D. Miller⁵, ¹Oregon Health and Science University, Portland, OR, ²Dallas Veterans Affairs Medical Center and University of Texas Southwestern Medical Center, Dallas, TX, ³Leuven University, Leuven, Belgium, ⁴Amgen Inc., Thousand Oaks, CA, ⁵Colorado Center for Bone Research, Lakewood, CO
Background/Purpose: Denosumab, a fully human monoclonal antibody to RANKL, has been shown to increase bone mineral density (BMD) in postmenopausal women with high or low…
Abstract Number: 836 • 2012 ACR/ARHP Annual Meeting
Clinical Responses and Patient Reported Outcomes to NNC0109-0012 (anti-IL-20 mAb) in Rheumatoid Arthritis (RA) Patients Following 12-Weeks Dosing and 13 Weeks Follow up: Results From a Phase 2a Trial
Ladislav ŠEnolt¹, Marie Göthberg², Xavier Valencia³ and Eva Dokoupilova⁴, ¹Institute of Rheumatology, Prague, Czech Republic, ²Biostatistics, Novo Nordisk, A/S, Soeborg, Denmark, ³Clinical Medical and Regulatory Affairs, Novo Nordisk, Inc., Princeton, NJ, ⁴Medical Plus s.r.o, Uherske Hradiste, Czech Republic
Background/Purpose: NNC0109-0012 (anti-IL-20 mAb) is a novel human monoclonal IgG4 antibody which binds to and neutralizes the activity of IL-20. Data from a phase 1…
Abstract Number: 1868 • 2012 ACR/ARHP Annual Meeting
Clinical Outcome in Fibromyalgia Patients Treated with Milnacipran Is Largely Independent of Symptom Duration
Philip J. Mease¹, Robert M. Bennett², Robert H. Palmer³ and Yong Wang⁴, ¹Swedish Medical Center and University of Washington, Seattle, WA, ²Medicine & Nursing, Oregon Health & Science University, Portland, OR, ³Forest Research Institute, Inc., Jersey City, NJ, ⁴Forest Research Institute, Jersey City, NJ
Background/Purpose: Patients with fibromyalgia (FM) usually experience pain, fatigue, and other debilitating symptoms for years. In clinical studies ranging from 3 months to >3 years,…
Abstract Number: 813 • 2012 ACR/ARHP Annual Meeting
Rilonacept for Gout Flare Prophylaxis in Patients with Chronic Kidney Disease: Analysis of 3 Clinical Trials
Robert Terkeltaub¹, Robert R. Evans², Steven P. Weinstein³, Richard Wu⁴ and H. Ralph Schumacher⁵, ¹Medicine-Rheumatology, VA Medical Ctr/University of California San Diego, San Diego, CA, ²Clinical Sciences, Regeneron Pharmaceuticals Inc, Tarrytown, NY, ³Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, NY, ⁴BioStatistics, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁵Department of Medicine, University of Pennsylvania and VA Medical Center, Philadelphia, PA
Background/Purpose: Gout flare (GF) prophylaxis in patients (pts) with chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR]
Abstract Number: 1870 • 2012 ACR/ARHP Annual Meeting
Financial Conflicts of Interest and Industry Sponsorship Are Associated with Positive Outcomes in Fibromyalgia Randomized Controlled Trials
Winnie K. Pang¹, Karen Yeter², Nasim A. Khan³ and Karina D. Torralba¹, ¹Rheumatology, University of Southern California Keck School of Medicine, Los Angeles, CA, ²Division of Rheumatology, University of Southern California Keck School of Medicine, Los Angeles, CA, ³Rheumatology, University of Arkansas for Medical Sciences and Central Arkansas Veterans Healthcare System, Little Rock, AR
Background/Purpose: Fibromyalgia randomized controlled trials (RCTs) have become more common in the past 15 years, in part due to industry sponsorship. Recently, there has been…
Abstract Number: 818 • 2012 ACR/ARHP Annual Meeting
Levotofisopam Has Uricosuric Activity and Reduces Serum Urate Levels in Patients with Gout
Robert J. Noveck¹, Zongyao Wang¹, Ann Forsthoefel¹, Kristina Sigmon², Pauliana C. Hall³, John C. Keogh⁴ and John S. Sundy², ¹Duke Clinical Research Unit, Duke University Medical Center, Durham, NC, ²Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, ³PCH Integrated Regulatory Services, Inc., Laguna Niguel, CA, ⁴Keogh Medical Writing, Philadelphia, PA
Background/Purpose: The investigational new drug levotofisopam is the S-enantiomer of racemic tofisopam, a 2,3-benzodiazepine derivative approved in over 20 countries outside the US for treatment…
Abstract Number: 1850 • 2012 ACR/ARHP Annual Meeting
Association of Clinical Trial Characteristics with Positive Study Outcome Reporting in Randomized Controlled Trials of Rheumatoid Arthritis Therapy
Fatima M. Khan¹, Juan I. Lombeida², Horace Spencer³, Karina D. Torralba⁴, Winnie K. Pang⁴ and Nasim A. Khan⁵, ¹Rheumatology/Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, ²Mercy Medical Center, Rogers, AR, ³University of Arkansas for Medical Sciences, Little Rock, AR, ⁴Rheumatology, University of Southern California Keck School of Medicine, Los Angeles, CA, ⁵Rheumatology, University of Arkansas for Medical Sciences and Central Arkansas Veterans Healthcare System, Little Rock, AR
Background/Purpose: Randomized controlled trials (RCTs) are considered the best research design for assessing healthcare intervention. Concerns have been raised about the increased likelihood of positive…
Abstract Number: 831 • 2012 ACR/ARHP Annual Meeting
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Brodalumab (AMG 827) in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Karel Pavelka¹, Yun Chon², Richard Newmark², Ngozi Erondu³ and Shao- Lee Lin², ¹Institute of Rheumatology and Department of Rheumatology, 1st Medical Faculty, Charles University Prague, Prague, Czech Republic, ²Clinical Development, Amgen Inc, Thousand Oaks, CA, ³Amgen Inc, Thousand Oaks, CA
Background/Purpose: A potential role for IL-17 in rheumatoid arthritis (RA) has been supported by data from clinical studies of inhibitors of the IL-17A ligand. To…
Abstract Number: 1857 • 2012 ACR/ARHP Annual Meeting
Identifying Core Symptom Domains in the Fibromyalgia Impact Questionnaire: Principal Component Analysis of Data From Milnacipran Clinical Studies
Philip J. Mease¹, Robert M. Bennett², Robert H. Palmer³ and Yong Wang⁴, ¹Swedish Medical Center and University of Washington, Seattle, WA, ²Medicine & Nursing, Oregon Health & Science Univ, Portland, OR, ³Forest Research Institute, Inc., Jersey City, NJ, ⁴Forest Research Institute, Jersey City, NJ
Background/Purpose: The Fibromyalgia Impact Questionnaire (FIQ) is a multidimensional instrument that encompasses many of the core domains recommended by OMERACT for evaluation in fibromyalgia (FM)…

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