Abstracts tagged "clinical trials"

Abstract Number: 1279 • 2012 ACR/ARHP Annual Meeting
First in Human Study with Recombinant Anti-IL-21 Monoclonal Antibody in Healthy Subjects and Patients with Rheumatoid Arthritis
Stanislav Ignatenko¹, Birte K. Skrumsager², Adam Steensberg³ and Ulrik Mouritzen³, ¹Charité Research Organization GmbH, Berlin, Germany, ²Clinical Pharmacology Biopharm, Novo Nordisk A/S, Copenhagen, Denmark, ³Medical & Science, Inflammation, Novo Nordisk A/S, Copenhagen, Denmark
Background/Purpose: Interleukin-21 (IL-21), a cytokine produced by activated T cells (especially T17 and TFH cells), has a proinflammatory and pleiotropic nature, and drives mainly activation…
Abstract Number: 152 • 2012 ACR/ARHP Annual Meeting
Rilonacept for Gout Flare Reduction: Estimation of Number Needed to Treat to Benefit (NNTB)
Robert R. Evans¹, Steven P. Weinstein², George D. Yancopoulos³ and Yuhwen Soo⁴, ¹Clinical Sciences, Regeneron Pharmaceuticals Inc, Tarrytown, NY, ²Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, NY, ³Research Labs, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁴BioStatistics, Regeneron Pharmaceuticals, Inc., Tarrytown, NY
Background/Purpose: Two similarly designed phase 3 randomized clinical trials (PRESURGE-1 and PRESURGE-2) in gout patients initiating urate-lowering therapy (ULT) showed that subcutaneous treatment with the…
Abstract Number: 1287 • 2012 ACR/ARHP Annual Meeting
Rheumatoid Arthritis Comparison of Active Therapies in Methotrexate Suboptimal Responders: Validation of the Strategy of Conventional Disease Modifying Anti-Rheumatic Drugs Before Biologicals
James R. O'Dell¹, Ted R. Mikuls², Thomas Taylor³, Vandana Ahluwalia⁴, Mary Brophy⁵, Stuart Warren⁶, Robert Lew⁵, Ciaran Phibbs⁷, Aslam H. Anis⁸, Amy C. Cannella⁹, Gary A. Kunkel¹⁰, Alan R. Erickson², Edward Keystone¹¹ and the CSP551 RACAT Research Group¹², ¹Dept of Internal Medicine, Omaha VA and University of Nebraska Medical Center, Omaha, NE, ²Omaha VA Medical Center and University of Nebraska Medical Center, Omaha, NE, ³VA Medical Center, White River Junction, VT, ⁴William Osler Health Center, Brampton, ON, Canada, ⁵VA Boston Heathcare System, Boston, MA, ⁶VA CSP Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, ⁷Health Economics Resource Center (152), Palo Alto VA Health Care System, Menlo Park, CA, ⁸Population and Public Health, Univ of British Columbia, Vancouver, BC, Canada, ⁹Divison of Rheumatology, Omaha VA and University of Nebraska Medical Center, Omaha, NE, ¹⁰Div of Rheumatology, George Wahlen Veterans Affairs Medical Center, Salt Lake City, UT, ¹¹University of Toronto, Toronto, ON, Canada, ¹²Boston, MA
Background/Purpose: Double-blind placebo controlled randomized trials have demonstrated the efficacy of 15 different therapies in RA patients with active disease despite methotrexate (MTX). No blinded…
Abstract Number: L13 • 2012 ACR/ARHP Annual Meeting
Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Results of a Phase 3, Randomized, Controlled Trial
Arthur Kavanaugh¹, Philip J. Mease², Juan J. Gomez-Reino³, Adebajo Adewale⁴, Jürgen Wollenhaupt⁵, ChiaChi Hu⁶ and Randall Stevens⁶, ¹UCSD School of Medicine, La Jolla, CA, ²Rheumatology Research, Swedish Medical Center, Seattle, WA, ³Rheumatology, Hospital Clinico Universitario, Santiago, Spain, ⁴University of Sheffield, Sheffield, United Kingdom, ⁵Schön Klinik Hamburg Eilbek, Hamburg, Germany, ⁶Celgene Corporation, Warren, NJ
Background/Purpose: Apremilast, an oral phosphodiesterase 4 inhibitor, works intracellularly to modulate a network of pro- and anti-inflammatory mediators, including those implicated in the etiopathogenesis of…
Abstract Number: 1295 • 2012 ACR/ARHP Annual Meeting
Effectiveness and Tolerability of Subcutaneous Tocilizumab in Rheumatoid Arthritis Patients Switched From Intravenous Tocilizumab: Results From the Extension Period of the Musashi Study
Atsushi Ogata¹ and the MUSASHI study group², ¹Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine, Suita, Japan, ²Japan
Background/Purpose: In the MUSASHI study (i.e., Double-blind, parallel-group, Phase III non-inferiority study comparing subcutaneous tocilizumab [SC-TCZ] monotherapy versus intravenous tocilizumab [IV-TCZ] monotherapy), the effectiveness and…
Abstract Number: 2597 • 2012 ACR/ARHP Annual Meeting
Degree of Initial Intracellular Folate Depletion May Predict Methotrexate Response in Juvenile Idiopathic Arthritis
Leon van Haandel¹, Ryan S. Funk¹, Maria F. Ibarra², Mark F. Hoeltzel³, Andrew Lasky⁴, Daisy Dai⁵, Rodger Gaedigk¹, J. Steven Leeder⁶ and Mara L Becker⁵, ¹Clinical Pharmacology and Medical Toxicology, Children's Mercy Hospital, Kansas City, MO, ²Pediatric Rheumatolgy, Children's Mercy Hospital, Kansas City, MO, ³Rheumatology Section, Children's Mercy Hospital, Kansas City, MO, ⁴Pediatrics Rheumatology, Children's Mercy Hospital, Kansas City, MO, ⁵Clinical Pharmacology and Rheumatology, Children's Mercy Hospital, Kansas City, MO, ⁶Individualized medicine, Children's Mercy Hospital, Kansas City, MO
Background/Purpose: Despite widespread use, there are no predictors of methotrexate (MTX) response or toxicity. The objective of this study is to test the hypothesis that…
Abstract Number: 1015 • 2012 ACR/ARHP Annual Meeting
Analysis of Integrated Radiographic Data for Two Long-Term, Open-Label Extension Studies of Adalimumab
Désirée van der Heijde¹, Robert Landewé², Edward Keystone³, Ferdinand C. Breedveld⁴, Shufang Liu⁵ and Neelufar Mozaffarian⁶, ¹Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ²Int Med/Rheumatology, Academic Medical Center, Amsterdam, Netherlands, ³University of Toronto, Professor of Medicine, Toronto, ON, Canada, ⁴Dept of Rheumatology C1R, Leiden University Medical Center, Leiden, Netherlands, ⁵Immunology Development, Abbott, Abbott Park, IL, ⁶Abbott, Abbott Park, IL
Background/Purpose: The assessment of radiographic data from long-term studies in patients (pts) with rheumatoid arthritis (RA) poses a significant challenge, given the potential involvement of…
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…

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