Abstracts tagged "clinical trials"

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)…
Abstract Number: 755 • 2012 ACR/ARHP Annual Meeting
Sifalimumab, an Anti-IFN-Alpha Monoclonal Antibody Shows Target Suppression of a Type I IFN Signature in Blood and Muscle of Dermatomyositis and Polymyositis Patients
Brandon W. Higgs¹, Wei Zhu², Chris Morehouse¹, Wendy White³, Philip Brohawn¹, Charles Le⁴, Anthony A Amato⁵, David Fiorentino⁶, Steven A. Greenberg⁵, Laura Richman¹, Warren Greth⁴, Bahija Jallal¹ and Yihong Yao³, ¹Translational Sciences, MedImmune, LLC, Gaithersburg, MD, ²Translational Science, MedImmune, LLC, Gaithersburg, MD, ³Translational Sciences, MedImmune, Gaithersburg, MD, ⁴Clinical Development, MedImmune, LLC, Gaithersburg, MD, ⁵Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ⁶Dermatology, Stanford University School of Medicine, Redwood City, CA
Background/Purpose: To assess the pharmacodynamic effects of sifalimumab, an investigational anti-IFN-alpha monoclonal antibody, in the blood and muscle of adult dermatomyositis and polymyositis patients by…
Abstract Number: 1713 • 2012 ACR/ARHP Annual Meeting
Developing an Index for Disease Activity and Therapeutic Response in Connective Tissue Disease Related Interstitial Lung Disease: Results From A Delphi Exercise: Delivering A Consensus On Domains
Lesley Ann Saketkoo¹, Dörte Huscher², Dinesh Khanna³, Paul F. Dellaripa⁴, Kevin Flaherty⁵, Chester V. Oddis⁶, Kristine Phillips⁷, Athol U. Wells⁸, Christopher P. Denton⁹, Oliver Distler¹⁰, Otylia M. Kowal-Bielecka¹¹, Romy Christmann¹², Nora Sandorfi¹³, David Pittrow¹⁴, Vibeke Strand¹⁵, James R. Seibold¹⁶, Kevin K. Brown¹⁷ and Eric L. Matteson¹⁸, ¹LSU Scleroderma and Sarcoidosis Patient Care and Research Center, New Orleans, LA, ²German Rheumatism Research Centre and Charité University Medicine, Berlin, Germany, ³Division of Rheumatology, University of Michigan Medical Center, Ann Arbor, MI, ⁴Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, ⁵Department of Critical Care and Pulmonary Medicine, University of Michigan, Ann Arbor, MI, ⁶Rheum/Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, ⁷Rheumatology, University of Michigan, Ann Arbor, MI, ⁸Royal Brompton and Harefield NHS Foundation Trust, Department of Radiology, London, United Kingdom, ⁹Centre for Rheumatology and Connective Tissue Diseases, UCL Medical School, London, United Kingdom, ¹⁰Department of Rheumatology and Center of Experimental Rheumatology, University Hospital Zurich, Zurich, Switzerland, ¹¹Department of Rheumatology and Internal Medicine, Medical University in Bialystok, Bialystok, Poland, ¹²Rheumatology, Boston University School of Medicine, Boston, MA, ¹³Division of Rheumatology, Thomas Jefferson Univ Med Coll, Philadelphia, PA, ¹⁴Institute of Clinical Pharmacology - University of Dresden, Dresden, Germany, ¹⁵Adjunct, Division of Immunology / Rheumatology, Stanford University, Portola Valley, CA, ¹⁶Scleroderma Research Consultants LLC, Avon, CT, ¹⁷Autoimmune Lung Center, National Jewish Hospital, Denver, CO, ¹⁸Rheumatology, Mayo Clinic, Rochester, MN
Background/Purpose: Lack of reliable and valid measures of disease activity and clinical response in patients with connective tissue disease (CTD)-related interstitial lung disease (ILD) makes…
Abstract Number: 692 • 2012 ACR/ARHP Annual Meeting
A Phase 1 Multicenter, Open-Label Study of MEDI-546, a Human Anti-Type I Interferon Receptor Monoclonal Antibody, in Adults with Scleroderma
Avram Z. Goldberg¹, Thomas D. Geppert², Elena Schiopu³, Tracy M. Frech⁴, Vivien M. Hsu⁵, Robert W. Simms⁶, Stanford L. Peng⁷, Yihong Yao⁸, Nairouz Elgeioushi⁹, Bing Wang¹⁰, Linda Chang¹¹ and Stephen Yoo¹², ¹Div of Rheumatology, North Shore-LIJ Health System, Lake Success, NY, ²Metroplex Clinical Research Center, LLC, Dallas, TX, ³Rheumatology/Internal Medicine, University of Michigan, Ann Arbor, MI, ⁴Internal Medicine-Division of Rheumatology, University of Utah School of Medicine, SLC, UT, ⁵Rheumatology, RWJ Med Schl Scleroderma Prog, New Brunswick, NJ, ⁶Rheumatology, Boston University School of Medicine, Boston, MA, ⁷Department of Rheumatology, Benaroya Research Institute at Virginia Mason Medical Center, Seattle, WA, ⁸Translational Sciences, MedImmune, Gaithersburg, MD, ⁹Medical Biostatistics, MedImmune, Gaithersburg, MD, ¹⁰Clinical Pharmacology and DMPK, Medimmune, Mountain View, CA, ¹¹Translational Sciences, MedImmune, Hayward, CA, ¹²Clinical Development, MedImmune, Gaithersburg, MD
Background/Purpose: Type I interferons (IFNs) have been implicated in the pathogenesis of scleroderma. This phase 1 study evaluated safety, pharmacokinetics (PK), pharmacodynamics, and immunogenicity of…
Abstract Number: 1594 • 2012 ACR/ARHP Annual Meeting
Clinical and Radiological Outcomes After One Year of Remission Steered Combination Treatment in Patients with Early Rheumatoid and Undifferentiated Arthritis
L. Heimans¹, K.V.C. Wevers-de Boer¹, K. Visser¹, H.K. Ronday², M. van Oosterhout³, J. H. L. M. Van Groenendael⁴, A.J. Peeters⁵, G. Steup-Beekman⁶, G. Collee⁷, P.B.J Sonnaville⁸, B.A. Grillet⁹, Tom Huizinga¹ and C.F. Allaart¹, ¹Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ²Rheumatology, Haga Hospital, The Hague, Netherlands, ³Rheumatology, Groene Hart Hospital, Gouda, Netherlands, ⁴Franciscus Hospital, Roosendaal, Netherlands, ⁵Rheumatology, Reinier de Graaf Gasthuis, Delft, Netherlands, ⁶Rheumatology, Bronovo Hospital, Netherlands, ⁷MCH, The Hague, Netherlands, ⁸Admiraal de Ruyter Ziekenhuis, Goes, Netherlands, ⁹Department of Rheumatology, Zorgsaam Hospital, Terneuzen, Netherlands
Background/Purpose: To evaluate the 1 year clinical and radiological outcomes of remission steered therapy in early arthritis patients treated aiming at remission (DAS
Abstract Number: 360 • 2012 ACR/ARHP Annual Meeting
Initial Introduction of Treat-to-Target Strategy in Patients with Recent Onset Rheumatoid Arthritis Is More Effective Than Delayed Introduction of Strategy with More Clinical and Functional Remission Achieved for 2-Years: Results of the Treating to Twine Targets (T-4) Study
Yukitomo Urata¹, Yoshihide Nakamura² and Ken-ichi Furukawa³, ¹Rheumatology, Seihoku Central Hospital, United Municipalities of Tsugaru, Gosyogawara, Japan, ²Orthopaedic Surgery, Seihoku Central Hospital, United Municipalities of Tsugaru, Gosyogawara, Japan, ³Pharmacology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan
Background/Purpose: To compare the clinical, radiological and functional efficacy of initial versus delayed introduction of strategy which is treat-to-target to patients with recent onset rheumatoid…
Abstract Number: 1320 • 2012 ACR/ARHP Annual Meeting
Sarilumab, a Subcutaneously-Administered, Fully-Human Monoclonal Antibody Inhibitor of the IL-6 Receptor: Effects On Hemoglobin Levels in a Clinical Trial for the Treatment of Moderate-to-Severe Rheumatoid Arthritis
Mark C. Genovese¹, Roy Fleischmann², Martine Jasson³, Allen R. Radin⁴, Jennifer Hamilton⁵ and Tom W.J. Huizinga⁶, ¹Division of Rheumatology, Stanford University, Palo Alto, CA, ²Southwestern Medical Center at Dallas, University of Texas, Dallas, TX, ³Clinical Development, Sanofi-Aventis, Paris, France, ⁴Translational Medicine, Regeneron Pharmaceuticals Inc, Tarrytown, NY, ⁵Predictive Medicine, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁶Rheumatology, Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Anemia of chronic disease, a common extra-articular manifestation of rheumatoid arthritis (RA), which has a substantial impact on patient function, is driven in part…
Abstract Number: 257 • 2012 ACR/ARHP Annual Meeting
Meta-Analysis of Four 12-Week Phase III Clinical Trials Investigating the Effect of TDT 064, a Transdermal Gel, in Osteoarthritis of the Knee
Matthias Rother¹, Johannes C. Vester², Wolfgang W. Bolten³ and Philip G. Conaghan⁴, ¹IMR Partner GmbH, Graefelfing, Germany, ²IDV Data Analysis and Study Planning, Krailling, Germany, ³Rheumatology, Klaus-Miehlke-Klink, Wiesbaden, Germany, ⁴University of Leeds, Leeds, United Kingdom
Background/Purpose: A transfersome is an ultradeformable lipid vesicle originally developed to deliver high concentrations of drug (eg NSAIDs) transdermally. Large interventional trials in osteoarthritis (OA)…
Abstract Number: 1322 • 2012 ACR/ARHP Annual Meeting
Coadministration of ASP015K, a Novel Janus Kinase Inhibitor with Methotrexate Demonstrates Tolerability and Lack of Pharmacokinetic Interactions in Patients with Rheumatoid Arthritis
Tong Zhu¹, Kazuo Oda², Udaya Valluri¹, Bogie Moore¹, Ying Cao¹, Vishala Chindalore³ and Bola Akinlade⁴, ¹Astellas Pharma Global Development, Inc., Northbrook, IL, ²Drug Metabolism Research Labs. Drug Discovery Research, Astellas Pharma Inc., Osaka, Japan, ³Pinnacle Research Group/Anniston Medical Clinic, Anniston, AL, ⁴Immunology Development, Astellas Pharma Global Development, Inc., Northbrook, IL
Background/Purpose: ASP015K is an oral Janus kinase (JAK) inhibitor with selectivity for JAK1/3 in development for treatment of rheumatoid arthritis (RA) and other autoimmune diseases.…

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