Abstracts tagged "clinical trials"

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.…
Abstract Number: 258 • 2012 ACR/ARHP Annual Meeting
Efficacy and Safety of the Chinese Herbal Compound Hou-Lou-Xiao-Ling Dan in Patients with Osteoarthritis of the Knee: Results of a Phase II International Study
Marc C. Hochberg¹, Lixing Lao², Patricia Langenberg³, Harry H. S. Fong⁴, David Y-W. Lee⁵ and Brian Berman², ¹Department of Medicine, University of Maryland, Baltimore, MD, ²Center for Integrative Medicine, University of Maryland, Baltimore, MD, ³University of Maryland, Baltimore, MD, ⁴University of Illinois at Chicago, Chicago, IL, ⁵Harvard Medical School, Boston, MA
Background/Purpose: Traditional Chinese Medicine (TCM), which includes the use of herbal medicines, is widely used to treat osteoarthritis (OA) of the knee in Asian societies;…
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…

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