Abstracts tagged "clinical trials"

Abstract Number: 1412 • 2013 ACR/ARHP Annual Meeting
Use Of a Biologic Marker For An Integrated Pharmacodynamic and Clinical Analysis To Inform Further Clinical Development, Including Dose Selection For The Phase 2b Trial – Treat 2b – Of Tregalizumab In Rheumatoid Arthritis
Eva Dokoupilova¹, Slawomir Jeka², Jiri Vencovsky³, Janusz Badurski⁴, Klaas Prins⁵, Vibeke Strand⁶, Edward C. Keystone⁷, Ronald F van Vollenhoven⁸, Jurgen Wollenhaupt⁹, Andrea Wartenberg-Demand¹⁰, Gabriele Niemann¹⁰, Ahmed Abufarag¹⁰, Silke Aigner¹⁰, Sibylle Kaiser¹⁰, Faiza Rharbaoui¹⁰, Niklas Czeloth¹¹, Ralf Wolter¹⁰, Benjamin Dälken¹⁰ and Thorsten Holzkämper¹⁰, ¹Medical Plus s.r.o, Uherske Hradiste, Czech Republic, ²Clinic of Rheumatology and Connective Tissue Diseases University Hospital No 2 in Bydgoszcz Collegium Medicum UMK in Torun, Bydgoszcz, Poland, ³Institute of Rheumatology, Department of Clinical and Experimental Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic, ⁴Center of Osteoporosis and Osteo-articular Diseases, Bialystock, Poland, ⁵qPharmetra, Nijmegen, Netherlands, ⁶Adjunct, Division of Immunology / Rheumatology, Stanford University, Portola Valley, CA, ⁷Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ⁸ClinTRID, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, ⁹Schoen-Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, ¹⁰Biotest AG, Dreieich, Germany, ¹¹Global Research Immunology, Biotest AG, Dreieich, Germany
Background/Purpose: In patients with rheumatoid arthritis (RA) reduced numbers and functional impairment of regulatory T cells (Tregs) have been observed. Tregalizumab is a humanized, agonistic…
Abstract Number: 1237 • 2013 ACR/ARHP Annual Meeting
Denosumab Leads To Significantly Greater Increases In Bone Mineral Density Than Ibandronate and Risedronate In Postmenopausal Women At High Risk For Fracture Who Were Previously Treated With An Oral Bisphosphonate
Jacques P. Brown¹, Michael A. Bolognese², Pei-Ran Ho³, Jesse Hall³, Christian Roux⁴, Henry G. Bone⁵, Sydney Bonnick⁶, Joop van den Bergh⁷, Irene Ferreira⁸, Prayashi Ghelani⁹, Paula Dakin³, Rachel B. Wagman³ and Chris Recknor¹⁰, ¹CHU de Québec Research Centre and Laval University, Quebec City, QC, Canada, ²Bethesda Health Research Center, Bethesda, MD, ³Amgen Inc., Thousand Oaks, CA, ⁴Paris Descartes University, Paris, France, ⁵Michigan Bone and Mineral Clinic, Detroit, MI, ⁶Clinical Research Center of North Texas, Denton, TX, ⁷VieCuri Medical Centre and Maastricht University, Venlo, Netherlands, ⁸Amgen Inc., Cambridge, United Kingdom, ⁹Ovatech Solutions, London, United Kingdom, ¹⁰United Osteoporosis Centers, Gainesville, GA
Denosumab Leads to Significantly Greater Increases in Bone Mineral Density Than Ibandronate and Risedronate in Postmenopausal Women at High Risk for Fracture Who Were Previously…
Abstract Number: 884 • 2013 ACR/ARHP Annual Meeting
Treatment Of Lupus Nephritis With Abatacept Plus Low-Dose Pulse Cyclophosphamide Followed By Azathioprine (the Euro-Lupus Regimen): Twenty-Four Week Data From a Double-Blind Controlled Trial
David Wofsy¹, Anca Askanase², Patricia C. Cagnoli³, W. Winn Chatham⁴, Gabriel Contreras⁵, Maria Dall'era⁶, Mary Anne Dooley⁷, Hilda Fragoso-Loyo⁸, David R. Karp⁹, Meenakshi Jolly¹⁰, Kenneth Kalunian¹¹, Diane L. Kamen¹², Iris Lee¹³, Marc C. Levesque¹⁴, S. Sam Lim¹⁵, Meggan Mackay¹⁶, Cesar Ramos-Remus¹⁷, Brad H. Rovin¹⁸, Tammy O. Utset¹⁹, Swamy Venuturupalli²⁰, Robert Winchester²¹, Linna Ding²², Wendy Gao²², Lynette Keyes-Elstein²³ and Patti Tosta²⁴, ¹Rheumatology/Immunology, University of California San Francisco and NIAID Autoimmunity Centers of Excellence, San Francisco, CA, ²NYU School of Medicine, New York, NY, ³Int Med/Div of Rheum, University of Michigan Health, Ann Arbor, MI, ⁴University of Alabama at Birmingham, Birmingham, AL, ⁵University of Miami, Miami, FL, ⁶Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁷University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁸Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, Mexico, ⁹Rheumatic Diseases Division, UT Southwestern Medical Center, Dallas, TX, ¹⁰Rheumatology, Rush University Medical Center, Chicago, IL, ¹¹UCSD School of Medicine, La Jolla, CA, ¹²Department of Medicine, Division of Rheumatology, Medical University of South Carolina, Charleston, SC, ¹³Nephrology, Temple University, Philadelphia, PA, ¹⁴Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, ¹⁵Emory University School of Medicine, Division of Rheumatology, Atlanta, GA, ¹⁶Autoimmune & Musculoskeletal Disease, Feinstein Institute for Medical Research, Manhasset, NY, ¹⁷Unidad de Investigacion en Enfermedades Cronico-Degenerativas, Guadalajara, Mexico, ¹⁸Division of Nephrology, Ohio State University Medical Center, Columbus, OH, ¹⁹Rheumatology, University of Chicago Medical Center, Chicago, IL, ²⁰Cedars-Sinai Medical Center, West Hollywood, CA, ²¹Dept of Medicine & Pathology, Columbia University, New York, NY, ²²NIAID, Bethesda, MD, ²³Rho Federal Systems, Inc., Chapel Hill, NC, ²⁴Immune Tolerance Network, San Francisco, CA
Background/Purpose: Studies in murine models for SLE have shown that CTLA4Ig can ameliorate murine lupus nephritis. Moreover, the combination of CTLA4Ig plus intravenous cyclophosphamide (IVC)…
Abstract Number: 817 • 2013 ACR/ARHP Annual Meeting
Clinical Response To Brodalumab, An Anti-Interleukin-17 Receptor Antibody, In Subjects With Psoriatic Arthritis
MC Genovese¹, Philip J. Mease², Maria W. Greenwald³, Christopher T. Ritchlin⁴, André Beaulieu⁵, Atul A. Deodhar⁶, Richard Newmark⁷, JingYuan Feng⁸, Ngozi Erondu⁸ and Ajay Nirula⁸, ¹Division of Rheumatology, Stanford University, Palo Alto, CA, ²Swedish Medical Center and University of Washington School of Medicine, Seattle, WA, ³Desert Medical Advances, Palm Desert, CA, ⁴Allergy, Immunology and Rheumatology, University of Rochester, Rochester, NY, ⁵Faculty of Medicine, Laval University, Quebec, QC, Canada, ⁶Oregon Health and Science University, Portland, OR, ⁷Clinical Development, Amgen Inc, Thousand Oaks, CA, ⁸Amgen Inc, Thousand Oaks, CA
Background/Purpose: Psoriasis-associated skin and joint disorders are characterized by ongoing inflammation mediated by similar molecular pathways. IL-17 plays a potential role in the pathogenesis and…
Abstract Number: 702 • 2013 ACR/ARHP Annual Meeting
Prediction Of Worsening Of Skin Fibrosis In Patients With Diffuse Systemic Sclerosis Using The EULAR Scleroderma Trials and Research (EUSTAR) Registry
Britta Maurer¹, Nicole Graf², Beat A. Michel³, Carola Metzig⁴, Vivian Lanius⁴, Dinesh Khanna⁵ and Oliver Distler¹, ¹Division of Rheumatology, University Hospital Zurich, Zurich, Switzerland, ²graf biostatistics, Winterthur, Switzerland, ³Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland, ⁴Bayer Pharma AG, Berlin, Germany, ⁵University of Michigan Health System, Ann Arbor, MI
Background/Purpose: To identify predictive parameters for the progression of skin fibrosis in patients with diffuse cutaneous SSc (dcSSc) to enable 1) risk-stratification in clinical practice…
Abstract Number: 281 • 2013 ACR/ARHP Annual Meeting
GO-Kids Imaging Substudy: MRI Treatment Response To 30 Mg/m² 4-Weekly Subcutaneous injections Of Golimumab In Children With Polyarticular JIA – Preliminary Results Of The Open Label Portion
Nikolay Tzaribachev¹, Catrin Tzaribachev¹ and Bernd Koos², ¹Pediatric Rheumatology, PRI - Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany, ²Clinic of Orthodontics, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany
GO-KIDS Imaging Substudy: MRI treatment response to 30 mg/m2 4-weekly subcutaneous injections of Golimumab in children with polyarticular JIA– preliminary results of the open label…
Abstract Number: 278 • 2013 ACR/ARHP Annual Meeting
Results Of a 24 Month Extension Study In Patients Who Participated In The Trial Of Early Aggressive Therapy In Polyarticular Juvenile Idiopathic Arthritis
Carol A. Wallace¹, John Bonsack², Steven J. Spalding³, Hermine Brunner⁴, Kathleen M. O'Neil⁵, Diana Milojevic⁶, Sarah Ringold⁷, Laura E. Schanberg⁸, Gloria C. Higgins⁹, Beth S. Gottlieb¹⁰, Joyce J. Hsu¹¹, Marilynn G. Punaro¹², Yukiko Kimura¹³ and Audrey F. Hendrickson¹⁴, ¹University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA, ²Pediatrics, University of Utah Health Sciences Center, Salt Lake City, UT, ³Pediatric Institute, Department of Pediatric Rheumatology, The Cleveland Clinic, Cleveland, OH, ⁴Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ⁵Pediatric Rheumatology, Riley Hospital for Children, Indianapolis, IN, ⁶Dept of Pediatric Rheumatology, University of California, San Francisco, San Francisco, CA, ⁷Pediatrics, Seattle Children's Hospital/Univ of Washington, Seattle, WA, ⁸Pediatrics, Duke University Medical Center, Durham, NC, ⁹Pediatric Rheumatology Ohio State University, Nationwide Childrens Hosp, Columbus, OH, ¹⁰Pediatric Rheumatology, Cohen Children's Medical Center of New York, New Hyde Park, NY, ¹¹Pediatric Rheumatology, Stanford University, Palo Alto, CA, ¹²Pediatric Rheumatology, Texas Scottish Rite Hospital, Dallas, TX, ¹³Pediatric Rheumatology, Joseph M Sanzari Children’s Hospital, Hackensack University Medical Center, Hackensack, NJ, ¹⁴Rheumatology, Seattle Children's Research Institute, Seattle, WA
Background/Purpose: The Trial of Early Aggressive Therapy in Polyarticular Juvenile Idiopathic Arthritis (TREAT-JIA) was a double-blind, randomized, placebo-controlled trial in 85 patients with onset of…
Abstract Number: 2830 • 2013 ACR/ARHP Annual Meeting
First Stage Of a Simon’s Two-Stage Optimal Approach Supports Placental Transfer Of Hydroxychloroquine and a Reduced Recurrence Rate Of The Cardiac Manifestations Of Neonatal Lupus
Peter M. Izmirly¹, Nathalie Costedoat-Chalumeau², Amit Saxena³, Amanda Zink⁴, Zoey Smith³, Deborah Friedman⁵ and Jill P. Buyon¹, ¹Medicine, Division of Rheumatology, New York University School of Medicine, New York, NY, ²Internal Medicine, Hopital Cochin, Paris, France, ³Rheumatology, New York University School of Medicine, New York, NY, ⁴NYU Hospital for Joint Diseases, New York University School of Medicine, New York, NY, ⁵Division of Pediatric Cardiology, New York Medical College, Valhalla, NY
Background/Purpose: A previous case control study suggested that hydroxychloroquine (HCQ) might prevent the development of cardiac Neonatal Lupus (cardiac NL) in anti-SSA/Ro antibody (ab) exposed…
Abstract Number: L6 • 2013 ACR/ARHP Annual Meeting
Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Co-Morbid Depression Receiving Concurrent Antidepressant Therapy: A Randomized, 2-Way Crossover, Double-Blind, Placebo-Controlled Study
Lesley M. Arnold¹, Piercarlo Sarzi-Puttini², Pierre Arsenault³, Tahira Khan⁴, Pritha Bhadra Brown⁵, Andrew Clair⁵, Joseph Driscoll⁴, Jaren Landen⁴ and Lynne Pauer⁴, ¹Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, ²Azienda Ospedaliera Polo Universitario L. Sacco, Milano, Italy, ³Département de Médecine de Famille, Université de Sherbrooke, Sherbrooke, QC, Canada, ⁴Pfizer Inc, Groton, CT, ⁵Pfizer Inc, New York, NY
Background/Purpose: Fibromyalgia (FM) is characterized by chronic widespread pain and often associated with mood disorders including depression. Approximately 50–70% of FM patients have a lifetime…
Abstract Number: 2765 • 2013 ACR/ARHP Annual Meeting
A Double-Blind Randomized Placebo-Controlled Trial Of Lovastatin in Patients with Rheumatoid Arthritis
Cynthia Aranow¹, John J. Cush², Marcy B. Bolster³, Christopher C. Striebich⁴, Maria Dall'era⁵, Meggan Mackay⁶, Ewa Olech⁷, Tracy M. Frech⁸, J. Box⁹, Richard M. Keating¹⁰, Mary Chester M. Wasko¹¹, E. William St Clair¹², Alan Kivitz¹³, Betty Diamond¹⁴, Anne Davidson¹⁵, Meagan Spychala¹⁶, Ellen A. Goldmuntz¹⁷ and Autoimmunity Centers of Excellence¹⁸, ¹Feinstein Institute for Medical Research, Manhasset, NY, ²Baylor Research Institute and Baylor University Medical Center, Dallas, TX, ³Medicine, Medical University of South Carolina, Charleston, SC, ⁴University of Colorado Denver, Aurora, CO, ⁵Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁶Autoimmune & Musculoskeletal Disease, Feinstein Institute for Medical Research, Manhasset, NY, ⁷Clinical Pharmacology, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁸Internal Medicine-Division of Rheumatology, University of Utah School of Medicine, SLC, UT, ⁹Carolina Bone and Joint, Charlotte, NC, ¹⁰Rheumatology Section, The University of Chicago, Chicago, IL, ¹¹West Penn Allegheny Health System, Temple University School of Medicine, Pittsburgh, PA, ¹²Medicine, Duke Unversity Medical Center, Durham, NC, ¹³Altoona Center for Clinical Research, Duncansville, PA, ¹⁴Autoimmune & Musculoskeletal, Feinstein Institute for Medical Research, Manhasset, NY, ¹⁵Autoimmunity and Musculoskeletal Diseases, Feinstein Institute for Medical Research, Manhasset, NY, ¹⁶Rho, Inc., Chapel Hill, NC, ¹⁷DAIT, NIAID/NIH, Bethesda, MD, ¹⁸NIAID, National Institutes of Health, Bethesda, MD
Background/Purpose: HMG -CoA reductase inhibitors (statins) are standard treatment for hyperlipidemia. In addition to lipid lowering abilities, statins exhibit multiple anti-inflammatory effects. The objectives of…
Abstract Number: 2675 • 2013 ACR/ARHP Annual Meeting
Phase 2 Trial On Triptorelin For Ovary Protection In Childhood-Onset Systemic Lupus Erythematosus
Rina Mina¹, Andreas Reiff², Clovis A. Silva³, Patricia Vega Fernandez⁴, Gloria C. Higgins⁵, Lisa F. Imundo⁶, Marisa S. Klein-Gitelman⁷, Calvin Williams⁸, Carol A. Wallace⁹, Nadia E. Aikawa¹⁰, Shannen L. Nelson¹¹, Jun Ying¹², Susan R. Rose¹³ and Hermine Brunner¹⁴, ¹Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ²Division of Rheumatology, Children's Hospital Los Angeles, Los Angeles, CA, ³Children's Institute, Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, Brazil, ⁴Cincinnati Children's Hospital Medica Center, CINCINNATI, OH, ⁵Pediatric Rheumatology Ohio State University, Nationwide Childrens Hosp, Columbus, OH, ⁶Pediatric and Adult Rheumatology Columbia University Medical Center, New York, NY, ⁷Division of Rheumatology, Children's Memorial Hospital, Chicago, IL, ⁸Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, ⁹University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA, ¹⁰Reumatologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil, ¹¹Rheumatology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ¹²Medicine-Internal Medicine-General Medicine, University of Cincinnati, Cincinnati, OH, ¹³Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ¹⁴PRCSG, Cincinnati, OH
Background/Purpose: Gonadotoxicity is a known side effect of cyclophosphamide (CYC) therapy in childhood-onset systemic lupus erythematosus (cSLE). Gonadotropin releasing hormone (GnRH) agonists, such as triptorelin,…
Abstract Number: 2392 • 2013 ACR/ARHP Annual Meeting
Impact Of CT-P13 and Originator Infliximab Treatment On Quality Of Life Derived From The Health Assessment Questionnaire (HAQ) and Short-Form 36 (SF-36) From a Randomized, Double-Blind Trial In Patients With Active RA
Dae-Hyun Yoo¹, Andriy Yagensky², Antoaneta Toncheva³, Osca Ruiz Santacruz⁴, Fidencio Cons Molina⁵, Yunju Bae⁶, Taek Kwon⁶, SinHye Kim⁶, Peter Lacouture⁷, Teresa Kok⁸ and Won Park⁹, ¹Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ²Lutsk City Hospital, Lutsk, Ukraine, ³National Multiprofile Transport Hospital, Sofia, Bulgaria, ⁴Centro Integral de Reumatología e Inmunología - CIREI S.A.S, Bogotá, Colombia, ⁵Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, ⁶Celltrion Inc., Incheon, South Korea, ⁷Hospira Inc, Lake forest, IL, ⁸Hospira Inc., Lake Forest, IL, ⁹Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea
Background/Purpose: Quality of life and functionality are important outcome metrics in understanding the value of therapeutic interventions in RA. Biological products have become an established…
Abstract Number: 2355 • 2013 ACR/ARHP Annual Meeting
Sarilumab, a Subcutaneously-Administered, Fully-Human Monoclonal Antibody Against The IL-6 Receptor Alpha: Using Acute Phase Reactants, Efficacy and Safety Parameters To Inform Phase 3 Dose Selection
Janet van Adelsberg¹, Steven P. Weinstein², Neil Graham³, Tanya Momtahen⁴, Chunpeng Fan⁵ and Stefano Fiore⁶, ¹Clinical Science, Regeneron Pharmaceutials, Inc., Tarrytown, NY, ²Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, NY, ³Program Direction, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁴Program Direction, Sanofi, Bridgewater, NJ, ⁵Biostatistics, Sanofi, Bridgewater, NJ, ⁶Clinical Science, Sanofi, Bridgewater, NJ
Background/Purpose: Sarilumab (SAR) is a fully human mAb directed against IL-6Rα. In phase 2 MOBILITY Part A (NCT01061736), SAR administered SC plus MTX (methotrexate 10-25…
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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