Abstracts tagged "Clinical research"

Abstract Number: 2302 • 2015 ACR/ARHP Annual Meeting
The Impact of Prior Fibromyalgia Treatment on the Response to Pregabalin in Fibromyalgia Clinical Trials
Lynne Pauer¹, Andrew Clair², Pritha Bhadra Brown², Marie Ortiz² and Joseph Scavone¹, ¹Pfizer Inc, Groton, CT, ²Pfizer Inc., New York, NY
Background/Purpose: Fibromyalgia (FM) is a chronic, widespread pain disorder for which Lyrica is an approved treatment. Antidepressants, gabapentin, muscle relaxants, and opioids are frequently used…
Abstract Number: 2440 • 2015 ACR/ARHP Annual Meeting
Using Patient-Relevant Variables to Describe the Disease Course in Children with Juvenile Idiopathic Arthritis
Jaime Guzman¹, Andrew Henrey², Thomas Loughin², Roberta Berard³, Natalie Shiff⁴, Roman Jurencak⁵, Susanne Benseler⁶, Lori B. Tucker⁷ and ReACCh-Out Investigators, ¹Rheumatology, Division of Rheumatology, BC Children's Hospital, Vancouver, BC, Canada, ²Statistics and Actuarial Science, Simon Fraser University, Burnaby, BC, Canada, ³Children's Hospital of Western Ontario, London, ON, Canada, ⁴Pediatric Rheumatology, University of Saskatchewan, Saskatoon, SK, Canada, ⁵University of Ottawa, Ottawa, ON, Canada, ⁶Alberta Children's Hospital Research Institute/University of Calgary, Calgary, AB, Canada, ⁷Rheumatology, BC Children's Hospital, Vancouver, BC, Canada
Background/Purpose: To define distinct disease course groups among children with Juvenile Idiopathic Arthritis (JIA) based on observed changes in quality of life, pain, medication requirements,…
Abstract Number: 2754 • 2015 ACR/ARHP Annual Meeting
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics of BI 655064, an Antagonistic Anti-CD40 Antibody Following Single-Dose Administration in Chinese and Japanese Healthy Volunteers
Jiyoon Kim¹, Yasuhiro Tsuda², Kazuhiko Yamamoto³, Ralf Thiedmann⁴, Corinna Schoelch⁴, Stephen Norris⁵, Steven Padula⁶, Juergen Steffgen⁴ and In-Jin Jang⁷, ¹Boehringer Ingelheim Korea Ltd., Seoul, South Korea, ²Clinical PK/PD department, Nippon Boehringer-Ingelheim.Co.,Ltd., Kobe, Japan, ³Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan, ⁴Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, ⁵Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, ⁶Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany, ⁷Seoul National University Hospital, Seoul, South Korea
Background/Purpose: The CD40-CD40L pathway may play a major role in autoimmune disorders like rheumatoid arthritis or SLE. Blocking this pathway may be a promising new…
Abstract Number: 3145 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Modified-Release Prednisone in Patients with Polymyalgia Rheumatica: Results of a Multicenter, Randomized, Active-Controlled Phase 3 Study
Maurizio Cutolo¹, Michael Hopp², Stefan Liebscher², Bhaskar Dasgupta³ and Frank Buttgereit⁴, ¹Research Laboratory and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, Genova, Italy, ²Medical Science, Mundipharma Research GmbH & Co. KG, Limburg, Germany, ³Rheumatology, Southend University Hospital, Essex, United Kingdom, ⁴Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany
Background/Purpose: Polymyalgia rheumatica (PMR) is characterized by persisting proximal pain and morning stiffness of the neck, shoulder and hip girdles of 2 weeks' duration, an…
Abstract Number: 314 • 2015 ACR/ARHP Annual Meeting
A Double-Blind, Randomized, Controlled, Four Parallel Arm, Dose-Finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Intra-Articular (IA) Injections of Fasitibant in Patients with Symptomatic OA of the Knee
Claudia Gabriele Werner¹, Karel Pavelka², Andrea Nizzardo³, Cristina Rossi³, Simona Scartoni³, Maria Paola Contini³, Serena di Molfetta³, Monica Bertolotti³, Angela Capriati³ and Carlo Alberto Maggi⁴, ¹Clinical Research, A. Menarini Research & Business Service GmbH, Berlin, Germany, ²Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ³Clinical Research Department, Menarini Ricerche S.p.A., Florence, Italy, ⁴Menarini Ricerche S.p.A., Florence, Italy
Background/Purpose: Fasitibant (FAS) is a competitive, potent and selective antagonist of the bradykinin B2 receptor administered IA for SOAK. In response to positive outcomes in…
Abstract Number: 969 • 2015 ACR/ARHP Annual Meeting
Namilumab, an Anti-Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) Monoclonal Antibody: Results of the First Study in Patients with Mild-to-Moderate Rheumatoid Arthritis (RA)
T. W. J. Huizinga¹, Anastas Batalov², Rumen Stoilov³, Eric Lloyd⁴, Thomas Wagner⁵, Didier Saurigny⁶, Bernard Souberbielle⁶ and Ehsanollah Esfandiari⁶, ¹Rheumatology, Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ²UMHAT Kaspela, Plovdiv, Bulgaria, ³University Hospital (MHAT) St Ivan Rilski, Sofia, Bulgaria, ⁴Takeda Pharmaceuticals, Deerfield, IL, ⁵Takeda Pharmaceuticals, Zurich, Switzerland, ⁶Takeda Pharmaceuticals, London, United Kingdom
Background/Purpose: GM-CSF mediates a range of immunological processes, such as stimulating the production of inflammatory mediators and differentiation of proinflammatory T-helper 17 cells, and may…
Abstract Number: 1045 • 2015 ACR/ARHP Annual Meeting
Baricitinib, Methotrexate, or Baricitinib Plus Methotrexate in Patients with Early Rheumatoid Arthritis Who Had Received Limited or No Treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs): Phase 3 Trial Results
Roy Fleischmann¹, Tsutomu Takeuchi², Douglas E. Schlichting³, William L. Macias³, Terence Rooney³, Sirel Gurbuz³, Ivaylo Stoykov³, Scott D. Beattie³, Wen-Ling Kuo³ and M Schiff⁴, ¹Rheumatology, Metroplex Clinical Research Center, Dallas, TX, ²Keio University School of Medicine, Tokyo, Japan, ³Eli Lilly and Company, Indianapolis, IN, ⁴School of Medicine, University of Colorado, Denver, CO
Background/Purpose: In 2 completed phase 3 studies, baricitinib (bari) improved disease activity with a satisfactory safety profile in patients (pts) with moderately-to-severely active RA who…
Abstract Number: 1254 • 2015 ACR/ARHP Annual Meeting
Deciphering the Immunome of Clinically Effective Immune Tolerization in Rheumatoid Arthritis
Jing Yao Leong^1,2, Raymond Ong Jr.³, Juntao Li⁴, Theodorus van den Broek⁵, Roberto Spreafico⁴, Maura Rossetti¹ and Salvatore Albani^1,2, ¹SingHealth Translational Immunology and Inflammation Centre, Singapore Health Services Pte Ltd, Singapore, Singapore, ²Duke-National University of Singapore Graduate Medical School, Singapore, Singapore, ³Singhealth Translational Immunology and Inflammation Centre (STIIC), Singapore Health Services Pte Ltd, Singapore, Singapore, ⁴SingHealth Translational Immunology and Inflammation Centre (STIIC), Singapore Health Services Pte Ltd, Singapore, Singapore, ⁵Translational Research Unit, Sanford-Burnham Medical Research Institute, La Jolla, CA
Background/Purpose: We have previously described (Nature Medicine, PNAS, A&R, Nature Rheum, Lancet) how oral treatment with the pro-inflammatory, heat shock protein-derived dnaJP1 peptide induces detectable…
Abstract Number: 1309 • 2015 ACR/ARHP Annual Meeting
Defining an Acceptable Level of MRI Inflammation in Rheumatoid Arthritis
Joshua Baker¹, Mikkel Østergaard², Daniel Baker³, Paul Emery⁴ and Philip G. Conaghan⁵, ¹Medicine/Rheumatology, University of Pennsylvania, Philadelphia, PA, ²Center for Rheumatology and Spine Diseases, Glostrup Hospital, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet - Glostrup, University of Copenhagen, Denmark, Glostrup, Denmark, ³Immunology, Centocor Inc., Malvern, PA, ⁴Division of Rheumatic and Musculoskeletal Disease, University of Leeds, Leeds, United Kingdom, ⁵University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, United Kingdom
Background/Purpose: Imaging-detected inflammation persists in many rheumatoid arthritis (RA) patients despite therapy. We used data from two clinical trials of golimumab to determine thresholds for…
Abstract Number: 1505 • 2014 ACR/ARHP Annual Meeting
The Biosimilar Landscape: A Systematic Review of Its Current Status
Niti Goel^1,2 and Kamali Chance³, ¹Rheumatology Center of Excellence, Quintiles, Durham, NC, ²Duke University Medical Center, Durham, NC, ³Global Biosimilars Unit, Quintiles, Durham, NC
Background/Purpose In the last 5 years, the number of biosimilars in development for the treatment of immunologic diseases has increased as innovator etanercept (ETA), infliximab (IFX), adalimumab…
Abstract Number: 1436 • 2014 ACR/ARHP Annual Meeting
Impact of Depression on Clinical and Social Outcomes in Patients with Rheumatoid Arthritis: Comparative Study in Germany and Brazil
Harriet Morf¹, Olga Malysheva², G da Rocha³, Anna Beatriz Vargas³ and Christoph G. Baerwald², ¹Department of Internal Medicine, University Hospital, Leipzig, Germany, ²Rheumatology, University Hospital, Leipzig, Germany, ³Ambulatório de reumatologia da Policlínica Piquet Carneiro, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil
Background/Purpose Rheumatoid Arthritis (RA) can be associated with psychological disorders and especially depression. About 13 – 20 % of patients have clinical significant depression. It…
Abstract Number: 1256 • 2014 ACR/ARHP Annual Meeting
Clinical and Temporal Characterization of Anti-Jo-1 Positive Anti-Synthetase Syndrome: Preliminary Results of an International Multicentre Study
Lorenzo Cavagna¹, Miguel A González-Gay², Santos Castañeda-Sanz³, Franco Franceschini⁴, Paolo Airo⁵, Ilaria Cavazzana⁶, Laura Nuno⁷, Trinitario Pina Murcia², Francisco Javier Lopez Longo⁸, Norberto Ortego-Centeno⁹, Rossella Neri¹⁰, Simone Barsotti¹⁰, Enrico Fusaro¹¹, Simone Parisi¹², Giuseppe Paolazzi¹³, Giovanni Barausse¹³, Luca Quartuccio¹⁴, Elena Bartoloni-Bocci¹⁵, Carlo Selmi¹⁶, Carlo Alberto Scirè¹⁷, Elena Bravi¹⁸, Javier Bachiller Corral¹⁹, Lesley Ann Saketkoo²⁰, Gianluigi Bajocchi²¹, Raffaele Pellerito²², Marcello Govoni²³, Andreas Schwarting²⁴, Christof Specker²⁵, Carlomaurizio Montecucco¹ and Roberto Caporali²⁶, ¹Rheumatology, University and IRCCS Policlinico S. Matteo Foundation, Pavia, Italy, ²Epidemiology, Genetics and Atherosclerosis Research Group on Systemic Inflammatory Diseases, Rheumatology Division, IDIVAL, Santander, Spain, ³Rheumatology, Hospital Universitario de La Princesa. Madrid. Spain, Madrid, Spain, ⁴AO Spedali Civili, Rheumatology and Clinical Immunology Unit, Brescia, Italy, ⁵Rheumatology and Clinical Immunology, Spedali Civili, AO Spedali Civili, Brescia, Italy, ⁶Rheumatology and Clinical Immunology Unit, AO Spedali Civili, Brescia, Italy, ⁷Rheumatology, Hospital Universitario La Paz, Madrid, Spain, ⁸Rheumatology, Hospital Gregorio Marañón. Madrid, Madrid, Spain, ⁹Systemic Autoimmune Diseases Unit, Hospital Clínico San Cecilio, Granada, Spain, ¹⁰Rheumatology Unit, University of Pisa, Pisa, Italy, ¹¹Department of Rheumatology, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino, Turin, Italy, ¹²Rheumatology, Azienda Ospedaliera Città Della Salute e della Scienza, Turin, Italy, ¹³Rheumatology, Santa Chiara Hospital, Trento, Italy, ¹⁴Rheumatology, DSMB, University Hospital Santa Maria della Misericordia, Udine, Italy, ¹⁵Clinical and Experimental Medicine, Rheumatology Unit, University of Perugia, Perugia, Italy, ¹⁶Rheumatology and Clinical Immunology, Humanitas Research Hospital, Rozzano, Italy, ¹⁷Italian Society for Rheumatology, Milan, Italy, ¹⁸Internal Medicine, Rheumatology Unit, Ospedale Guglielmo da Saliceto, Piacenza, Italy, ¹⁹Rheumatology, Hospital Ramon y Cajal, Madrid, Spain, ²⁰Scleroderma and Sarcoidosis Patient Care and Research Center, Rheumatology and Pulmonary Medicine, Louisiana State University Health Sciences Center, New Orleans, LA, ²¹Department of Internal Medicine, Rheumatology Unit, Arcispedale S Maria Nuova. IRCCS, Reggio Emilia, Italy, ²²Rheumatology, Ospedale Mauriziano, Turin, Italy, ²³Clinical and Experimental Medicine, Section of Rheumatology, University of Ferrara, Ferrara, Italy, ²⁴Rheumatology, University Hospital Johannes-Gutenberg, Mainz, Germany, ²⁵Rheumazentrum Rhein-Ruhr e.V., St. Josef Krankenhaus (Kliniken Essen Süd), Universitätsklinikum Essen, Esssen, Germany, ²⁶Rheumatology, Division of Rheumatology, University of Pavia, IRCCS Policlinico San Matteo, Pavia, Italy
Background/Purpose: anti Jo-1 antibodies are the main marker of the antisynthetase syndrome (As), a connective tissue disease chiefly characterized by arthritis (A), myositis (M) and…
Abstract Number: 912 • 2014 ACR/ARHP Annual Meeting
A Consensus Hybrid Definition Using a Conjoint Analysis Is the Proposed As Response Criteria for Minimal and Moderate Improvement for Adult Polymyositis and Dermatomyositis Clincal Trials
Rohit Aggarwal¹, Lisa G. Rider², Nicolino Ruperto³, Nastaran Bayat², Brian Erman⁴, Brian M. Feldman⁵, Adam M. Huber⁶, Chester V. Oddis⁷, Ingrid E. Lundberg⁸, Anthony A. Amato, MD^9,10, Robert G. Cooper, MD, FRCP¹¹, Hector Chinoy¹², Maryam Dastmalchi¹³, David Fiorentino¹⁴, David Isenberg¹⁵, James D. Katz¹⁶, Andrew L. Mammen¹⁷, Marianne de Visser¹⁸, Steven R. Ytterberg¹⁹, Katalin Danko²⁰, Luca Villa²¹, Mariangela Rinaldi²¹, Howard Rockette²², Peter A. Lachenbruch², Frederick W. Miller² and Jiri Vencovsky, MD, DSc²³, ¹Medicine, University of Pittsburgh, Pittsburgh, PA, ²Environmental Autoimmunity Group, NIEHS, NIH, Bethesda, MD, ³Pediatria II,, Istituto Giannina Gaslini, Genoa, Italy, ⁴Social and Scientific Systems, Inc., Durham, NC, ⁵Rheumatology, The Hospital for Sick Children, Toronto, ON, Canada, ⁶IWK Health Centre, Halifax, NS, Canada, ⁷Rheum/Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, ⁸Rheumatology Unit, Karolinska University Hospital, Solna, Karolinska Institutet, Stockholm, Sweden, ⁹Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ¹⁰Department of Neurology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, ¹¹MRC/ARUK Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom, ¹²Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom, ¹³Rheumatology Unit, Department of Medicine, Karolinska University Hospital in Solna, Karolinska Institutet, Stockholm, Sweden, ¹⁴Dermatology, Stanford University, Redwood City, CA, ¹⁵Centre for Rheumatology Research, Arthritis Research UK Centre for Adolescent Rheumatology, University College London, London, United Kingdom, ¹⁶NIAMS, NIH, Bethesda, MD, ¹⁷Neurology and Medicine, Johns Hopkins University, Baltimore, MD, ¹⁸Department of Neurology, Academic Medical Centre, Amsterdam, Netherlands, ¹⁹Rheumatology Division, Mayo Clinic, Rochester, MN, ²⁰Institute of Rheumatology, University of Debrecen, Hungary, Debrecen, Hungary, ²¹Pediatria II, Reumatologia, PRINTO, IRCCS Istituto G. Gaslini, Genova, Italy, ²²University of Pittsburgh, Pittsburgh, PA, ²³Institute of Rheumatology, Charles University, Prague, Czech Republic
Background/Purpose: To develop consensus on definitions of improvement (DOIs) for minimal and moderate improvement (and draft preliminary criteria for major improvement) in adult dermatomyositis (DM)…
Abstract Number: 895 • 2014 ACR/ARHP Annual Meeting
The Fibromyalgia Syndrome and Widespread Pain Frequency in Active Duty U.S. Service Members with Posttraumatic Stress Disorder
Bernard Hildebrand¹, Jay B. Higgs¹, Douglas Williamson², Edna Foa³, Patricia Resick⁴, Jim Mintz², Antoinette Brundige², Kevin Kelly⁵, Adam Borah⁵, Stacey Young-McCaughan², Brett Litz⁶, Elizabeth Hembree³ and Alan Peterson², ¹Rheumatology, San Antonio Military Medical Center, JBSA - Fort Sam Houston, TX, ²The University of Texas Health Science Center at San Antonio, San Antonio, TX, ³University of Pennsylvania, Philadelphia, PA, ⁴Duke University, Durham, NC, ⁵Carl R. Darnall Army Medical Center, Fort Hood, TX, ⁶VA Boston Healthcare System, Boston, MA
Background/Purpose: Posttraumatic stress disorder (PTSD) and pain are common amongst US military service members who have deployed to Iraq and Afghanistan. Studies suggest the co-morbidity…
Abstract Number: 719 • 2014 ACR/ARHP Annual Meeting
Target Modulation of a Type I Interferon (IFN) Gene Signature with Sifalimumab or Anifrolumab in Systemic Lupus Erythematosus (SLE) Patients in Two Open Label Phase 2 Japanese Trials
Chris Morehouse¹, Linda Chang², Liangwei Wang³, Philip Brohawn¹, Shinya Ueda⁴, Gabor Illei⁵, Warren Greth³, Stephen Yoo⁶, Lorin Roskos⁷, Yihong Yao⁸, Gabriel Robbie⁹ and Brandon W. Higgs¹, ¹Translational Sciences, MedImmune, LLC, Gaithersburg, MD, ²Translational Sciences, MedImmune, Hayward, CA, ³MedImmune, LLC, Gaithersburg, MD, ⁴PK, Astrazeneca, Osaka, Japan, ⁵Clinical Development, Medimmune, Gaithersburg, MD, ⁶Clinical Development, MedImmune, LLC, Gaithersburg, MD, ⁷One MedImmune Way, Medimmune, Gaithersburg, MD, ⁸Translational Sciences, MedImmune, Gaithersburg, MD, ⁹Clinical Pharmacology and DMPK, MedImmune, Gaithersburg, MD
Background/Purpose The pharmacokinetic (PK) and pharmacodynamic (PD) effects of two investigational monoclonal antibodies inhibiting type I IFN signaling - sifalimumab or anifrolumab, specific for IFN-α…

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