Abstracts tagged "clinical trials"

Abstract Number: 1647 • 2015 ACR/ARHP Annual Meeting
A Randomized, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of Etoricoxib in Patients with Rheumatoid Arthritis
Kara Bickham¹, Désirée van der Heijde², Narinder Rawal³, Joachim Sieper⁴, Boyd Scott⁵, Nancy Frontera¹, Sandhya Shah¹, Paul Stryszak¹, Dimitris Papanicolaou¹, Zoran Popmihajlov¹ and Paul Peloso¹, ¹Merck & Co., Inc., Kenilworth, NJ, ²University Hospital, Maastricht, Netherlands, ³Orebro University Hospital, Orebro, Sweden, ⁴Rheumatology, Charite - Campus Benjamin Franklin, Berlin, Germany, ⁵Merck Sharp & Dohme Corp., Whitehouse Station, NJ
Background/Purpose: Etoricoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, provides symptom modification in RA patients. Previous dose-ranging studies in RA demonstrated the clinical efficacy of etoricoxib 90…
Abstract Number: 1782 • 2015 ACR/ARHP Annual Meeting
a Double-Blind, Randomized, Parallel-Group Study of Hydroxychloroquine on Cutaneous Lupus Erythematosus in Japan
Naoto Yokogawa¹, Toshiya Takahashi², Toshiaki Sato³ and Naohisa Yokota⁴, ¹on behalf of Japanese Hydroxychloroquine Study Group, Japan, Japan, ²Sanofi K.K., Tokyo, Japan, ³Sanofi.KK, Tokyo, Japan, ⁴Sanofi KK, Tokyo, Japan
Background/Purpose: In Japan hydroxychloroquine (HCQ) is still unavailable due to the banning of chloroquine in 1974 following allegations that it caused severe retinopathy. Therefore, a…
Abstract Number: 1786 • 2015 ACR/ARHP Annual Meeting
Improvements in Health-Related Quality of Life and Fatigue Following Administration of an IL-6 Monoclonal Antibody (PF-04236921) in an Enriched Population of Subjects with Active SLE
Vibeke Strand¹, Annette Diehl², Jared Christensen², Joseph Wajdula², Sudhakar Sridharan³ and Paul J Healey², ¹Biopharmaceutical Consultant, Portola Valley, CA, ²Pfizer Inc, New York City, NY, ³PPD Inc, Rockville, MA
Background/Purpose: The 10 mg dose of PF-04236921 showed evidence of efficacy in a phase 2 randomized controlled trial (RCT) in SLE.1,2 Here patient-reported outcomes (PROs)…
Abstract Number: 2144 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Different Dose Regimens of a Selective IL-23p19 Inhibitor (BI 655066) Compared with Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis with and without Psoriatic Arthritis
Kim Papp¹, Alan Menter², Howard Sofen³, Stephen Tyring⁴, Jean-Philippe Lacour⁵, Beate Berner⁶, Nathan Bennett⁷, Stella Aslanyan⁷, Mary Flack⁷ and Paul Scholl⁷, ¹Probity Clinical Research, Waterloo, ON, Canada, ²Baylor Research Institute, Dallas, TX, ³Dermatology Research Associates, Los Angeles, CA, ⁴Center for Clinical Studies, Houston, TX, ⁵Dermatology Department, Hôpital de L’Archet, Nice, France, ⁶Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, ⁷Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT
Background/Purpose: IL-23 is essential for the differentiation and maintenance of Th17 cells in psoriasis and psoriatic arthritis (PsA). We assessed the efficacy and safety of…
Abstract Number: 2313 • 2015 ACR/ARHP Annual Meeting
Responder Rates and Numbers Needed to Treat Based on Clinically Meaningful Improvements in Patient Reported Outcomes (PROs) Including Health-Related Quality of Life (HRQoL) after Sarilumab Treatment during a Phase III Randomized Controlled Trial (RCT)
Vibeke Strand¹, Regina Rendas-Baum², George J. Joseph³, Chieh-I Chen⁴, Hubert van Hoogstraten⁵, T. W. J. Huizinga⁶ and Mark C. Genovese⁷, ¹Biopharmaceutical Consultant, Portola Valley, CA, ²QualityMetric Inc, Lincoln, RI, ³Global Health Economics & Outcomes Research (HEOR), Sanofi, Bridgewater, NJ, ⁴Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁵Sanofi, Bridgewater, NJ, ⁶Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁷Division of Rheumatology, Stanford University Medical Center, Palo Alto, CA
Background/Purpose: Sarilumab is a human monoclonal antibody (mAb) directed against the soluble IL-6 receptor (sIL-6R), administered subcutaneously (SC) every 2 weeks (q2w). In the phase…
Abstract Number: 2503 • 2014 ACR/ARHP Annual Meeting
Early Response to Full-Dose Etanercept-Plus-Methotrexate Induction Therapy Predicts Sustained Remission with Reduced-Dose Combination Therapy in Early Rheumatoid Arthritis Patients
Paul Emery¹, Ronald Pedersen², Jack Bukowski³ and Lisa Marshall⁴, ¹NIHR-Leeds Musculoskeletal Biomedical Research Unit and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds., United Kingdom, Leeds, United Kingdom, ²Specialty Care, Pfizer Inc, Collegeville, PA, ³Department of Specialty Care, Pfizer Inc, Collegeville, PA, ⁴Inflammation Immunology Disease Group, Pfizer Inc., Collegeville, PA
Background/Purpose: In early rheumatoid arthritis (RA), achievement of clinical remission and low disease activity (LDA) limits joint damage and disability.1 Anti-TNF agents are effective in…
Abstract Number: 891 • 2014 ACR/ARHP Annual Meeting
Randomized Clinical Trial of Group Vs. Individual Physical Therapy for Knee Osteoarthritis
Kelli D. Allen¹, Dennis Bongiorni², Hayden B. Bosworth³, Cynthia Coffman³, Santanu Datta⁴, David Edelman³, Jennifer H. Lindquist⁵, Eugene Oddone³ and Helen Hoenig⁶, ¹Health Services Research, Durham VA Medical Center and University of North Carolina at Chapel Hill, Durham, NC, ²Durham VA Medical Center, Durham, NC, ³Health Services Research, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁴Health Services Reserach, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁵Health Services Research, Durham VA Medical Center, Durham, NC, ⁶Durham VA Medical Center and Duke University Medical Center, Durham, NC
Background/Purpose: Physical therapy (PT) is a key component of treatment for knee osteoarthritis (OA). There is a high demand for PT services in many healthcare…
Abstract Number: 2420 • 2014 ACR/ARHP Annual Meeting
Quality Assessment of Controlled Trials Evaluating Chinese Herbal Medicine in Patients with Rheumatoid Arthritis: a Systematic Review
Xin Pan^1,2, Maria A. Lopez-Olivo², Pratibha Nayak³ and Maria E. Suarez-Almazor⁴, ¹Department of Rheumatology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China, ²Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁴The Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX
Background/Purpose: Chinese herbal medicine (CHM) is a mainstay in the treatment of rheumatoid arthritis (RA) in China. We conducted a systematic review to appraise the…
Abstract Number: 875 • 2014 ACR/ARHP Annual Meeting
Treatment-Related Outcomes in Connective Tissue Disease-Associated Pulmonary Arterial Hypertension: A Pooled Analysis of 12 Randomized Controlled Trials
Rennie L. Rhee¹, Nicole B. Gabler², Amy Praestgaard², Peter A. Merkel³ and Steven M. Kawut⁴, ¹Rheumatology, University of Pennsylvania, Philadelphia, PA, ²Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, ³University of Pennsylvania, Philadelphia, PA, ⁴Pulmonary and Critical Care, University of Pennsylvania, Philadelphia, PA
Background/Purpose: Recent studies have shown that therapies for pulmonary arterial hypertension (PAH) improve exercise capacity, but subgroup analyses suggest that these therapies may be less…
Abstract Number: 2254 • 2014 ACR/ARHP Annual Meeting
Changes in Subject Characteristics in the Denosumab Pivotal Fracture Trial and Its Extension for up to 8 Years
JD Adachi¹, CJF Lin², PR Ho², MA Bolognese³, HG Bone⁴, P Hadji⁵, S Papapoulos⁶, C Recknor⁷, NS Daizadeh², P Dakin², RB Wagman² and S Ferrari⁸, ¹McMaster University, Hamilton, ON, Canada, ²Amgen Inc., Thousand Oaks, CA, ³Bethesda Health Research Center, Bethesda, MD, ⁴Michigan Bone and Mineral Clinic, Detroit, MI, ⁵Philipps-University of Marburg, Marburg, Germany, ⁶Leiden University Medical Center, Leiden, Netherlands, ⁷United Osteoporosis Centers, Gainesville, GA, ⁸Geneva University Hospital, Geneva, Switzerland
Background/Purpose: Changes in demographics of study population enrolled in long-term osteoporosis clinical trials may affect interpretation of efficacy/safety outcomes. Denosumab is being evaluated for up…
Abstract Number: 581 • 2014 ACR/ARHP Annual Meeting
Evaluation of the Nonsteroidal Anti-Inflammatory Drug-Sparing Effect of Etanercept in Axial Spondyloarthritis: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Maxime Dougados¹, Emily Wood², Bernard Combe³, Corinne Miceli-Richard⁴, Francis Berenbaum⁵, Nandan Koppiker⁶, Arnaud Dubanchet⁷ and Isabelle Logeart⁷, ¹Université Paris René Descartes and Hôpital Cochin, Paris, France, ²Biostatistics, Quanticate, Hitchin, England, ³Immuno-Rhumatologie, Hôpital Lapeyronie, Montpellier, France, ⁴Rheumatology Department, Université Paris-Sud 11, Bicêtre Hospital,, Kremlin Bicêtre, France, ⁵Service de Rhumatologie, Saint-Antoine Hospital, Paris, France, ⁶Pfizer PGRD, Sandwich, United Kingdom, ⁷Pfizer, Paris, France
Background/Purpose Nonsteroidal anti-inflammatory drugs (NSAIDs) are first-line pharmacotherapy in axial spondyloarthritis (axSpA) but are recommended for use at the lowest effective dose for the shortest…
Abstract Number: 2255 • 2014 ACR/ARHP Annual Meeting
Vertebral Cortical Bone Mass and Structure Significantly Improved with Romosozumab Compared with Teriparatide: HR-QCT Analyses of Postmenopausal Women with Low BMD from a Phase 2 Study
T Damm¹, C Libanati², J Peña¹, G Campbell¹, R Barkmann¹, DA Hanley³, S Goemaere⁴, MA Bolognese⁵, C Recknor⁶, C Mautalen⁷, YC Yang² and CC Glüer¹, ¹Christian-Albrechts-Universität zu Kiel, Kiel, Germany, ²Amgen Inc., Thousand Oaks, CA, ³University of Calgary, Calgary, AB, Canada, ⁴Ghent University Hospital, Ghent, Belgium, ⁵Bethesda Health Research Center, Bethesda, MD, ⁶United Osteoporosis Centers, Gainesville, GA, ⁷Centro de Osteopatias Medicas, Buenos Aires, Argentina
Background/Purpose : Understanding the effect of therapies in the vertebral compartments is relevant to bone biology and clinical practice. We developed an improved technique using…
Abstract Number: 427 • 2014 ACR/ARHP Annual Meeting
Multimedia Patient Education Tool for Patients with Rheumatoid Arthritis
Maria A. Lopez-Olivo¹, Aparna Ingleshwar², Robert Volk², Andrea Barbo³, Maria Jibaja-Weiss⁴, Heather Lin⁵ and Maria E. Suarez-Almazor⁶, ¹Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ²General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁴Office of Outreach and Health Disparities, Baylor College of Medicine, Houston, TX, ⁵Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁶The Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX
Background/Purpose: Effective patient education provides individuals with essential information about their disease and treatment alternatives, and aids informed decision-making. The purpose of our study was…
Abstract Number: 2231 • 2014 ACR/ARHP Annual Meeting
Combined Chondroitin Sulfate and Glucosamine Is Comparable to Celecoxib for Painful Knee Osteoarthritis. Results from a Multicenter, Randomized, Double-Blind, PHASE IV NON-Inferiority TRIAL
Marc Hochberg¹, Johanne Martel-Pelletier², Jordi Monfort³, Ingrid Moller⁴, Juan Ramon Castillo⁵, Nigel K. Arden^6,7,8, Francis Berenbaum^9,10, Jean-Pierre Pelletier¹¹, Francisco J. Blanco¹², Philip G. Conaghan¹³, Yves Henrotin^14,15, Thomas Pap¹⁶, Pascal Richette^17,18,19, Allen Sawitzke²⁰, Patrick du Souich²¹ and Moves Investigation Group²², ¹University of Maryland School of Medicine, Baltimore, MD, ²Osteoarthritis Research Unit CR-CHUM, Notre-Dame Hospital 1560 Sherbrooke St East, Montreal, QC, Canada, ³Department of Rheumatology, Grup de recerca cel•lular en inflamació i cartílag. IMIM (Institut de Recerca Hospital del Mar), Barcelona, Spain, ⁴Instituto Poal, Barcelona, Spain, ⁵Head of Clinical Pharmacology Unit Hospital Universitario Virgen del Rocío, Sevilla, Spain;, Sevilla, Spain, ⁶NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, United Kingdom, ⁷Arthritis Research UK (ARUK), Center for Sports, Exercise and Osteoarthritis, University of Oxford, Nuffield Orthopaedic Centre, Oxford, United Kingdom, ⁸MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, United Kingdom, ⁹Sorbonne University, INSERM UMR S938, UPMC, University of Paris 06, DHU i2B, Paris, France, ¹⁰Department of Rheumatology, Assistance Publique – Hôpitaux de Paris, Saint-Antoine Hospital, Paris, France, ¹¹Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, QC, Canada, ¹²Rheumatology Service, INIBIC-Hospital Universitario A Coruña, A Coruña, Spain, ¹³University of Leeds, Leeds, United Kingdom, ¹⁴Physical Therapy and Rehabilitation Department, Princess Paola Hospital, Marche-en-Famenne, Belgium, ¹⁵Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, Institute of Pathology, CHU Sart-Tilman, Liege, Belgium, ¹⁶Institute of Experimental Muskuloskeletal Medicine University Hospital Münster, Münster, Germany, ¹⁷Université Paris Diderot, UFR médicale, Paris, France, ¹⁸INSERM 1132, Université Paris-Diderot, Hôpital Lariboisière, Paris, France, ¹⁹2 Rue Ambroise Pare, Hopital Lariboisiere, Paris, France, ²⁰Rheumatology, University of Utah Medical Center, Salt Lake City, UT, ²¹Department of Pharmacology, Faculty of Medicine, University of Montreal, Montreal, QC, Canada, ²²Spain, Germany, France and Poland, Barcelona, Spain
Background/Purpose The Multicentre Osteoarthritis interVEntion trial with Sysadoa (MOVES) compared efficacy and safety of Chondroitin sulfate (CS) and Glucosamine Hydrochloride (GH) with that of Celecoxib…
Abstract Number: 254 • 2014 ACR/ARHP Annual Meeting
The Effect of Milnacipran on Pain in Rheumatoid Arthritis Patients with Widespread Pain: a Randomized Blinded Crossover Trial
Yvonne C. Lee¹, Elena Massarotti², Robert R. Edwards³, Bing Lu⁴, Chih-Chin Liu⁵, Yuanyu Lo⁴, Alyssa Wohlfahrt⁴, Nancy Kim⁶, Daniel J. Clauw⁷ and Daniel H. Solomon⁸, ¹Department of Medicine, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ²Rheumatology/PBB-3, Brigham & Women's Hosp, Boston, MA, ³Anesthesiology, Brigham & Womens Hospital, Chestnut Hill, MA, ⁴Brigham and Women's Hospital, Boston, MA, ⁵Rheumatology & Immunology, Brigham & Women's Hospital, Boston, MA, ⁶Div of Rheumatology, Massachusetts General Hospital, Charlestown, MA, ⁷Anesthesiology/Internal Medicine (Rheum), University of Michigan, Ann Arbor, MI, ⁸Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA
Background/Purpose: Clinical trials have shown that serotonin norepinephrine reuptake inhibitors, such as milnacipran, decrease pain in chronic non-inflammatory pain conditions like fibromyalgia and osteoarthritis. We…

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