Abstracts tagged "RCT"

Abstract Number: 1144 • 2016 ACR/ARHP Annual Meeting
Impact of Decision-Making Role Preferences in the Efficacy of a Multimedia Patient Education Tool for Patients with Common Rheumatologic Conditions
Andrea Barbo¹, Maria Suarez-Almazor² and Maria A. Lopez-Olivo³, ¹Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ²Section of Rheumatology and Clinical Immunology, Department of General Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA., Houston, TX, ³Section of Rheumatology and Clinical Immunology, Department of General Internal Medicine,The University of Texas MD Anderson Cancer Center, Houston, Texas, USA,, Houston, TX
Background/Purpose: A preference for shared decision-making among patients with chronic conditions has been associated with better health outcomes. We compared the impact of a multimedia…
Abstract Number: 2054 • 2016 ACR/ARHP Annual Meeting
Effect of Temporary Methotrexate Discontinuation on Efficacy of Seasonal Influenza Vaccination in Patients with Rheumatoid Arthritis: A Randomized Clinical Trial
Jin Kyun Park¹, Min Ah Lee Lee², Kyung Hee Lee², Eun Young Lee¹, Yeong Wook Song³, Yunhee Choi⁴, Kevin L. Winthrop⁵ and Eun Bong Lee⁶, ¹Division of Rheumatology, Department of Internal Medicine, Seoul National University, Seoul, South Korea, ²Internal Medicine, Seoul National University College of Medicine, Seoul, Korea, The Republic of, ³Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, South Korea, ⁴Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University College of Medicine, Seoul, Korea, The Republic of, ⁵Oregon Health and Sciences University, Portland, OR, ⁶Seoul National University, Seoul, Korea, Republic of
Background/Purpose: Patients with rheumatoid arthritis (RA) are at a higher risk of infection due to the underlying immune dysfunction and immune suppression associated with treatment.…
Abstract Number: 2371 • 2016 ACR/ARHP Annual Meeting
Effect of Etanercept on Several Soluble Biomarkers in a Randomized Controlled Trial of Patients with Erosive Hand Osteoarthritis
Féline Kroon¹, Ruth Wittoek², Wing-Yee Kwok¹, Klaus Bobacz³, Dirk Elewaut², Marta Favero⁴, Tom Huizinga⁵, Josef Smolen³, Bert Vander Cruyssen², Ron Wolterbeek⁶, Leonardo Punzi⁷, Gust Verbruggen², Margreet Kloppenburg⁸ and Roberta Ramonda⁷, ¹Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ²Rheumatology, Ghent University Hospital, Ghent, Belgium, ³Internal Medicine III, Div. of Rheumatology, Medical University of Vienna, Vienna, Austria, ⁴Rheumatology Unit,Department of Medicine–DIMED, University of Padova, Rheumatology Unit,University of Padova, Padova, Italy, ⁵Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁶Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, Netherlands, ⁷Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova, Italy, ⁸Rheumatology and Clinical Epidemiology, Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Erosive hand osteoarthritis (OA) is a hand OA subset with high disease burden, although effective therapies are still lacking and clinical trials are scarce.…
Abstract Number: 3183 • 2016 ACR/ARHP Annual Meeting
Tocilizumab for the Treatment of Giant Cell Arteritis – MR-Angiography Results from the First Randomized Placebo-Controlled Trial
Stephan Reichenbach^1,2, Sabine Adler³, Jennifer Cullmann⁴, Harald Bonel⁴, Stefan Kuchen⁵, Felix Wermelinger¹, Diana Dan¹, Michael Seitz¹ and Peter M. Villiger¹, ¹Department of Rheumatology, Immunology and Allergology, University Hospital Bern, Bern, Switzerland, ²Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland, ³Rheumatology, Immunology, Allergology, University Hospital Bern, Bern, Switzerland, ⁴Department of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern, Bern, Switzerland, ⁵Rheumatology, Immunology, and Allergology, University of Bern, Bern, MD, Switzerland
Background/Purpose: As published in The Lancet online, March 4, 2016, the first randomized, placebo-controlled trial (RCT) of tocilizumab (TCZ) in giant cell arteritis (GCA) showed…
Abstract Number: 3210 • 2016 ACR/ARHP Annual Meeting
10+ Years’ Follow-up of a Danish 2-Year Treat-to-Target RCT in Patients with Early Rheumatoid Arthritis: Baseline Predictors of Functional and Radiographic Outcomes
Merete Lund Hetland¹, Kristian Stengaard-Pedersen², Peter Junker¹, Hanne Lindegaard¹, Torkell Ellingsen¹, Jan Pødenphant², Henrik Skjødt¹, Aage Vestergaard², Bo Jannik Ejbjerg¹, Søren Jacobsen¹, Niels Steen Krogh¹, Mikkel Ostergaard¹ and Kim Hørslev-Petersen², ¹Rigshospitalet (Glostrup and Blegdamsvej), Århus University Hospital, Odense University Hospital, Herlev/Gentofte Hospital, Slagelse Sygehus, Chr X hospital (University of South Denmark) and Zitelab Aps, DANBIO Registry and Departments of Rheumatology, Glostrup, Denmark, ²Rigshospitalet (Glostrup and Blegdamsvej), Århus University Hospital, Odense University Hospital, Herlev/Gentofte Hospital, Slagelse Sygehus, Chr X hospital (University of South Denmark) and Zitelab Aps, DANBIO Registry and Departments of Rheumatology, Copenhagen, Denmark
Background/Purpose: Few RCTs have investigated long-term (10+ years) outcomes of goal-directed synovitis suppression in early rheumatoid arthritis (RA). The CIMESTRA trial was a 2-year double-blinded…
Abstract Number: 1495 • 2015 ACR/ARHP Annual Meeting
Person-Centred Care Can Help Patients to Become More Effective Consumers in the Use of Health Information Than Regular Care – an RCT in Patients with Arthritis Undergoing Biological Therapy
Ingrid Larsson^1,2, Stefan Bergman^2,3,4 and Ann Bremander^2,3,5, ¹School of Health and Welfare, Halmstad University, Halmstad, Sweden, ²FoU Spenshult, Halmstad, Sweden, ³Department of Clinical Sciences, Lund, Section of Rheumatology, Lund University, Lund, Sweden, ⁴Primary Health Care Unit, Department of Public Health and Community Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, ⁵School of Business, Engineering and Science, Halmstad University, Halmstad, Sweden
Background/Purpose: Person-centred care (PCC) is a holistic approach with respectful and individualized care allowing negotiation of care where persons with health problems are empowered to…
Abstract Number: 1783 • 2015 ACR/ARHP Annual Meeting
Dietary Fish Oil Supplementation Raises Serum Essential Fatty Acid Concentrations in Patients with Systemic Lupus Erythematosus and Correlates with Improvements in Inflammation and Pain
Cristina Arriens¹, Carlos Rodriguez-Navas², David R. Karp¹, Jeffrey McDonald² and Chandra Mohan³, ¹Internal Medicine - Rheumatic Diseases, University of Texas Southwestern Medical Center, Dallas, TX, ²Molecular Genetics, University of Texas Southwestern Medical Center, Dallas, TX, ³Biomedical Engineering, University of Houston, Houston, TX
Background/Purpose: A comprehensive metabolomic screen comparing sera from patients with systemic lupus erythematosus (SLE) to healthy controls (HC) indicated a relative deficiency in omega-3 fatty…
Abstract Number: 1812 • 2015 ACR/ARHP Annual Meeting
The First Randomized Control Trial to Evaluate the Effectiveness of Bortezomib for Refractory Systemic Lupus Erythematosus
Tomonori Ishii¹, Yoshiya Tanaka², Atsushi Kawakami³, Kazuyoshi Saito², Kunihiro Ichinose⁴, Yuko Shirota⁵, Hiroshi Fujii⁵, Yoko Fujita⁶, Yukiko Kamogawa⁵, Tomoaki Machiyama⁵, Kanae Akita⁵ and Hideo Harigae⁵, ¹Department of Clinical Trial Implementation, Tohoku University Hospital, Clinical Research, Innovation and Education Center, Sendai, Japan, ²The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ³Department of Immunology and Rheumatology, Nagasaki University, Nagasaki, Japan, ⁴Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan, ⁵Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan, ⁶Department of Hematolgy and Rheumatolgy, Tohoku University Graduate School of Medicine, Sendai, Japan
Background/Purpose: Systemic lupus erythematosus (SLE) is a disease characterized by production and deposition of anti-dsDNA antibody. In recent years, treatment methods targeting antibody-producing B cell…
Abstract Number: 2126 • 2015 ACR/ARHP Annual Meeting
Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Patients with Rheumatoid Arthritis
George D. Kitas¹, Peter Nightingale², Jane Armitage³, Naveed Sattar⁴, Jill Belch⁵, Deborah P.M. Symmons⁶ and TRACE RA Consortium, ¹Dudley Group NHS Foundation Trust, Dudley, and Arthritis Research Campaign Epidemiology Unit, University of Manchester, Manchester, United Kingdom, ²Wolfson Computer Laboratory, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom, ³Clinical Trial Service Unit and Epidemiology Unit, University of Oxford, Oxford, United Kingdom, ⁴University of Glasgow, BHF Glasgow Cardiovascular Research Centre, Glasgow, United Kingdom, ⁵Division of Cardiovascular and Diabetes Medicine, University of Dundee, Dundee, United Kingdom, ⁶NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester University Hospitals NHS Foundation Trust, Manchester, United Kingdom
Background/Purpose: Patients with rheumatoid arthritis (RA) are at increased risk for cardiovascular disease (CVD) compared to the general population, both due to classical and novel…
Abstract Number: 2218 • 2015 ACR/ARHP Annual Meeting
A Randomized Controlled Trial to Evaluate a Multimedia Patient Education Tool in Patients with Knee Osteoarthritis. Six-Month Results
Maria A. Lopez-Olivo¹, Andrea Barbo², Tara Rizvi³, Robert Volk⁴, Heather Lin⁵ and Maria E. Suarez-Almazor¹, ¹General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ²Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³Rheumatology, Baylor College of Medicine, Houston, TX, ⁴General Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, ⁵Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX
Background/Purpose: Video modelling is often used in patient education to improve patient outcomes. We conducted a multi-centered, open-label, parallel, randomized controlled trial that evaluated the…
Abstract Number: 2219 • 2015 ACR/ARHP Annual Meeting
Improving Outcomes with a Multimedia Patient Education Tool in Patients with Osteoporosis after 6 Months. a Randomized Controlled Trial
Maria A. Lopez-Olivo¹, Andrea Barbo², Tara Rizvi³, Robert Volk⁴, Heather Lin⁵ and Maria E. Suarez-Almazor¹, ¹General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ²Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³Rheumatology, Baylor College of Medicine, Houston, TX, ⁴General Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, ⁵Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX
Background/Purpose: We conducted a 6-month multi-centered, open-label, parallel, randomized control trial to compare a multimedia-patient education tool (MM-PtET) including storylines and narratives with a written…
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: 2315 • 2015 ACR/ARHP Annual Meeting
Six-Month Effects of a Multimedia Patient Education Tool in Patients with Rheumatoid Arthritis. a Randomized Controlled Trial
Maria A. Lopez-Olivo¹, Andrea Barbo², Tara Rizvi³, Robert Volk⁴, Heather Lin⁵ and Maria E. Suarez-Almazor⁶, ¹Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ²Department of Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³Rheumatology, Baylor College of Medicine, Houston, TX, ⁴Health Services Research, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁵Biostatistics, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁶General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX
Background/Purpose: We conducted a multi-centered, open-label, parallel, randomized controlled trial to evaluate the efficacy of a multimedia-patient education tool (MM-PtET) for patients with rheumatoid arthritis…
Abstract Number: L4 • 2014 ACR/ARHP Annual Meeting
Safety and Efficacy of Sifalimumab, an Anti IFN-Alpha Monoclonal Antibody, in a Phase 2b Study of Moderate to Severe Systemic Lupus Erythematosus (SLE)
Munther Khamashta^1,2, Joan T. Merrill³, Victoria P. Werth^4,5, Richard Furie⁶, Kenneth Kalunian⁷, Gabor G. Illei⁸, Jorn Drappa⁸, Liangwei Wang⁸ and Warren Greth⁸, ¹Division of Women's Health, Graham Hughes Lupus Research Laboratory, King's College London, London, United Kingdom, ²Lambeth Wing, The Rayne Institute, St Thomas' Hospital London, London, United Kingdom, ³Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁴Philadelphia VA Medical Center, Philadelphia, PA, ⁵University of Pennsylvania, Philadelphia, PA, ⁶North Shore-LIJ Health System, Lake Success, NY, ⁷UCSD School of Medicine, La Jolla, CA, ⁸MedImmune, LLC, Gaithersburg, MD
Background/Purpose: Efficacy and safety of sifalimumab were assessed in a Phase 2b, randomized, double-blind, placebo (PBO)-controlled study in subjects with SLE (NCT01283139). Methods: Adults (n=431)…
Abstract Number: 2896 • 2014 ACR/ARHP Annual Meeting
a Multi-Center Double-Blind, Randomized, Controlled Trial (db-RCT) to Evaluate the Effectiveness and Safety of Co-Administered Traumeel^® (Tr14) and Zeel^® (Ze14) Intra‑articular (IA) Injections Versus IA Placebo in Patients with Moderate-to-Severe Pain Associated with OA of the Knee
Carlos Lozada¹, Eve del Rio², Donald Reitberg², Robert Smith², Charles Kahn³ and Roland W. Moskowitz⁴, ¹Rheumatology, University of Miami Miller School of Medicine, Miami, FL, Miami, FL, ²Clinical Research, Rio Pharmaceutical Services, LLC, Bridgewater, NJ, ³South Florida Rheumatology, Hollywood, FL, ⁴Div of Rheum/Dept of Medicine, University Hospitals Case Medical Center, Cleveland, OH
Background/Purpose: Tr14 & Ze14 is a combination of dilute biological and mineral extracts administered IA for painful knee OA. In response to clinician impressions of…

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