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Abstracts tagged "RCT"

  • Abstract Number: 097 • 2020 Pediatric Rheumatology Symposium

    A Pilot Randomized Controlled Trial of the iCanCope Pain Self-management Application for Adolescents with Juvenile Idiopathic Arthritis

    Chitra Lalloo 1, Lauren Harris 2, Amos Hundert 2, Roberta Berard 3, Joseph Cafazzo 4, Mark Connelly 5, Brian Feldman 2, Kristin Houghton 6, Adam Huber 7, Ronald Laxer 8, Nadia Luca 9, Heinrike Schmeling 10, Lynn Spiegel 11, Lori Tucker 12, Quynh Pham 4, Cleo Davies-Chalmers 13 and Jennifer Stinson14, 1The Hospital for Sick Children, Toronto, Ontario, Canada, 2The Hospital for Sick Children, Toronto, Canada, 3Children's Hospital London Health Sciences Centre, London, Canada, 4University of Toronto, Toronto, Canada, 5Kansas City, 6University of British Columbia - Vancouver, Vancouver, Canada, 7IWK Health Centre & Dalhousie University, Halifax, Nova Scotia, Canada, 8The Hospital for Sick Children and University of Toronto, Toronto, Canada, 9University of Calgary, Calgary, Alberta, Canada, 10Alberta Children's Hospital/University of Calgary, Calgary, Alberta, Canada, 11University of Toronto/Hospital for Sick Children, Thornhill, Canada, 12BC Children's Hospital, Vancouver, British Columbia, Canada, 13The Hospital for Sick Children, Toonto, Canada, 14University of Toronto & The Hospital for Sick Children, Toronto, Ontario, Canada

    Background/Purpose: Pain is the most common symptom of Juvenile Idiopathic Arthritis (JIA), a chronic childhood illness that has potentially debilitating effects on health-related quality of…
  • Abstract Number: 506 • 2019 ACR/ARP Annual Meeting

    Efficacy and Safety of Filgotinib for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: FINCH1 Primary Outcome Results

    Bernard Combe1, Alan Kivitz 2, Yoshiya Tanaka 3, Désirée van der Heijde 4, Franziska Matzkies 5, Beatrix Bartok 5, Lei Ye 5, Ying Guo 5, Chantal Tasset 6, John Sundy 5, Neelufar Mozaffarian 5, Robert B.M. Landewé 7, Sang-Cheol Bae 8, Edward Keystone 9 and Peter Nash 10, 1CHU Montpellier, Montpellier University, Montpellier, France, 2Altoona Center for Clinical Research, Duncansville, PA, 3University of Occupational and Environmental Health Japan, Kitakyushu, Japan, 4Leiden University Medical Center, Leiden, Netherlands, 5Gilead Sciences, Inc., Foster City, CA, 6Galapagos NV, Mechelen, Belgium, 7Amsterdam University Medical Center, Amsterdam, Netherlands, 8Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 9Mount Sinai Hospital and University of Toronto, Toronto, ON, Canada, 10University of Queensland, Brisbane, Queensland, Australia

    Background/Purpose: Filgotinib (FIL) is an orally administered, potent and selective inhibitor of Janus kinase 1 (JAK1) that has shown good efficacy and was well tolerated…
  • Abstract Number: 875 • 2019 ACR/ARP Annual Meeting

    Effect of the Dr. Bart Application on Healthcare Use and Clinical Outcomes in People with Osteoarthritis of the Knee And/or Hip in the Netherlands; A Randomized Controlled Trial

    Tim Pelle1, Karen Bevers 1, Job van der Palen 2, Frank van den Hoogen 3 and Cornelia van den Ende 1, 1Sint Maartenskliniek Nijmegen, Nijmegen, Netherlands, 2Department of research methodology, Univeristy of Twente, Enschede, Netherlands, 3Sint Maartenskliniek, Nijmegen, Netherlands

    Background/Purpose: Self-management is of paramount importance in non-surgical treatment of knee/hip osteoarthritis (OA). Modern technologies offer the possibility to support self-management 24/7. We developed an…
  • Abstract Number: 1679 • 2019 ACR/ARP Annual Meeting

    Adaptive Study Design of a Randomized, Multicenter, 2-Part Phase 2 Trial of Replacement of Glucocorticoids by IFX-1, a C5a Inhibitor, in Active Granulomatosis with Polyangiitis and Microscopic Polyangiitis

    Peter Merkel1, Bernhard Hellmich 2, David Jayne 3, Simon Rückinger 4, Zsuzsanna Tamas 5, Claus Thielert 5 and Othmar Zenker 6, 1University of Pennsylvania, Philadelphia, PA, 2Department of Internal Medicine, Rheumatology and Immunology, Vasculitis-Center Tübingen-Kirchheim, Medius Klinik Kirchheim, University of Tübingen, Kirchheim-Teck, Germany, Kirchheim, Germany, 3Vasculitis and Lupus Clinic, Addenbrooke’s Hospital, University of Cambridge, UK, Cambridge, United Kingdom, 4Metronomia Clinical Research GmbH, Munich, Germany, 5InflaRx GmbH, Planegg, Germany, 6InflaRx GmbH, Jena, Germany

    Background/Purpose: Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are life-threatening rare autoimmune diseases are both forms of anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). Standard of…
  • Abstract Number: 1680 • 2019 ACR/ARP Annual Meeting

    Design of a Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of 2 Different Dose Regimens of IFX-1, a C5a Inhibitor, as an Add-On Therapy for Granulomatosis with Polyangiitis or Microscopic Polyangiitis

    Peter Merkel1, Bernhard Hellmich 2, David Jayne 3, Simon Rückinger 4, Zsuzsanna Tamas 5, Claus Thielert 5 and Othmar Zenker 6, 1University of Pennsylvania, Philadelphia, PA, 2Department of Internal Medicine, Rheumatology and Immunology, Vasculitis-Center Tübingen-Kirchheim, Medius Klinik Kirchheim, University of Tübingen, Kirchheim-Teck, Germany, Kirchheim, Germany, 3Vasculitis and Lupus Clinic, Addenbrooke’s Hospital, University of Cambridge, UK, Cambridge, United Kingdom, 4Metronomia Clinical Research GmbH, Munich, Germany, 5InflaRx GmbH, Planegg, Germany, 6InflaRx GmbH, Jena, Germany

    Background/Purpose: Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are life-threatening rare autoimmune diseases to anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Standard of care (SOC)…
  • Abstract Number: 2085 • 2019 ACR/ARP Annual Meeting

    Too Soon to Say: Promising Results from a Community-Delivered RCT Examining Work-Related Outcomes of the Chronic Disease Self-Management Program

    Kristina Theis1, Teresa Brady 2 and Shawn Kneipp 3, 1Centers for Disease Control and Prevention, Atlanta, 2Clarity Consulting and Communications, Atlanta, GA, 3School of Nursing, The University of North Carolina at Chapel Hill, Atlanta, GA

    Background/Purpose: More than two-thirds of U.S. adults with arthritis are working-age (< 65), and arthritis is a leading cause of work disability. The Chronic Disease…
  • Abstract Number: L10 • 2018 ACR/ARHP Annual Meeting

    Clinical Efficacy of Leflunomide/Hydroxychloroquine Combination Therapy in Patients with Primary Sjogren’s Syndrome: Results of a Placebo-Controlled Double-Blind Randomized Clinical Trial

    Timothy R.D.J. Radstake1, Eefje H.M. van der Heijden2, Frederique M. Moret3, Maarten R. Hillen4, Ana P. Lopes5, Toine Rosenberg6, Nard Janssen6, Aike A. Kruize7 and Joel A.G. van Roon3, 1Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands, 2Department of Rheumatology and Clinical Immunology, Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht, Netherlands, 3Rheumatology & Clinical Immunology/ Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht, Netherlands, 4Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands, 5Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht, Netherlands, 6Department of Oral-Maxillofacial Surgery, University Medical Center Utrecht, Utrecht, Netherlands, 7Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands

    Background/Purpose: Primary Sjogren’s syndrome (pSS) is a systemic, progressive autoimmune disease characterized by secretory gland dysfunction which lacks effective therapy. Clinical trials in patients with…
  • Abstract Number: 1926 • 2018 ACR/ARHP Annual Meeting

    Effects of Social Networking on Chronic Disease Management in Rheumatoid Arthritis

    Maria A. Lopez-Olivo1, Jessica Foreman2, Heather Lin3, Cheuk Hong Leung4, Tiffany Westrich-Robertson5, Catherine Hofstetter6, Susan K. Peterson7, Anne Lyddiatt8, Amye L. Leong9, Irmgard U. Willcockson10 and Maria Suarez-Almazor1, 1Section of Rheumatology and Clinical Immunology, Department of General Internal Medicine, 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, 3Biostatistics, Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA, Houston, TX, 4Department of Biostatistics, Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA, Houston, TX, 5International Foundation for Autoimmune and Autoinflammatory Arthritis, Saint Louis, Missouri, USA, St Louis, MO, 6OMERACT patient research partner group, Ottawa, ON, Canada, 7Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston Texas, USA, Houston, TX, 8Musculoskeletal Group, Cochrane Collaboration, Hamilton, ON, Canada, 9Spokesperson; Strategic Relations, Bone and Joint Decade, Santa Barbara, CA, 10School of Biomedical Informatics, University of Texas Health Science Center at Houston, Houston, TX

    Background/Purpose: We evaluated a social networking intervention to help patients with rheumatoid arthritis become active partners in their own care. We developed a closed independent…
  • Abstract Number: 14L • 2017 ACR/ARHP Annual Meeting

    Miv-711, a Novel Cathepsin K Inhibitor Demonstrates Evidence of Osteoarthritis Structure Modification: Results from a 6 Month Randomized Double-Blind Placebo-Controlled Phase IIA Trial

    Philip G. Conaghan1, Michael A Bowes2, Sarah R. Kingsbury1, Alan Brett2, Gwenael Guillard2, Åsa Jansson3, Cecilia Wadell3, Richard Bethell3 and John Öhd3, 1University of Leeds, Leeds, United Kingdom, 2Imorphics Ltd, Manchester, United Kingdom, 3Medivir AB, Huddinge, Sweden

    Background/Purpose: The need for drugs that achieve structure modification in OA is imminent but their development has been burdened by the need for large, long…
  • Abstract Number: 2183 • 2017 ACR/ARHP Annual Meeting

    Two-Year Changes in Knee Osteoarthritis Symptoms: Comparing Clinical Relevance of Patient-Reported Outcomes By Anchoring to Knee Replacement

    C. Kent Kwoh1, Hans Guehring2, Erin Ashbeck3, Michael J Hannon4 and Aida Aydemir5, 1University of Arizona Arthritis Center, Tuscan, AZ, 2Merck KGaA, Darmstadt, Germany, 3The University of Arizona Arthritis Center, Tucson, AZ, 4Medicine, University of Pittsburgh, Pittsburgh, PA, 5EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA

    Background/Purpose: Randomized controlled trials (RCTs) of interventions for knee OA (KOA) may include a patient-reported outcome (PRO) measure as a primary endpoint. Several measures of…
  • Abstract Number: 2968 • 2017 ACR/ARHP Annual Meeting

    Less Fatigue in Psoriatic Arthritis after High Intensity Interval Training. a Randomized Controlled Trial

    Ruth Stoklund Thomsen1, Tom Ivar Lund Nilsen2, Glenn Haugeberg3, Anja Bye3, Arthur Kavanaugh4 and Mari Hoff5, 1Faculty of Medicine, Department of Public Health and Nursing, NTNU, Norwegian University of Science and Technology, Trondheim, Norway, 2Faculty of medicine, Department of public health and nursing, NTNU, Norwegian University of Science and Technology, Trondheim, Norway, 3NTNU, Norwegian University of Science and Technology, Trondheim, Norway, 4Medicine, University of California, San Diego, La Jolla, CA, 5Rheumatolgy, University Hospital, St. Olavs Hospital, NTNU, Trondheim, Norway

    Background/Purpose: Patients with psoriatic arthritis (PsA) have a high disease burden with increased pain and more fatigue than the general population. Physical exercise is recommended…
  • 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 Reichenbach1,2, 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…
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