Abstracts tagged "RCT"

Abstract Number: 1686 • ACR Convergence 2021
Efficacy and Safety of Olokizumab in a Phase III Trial of Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by TNF-α Inhibitor Therapy
Eugen Feist¹, Saeed Fatenejad², Sergey Grishin³, Elena Korneva³, Michael Luggen⁴, Evgeniy Nasonov⁵, Mikhail Samsonov⁶ and Roy Fleischmann⁷, ¹Helios Department of Rheumatology, Vogelsang-Gommern, Germany, ²SFC Medica, LLC, Charlotte, NC, ³R-Pharm, Moscow, Russia, ⁴Cincinnati Rheumatic Disease Study Group, Inc., and University Hospital/University of Cincinnati College of Medicine, Cincinnati, OH, ⁵V.A. Nasonova Reseach Institute of Rheumatology, Moscow, Russia, ⁶RPharm, Moscow, Russia, ⁷Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: Olokizumab (OKZ), a humanized monoclonal antibody targeting IL-6, was studied in patients with active Rheumatoid Arthritis (RA) despite methotrexate (MTX) (NCT02760368, NCT02760407) [1]. Here…
Abstract Number: 1685 • ACR Convergence 2021
Efficacy and Safety of Olokizumab in a Phase III Trial of Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate – Placebo and Active Controlled Study
Eugen Feist¹, Saeed Fatenejad², Sergey Grishin³, Elena Korneva³, Evgeniy Nasonov⁴, Anna Rowińska-Osuch⁵, Mikhail Samsonov⁶ and Roy Fleischmann⁷, ¹Helios Department of Rheumatology, Vogelsang-Gommern, Germany, ²SFC Medica, LLC, Charlotte, NC, ³R-Pharm, Moscow, Russia, ⁴V.A. Nasonova Reseach Institute of Rheumatology, Moscow, Russia, ⁵MCM Polimedica, Warsaw, Poland, ⁶RPharm, Moscow, Russia, ⁷Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: Olokizumab (OKZ) is a humanized monoclonal antibody targeting IL-6 [1]. Here we present the results of a global phase III, head-to-head, randomized placebo (PBO)…
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.…