Abstracts tagged "Randomized Trial"

Abstract Number: 1441 • ACR Convergence 2020
Effects of Belimumab on Renal Outcomes, Overall SLE Control and Biomarkers: Findings from a Phase 3, Randomized, Placebo-controlled 104-week Study in Patients with Active Lupus Nephritis
Richard Furie¹, Brad Rovin², Frédéric Houssiau³, Gabriel Contreras⁴, Ana Malvar⁵, Amit Saxena⁶, Xueqing Yu⁷, Y K Onno Teng⁸, Pieter van Paassen⁹, Ellen M Ginzler¹⁰, Diane Kamen¹¹, Mary Oldham¹², Damon Bass¹³, Andre van Maurik¹⁴, Mary Beth Welch¹³, Yulia Green¹⁵, Beulah Ji¹⁵, Christi Kleoudis¹⁶ and David Roth¹⁷, ¹Northwell Health, Great Neck, NY, ²The Ohio State University, Columbus, ³Cliniques Universitaires Saint-Luc, Brussels, Belgium, ⁴University of Miami Miller School of Medicine, Miami, ⁵Organizacion Medica de Investigacion, Buenos Aires, Argentina, ⁶NYU School of Medicine, New York, ⁷Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China (People's Republic), ⁸Leiden University Medical Center, Leiden, Netherlands, ⁹Maastricht University, Academisch Ziekenhuis Maastricht, Maastricht, Netherlands, ¹⁰SUNY Downstate Health Sciences University, Brooklyn, ¹¹Medical University of South Carolina, Charleston, SC, ¹²GlaxoSmithKline, Stevenage, United Kingdom, ¹³GlaxoSmithKline, Research Triangle Park, ¹⁴GlaxoSmithKline, Stevenage, ¹⁵GlaxoSmithKline, Uxbridge, ¹⁶Parexel (*At the time of study), Durham, ¹⁷GlaxoSmithKline, Collegeville
Background/Purpose: Belimumab (BEL) has demonstrated efficacy in systemic lupus erythematosus (SLE) in 4 positive pivotal trials. This study assessed the efficacy and safety of intravenous…
Abstract Number: 0897 • ACR Convergence 2020
Temporal Achievement of Clinical Response and Inactive Disease Status in Patients with Axial Spondyloarthritis Treated with Etanercept
Xenofon Baraliakos¹, Annette Szumski², Kenneth Kwok³ and Bonnie Vlahos⁴, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany, ²Syneos Health, Princeton, ³Pfizer, New York, NY, ⁴Pfizer, Collegeville, PA
Background/Purpose: Treatment with etanercept (ETN) is effective and well tolerated in patients with axial spondyloarthritis (AS), but the time frames within which patients tend to…
Abstract Number: 1444 • ACR Convergence 2020
Cluster-randomized Pragmatic Clinical Trial Evaluating the Potential Benefit of a Tight-control and Treat-to-target Strategy in Axial Spondyloarthritis: The Results of the TICOSPA Trial
Anna Molto¹, Clementina Lopez-Medina², Filip Van den Bosch³, Annelies Boonen⁴, Casper Webers⁴, Emmanuelle Dernis⁵, Floris van Gaalen⁶, Martin Soubrier⁷, Pascal Claudepierre⁸, Athan Baillet⁹, Mirian Starsman-Kool¹⁰, Anneke Spoorenberg¹¹, Désirée van der Heijde¹² and Maxime Dougados¹³, ¹Rheumatology Department, Cochin Hospital, APHP, Paris, France, Paris, France, ²INSERM U1153, Universtity of Paris, PAris, France, ³Ghent University Hospital, Ghent, Belgium, ⁴Maastricht University Medical Center, Maastricht, Netherlands, ⁵CH Le Mans, department of rheumatology, Le Mans, France, ⁶Leiden University Medical Center (LUMC), Leiden, Netherlands, ⁷CHU Gabriel Montpied, Clermont-Ferrand, France, ⁸Hôpital Henri Mondor, Université Paris Est Créteil, EA 7379 EpiDermE, department of rheumatology, Créteil, France, ⁹CHU Grenoble, Echirolles, France, ¹⁰ATRIUM Medical Center, Heerlen, ¹¹University Medical Centre Groningen and Medical centre Leeuwarden, Groningen, Netherlands, ¹²Leiden University Medical Center, Leiden, Netherlands, ¹³Université de Paris, Department of Rheumatology, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France
Background/Purpose: Recommendations for axial spondyloarthritis (axSpA) management include tight control and treat-to-target (TC), but no study has evaluated its potential benefit. The objective of this…
Abstract Number: 0907 • ACR Convergence 2020
Long-term Outcomes with Filgotinib, an Oral Selective Janus Kinase 1 Inhibitor: 100-week Data from an Open-label Extension (OLE) Study in Patients with Active Psoriatic Arthritis (PsA)
Laura Coates¹, Dafna Gladman², Filip Van den Bosch³, Philip Helliwell⁴, Anna Rychlewska-Hańczewska⁵, Mykola Stanislavchuk⁶, Leen Gilles⁷, Lien Gheyle⁷, Ke Liu⁸, Mona Trivedi⁸, Muhsen Alani⁹, Robin Besuyen¹⁰ and Philip Mease¹¹, ¹University of Oxford, Oxford, United Kingdom, ²Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ³Ghent University Hospital, Ghent, Belgium, ⁴Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁵Ai Centrum Medyczne, Poznań, Poland, ⁶National Pirogov Memorial Medical University, Vinnytsya, Ukraine, ⁷Galapagos NV, Mechelen, Belgium, ⁸Gilead Sciences, Inc., Foster City, CA, ⁹Gilead Sciences, Inc. and University of Washington, Foster City, CA, ¹⁰Galapagos BV, Leiden, Netherlands, ¹¹Seattle Rheumatology Associates, P.L.L.C., Seattle, WA
Background/Purpose: EQUATOR (NCT03101670) was a randomized, 16-week, Phase 2, multicenter, double-blind, placebo (PBO)‑controlled trial of filgotinib (FIL) in patients with active PsA ( Mease P,…
Abstract Number: 1467 • ACR Convergence 2020
Effectiveness of the Making It Work™ Program at Improving Presenteeism and Work Cessation in Workers with Inflammatory Arthritis – Results of a Randomized Controlled Trial
Andre Luquini¹, Yufei Zheng², Hui Xie³, Catherine Backman¹, Pamela Rogers³, Alex Kwok³, Astrid Knight³, Monique Gignac⁴, Dianne Mosher⁵, Linda Li¹, John Esdaile⁶, Carter Thorne⁷ and Diane Lacaille¹, ¹University of British Columbia / Arthritis Research Canada, Richmond, BC, Canada, ²Simon Fraser University / Arthritis Research Canada, Richmond, BC, Canada, ³Arthritis Research Canada, Richmond, BC, Canada, ⁴Institute for Work & Health / University of Toronto, Toronto, ON, Canada, ⁵University of Calgary, Calgary, AB, Canada, ⁶Arthritis Research Canada, Vancouver, BC, Canada, ⁷Southlake Regional Health Centre, Newmarket, ON, Canada
Background/Purpose: Arthritis often leads to presenteeism (decreased at-work productivity) and permanent work disability, the worst occupational outcome of a disease, leading to reduced quality of…
Abstract Number: 0910 • ACR Convergence 2020
Effect of Filgotinib on the Complete Resolution of Enthesitis in Psoriatic Arthritis (PsA) Patients: 52-week Results from EQUATOR2
Philip Mease¹, Laura Coates², Filip Van den Bosch³, Philip Helliwell⁴, Dafna Gladman⁵, Leen Gilles⁶, Lien Gheyle⁶, Mona Trivedi⁷, Muhsen Alani⁸ and Robin Besuyen⁹, ¹Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, ²University of Oxford, Oxford, United Kingdom, ³Ghent University Hospital, Ghent, Belgium, ⁴Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁵Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ⁶Galapagos NV, Mechelen, Belgium, ⁷Gilead Sciences, Inc., Foster City, CA, ⁸Gilead Sciences, Inc. and University of Washington, Foster City, CA, ⁹Galapagos BV, Leiden, Netherlands
Background/Purpose: EQUATOR (NCT03101670) was a 16-week, Phase 2, double-blind, randomized placebo-controlled trial of filgotinib for PsA. At Week 16, placebo-treated patients could switch to filgotinib…
Abstract Number: 1483 • ACR Convergence 2020
A Randomised Controlled Trial Evaluating the Efficacy of Internet-based Exercises Aimed at Treating Knee Osteoarthritis (iBEAT-OA)
Sameer Gohir¹, Abhishek Abhishek², Anthony Kelly² and Ana M Valdes³, ¹NIHR Nottingham Biomedical Research Centre, GRAYS ESSEX, England, United Kingdom, ²University of Nottingham, Nottingham, United Kingdom, ³NIHR Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, England, United Kingdom
Background/Purpose: Osteoarthritis (OA) is the commonest cause of pain and disability in the general population and is usually managed by family doctors and physiotherapists. This…
Abstract Number: 0935 • ACR Convergence 2020
Efficacy and Safety Results from a Phase 2, Randomized, Double-Blind Trial of BIIB059, an Anti-Blood Dendritic Cell Antigen 2 Antibody, in SLE
Richard Furie¹, Ronald van Vollenhoven², Kenneth Kalunian³, Sandra Navarra⁴, Juanita Romero-Díaz⁵, Victoria Werth⁶, Xiaobi Huang⁷, Hua Carroll⁸, Adam Meyers⁷, Cristina Musselli⁷, Catherine Barbey⁹ and Nathalie Franchimont⁷, ¹Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ²Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, ³University of California San Diego, La Jolla, CA, ⁴University of Santo Tomas, Manila, Philippines, ⁵Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico, ⁶University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, ⁷Biogen, Cambridge, MA, ⁸Biogen, Cambridge, ⁹Biogen, Baar, Switzerland
Background/Purpose: Type I interferons (IFN-I), inflammatory mediators principally produced by plasmacytoid dendritic cells (pDCs), components of the innate immune system, have been implicated in the…
Abstract Number: 1484 • ACR Convergence 2020
Efficacy of Tocilizumab in Patients with Hand Osteoarthritis: Double Blind, Randomized, Placebo Controlled, Multicenter Trial
Pascal Richette¹, Augustin Latourte², Jeremie Sellam³, Daniel Wendling⁴, Muriel Piperno⁵, Philippe Goupille⁶, Yves-Marie Pers⁷, Florent Eymard⁸, Sebastien Ottaviani⁹, Paul Ornetti¹⁰, Rene-Marc Flipo¹¹, Bruno Fautrel¹², Jean-Pierre Bertola¹³, Eric Vicaut¹⁴ and Xavier Chevalier¹⁵, ¹Department of Rheumatology, Lariboisière Hospital, AP-HP Université de Paris, INSERM U1132, Paris, ²Department of Rheumatology, Lariboisière Hospital, AP-HP Université de Paris, INSERM U1132, Paris, France, ³AP-HP, Hôpital Saint-Antoine, Service de Rhumatologie, Centre de Recherche Saint-Antoine, INSERM UMR_S 938,Sorbonne Université, Paris, 75012, France, Paris, France, ⁴CHU Besançon, department of rheumatology, Besancon, France, ⁵Rheumatology Department, Lyon University Hospital, Lyon, France, ⁶CHU Tours, department of rheumatology, Tours, France, ⁷IRMB, University of Montpellier, Inserm U1183, University Hospital of Montpellier, Montpellier, France, ⁸APHP Henri Mondor Hospital, Creteil, France, ⁹Rheumatology Department, Bichat hospital, APHP, Paris, France, ¹⁰CHU Dijon, INSERM CAPS 1093, plateforme d’investigation technologique CIC1432, Dijon, France, ¹¹Lille University Hospital, Lille, France, ¹²Sorbonne University, INSERM, IPLES; Pitié-Salpêtrière Hospital, Paris, Ile-de-France, France, ¹³CHUGAI PHARMA FRANCE, Paris, France, ¹⁴Clinical Research Unit, Paris, ¹⁵AP-HP, UPEC, Créteil
Background/Purpose: To evaluate the efficacy of tocilizumab, an antibody against interleukin-6 receptor (IL-6R), in patients with hand osteoarthritis.Methods: This was a multicenter, 12-week, randomized, double-blind,…
Abstract Number: 0955 • ACR Convergence 2020
Efficacy and Safety of IVIg (Octagam 10%) in Patients with Active Dermatomyositis. Results of a Randomized, Double-Blind, Placebo-Controlled Phase III Trial (ProDERM Study)
Rohit Aggarwal¹, Christina Charles-Schoeman², Joachim Schessl³, Zsuzsanna Bata-Csorgo⁴, Mazen Dimachkie⁵, Zoltan Griger⁶, Sergey Moiseev⁷, Chester Oddis⁸, Elena Schiopu⁹, Jiří Vencovský¹⁰, Beckmann Irene¹¹, Clodi Elisabeth¹¹, Todd Levine¹² and and the ProDERM Investigators¹³, ¹University of Pittsburgh, Pittsburgh, PA, ²University of California, Los Angeles, Los Angeles, CA, ³Städtisches Klinikum Karlsruhe, Karlsruhe, Germany, ⁴University of Szeged, Faculty of Medicine, Szeged, Hungary, ⁵Univeristy of Kansas, Medical Center, Kansas City, KS, ⁶University of Debrecen, Debrecen, Hungary, ⁷First Moscow State Medical University, Moscow, Russia, ⁸Department of Medicine, Division of Rheumatology, University of Pittsburgh, Pittsburgh, PA, ⁹Michigan Medicine, Ann Arbor, MI, ¹⁰Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ¹¹Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria, ¹²Phoenix Neurological Associates, LTD, Phoenix, AZ, ¹³Different Institutions in several countries, Vienna, Austria
Background/Purpose: Dermatomyositis (DM) is a rare chronic systemic autoimmune disease with characteristic skin rash and progressive proximal muscle weakness. Intravenous immunoglobulin (IVIg) has long been…
Abstract Number: 1485 • ACR Convergence 2020
LNA043, a Novel Cartilage Regenerative Treatment for Osteoarthritis: Results from a First-In-Human Trial in Patients with Knee Osteoarthritis
Celeste Scotti¹, Joseph Gimbel², Didier Laurent¹, Aviv Madar³, Thomas Peters¹, Yunyu Zhang³, Florine Polus¹, Michael Beste³, Igor Vostiar¹, Subhajit Choudhury⁴, Nicole Gerwin¹, Jörg Goldhahn⁵, Matthias Schieker¹ and Ronenn Roubenoff¹, ¹Novartis Institutes for BioMedical Research, Basel, Switzerland, ²Arizona Research Center, Phoenix, ³Novartis Institutes for BioMedical Research, Cambridge, ⁴Biostatistics & Pharmacometrics, Novartis Healthcare Pvt. Ltd., Hyderabad, India, ⁵Department of Health Sciences and Technology, ETH Zürich, Zurich, Switzerland
Background/Purpose:LNA043 is a modified human angiopoietin-like 3 (ANGPTL3) protein identified in a phenotypic screen for inducers of chondrogenesis and cartilage repair. The primary objective of…
Abstract Number: 0200 • ACR Convergence 2020
Predictors of Durable Clinical Response to Tofacitinib 11 Mg Once Daily with or Without Methotrexate in Patients with Rheumatoid Arthritis: Post Hoc Analysis of Data from a Phase 3b/4 Methotrexate Withdrawal Study
Kunihiro Yamaoka¹, Stanley B Cohen², Naonobu Sugiyama³, Harry Shi⁴, Jose L Rivas⁵, Annette Diehl⁴ and Josef Smolen⁶, ¹Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan, ²Metroplex Clinical Research Center, Dallas, TX, ³Pfizer Japan Inc, Tokyo, Japan, ⁴Pfizer Inc, Collegeville, PA, ⁵Pfizer SLU, Madrid, Spain, ⁶Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria
Background/Purpose: ORAL Shift, a global Phase 3b/4 non-inferiority study, demonstrated sustained efficacy/safety of tofacitinib modified-release (MR) 11 mg QD following MTX withdrawal in patients (pts)…
Abstract Number: 0962 • ACR Convergence 2020
Efficacy of Clomipramine for Chronic Lumbar Radicular Pain a Randomized Clinical Trial
Saloua Afilal¹, Safaa Fellous¹, Ilham Aachari¹, Redouane Abouqal², Ihsane Hmamouchi³, Nada Alami¹, Latifa Tahiri¹, Hanan Rkain¹, Najia Hajjaj-Hassouni⁴ and Fadoua Allali¹, ¹Rheumatology B Department, El Ayachi Hospital, Faculty of Medicine and Pharmacy of Rabat, Mohammed V University, Rabat, Morocco., Rabat, Morocco, ²Laboratory of Biostatistics, Clinical Research and Epidemiology (LBRCE), Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco., Rabat, Morocco, ³Temara Hospital, Laboratory of Biostatistics, Clinical Research and Epidemiology (LBRCE), Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco, Rabat, Morocco, ⁴Health Sciences College, International University of Rabat (UIR), Rabat, Morocco
Background/Purpose: Lumbar radicular pain is the most common chronic neuropathic pain syndrome. Antidepressants are highly recommended for neuropathic pain, but there is no evidence for…
Abstract Number: 1486 • ACR Convergence 2020
Long-term Efficacy and Safety of Intra-articular Sprifermin in Patients with Knee Osteoarthritis: Results from the 5-Year Forward Study
Felix Eckstein¹, Marc Hochberg², Hans Guehring³, Flavie Moreau⁴, Victor Ona⁴, Asger Bihlet⁵, Inger Byrjalsen⁵, Jeppe Andersen⁵, Benjamin Daelken³, Oliver Guenther³, Christoph Ladel³, Martin Michaelis³ and Philip G Conaghan⁶, ¹Paracelsus Medical University, Salzburg, Austria, ²University of Maryland School of Medicine, Baltimore, MD, ³Merck KGaA, Darmstadt, Germany, ⁴EMD Serono (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, ⁵Nordic Bioscience, Herlev, Denmark, ⁶Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and National Institute for Health Research Leeds Biomedical Research Centre, Leeds, United Kingdom
Background/Purpose: The 5-year Phase II FORWARD study assessed the efficacy and safety of the potential disease-modifying osteoarthritis drug (DMOAD) sprifermin (recombinant human fibroblast growth factor…
Abstract Number: 0220 • ACR Convergence 2020
Impact of Concomitant Glucocorticoids on the Clinical Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: An Ad Hoc Analysis of Data from Three Phase 3 Studies
Bernard Combe¹, Frank Buttgereit², Andrew Östör³, Ricardo Xavier⁴, Alain Saraux⁵, Capucine Daridon⁶, Kirsten Famulla⁷, Yanna Song⁸, Ivan Lagunes-Galindo⁹ and Gerd Burmester¹⁰, ¹University of Montpellier, Montpellier, France, ²Charité University Medicine, Berlin, Germany, ³Cabrini Medical Center, Monash University, Malvern, Victoria, Australia, ⁴Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rio Grande do Sul, Rio Grande do Sul, Brazil, ⁵Department of Rheumatology, UBO, CHU, INSERM 1227 (LBAI), Brest, France, ⁶AbbVie France, Rungis, France, ⁷AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, ⁸AbbVie Inc., North Chicago,, IL, ⁹AbbVie Inc., North Chicago, IL, ¹⁰Charité University Hospital Berlin, Berlin, Germany
Background/Purpose: Glucocorticoid (GC) therapy has strong anti-inflammatory effects and helps slow radiographic progression in RA1; however, GCs can be associated with adverse events (AEs) such…

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