Abstracts tagged "Randomized Trial"

Abstract Number: 2009 • ACR Convergence 2020
Treat-to Target for Early RA Patients in Usual Clinical Practice, a Randomized Study with a Favorable Effect of a Second Oral Pulse of Prednisolone. the Amsterdam COBRA Treat-to-target Study
Linda Hartman¹, Linda Rasch², Samina Turk³, Marieke ter Wee¹, Pit Kerstens⁴, Conny van der Laken⁵, Mike Nurmohamed⁶, Dirkjan van Schaardenburg⁷, Lilian van Tuyl⁸, Alexandre Voskuyl¹, Maarten Boers⁷ and Willem Lems¹, ¹Amsterdam Rheumatology and Immunology Center, location Amsterdam UMC, VUmc, Amsterdam, Netherlands, ²Amsterdam Rheumatology and Immunology Center, location Amsterdam UMC, VUmc, Amsterdam, ³Amsterdam Rheumatology and Immunology Center, location Reade, Amsterdam, Netherlands, ⁴Westfriesgasthuis, Hoorn, Netherlands, ⁵Amsterdam Rheumatology and immunology Center, location Amsterdam UMC, VU medical center, Amsterdam, Netherlands, ⁶Amsterdam Rheumatology and immunology Center, location Reade and Amsterdam UMC, VU medical center, Amsterdam, Netherlands, ⁷Amsterdam Rheumatology and immunology Center | Reade and Amsterdam UMC, Amsterdam, Netherlands, ⁸Nivel, Utrecht, Netherlands
Background/Purpose: EULAR guidelines advise to start with methotrexate (MTX) for early rheumatoid arthritis (RA), either alone or combined with prednisolone. Since this strategy is not…
Abstract Number: 0799 • ACR Convergence 2020
Effectiveness of Electronic Drug Monitoring Feedback in Order to Increase Adherence in RA Patients Starting with a Biological DMARD
Renske Hebing¹, Wouter Bos¹, Mike Nurmohamed² and Bart van den Bemt³, ¹Amsterdam Rheumatology and Immunology Center | Reade, Amsterdam, Netherlands, ²Amsterdam Rheumatology and immunology Center, location Reade and Amsterdam UMC, VU medical center, Amsterdam, Netherlands, ³Sint Maartenskliniek, Nijmegen, Netherlands
Background/Purpose: Medication non-adherence in rheumatoid arthritis (RA) is associated with disease flares, increased disability and increased costs. Electronic Monitoring Feedback (EMF) to improve adherence has…
Abstract Number: 1213 • ACR Convergence 2020
Discrepancy Between the Multi-biomarker Disease Activity Score and Clinical Disease Activity Scores in a 2‑Part, Multicenter Study of Repository Corticotropin Injection (Acthar® Gel) for Patients with Persistently Active Rheumatoid Arthritis
Roy Fleischmann¹, Jingyu Liu², Julie Zhu², Oscar Segurado³ and Daniel Furst*⁴, ¹Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, ²Mallinckrodt Pharmaceuticals, Bedminster, NJ, ³SSI Strategy, San Jose, CA, ⁴Department of Medicine, Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA, Los Angeles, CA
Background/Purpose: Assessment of disease activity in RA with validated measures, such as the Disease Activity Score with 28 joint count and erythrocyte sedimentation rate (DAS28-ESR)…
Abstract Number: 2010 • ACR Convergence 2020
Stable versus Tapered and Withdrawn Treatment with Tumor Necrosis Factor Inhibitor in Rheumatoid Arthritis Remission: A Randomized, Open-Label, Phase 4, Non-Inferiority Trial
Siri Lillegraven¹, Nina Paulshus Sundlisæter¹, Anna-Birgitte Aga¹, Joseph Sexton¹, Inge C. Olsen², Åse Lexberg³, Tor Magne Madland⁴, Hallvard Fremstad⁵, Christian Høili⁶, Gunnstein Bakland⁷, Cristina Spada⁸, Hilde Haukeland⁹, Inger Myrnes Hansen¹⁰, Ellen Moholt¹, Till Uhlig¹, Daniel H. Solomon¹¹, Désirée van der Heijde¹², Tore K. Kvien¹ and Espen A. Haavardsholm¹, ¹Diakonhjemmet Hospital, Oslo, Norway, ²Oslo University Hospital, Oslo, Norway, ³Vestre Viken HF, Drammen, Norway, ⁴Haukeland University Hospital, Bergen, Norway, ⁵Ålesund Hospital, Ålesund, Norway, ⁶Hospital Øsftfold HF, Moss, Norway, ⁷University Hospital of North Norway, Tromsø, Norway, ⁸Revmatismesykehuset, Lillehammeer, Norway, ⁹Martina Hansens Hospital, Bærum, Norway, ¹⁰Helgelandssykehuset Mo i Rana, Mo i Rana, Norway, ¹¹Brigham & Women's Hospital and Harvard Medical School, Boston, MA, ¹²Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Remission is the preferred treatment target in rheumatoid arthritis (RA), and many patients require biologic disease-modifying antirheumatic drugs (DMARDs) to reach this state. It…
Abstract Number: 0865 • ACR Convergence 2020
Efficacy and Safety of Evobrutinib (M2951) in Adult Patients with Systemic Lupus Erythematosus Who Received Standard of Care Therapy: A Phase II, Randomized, Double-blind, Placebo-controlled Dose Ranging Study
Daniel J Wallace¹, Thomas Dörner², David Pisetsky³, F Jorge Sanchez-Guerrero⁴, Amy Kao⁵, Dana Parsons-Rich⁵, Anand Patel⁶, Yulia Zima⁵, Claire Le Bolay⁷, Karthinathan Thangavelu⁶ and Maria Dall'Era⁸, ¹Cedars-Sinai Medical Center, Beverly Hills, CA, ²DRFZ and Charité University Hospitals, Berlin, Germany, ³Duke University Medical Center, Durham, NC, ⁴University Health Network/Sinai Health system, Toronto, ON, Canada, ⁵EMD Serono (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, ⁶EMD Serono (a business of Merck KGaA, Darmstadt, Germany), Billerica, ⁷Merck KGaA, Darmstadt, Germany, ⁸Division of Rheumatology, University of California, San Francisco, CA
Background/Purpose: Bruton’s tyrosine kinase (BTK) is involved in signalling pathways known to be important to the pathogenesis of systemic lupus erythematosus (SLE). Evobrutinib is a…
Abstract Number: 1344 • ACR Convergence 2020
Guselkumab, an IL-23 Inhibitor That Specifically Binds to the IL23p19-Subunit, for Active Psoriatic Arthritis: One Year Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Patients Who Were Biologic-Naïve or TNFα Inhibitor-Experienced
Christopher Ritchlin¹, Philip Helliwell², Wolf-Henning Boehncke³, Elizabeth Hsia⁴, Alexa Kollmeier⁵, Ramanand Subramanian⁶, Xie Xu⁷, Shihong Sheng⁶, Yusang Jiang⁶, Bei Zhou⁶ and Atul Deodhar⁸, ¹Department of Medicine, University of Rochester Medical Center, Rochester, NY, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³Geneva University Hospitals, Geneva, Switzerland, ⁴Janssen Research & Development, LLC and University of Pennsylvania Medical Center, Spring House, PA, ⁵Janssen Research & Development, LLC, La Jolla, CA, ⁶Janssen Research & Development, LLC, Spring House, PA, ⁷Janssen Research & Development, LLC, San Marcos, CA, ⁸Oregon Health & Science University, Portland, OR
Background/Purpose: Guselkumab (GUS), a monoclonal antibody that specifically binds to the p19-subunit of IL-23, is approved to treat psoriasis (PsO). At Week 24 of the…
Abstract Number: 2012 • ACR Convergence 2020
A Phase IIb, Randomized, Double-blind Study in Patients with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Patients with an Inadequate Response to Methotrexate
Charles Peterfy¹, Maya Buch², Ernest Choy³, Georg Schett⁴, Dana Parsons-Rich⁵, Anand Patel⁶, Yulia Zima⁵, Claire Le Bolay⁷ and Mark Genovese⁸, ¹Spire Sciences, Inc., Boca Raton, FL, ²Centre of Musculoskeletal Research, School of Biological Sciences, University of Manchester, Manchester, United Kingdom, ³CREATE Centre, Cardiff University, Cardiff, Wales, United Kingdom, ⁴Friedrich-Alexander-Universität Erlangen- Nuremberg, Erlangen, Germany, ⁵EMD Serono (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, ⁶EMD Serono (a business of Merck KGaA, Darmstadt, Germany), Billerica, ⁷Merck KGaA, Darmstadt, Germany, ⁸Division of Immunology and Rheumatology, Stanford University, Palo Alto, CA
Background/Purpose: Bruton’s tyrosine kinase (BTK) is involved in multiple signalling pathways potentially implicated in rheumatoid arthritis (RA). Evobrutinib is a highly selective, oral BTK inhibitor.…
Abstract Number: 0875 • ACR Convergence 2020
Secukinumab Provides Sustained Improvements in Subgroup Analyses of Joint Tenderness and Swelling in Patients with Psoriatic Arthritis: 5‑Year Results from the Phase 3 FUTURE 2 Study
Iain McInnes¹, Hector Chinoy², Darren Asquith³, Abigail White³ and Corine Gaillez⁴, ¹Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, ²The University of Manchester, Manchester, United Kingdom, ³Novartis Pharmaceuticals UK Ltd., London, United Kingdom, ⁴Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Secukinumab, a fully human monoclonal antibody that neutralizes interleukin‑17A, has shown long-term efficacy and tolerability in patients with psoriatic arthritis (PsA) in FUTURE 2.…
Abstract Number: 1348 • ACR Convergence 2020
What Influence Do Clinical Domains Other Than Arthritis Have on Composite Clinical Outcomes in Psoriatic Arthritis?: Comparison of Treatment Effects in the SEAM-PsA Trial
Philip Helliwell¹, Philip Mease², Arthur Kavanaugh³, Laura Coates⁴, Alexis Ogdie⁵, Atul Deodhar⁶, Vibeke Strand⁷, Ervant Maksabedian⁸, Gregory Kricorian⁹, Lyrica Liu⁹, David Collier¹⁰ and Dafna Gladman¹¹, ¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ²Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, ³UC San Diego Health System, San Diego, CA, ⁴University of Oxford, Oxford, United Kingdom, ⁵University of Pennsylvania, Philadelphia, PA, ⁶Oregon Health & Science University, Portland, OR, ⁷Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, ⁸Amgen Inc., LOS ANGELES, CA, ⁹Amgen Inc., Thousand Oaks, CA, ¹⁰Amgen, Thousand Oaks, CA, ¹¹Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada
Background/Purpose: Psoriatic arthritis is broadly characterized by clinical domains such as enthesitis, dactylitis, nail manifestations, and psoriasis. How these clinical domains influence the response to…
Abstract Number: 2023 • ACR Convergence 2020
Efficacy and Safety of Upadacitinib in Patients with Active Ankylosing Spondylitis: 1-Year Results from a Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension
Atul Deodhar¹, Désirée van der Heijde², Joachim Sieper³, Filip Van den Bosch⁴, Walter Maksymowych⁵, Tae-Hwan Kim⁶, Mitsumasa Kishimoto⁷, Andrew Östör⁸, Bernard Combe⁹, Yunxia Sui¹⁰, Xin Wang¹⁰, Alvina D. Chu¹¹ and In-Ho Song¹⁰, ¹Oregon Health & Science University, Portland, OR, ²Leiden University Medical Center, Leiden, Netherlands, ³Charité Universitätsmedizin Berlin, Berlin, Germany, ⁴Ghent University Hospital, Ghent, Belgium, ⁵University of Alberta, Edmonton, AB, Canada, ⁶Hanyang University Hospital for Rheumatic Diseases, Seoul, Seoul-t'ukpyolsi, Republic of Korea, ⁷Department Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, ⁸Cabrini Medical Center, Monash University, Malvern, Victoria, Australia, ⁹University of Montpellier, Montpellier, France, ¹⁰AbbVie Inc., North Chicago, IL, ¹¹AbbVie, North Chicago, IL
Background/Purpose: Upadacitinib (UPA), a Janus kinase (JAK) inhibitor, was efficacious and well tolerated vs placebo (PBO) during the first 14 weeks (wks) of the phase…
Abstract Number: 0886 • ACR Convergence 2020
Achievement of Partial Remission and Inactive Disease in Upadacitinib-Treated Patients with Ankylosing Spondylitis
Atul Deodhar¹, Andrew Östör², Anna Maniccia³, Fabiana Ganz⁴, Tianming Gao³, Alvina D. Chu⁵ and Denis Poddubnyy⁶, ¹Oregon Health & Science University, Portland, OR, ²Cabrini Medical Center, Monash University, Malvern, Victoria, Australia, ³AbbVie Inc., North Chicago, IL, ⁴AbbVie Inc., Baar, Switzerland, ⁵AbbVie, North Chicago, IL, ⁶Charité – Universitätsmedizin Berlin, Berlin, Germany
Background/Purpose: Assessment of SpondyloArthritis international Society (ASAS) response criteria and AS Disease Activity Score (ASDAS) are both commonly used, rigorous composite indices consisting of components…
Abstract Number: 1372 • ACR Convergence 2020
Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis and Axial Involvement
Atul Deodhar¹, Roberto Ranza², Fabiana Ganz³, Tianming Gao⁴, Jaclyn K Anderson⁴ and Andrew Östör⁵, ¹Oregon Health & Science University, Portland, OR, ²Hospital de Clinicas, Universidade Federal de Uberlândia, Uberlândia, Brazil, ³AbbVie Inc., Baar, Switzerland, ⁴AbbVie Inc., North Chicago, IL, ⁵Cabrini Medical Center, Monash University, Malvern, Victoria, Australia
Background/Purpose: Upadacitinib (UPA) has demonstrated efficacy for the treatment of AS in patients (pts) who were NSAID inadequate responders (IR).1 Pts with psoriatic arthritis (PsA)…
Abstract Number: 2024 • ACR Convergence 2020
Effects of Filgotinib on Spinal Lesions in Patients with Ankylosing Spondylitis: Magnetic Resonance Imaging Data from the Placebo-Controlled, Double‑Blind, Randomized TORTUGA Trial
Walter Maksymowych¹, Mikkel Østergaard², Robert Landewé³, William Barchuk⁴, Ke Liu⁴, Chantal Tasset⁵, Leen Gilles⁵, Thijs Hendrikx⁶, Robin Besuyen⁶ and Xenofon Baraliakos⁷, ¹University of Alberta, Edmonton, AB, Canada, ²Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, ³Amsterdam University Medical Center & Zuyderland Hospital, Amsterdam, Netherlands, ⁴Gilead Sciences, Inc., Foster City, CA, ⁵Galapagos NV, Mechelen, Belgium, ⁶Galapagos BV, Leiden, Netherlands, ⁷Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany
Background/Purpose: The oral, selective Janus kinase 1 inhibitor filgotinib (FIL) significantly improved Spondyloarthritis Research Consortium of Canada (SPARCC) MRI inflammation scores (bone marrow edema) in…
Abstract Number: 0896 • ACR Convergence 2020
Impact of Upadacitinib on Reducing Pain in Patients with Active Psoriatic Arthritis: Results from Two Phase 3 Trials in Patients with Inadequate Response to Non-biologic or Biologic DMARDs
Iain McInnes¹, William Tillett², Philip Mease³, Kurt de Vlam⁴, Louis Bessette⁵, Ralph Lippe⁶, Anna Maniccia⁷, Patrick Zueger⁷, Dai Feng⁷, Koji Kato⁸ and Andrew Östör⁹, ¹Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, ²Royal National Hospital for Rheumatic Diseases, Bath, UK; Department of Pharmacy and Pharmacology, University of Bath, Bath, UK, Bath, United Kingdom, ³Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, ⁴Department of Rheumatology, University of Leuven, Belgium, Leuven, Belgium, ⁵Laval University, Quebec, Canada, ⁶AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, ⁷AbbVie Inc., North Chicago, IL, ⁸AbbVie Inc, North Chicago, IL, ⁹Cabrini Medical Center, Monash University, Malvern, Victoria, Australia
Background/Purpose: Pain is a dominant symptom of psoriatic arthritis (PsA), and pain reduction is a priority for patients (pts) that is often assessed in clinical…
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…

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