ACR Meeting Abstracts

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Abstracts tagged "clinical trials"

  • Abstract Number: 940 • 2019 ACR/ARP Annual Meeting

    Response to Placebo in Randomized Clinical Trials with Biologics in Non-renal, Non-neuropsychiatric Systemic Lupus Erythematosus: A Systematic Review and Pooled Analysis

    Konstantinos Tselios1, Laura Wakani 2, Dafna Gladman 3, Jiandong Su 4 and Murray Urowitz 4, 1University Health Network, University of Toronto, Toronto, Canada, 2University Health Network, Toronto, Canada, 3Toronto Western Hospital, Toronto, Canada, Toronto, ON, Canada, 4University Health Network, University of Toronto, Toronto, ON, Canada

    Background/Purpose: Most randomized controlled trials (RCTs) with biologic medicines in systemic lupus erythematosus (SLE) failed to reach their respective end-points with the rates of the…
  • Abstract Number: 1760 • 2019 ACR/ARP Annual Meeting

    Six-week Treatment with Low-dose Prednisolone in Patients with Painful Hand Osteoarthritis (HOPE): Results from a Randomised Double-blind Placebo-controlled Trial

    Féline Kroon1, Marion Kortekaas 1, Annelies Boonen 2, Stephan Böhringer 3, Monique Reijnierse 1, Frits R Rosendaal 3, Naghmeh Riyazi 4, Mirian Starmans 5, Franktien Turkstra 6, Jende van Zeben 7, CF Allaart 8 and Margreet Kloppenburg 3, 1Leiden University Medical Center, Leiden, Netherlands, 2Maastricht University Medical Center, Maastricht, Netherlands, 3Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands, 4Haga Hospital, The Hague, Netherlands, 5Zuyderland Medical Center, Heerlen, Netherlands, 6Amsterdam Rheumatology and immunology Center | Reade, Amsterdam, Netherlands, 7Sint Franciscus Vlietland Groep, Rotterdam, Netherlands, 8Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Leiden, Netherlands

    Background/Purpose: Hand osteoarthritis (OA) is a prevalent joint disease with high disease-burden in need for effective therapeutic options. Studies have shown that synovial inflammation is…
  • Abstract Number: 941 • 2019 ACR/ARP Annual Meeting

    Treatment of Lupus Nephritis with anti-CD20 Followed by Anti-BAFF: Impact on B Cell Reconstitution, B Cell Subsets, and Autoreactivity

    Yemil Atisha Fregoso1, Susan Malkiel 2, Kristina Harris 3, Sai Kanaparthi 3, Margie Byron 4, Linna Ding 5, Dawn Smilek 6, David Wofsy 7, Maria Dall'Era 8, Cynthia Aranow 1 and Betty Diamond 9, 1Feinstein Institute for Medical Research, Manhasset, NY, 2Feinstein Institute for Medical Research, Manhasset, 3Immune Tolerance Network, Bethesda, 4Rho Federal Systems, Inc., Chapel Hill, NC, 5National Institute of Allergy and Infectious Diseases, Bethesda, MD, 6Immune Tolerance Network, San Francisco, CA, 7UCSF, San Francisco, 8University of California, San Francisco, San Francisco, CA, 9Feinstein Institutes for Medical Research, Manhasset

    Background/Purpose: Despite the relevance of B cells in lupus, two clinical trials of anti-CD20 failed to meet primary endpoints in patients with lupus and lupus…
  • Abstract Number: 2174 • 2019 ACR/ARP Annual Meeting

    Test-Retest Reliability and Validity of a Mobile Health Application to Automate the 30 Seconds Chair Stand Test – Preliminary Data to Create a Contemporary Instrument for Randomized Clinical Trials

    Lucas Dantas1, Matthew Harkey 2, André Dantas 3, Lori Lyn Price 4, Jeffrey Driban 5 and Timothy McAlindon 1, 1Tufts Medical Center, Boston, MA, 2Tufts Medical Center, University of Massachusetts Medical School, Boston, MA, 3CI&T, Tokyo, Japan, 4Tufts Medical Center, Tufts University, Boston, MA, 5Tufts Medical Center, Boston

    Background/Purpose: Contemporary technologies offer potential solutions to improve and automate data collection of randomized clinical trials by transitioning assessments from the clinic to the real-world.…
  • Abstract Number: 946 • 2019 ACR/ARP Annual Meeting

    Improvements in Disease Activity and Quality of Life for up to 64 Weeks in Patients with Behçet’s Syndrome: Results from a Phase III Study

    Gulen Hatemi1, Alfred Mahr 2, Mitsuhiro Takeno 3, Doyoung Kim 4, Melike Melikoglu 5, Sue Cheng 6, Shannon McCue 7, Maria Paris 6, Mindy Chen 8 and Yusuf Yazici 9, 1Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul University-Cerrahpasa, Behcet's Disease Research Center, Istanbul, Turkey, Istanbul, Turkey, 2Hospital Saint-Louis, University Paris Diderot, Paris, France, 3Nippon Medical School, Tokyo, Japan, 4Yonsei University College of Medicine and Severance Hospital, Seoul, Republic of Korea, 5Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul University – Cerrahpasa, Behçet’s Disease Research Center, Istanbul, Turkey, Istanbul, Turkey, 6Celgene Corporation, Summit, 7Celgene Corporation, Summit, NJ, 8Celgene Corporation, Berkeley Heights, NJ, 9New York University School of Medicine, New York

    Background/Purpose: Behçet’s syndrome is a chronic, multi-system inflammatory disorder characterized by painful, recurrent oral ulcers (OU) that can impair quality of life (QoL). Apremilast (APR),…
  • Abstract Number: 2710 • 2019 ACR/ARP Annual Meeting

    Sarilumab, a Human Monoclonal Antibody to the Interleukin-6 Receptor, in Polyarticular-course Juvenile Idiopathic Arthritis: A 12-week, Multinational, Open-label, Dose-finding Study

    Fabrizio De Benedetti1, Inmaculada Calvo Penadés 2, Nadina Rubio-Pérez 3, Alexey Maschan 4, Pierre Quartier 5, Zbigniew Żuber 6, Marina Stanislav 7, Raul Barria 8, Daniel Clemente 9, Gabriel Vega-Cornejo 10, Nancy Liu 11, Christine Xu 11, Angeliki Giannelou 12, Bolanle Akinlade 12 and Lydie Baret-Cormel 13, 1Bambino Gesù Children’s Hospital, Rome, Italy, 2Hospital Univ. La Fe, Valencia, Spain, 3University Hospital Dr. José Eleuterio González, Monterrey, Mexico, 4Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russia, 5Necker Hospital, Paris, France, 6Andrzej Frycz Modrzewski Krakow University, Kraków, Poland, 7V.A. Nasonova Research Rheumatology Institute, Moscow, Russia, 8Bioreuma, Concepción, Chile, 9Hospital Infantil Universitario Niño Jesús, Madrid, Spain, 10CREA de Guadalajara, Jalisco, Mexico, 11Sanofi, Bridgewater, NJ, 12Regeneron, New York, NY, 13Sanofi, Chilly-Mazarin, France

    Background/Purpose: Sarilumab blocks interleukin-6 (IL-6) from binding to membrane and soluble IL-6 receptor-α. Sarilumab is approved for adults with rheumatoid arthritis (RA) and is being…
  • Abstract Number: 1144 • 2019 ACR/ARP Annual Meeting

    Understanding Clinical Trials Participation Among Individuals of African Descent with Lupus Through the Lens of Critical Race Theory: A Qualitative Analysis

    Candace Feldman1, Jessica Williams 1, Courtnie Phillip 1, Corine Sinnette 1, Karen Mancera-Cuevas 2, Patricia Canessa 3, Gina Curry 4, Maryann Mason 2 and Rosalind Ramsey-Goldman 2, 1Brigham and Women's Hospital, Boston, MA, 2Northwestern University, Chicago, IL, 3IPHA, Chicago, IL, 4University of Chicago, Chicago, IL

    Background/Purpose: Despite a disproportionate burden of lupus and poorer outcomes among individuals of African descent (hereafter “black”) compared to white individuals, black individuals are underrepresented…
  • Abstract Number: 2771 • 2019 ACR/ARP Annual Meeting

    A Phase I, Randomized, Double-blind, Placebo-controlled, Single Center, Single-dose Escalation to Investigate the Safety, Tolerability, and Pharmacodynamics of Subcutaneously Administered DEN-181 in Adult Patients with ACPA+ Rheumatoid Arthritis on Stable Methotrexate

    Amee Sonigra 1, Hendrik Nel 2, Nishta Ramnoruth 2, Meghna Talekar 2, Joanne Tesiram 3, Frederik Stuurman 4, Lavinia Proctor 5, Helen Roberts 6, Robin Thurmond 7, Phillip Vecchio 3, Ian Gourley 8, Mark Rigby 9, Nathan Felix 10, Stephane Becart 11, Kim Campbell 12 and Ranjeny Thomas2, 1Princess Alexandra Hospital, Woolloongabba, Queensland, Australia, 2University of Queensland, Woolloongabba, Australia, 3Princess Alexandra Hospital, Woolloongabba, Australia, 4Centre for Human Drug Research, Leiden, Netherlands, 5Dendright, Woolloongabba, Australia, 6Dendright, Woolloongabba, Queensland, Australia, 7Janssen Research & Development, La Jolla, CA, 8Janssen Research & Development, Springhouse, 9Janssen Research & Development, La Jolla, 10Janssen R&D, Spring House, PA, 11Janssen R&D, La Jolla, CA, 12Janssen Research & Development, LLC, Spring House, PA

    Background/Purpose: Antigen-specific immunological tolerance strategies leverage the natural process of antigen presentation by dendritic cells (DCs) to regulate pathogenic T cells and B cells. We…
  • Abstract Number: 1217 • 2019 ACR/ARP Annual Meeting

    Phase 2 Dose-ranging Study of SEL-212 in Symptomatic Gout Patients: Selection of Doses for Further Clinical Development

    Rehan Azeem1, Alan Kivitz 2, Horacio Plotkin 1, Lloyd Johnston 1, Takashi K. Kishimoto 1, Justin Park 1, Stephen Smolinski 1 and Wesley DeHaan 1, 1Selecta Biosciences, Watertown, MA, 2Altoona Center for Clinical Research, Duncansville, PA

    Background/Purpose: Gout is caused by the deposition of monosodium urate (MSU) crystals in joints due to chronic hyperuricemia. Long-term treatment focuses on reducing serum uric…
  • Abstract Number: 2843 • 2019 ACR/ARP Annual Meeting

    Safety and Efficacy of Lenabasum at Week 68 in an Open-Label Extension of a Phase 2 Study of Lenabasum in Refractory Skin-Predominant Dermatomyositis (DM) Subjects

    Victoria Werth1, David Pearson 2, Joyce Okawa 2, Rui Feng 3, Josef Concha 2, Basil Patel 2, Emily Hejazi 2, Scott Constantine 4, Nancy Dgetluck 4 and Barbara White 4, 1Corporal Michael J. Crescenz VAMC, Philadelphia, PA, USA and Department of Dermatology, University of Pennsylvania, Philadelphia, PA, USA, Philadelphia, PA, 2Philadelphia Veteran Affairs Medical Center, University of Pennsylvania, Philadelphia, PA, 3University of Pennsylvania, Philadelphia, 4Corbus Pharmaceuticals, Norwood, MA

    Background/Purpose: Lenabasum is a rationally-designed preferential cannabinoid receptor type 2 agonist that activates resolution of innate immune responses to reduce tissue inflammation and fibrotic processes.…
  • Abstract Number: 1218 • 2019 ACR/ARP Annual Meeting

    Monthly Dosing of ImmTOR Tolerogenic Nanoparticles Combined with Pegylated Uricase (Pegadricase) Enables Sustained Reduction of Acute Gout Flares in Symptomatic Gout Patients

    Rehan Azeem1, Justin Park 1, Horacio Plotkin 1, Alan Kivitz 2, Lloyd Johnston 1, Takashi K. Kishimoto 1, Stephen Smolinski 1 and Wesley DeHaan 1, 1Selecta Biosciences, Watertown, MA, 2Altoona Center for Clinical Research, Duncansville, PA

    Background/Purpose: Long term gout treatment focuses on reducing sUA levels, thus allowing MSU crystals to dissolve. Rapid dissolution of MSU crystals during initial phase of…
  • Abstract Number: 2876 • 2019 ACR/ARP Annual Meeting

    Go-Dact: A Phase 3b Randomized Double-Blind Placebo-Controled Proof-Of-Concept Trial, of Golimumab Plus Methotrexate (MTX) versus MTX Monotherapy, in Improving Dactylitis, in MTX Naïve Psoriatic Arthritis Patients

    Elsa Vieira-Sousa1, Pedro Alves 2, Ana Maria Rodrigues 3, Filipa Teixeira 4, José Tavares-Costa 5, Alexandra Bernardo 6, Sofia Pimenta 6, Fernando Pimentel-Santos 7, João Lagoas Gomes 8, Renata Aguiar 9, Patrícia Pinto 10, Taciana Videira 10, Cristina Catita 11, Helena Santos 12, Joana Borges 13, Graça Sequeira 14, Célia Ribeiro 14, Lídia Teixeira 15, Pedro Ávila-Ribeiro 16, Fernando M Martins 17, Helena Canhão 18, Ruy M Ribeiro 19 and João Eurico Fonseca 16, 1Rheumatology and Metabolic Bone Diseases, Hospital de Santa Maria - Centro Hospitalar Lisboa Norte, EPE | Rheumatology Research Unit, Instituto de Medicina Molecular - Faculty of Medicine, University of Lisbon, Lisbon Academic Medical Centre, Lisbon, Portugal,, Lisbon, Portugal, 2Radiology Department, CHLC, Lisbon, Portugal, 3Rheumatology Unit, , HSEIT, Ilha Terceira, Açores e FMUL, Centro Académico de Medicina de Lisboa, Lisbon, Portugal, 4Rheumatology Department, ULSAM, Ponte de Lima, Portugal, 5ULSAM, Ponte de Lima, Portugal, 6Rheumatology Department, CHSJ, Porto, Portugal, 7CEDOC, NOVA-Medical School | Hospital Egas Moniz, CHLO, Lisbon, Lisbon, Portugal, 8Rheumatology Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental; CEDOC, NOVA Medical School, Faculdade de Ciências Médicas, Lisbon., Lisbon, Portugal, 9Rheumatology Department, CHBV, Aveiro, Portugal, 10Rheumatology Department, CHVNG, Vila Nova de Gaia, Portugal, 11Hospital Particular do Algarve, Faro, Portugal, 12Instituto Português de Reumatologia (IPR), Lisbon, Portugal, 13Instituto Português de Reumatologia, Lisbon, Portugal, 14Rheumatology Unit, CHA, Faro, Portugal, 15Rheumatology Department, HGO, Almada, Portugal, 16Rheumatology and Bone Diseases Department, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte; Unidade de Investigação em Reumatologia, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa; Centro Académico de Medicina de Lisboa; Lisbon, Portugal., Lisbon, Portugal, 17Portuguese Society of Rheumatology, Lisbon, Portugal, 18CEDOC, EpiDoC Unit, NOVA Medical School, Lisbon, Lisbon, Portugal, 19Laboratório de Biomatemática, FMUL, Lisbon, Portugal

    Background/Purpose: Psoriatic arthritis (PsA) dactylitis is associated with an increased risk of erosions and higher disease activity. Dactylitis treatment strategies are however controversial due to…
  • Abstract Number: 1235 • 2019 ACR/ARP Annual Meeting

    Monthly Dosing of ImmTOR Tolerogenic Nanoparticles Combined with Pegylated Uricase (Pegadricase) Mitigates Formation of Anti-Drug Antibodies Resulting in Sustained Uricase Activity in Symptomatic Gout Patients

    Wesley DeHaan1, Alan Kivitz 2, Rehan Azeem 1, Horacio Plotkin 1, Lloyd Johnston 1, Takashi K. Kishimoto 1, Justin Park 1, Stephen Smolinski 1 and Sheldon Leung 1, 1Selecta Biosciences, Watertown, MA, 2Altoona Center for Clinical Research, Duncansville, PA

    Background/Purpose: Gout is caused by the deposition of monosodium urate (MSU) crystals in joints due to chronic hyperuricemia. Long term treatment focuses on reducing sUA…
  • Abstract Number: 2881 • 2019 ACR/ARP Annual Meeting

    Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with Active Psoriatic Arthritis: Disease Activity and Remission in a 48-Week Phase 2b, Randomized, Double‑Blind, Placebo-Controlled, Dose-Ranging Study

    Philip Mease1, Laure Gossec 2, Laura Coates 3, Alice B. Gottlieb 4, Deepak Assudani 5, Barbara Ink 5, Jason Coarse 6, Oscar Irvin-Sellers 5 and Dafna Gladman 7, 1Swedish Medical Center/Providence St Joseph Health, and University of Washington, Seattle, WA, 2Sorbonne Université and Hôpital Pitié-Salpêtrière, Paris, France, 3University of Oxford, Oxford, United Kingdom, 4Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA, Philadelphia, PA, 5UCB Pharma, Slough, UK, Slough, United Kingdom, 6UCB Pharma, Raleigh, NC, USA, Raleigh, NC, 7Toronto Western Hospital, Toronto, Canada, Toronto, ON, Canada

    Background/Purpose: The ultimate goal of therapy in patients with psoriatic arthritis (PsA) is clinical remission, defined as ‘the absence of clinical and laboratory evidence of…
  • Abstract Number: 1240 • 2019 ACR/ARP Annual Meeting

    A Randomized, Phase 2 Study Evaluating the Efficacy and Safety of Anakinra in Difficult-To-Treat Acute Gouty Arthritis: The anaGO Study

    Kenneth Saag1, Alexander So 2, Puja Khanna 3, Robert Keenan 4, Sven Ohlman 5, Torbjörn Kullenberg 5, Lisa Osterling Koskinen 5, Michael Pillinger 6 and Robert Terkeltaub 7, 1University of Alabama at Birmingham, Birmingham, AL, 2Université de Lausanne, Lausanne, Switzerland, 3University of Michigan Medical School, Ann Arbor, 4Duke University School of Medicine, Durham, 5Sobi, Stockholm, Sweden, 6New York University School of Medicine, New York, 7San Diego VA/UCSD, San Diego, CA

    Background/Purpose: In gout, urate crystals deposited in and around joints trigger episodes of acute arthritis, mediated by the proinflammatory cytokine IL-1β. In uncontrolled studies, the…
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