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…