Abstracts tagged "clinical trials"

Abstract Number: 865 • 2019 ACR/ARP Annual Meeting
Safety and Efficacy of Lenabasum at 21 Months in an Open-Label Extension of a Phase 2 Study in Diffuse Cutaneous Systemic Sclerosis Subjects
Robert Spiera¹, Laura Hummers ², Lorinda Chung ³, Tracy Frech ⁴, Robyn Domsic ⁵, Vivien Hsu ⁶, Daniel Furst ⁷, Jessica Gordon ¹, Madeline Myers ⁸, Robert W Simms ⁹, Elizabeth Lee ¹⁰, Scott Constantine ¹⁰, Nancy Dgetluck ¹⁰, Bradley Bloom ¹⁰ and Barbara White ¹⁰, ¹Hospital for Special Surgery, New York, NY, ²Johns Hopkins University School of Medicine, Division of Rheumatology, Baltimore, MD, USA, Baltimore, MD, ³Stanford, Palo Alto, Palo Alto, CA, ⁴Division of Rheumatology, University of Utah and Salt Lake VAMC, Salt Lake City, UT, ⁵University of Pittsburgh, Pittsburgh, PA, ⁶Rutgers- RWJ Medical School, SOUTH PLAINFIELD, NJ, ⁷University of California, Los Angeles, CA, ⁸University of Texas, Houston, Houston, TX, ⁹Boston University, Boston, MA, ¹⁰Corbus Pharmaceuticals, Norwood, MA
Background/Purpose: Lenabasum is a synthetic, non-immunosuppressive, selective cannabinoid receptor type 2 agonist that activates resolution of innate immune responses and limits fibrosis in animal models…
Abstract Number: 1475 • 2019 ACR/ARP Annual Meeting
Comparison of Different Remission Indices in Patients with Psoriatic Arthritis: A Post Hoc Analysis of Data from Phase 3 Tofacitinib Studies
Gustavo Citera¹, Emilce Schneeberger ², Peter Nash ³, Josef Smolen ⁴, Philip Mease ⁵, Enrique Soriano ⁶, Vesna Matulic ⁷, Claudia Helling ⁸, Annette Szumski ⁹, Rajiv Mundayat ¹⁰, Daniela Graham ¹¹ and Dario Ponce de Leon ¹², ¹Instituto de Rehabilitación Psicofísica, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, ²Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, ³University of Queensland, Brisbane, Queensland, Australia, ⁴Medical University of Vienna, Vienna, Austria, ⁵Swedish Medical Center/Providence St Joseph Health, and University of Washington, Seattle, WA, ⁶Rheumatology Section, Internal Medicine Service, Hospital Italiano de Buenos Aires, Argentina., Buenos Aires, Buenos Aires, Argentina, ⁷Pfizer Chile S.A., Santiago, Chile, ⁸Pfizer Inc, Buenos Aires, Argentina, ⁹Syneos Health, Princeton, NJ, ¹⁰Pfizer Inc, New York, NY, ¹¹Pfizer Inc, Groton, CT, ¹²Pfizer Inc, Lima, Peru
Background/Purpose: An international task force has agreed that remission or low disease activity (LDA) are key treatment targets for patients (pts) with PsA, and recommends…
Abstract Number: 929 • 2019 ACR/ARP Annual Meeting
Efficacy and Safety of Fenebrutinib, a BTK Inhibitor, Compared to Placebo in Rheumatoid Arthritis Patients with Active Disease Despite TNF Inhibitor Treatment: Randomized, Double Blind, Phase 2 Study
Stanley Cohen¹, Katie Tuckwell ², Rebecca Kunder ², Tamiko Katsumoto ³, Rui Zhao ², Alberto Berman ⁴, Nemanja Damjanov ⁵, Dmytro Fedkov ⁶, Slawomir Jeka ⁷ and Mark Genovese ³, ¹Metroplex Clinical Research Center, Dallas, TX, ²Genentech, Inc., South San Francisco, CA, ³Stanford University, Stanford, CA, ⁴Universidad Nacional de Tucuman and Centro Médico Privado de Reumatología, Tucuman, Argentina, ⁵Institute of Rheumatology, Belgrade University School of Medicine, Belgrade, Serbia, Belgrade, Serbia, ⁶Bohomolets National Medical University, Kyiv, Ukraine, ⁷University Hospital Bydgoszcz no 2, CM UMK, Bydgoszcz, Poland
Background/Purpose: Fenebrutinib (GDC-0853, FEN) is an orally administered, highly selective, non-covalent, and reversible small molecule inhibitor of Bruton’s Tyrosine Kinase (BTK).1 We report the efficacy…
Abstract Number: 1489 • 2019 ACR/ARP Annual Meeting
Impact of Apremilast on PsA Impact of Disease Core Components in Patients with a Limited Number of Active Joints: Results from a Real-World Study
Tim Jansen¹, Eric-Jan Kroot ², Arie van Vliet ³, Jan Pander ⁴ and Marijn Vis ⁵, ¹Viecuri MC, Venlo, Netherlands, ²Elkerliek, Helmond, Netherlands, ³Celgene, Utretcht, Netherlands, ⁴Celgene, Utrecht, Netherlands, ⁵ErasmusMC, Rotterdam, Netherlands
Background/Purpose: Recent data suggest that patients with moderately active psoriatic arthritis (PsA) and a limited number of active joints have a high likelihood of achieving…
Abstract Number: 930 • 2019 ACR/ARP Annual Meeting
Neurostimulation for Treatment of Drug Refractory Rheumatoid Arthritis: A First-in-Human Study Using a Novel Vagus Nerve Stimulator
Norman Gaylis¹, David Sikes ², Alan Kivitz ³, Diane Horowitz ⁴, Charles Peterfy ⁵, Yaakov Levine ⁶, David Chernoff ⁶ and Mark Genovese ⁷, ¹Arthritis and Rheumatic Disease Specialties, Aventura, FL, ²Florida Medical Clinic, Land O Lakes, FL, ³Altoona Center for Clinical Research, Duncansville, PA, ⁴Northwell Health, Manhasset, NY, ⁵Spire Sciences Inc, Boca Raton, ⁶SetPoint Medical, Valencia, CA, ⁷Stanford University, Stanford, CA
Background/Purpose: The inflammatory reflex is an endogenous neuroimmune circuit that helps regulate innate and adaptive immunity (Annu. Rev. Immunol. 2012; 30:313). Activation of this reflex by…
Abstract Number: 1694 • 2019 ACR/ARP Annual Meeting
Pharmacogenetics and Pharmacodynamics of Response to Apremilast in a Phase 3 Clinical Study in Subjects with Active Behçet’s Disease
Joseph Maranville¹, Irina Medvedeva ¹, Robert Yang ¹, Mindy Chen ², Lorraine (Ruoying) Fang ², Sandra Collazo ³, Shannon McCue ³, Marla Hochfeld ³ and Peter Schafer ³, ¹Celgene Corporation, Cambridge, MA, ²Celgene Corporation, Berkeley Heights, NJ, ³Celgene Corporation, Summit, NJ
Background/Purpose: This was an exploratory analysis of genetic polymorphisms, plasma biomarkers, and blood leukocytes with clinical response in the phase 3 clinical study CC-10004-BCT-002 (NCT02307513).Methods:…
Abstract Number: 937 • 2019 ACR/ARP Annual Meeting
Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with Active Ankylosing Spondylitis: 48-Week Efficacy and Safety Results from a Phase 2b, Randomized, Blinded, Placebo-Controlled, Dose-Ranging Study
Désirée van der Heijde¹, Lianne Gensler ², Atul Deodhar ³, Xenofon Baraliakos ⁴, Denis Poddubnyy ⁵, Alan Kivitz ⁶, Marga Oortgiesen ⁷, Dominique Baeten ⁸, Nadine Goldammer ⁹, Jason Coarse ⁷, MK Farmer ⁷ and Maxime Dougados ¹⁰, ¹Leiden University Medical Center, Leiden, Netherlands, ²University San Francisco California, San Francisco, CA, ³Oregon Health & Science University, Portland, OR, ⁴Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, Herne, Germany, ⁵Charité - Universitätsmedizin Berlin and German Rheumatism Research Centre, Berlin, Germany, Berlin, Germany, ⁶Altoona Center for Clinical Research, Duncansville, PA, ⁷UCB Pharma, Raleigh, NC, USA, Raleigh, NC, ⁸UCB Pharma, Brussels, Belgium, Brussels, ⁹UCB Pharma, Monheim, Germany, Monheim, Germany, ¹⁰Cochin Hospital, Paris, France
Background/Purpose: The monoclonal antibody bimekizumab potently and selectively neutralizes both IL-17A and IL-17F. We report the 48-week efficacy and safety of bimekizumab in patients (pts)…
Abstract Number: 1697 • 2019 ACR/ARP Annual Meeting
Efficacy of Apremilast for Oral Ulcers Associated with Active Behçet’s Syndrome over 64 Weeks: Long-term Results from the Japanese Subgroup in a Phase III Study
Mitsuhiro Takeno¹, Yoshiya Tanaka ², Hajime Kono ³, Shoji Sugii ⁴, Mitsumasa Kishimoto ⁵, Sue Cheng ⁶, Shannon McCue ⁷, Mindy Chen ⁸, Maria Paris ⁶ and Hiroaki Dobashi ⁹, ¹Nippon Medical School, Tokyo, Japan, ²University of Occupational and Environmental Health Japan, Kitakyushu, Japan, ³Teikyo University School of Medicine, Tokyo, Japan, ⁴Department of Rheumatic Diseases, Tokyo Metropoitan Tama Medica Center, Fuchu, Japan, ⁵Immuno-Rheumatology Center, St. Luke’s International Hospital, Tokyo, Japan, ⁶Celgene Corporation, Summit, ⁷Celgene Corporation, Summit, NJ, ⁸Celgene Corporation, Berkeley Heights, NJ, ⁹Kagawa University, Kagawa, Japan
Background/Purpose: Behçet’s syndrome is a chronic, multi-system, variable vessel vasculitis characterized by painful, recurrent oral ulcers (OU) that can be disabling and may impair quality…
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…

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