ACR Meeting Abstracts

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Abstracts tagged "clinical trials"

  • Abstract Number: 028 • 2020 Pediatric Rheumatology Symposium

    A Randomized, Double-blind, Placebo-controlled Study of Anakinra in Pediatric and Adult Patients with Still’s Disease

    Laura Schanberg1, Peter Nigrovic 2, Ashley Cooper 3, Winn Chatham 4, Shoghik Akoghlanian 5, Namrata Singh 6, C. Egla Rabinovich 7, Akaluck Thatayatikom 8, Alysha Taxter 9, Jonathan Hausmann 10, Milan Zdravkovic 11, Sven Ohlman 11, Henrik Andersson 11, Susanna Cederholm 12, Gunilla Huledal 11, Rayfel Schneider 13 and Fabrizio De Benedetti 14, 1Duke Children's Hospital & Health Center, Durham, North Carolina, 2Boston Children's Hospital, Boston, Massachusetts, 3Children's Mercy Kansas City, Kansas City, 4University of Alabama at Birmingham, Birmingham, 5Nationwide Children's Hospital, Columbus, 6University of Iowa Hospitals and Clinics, Iowa, Iowa, 7Duke University Hospital, Durham, 8University of Florida, Gainesville, 9Wake Forest Baptist Medical Center, Winston-Salem, 10Division of Immunology, Boston Children's Hospital; Rheumatology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, 11Sobi, Stockholm, Sweden, 12Stockholm, Sweden, 13The Hospital for Sick Children, Toronto, Canada, 14Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesu', Rome, Italy

    Background/Purpose: Adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) are rare systemic disorders of auto-inflammatory nature. There is a growing understanding that SJIA…
  • Abstract Number: L18 • 2019 ACR/ARP Annual Meeting

    A Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), Telitacicept (RC18), in Systemic Lupus Erythematosus (SLE): Results of a Phase 2b Study

    Di Wu1, Jing Li 2, Dong Xu 2, Wenxiang Wang 3, Lin Li 4, Jianmin Fang 3 and Fengchun Zhang 5, 1Peking Union Medical College Hospital, Beijing, Beijing, China (People's Republic), 2Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Beijing, China (People's Republic), 3RemeGen, Ltd., Yantai, China (People's Republic), 4RemeGen, Ltd., Beijing, China (People's Republic), 5Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (People's Republic)

    Background/Purpose: Telitacicept, also named RC18, is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and…
  • Abstract Number: L21 • 2019 ACR/ARP Annual Meeting

    Secukinumab 150 mg Significantly Improved Signs and Symptoms of Non-radiographic Axial Spondyloarthritis: Results from a Phase 3 Double-blind, Randomized, Placebo-controlled Study

    Atul Deodhar1, Ricardo Blanco 2, Eva Dokoupilova 3, Marleen van de Sande 4, Stephen Hall 5, Anna Wiksten 6, Brian Porter 7, Hanno Richards 6, Sibylle Haemmerle 6 and Jürgen Braun 8, 1Oregon Health & Science University, Portland, OR, 2Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, Santander, Spain, 3MEDICAL PLUS s.r.o., Uherske Hradiste; University of Veterinary and Pharmaceutical sciences, Faculty of Pharmacy, Department of Pharmaceutics, Brno, Czech Republic, 4Amsterdam Rheumatology and immunology Center, Department of Rheumatology and Clinical Immunology, Amsterdam UMC /University of Amsterdam, Amsterdam, Netherlands, 5Monash University, Melbourne, Australia, 6Novartis Pharma AG, Basel, Switzerland, 7Novartis Pharmaceuticals Corporation, East Hanover, NJ, 8Rheumazentrum Ruhrgebiet/Ruhr University, Herne, Germany

    Background/Purpose: Non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) are considered part of the spectrum of axSpA. Patients (pts) are classified as nr-axSpA due to…
  • Abstract Number: 503 • 2019 ACR/ARP Annual Meeting

    A Pilot Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P17 and Humira in Healthy Male Subjects

    Edward Keystone1, Daniel Furst 2, Malcolm Boyce 3, Frans van den Berg 3, SangJoon Lee 4, SungHyun Kim 4, YunJu Bae 4, GoEun Yang 4, JuHeon Koo 4, EunJin Choi 4 and Jonathan Kay 5, 1Mount Sinai Hospital, Toronto, Canada, 2University of California, Los Angeles, CA, 3Hammersmith Medicines Research, London, United Kingdom, 4Celltrion Inc., Incheon, Republic of Korea, 5UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA

    Background/Purpose: CT-P17 is a recombinant humanized monoclonal antibody that was developed as a biosimilar to the reference product, adalimumab. This was a first in human…
  • Abstract Number: 1309 • 2019 ACR/ARP Annual Meeting

    Concordance of Baseline Pain Measures (Across Two Reporting Instruments) Influences Treatment Effect: Post Hoc Analysis of a Phase 3 Randomized Controlled Trial of Triamcinolone Acetonide Extended-Release in Patients with Knee Osteoarthritis

    Philip G Conaghan1, Edgar Ross 2, Alan Kivitz 3, Dennis Turk 4, Andrew Spitzer 5, Deryk Jones 6, Ryan Lanier 7, Amy Cinar 8, Joelle Lufkin 8 and Scott Kelley 8, 1Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom, 2Brigham and Women's Hospital, Boston, MA, 3Altoona Center for Clinical Research, Duncansville, PA, 4University of Washington, Seattle, 5Cedars-Sinai Medical Center, Los Angeles, 6Ochsner Sports Medicine Institute, Harahan, GA, 7Analgesic Solutions, Natick, 8Flexion Therapeutics, Burlington

    Background/Purpose: In a Phase 3 randomized controlled study, differing efficacy results were observed when triamcinolone acetonide extended-release (TA-ER) was compared to conventional TA crystalline suspension…
  • Abstract Number: 831 • 2019 ACR/ARP Annual Meeting

    Maintaining Musculoskeletal Health: A Randomized Controlled Prevention Trial Amongst People at High Risk of Developing Chronic Widespread Pain

    Gary Macfarlane1, Marcus Beasley 1, Neil Scott 1, Gordon Prescott 2, Paul McNamee 1, John McBeth 3, Gareth Jones 1, Neil Basu 4, Phil Hannaford 1, Phil Keeley 5 and Karina Lovell 6, 1University of Aberdeen, Aberdeen, United Kingdom, 2University of Central Lancashire, Preston, United Kingdom, 3Versus Arthritis Centre for Epidemiology, Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom, Manchester, United Kingdom, 4University of Glasgow, Glasgow, United Kingdom, 5University of Huddersfield, Huddersfield, United Kingdom, 6University of Manchester, Manchester, United Kingdom

    Background/Purpose: Cognitive behaviour therapy (CBT) is effective in the management of fibromyalgia (and its characteristic feature Chronic Widespread Pain (CWP). CBT is recommended in all…
  • Abstract Number: 1383 • 2019 ACR/ARP Annual Meeting

    Glucocorticoid Tapering in Monthly 1-mg Decrements Does Not Result in Clinically Manifest Adrenal Insufficiency in Patients with Rheumatoid Arthritis: Learnings from a Phase 3/4 Study

    Frank Buttgereit1, J. Michael Nebesky 2, Gerd Burmester 3, Corrado Bernasconi 2, Markus R. John 2 and Marc Y. Donath 4, 1Charité-Universitätsmedizin Berlin, Berlin, Germany, 2F. Hoffmann-La Roche, Basel, Switzerland, 3Charité—University Medicine Berlin, Berlin, Germany, 4University Hospital Basel, Basel, Switzerland

    Background/Purpose: Systemic glucocorticoids (GCs) are used to treat serious inflammatory diseases but are associated with adverse events. Guidelines recommend tapering GCs to the lowest possible…
  • 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…
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