Abstracts tagged "clinical trials"

Abstract Number: 222 • 2019 ACR/ARP Annual Meeting
Acupuncture for Chronic Musculoskeletal Pain: A Review of Randomized Controlled Trials
Yujuan Zhang¹ and Chenchen Wang ², ¹Floating Hospital at Tufts Medical Center, Boston, ²Tufts Medical Center, Boston
Background/Purpose: Acupuncture has been widely used for pain relief in adults. Evidence on effects of acupuncture for pediatric chronic musculoskeletal pain is scarce. We have reviewed existing…
Abstract Number: 1298 • 2019 ACR/ARP Annual Meeting
A Randomised Clinical Trial of Curcuma Longa Extract for Treating Symptoms and Effusion-Synovitis of Knee Osteoarthritis
Zhiqiang Wang ¹, Graeme Jones ², Tania Winzenberg ¹, Guoqi Cai ¹, Laura Laslett ², Dawn Aitken ¹, Ingrid Hopper ³, Robert Jones ⁴, Changhai Ding ², Jurgen Fripp ⁵ and Benny Antony², ¹Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia, ²Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia, ³Department of Epidemiology, Monash University, Melbourne, Victoria, Australia, ⁴Royal Hobart Hospital, Hobart, Tasmania, Australia, ⁵The University of Queensland, Brisbane, Queensland, Australia
Background/Purpose: Pharmacological therapies are limited, associated with off-target effects, are frequently contraindicated, and only modestly effective for pain in osteoarthritis (OA). Effusion and synovitis are…
Abstract Number: 390 • 2019 ACR/ARP Annual Meeting
Preliminary Response to Janus Kinase (JAK) Inhibition with Baricitinib in Refractory Juvenile Dermatomyositis
Hanna Kim¹, Samantha Dill ², Michelle O'Brien ², Minal Jain ³, Shajia Lu ⁴, Wanxia Tsai ⁴, Yinghui Shi ⁵, Laura Vian ⁴, Massimo Gadina ⁴, Michelle Millwood ², April Brundidge ², Lisa G. Rider ⁶ and Robert Colbert ¹, ¹Pediatric Clinical Trials Unit, Pediatric Translational Research Branch, NIAMS, NIH, Bethesda, MD, ²Pediatric Clinical Trials Unit (PCTU), Office of the Clinical Director, NIAMS, NIH, Bethesda, MD, ³Rehabilitation Medicine Department, Physical Therapy Section, Clinical Research Center, NIH, Bethesda, MD, ⁴Translational Immunology Section, NIAMS, NIH, Bethesda, MD, ⁵Office of Clinical Director, NIAMS, NIH, Bethesda, MD, ⁶Environmental Autoimmunity Group, Clinical Research Branch, NIEHS, NIH, Bethesda, MD
Background/Purpose: Juvenile dermatomyositis (JDM) is a systemic autoimmune disease with a prominent interferon (IFN) signature. Treatment often requires prolonged high-dose steroids and other immunosuppressive medications.…
Abstract Number: 1303 • 2019 ACR/ARP Annual Meeting
Intra-Articular TPX-100 Significantly Delays Pathological Bone Shape Change at 6 and 12 Months in Moderate to Severe Tibiofemoral OA
Dawn McGuire¹, Michael Bowes ², Alan Brett ², Neil Segal ³, Meghan Miller ⁴, David Rosen ⁴ and Yoshinari Kumagai ⁴, ¹OrthoTrophix, Orinda, CA, ²Imorphics, Manchester, England, United Kingdom, ³University of Kansas Medical Center, Kansas City, KS, ⁴OrthoTrophix, Oakland, CA
Background/Purpose: Pathological bone shape changes in the femur precede cartilage changes in knee OA and predict disease onset and progression to joint failure (Neogi 2013;…
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)…

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