Abstracts tagged "clinical trials"

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…
Abstract Number: 2910 • 2019 ACR/ARP Annual Meeting
Improving the Efficiency of Clinical Trial Recruitment Using Electronic Health Record Data, Natural Language Processing, and Machine Learning
Tianrun Cai¹, Fiona Cai ², Kumar Dahal ³, Chuan Hong ⁴ and Katherine Liao ¹, ¹Brigham and Women's Hospital, Boston, ²Stuyvesant High School, New York, ³Brigham and Women's Hospital, Boston, MA, ⁴Harvard Medical School, Boston, MA
Background/Purpose: Efficiently identifying eligible patients is an important component of a successful clinical trial. Billing codes from electronic health record (EHR) data are commonly used…
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…

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