Abstracts tagged "clinical trial"

Abstract Number: 1773 • ACR Convergence 2021
Comparing Efficacy of Guselkumab versus Ustekinumab in Patients with Psoriatic Arthritis: An Adjusted Comparison Using Individual Patient Data from DISCOVER 1&2 and PSUMMIT Trials
Joris Diels¹, Pushpike Thilakarathne², Agata Schubert³, Fareen Hassan⁴, Steven Peterson⁵ and Wim Noël¹, ¹Janssen Pharmaceutica, HEMAR Department, Beerse, Belgium, ²JanssenCilag Ltd, HEMAR Department, Beerse, Belgium, ³Janssen-Cilag Poland, HEMAR Department, Warsaw, Poland, ⁴Janssen-Cilag Ltd, HEMAR Department, High Wycombe, United Kingdom, ⁵Janssen Immunology Global Commercial Strategy Organization, Raritan, NJ
Background/Purpose: Guselkumab is an anti-interleukin (IL)-23 monoclonal antibody recently approved for the treatment of psoriatic arthritis (PsA). In two large Phase III trials of patients…
Abstract Number: 1941 • ACR Convergence 2021
The Risk of Venous Thromboembolic Events in Patients with RA Aged ≥ 50 Years with ≥ 1 Cardiovascular Risk Factor: Results from a Phase 3b/4 Randomized Safety Study of Tofacitinib vs TNF Inhibitors
Christina Charles-Schoeman¹, Roy Fleischmann², Eduardo Mysler³, Maria Greenwald⁴, Cunshan Wang⁵, All-shine Chen⁵, Carol A Connell⁵, John C Woolcott⁶, Sujatha Menon⁵, Yan Chen⁷, Kristen Lee⁷ and Zoltan Szekanecz⁸, ¹Department of Medicine, University of California, Los Angeles, Los Angeles, CA, ²Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ³Organización Médica de Investigación, Buenos Aires, Argentina, ⁴Desert Medical Advances, Palm Desert, CA, ⁵Pfizer Inc, Groton, CT, ⁶Pfizer Inc, Collegeville, PA, ⁷Pfizer Inc, New York, NY, ⁸Division of Rheumatology, University of Debrecen, Faculty of Medicine, Debrecen, Hungary
Background/Purpose: ORAL Surveillance (NCT02092467) was a randomized, open-label, non-inferiority, Phase 3b/4 study that assessed the relative risk of major adverse cardiovascular (CV) events (MACE) and…
Abstract Number: 0249 • ACR Convergence 2021
Open-label, Long-term (10-year) Study of the Safety of Etanercept in Children with Extended Oligoarticular Arthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis
Jelena Vojinović¹, Joke Dehoorne², Violeta Panaviene³, Gordana Susic⁴, Gerd Horneff⁵, Valda Stanevicha⁶, Katarzyna Kobusinska⁷, Zbigniew Zuber⁸, Bogna Dobrzyniecka⁹, Jonathan Akikusa¹⁰, Tadej Avcin¹¹, Alberto Martini¹², Cecilia Borlenghi¹³, Edmund Arthur¹⁴, Svitlana Tatulych¹⁵, Chuanbo Zang¹⁶, Bonnie Vlahos¹⁶ and Nicolino Ruperto¹⁷, ¹Paediatric Rheumatology International Trials Organisation (PRINTO), Nis, Serbia, ²Paediatric Rheumatology International Trials Organisation (PRINTO), Gent, Belgium, ³Paediatric Rheumatology International Trials Organisation (PRINTO), Vilnius, Lithuania, ⁴Paediatric Rheumatology International Trials Organisation (PRINTO), Belgrade, Serbia, ⁵Paediatric Rheumatology International Trials Organisation (PRINTO), Sankt Augustin, Germany, ⁶Paediatric Rheumatology International Trials Organisation (PRINTO), Riga, Latvia, ⁷Paediatric Rheumatology International Trials Organisation (PRINTO), Bydgoszcz, Poland, ⁸Paediatric Rheumatology International Trials Organisation (PRINTO), Lodz, Poland, ⁹Paediatric Rheumatology International Trials Organisation (PRINTO), Warsaw, Poland, ¹⁰Paediatric Rheumatology International Trials Organisation (PRINTO), Melbourne, Australia, ¹¹Paediatric Rheumatology International Trials Organisation (PRINTO), Ljubljana, Slovenia, ¹²Paediatric Rheumatology International Trials Organisation (PRINTO), Genoa, Italy, ¹³Pfizer, Buenos Aires, Argentina, Buenos Aires, Argentina, ¹⁴Pfizer, Peapack, NJ, ¹⁵Pfizer, Groton, CT, ¹⁶Pfizer, Collegeville, PA, ¹⁷IRCCS Istituto Giannina Gaslini; PRINTO, Clinica Pediatrica e Reumatologia, Genova, Italy
Background/Purpose: CLIPPER2 was an 8-year, open-label extension of the phase 3b, multicenter, 2-year CLIPPER study of the safety and efficacy of etanercept (ETN) in the…
Abstract Number: 0837 • ACR Convergence 2021
Sustainability of Response Between Upadacitinib and Adalimumab in Patients with Rheumatoid Arthritis: Results Through 3 Years from the SELECT-COMPARE Trial
Peter Nash¹, Arthur Kavanaugh², Maya Buch³, Bernard Combe⁴, Louis Bessette⁵, In-Ho Song⁶, Tim Shaw⁷, Yanna Song⁶, Jessica Suboticki⁶ and Roy Fleischmann⁸, ¹Griffith University, Brisbane, Australia, ²University of California San Diego, La Jolla, CA, ³University of Leeds, Leeds, United Kingdom, ⁴CHU Montpellier Montpellier University, Montpellier, France, ⁵Laval University, Québec City, QC, Canada, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., North Chicago, ⁸Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: The primary treatment target for patients with active rheumatoid arthritis (RA) is sustained clinical remission (REM) or low disease activity (LDA).1,2 A greater proportion…
Abstract Number: 1330 • ACR Convergence 2021
Effect of Guselkumab (TREMFYA®), a Selective IL-23p19 Inhibitor, on Axial-Related Endpoints in Patients with Active PsA: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study Through 2 Years
Philip Mease¹, Philip S Helliwell², Dafna Gladman³, Denis Poddubnyy⁴, Xenofon Baraliakos⁵, Soumya Chakravarty⁶, Alexa Kollmeier⁷, Xie Xu⁸, Shihong Sheng⁸, Stephen Xu⁸, May Shawi⁹, Désirée van der Heijde¹⁰ and Atul Deodhar¹¹, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ⁴Department of Rheumatology, Charité – Universitätsmedizin, Berlin, Germany, ⁵Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, ⁶Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁷Janssen Research & Development, LLC, La Jolla, CA, ⁸Janssen Research & Development, LLC, Spring House, PA, ⁹Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ¹⁰Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, ¹¹Oregon Health & Science University, Portland, OR
Background/Purpose: Guselkumab (GUS), a selective IL-23p19 inhibitor, resulted in greater mean improvements in BASDAI scores vs placebo (PBO) at W24 among patients (pts) with active…
Abstract Number: 1585 • ACR Convergence 2021
Suprascapular Nerve Block for the Treatment of Adhesive Capsulitis
Ernst Shanahan¹, Elizabeth Briggs¹, Tiffany Gill², Catherine Hill³ and Tim Morris⁴, ¹SA Health, Adelaide, Australia, ²University of Adelaide, Adelaide, Australia, ³Queen Elizabeth Hospital, Woodville, Australia, ⁴Flinders University, Adelaide, Australia
Background/Purpose: To investigate the value of suprascapular nerve block (SSNB) as a treatment option for adhesive capsulitis.Methods: Patients with adhesive capsulitis confirmed by a rheumatologist…
Abstract Number: 1739 • ACR Convergence 2021
SLE Treatment History and Anifrolumab Efficacy by Baseline Standard Therapies in Patients with SLE from 2 Phase 3 Trials
Susan Manzi¹, Richard Furie², Eric Morand³, Yoshiya Tanaka⁴, Gabriel Abreu⁵, Catharina Lindholm⁵ and Raj Tummala⁶, ¹Allegheny Health Network, Pittsurgh, PA, ²Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ³Monash University, Melbourne, Australia, ⁴University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁶BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD
Background/Purpose: In the phase 3 TULIP-1 and TULIP-2 trials, anifrolumab, a type I IFN receptor mAb, improved disease activity versus placebo in patients with moderate…
Abstract Number: 1801 • ACR Convergence 2021
The Effect of Ixekizumab versus Adalimumab on Individual Components of the ACR Composite Score, with and Without Concomitant Methotrexate or Other Conventional Synthetic DMARDs at 52 Weeks in Patients with Psoriatic Arthritis
Elaine Husni¹, Sona Kamat², Keri Stenger³, Rebecca Bolce³, Thorsten Holzkaemper⁴, Cameron Helt³, So Young Park³, Jeffrey Lisse⁵ and Luca Idolazzi⁶, ¹Cleveland Clinic, Cleveland, OH, ²St Louis University, Saint Louis, MO, ³Eli Lilly and Company, Indianapolis, IN, ⁴Eli Lilly and Company, Bad Homburg, Germany, ⁵Eli Lilly and Company, Tucson, AZ, ⁶University of Verona, Verona, Italy
Background/Purpose: It is important to understand how to select among the multiple treatment options for active psoriatic arthritis (PsA). Since individual patient domains may influence…
Abstract Number: 0411 • ACR Convergence 2021
Pharmacokinetics, Safety, and Efficacy of Subcutaneous Brodalumab for Systemic Sclerosis with Moderate-to-severe Skin Thickening: A Single-arm, Open-label, Multi-dose, Phase 1 Trial
Takemichi Fukasawa¹, Ayumi Yoshizaki², Satoshi Ebata² and Shinichi Sato², ¹Department of Dermatology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan, ²University of Tokyo Graduate School of Medicine, Tokyo, Japan
Background/Purpose: The exact role of interleukin-17 in systemic sclerosis (SSc) has not been established. This trial assessed the pharmacokinetics (PK), safety, and efficacy of multiple…
Abstract Number: 0920 • ACR Convergence 2021
Influence of Baseline Demographics on Improvements in Disease Activity Measures in Patients with Ankylosing Spondylitis Receiving Upadacitinib: A Post Hoc Subgroup Analysis
Filip Van den Bosch¹, Denis Poddubnyy², Jayne Stigler³, Andrew Ostor⁴, Salvatore D'Angelo⁵, Victoria Navarro-Compán⁶, In-Ho Song³, Tianming Gao³, Fabiana Ganz³ and Lianne Gensler⁷, ¹Dept. of Rheumatology - Ghent University Hospital, Ghent, Belgium, Ghent, Belgium, ²Department of Rheumatology, Charité – Universitätsmedizin, Berlin, Germany, ³AbbVie Inc., North Chicago, IL, ⁴Monash University, Cabrini Hospital, and Emertius Research, Malvern, Australia, ⁵Rheumatology Institute of Lucania (IReL) – Rheumatology Department of Lucania, “San Carlo” Hospital of Potenza and “Madonna delle Grazie” Hospital of Matera, Potenza, Italy, ⁶Rheumatology service, Hospital Universitario La Paz-IdiPaz, Madrid, Spain, ⁷Department of Rheumatology, University of California San Francisco, San Francisco, CA
Background/Purpose: Upadacitinib (UPA), an oral Janus kinase inhibitor, has demonstrated efficacy and safety through 14 weeks in the SELECT-AXIS 1 study in biologic disease-modifying antirheumatic…
Abstract Number: 1331 • ACR Convergence 2021
Guselkumab (TREMFYA®) Improves Anemia in Patients with Active Psoriatic Arthritis: Results from Two Phase 3 Randomized Controlled Clinical Trials
Arthur Kavanaugh¹, Yan Liu², Proton Rahman³, Philip Mease⁴, Laure Gossec⁵, Xie Xu², Elizabeth Hsia², May Shawi⁶, Chenglong Han², Marlies Neuhold⁷ and Atul Deodhar⁸, ¹University of California San Diego, La Jolla, CA, ²Janssen Research & Development, LLC, Spring House, PA, ³Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ⁴Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁵Sorbonne Université; APHP, Rheumatology Department, Pitié-Salpêtrière Hospital, Paris, France, ⁶Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁷Janssen-Cilag, Zug, Switzerland, ⁸Oregon Health & Science University, Portland, OR
Background/Purpose: Anemia related to systemic inflammation can be an important feature of psoriatic arthritis (PsA). Hemoglobin (Hgb) levels have been shown to be inversely related…
Abstract Number: 1614 • ACR Convergence 2021
Preliminary Results from a Pilot Feasibility and Acceptability Trial of Resilience Coaching for Adolescent Chronic Musculoskeletal Pain
Sabrina Gmuca¹, Pamela Weiss¹, Mackenzie McGill¹, Maitry Sonagra², David D. Sherry¹, Peter Cronholm³, Jeffrey S. Gerber¹, Tonya M. Palermo⁴, Jami F. Young¹ and Abby R. Rosenberg⁴, ¹Children's Hospital of Philadelphia, Philadelphia, PA, ²Children's Hospital of Philadelphia, Cherry Hill, NJ, ³University of Pennsylvania, Philadelphia, PA, ⁴Seattle Children's Hospital, Seattle, WA
Background/Purpose: Chronic musculoskeletal pain (CMP) affects up to 40% of youth and is associated with physical disability and psychological distress. Resilience coaching interventions, such as…
Abstract Number: 1740 • ACR Convergence 2021
Efficacy of Anifrolumab in Patients with SLE Previously Treated with Biologics: Post Hoc Analysis of Data from 2 Phase 3 Trials
Richard Furie¹, Eric Morand², Kenneth Kalunian³, Konstantina Psachoulia⁴, Emmanuelle Maho⁵, Catharina Lindholm⁶ and Raj Tummala⁴, ¹Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ²Monash University, Melbourne, Australia, ³University of California, La Jolla, CA, ⁴BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁵BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ⁶BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
Background/Purpose: In the phase 3 TULIP-1 and TULIP-2 trials, anifrolumab, a type I IFN receptor mAb, improved disease activity in patients with SLE.1,2 We investigated…
Abstract Number: 1802 • ACR Convergence 2021
Comparison of Axial and Peripheral Manifestations in Patients with Psoriatic Arthritis and Ankylosing Spondylitis in Upadacitinib Clinical Trials
Xenofon Baraliakos¹, Atul Deodhar², Roberto Ranza³, Simona Rednic⁴, Francesco Ciccia⁵, Fabiana Ganz⁶, Tianming Gao⁶, Apinya Lertratanakul⁶, In-Ho Song⁶, Andrew Ostor⁷ and Laura Coates⁸, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, ²Oregon Health & Science University, Portland, OR, ³Hospital de Clinicas, Universidade Federal de Uberlândia, Uberlandia, MG, Brazil, ⁴Emergency Clinical County Hospital, Rheumatology and Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania, ⁵University of Campania “Luigi Vanvitelli", Naples, Italy, ⁶Abbvie Inc., North Chicago, IL, ⁷Monash University, Cabrini Hospital, and Emertius Research, Malvern, Australia, ⁸Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom
Background/Purpose: Axial, peripheral, and other disease manifestations often overlap between psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Upadacitinib (UPA) is an oral Janus kinase inhibitor…
Abstract Number: 0441 • ACR Convergence 2021
A Randomized, Double-blind, Placebo-controlled Study of Arimoclomol in Patients with Inclusion Body Myositis
Pedro Machado¹, Richard Barohn², Michael McDermott³, Thomas Blaetter⁴, Tom Lloyd⁵, Aziz Shaibani⁶, Miriam Freimer⁷, Anthony Amato⁸, Emma Ciafaloni³, Sarah Jones⁹, Tahseen Mozaffar¹⁰, Summer Gibson¹¹, Matthew Wicklund¹², Todd Levine¹³, Claus Sundgreen⁴, Tim Carstensen⁴, Karen Bonefeld⁴, Anders Jørgensen⁴, Karina Phonekeo⁴, Andrew Heim¹⁴, Laura Herbelin¹⁴, Michael Hanna¹⁵ and Mazen Dimachkie¹⁴, ¹Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, United Kingdom, ²University of Missouri - Columbia, Columbia, MO, ³University of Rochester, Rochester, NY, ⁴Orphazyme A/S, Copenhagen, Denmark, ⁵Johns Hopkins University, Baltimore, MD, ⁶Nerve and Musle Center, Houston, TX, ⁷Ohio State University, Columbus, OH, ⁸Brigham and Women's Hospital, Boston, MA, ⁹University of Virginia, Charlottesville, VA, ¹⁰University of California Irvine, Irvine, CA, ¹¹University of Utah, Salt Lake City, UT, ¹²University of Colorado, Denver, CO, ¹³Phoenix Neurological Associates, Phoenix, AZ, ¹⁴University of Kansas Medical Center, Kansas City, KS, ¹⁵University College London, London, United Kingdom
Background/Purpose: Inclusion body myositis (IBM) is the most common idiopathic inflammatory myopathy occurring in patients over the age of 45 years. Since immune suppression has…

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