Abstracts tagged "clinical trial"

Abstract Number: 1742 • ACR Convergence 2021
Efficacy of Anifrolumab in Serological Subgroups of Patients with SLE Participating in 2 Phase 3 Trials
Ian N. Bruce¹, Ronald Van Vollenhoven², Yoshiya Tanaka³, Eric Morand⁴, Richard Furie⁵, Konstantina Psachoulia⁶, Emmanuelle Maho⁷, Catharina Lindholm⁸, Christi Kleoudis⁹ and Raj Tummala⁶, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ²Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, ³University of Occupational and Environmental Health, Kitakyushu, Japan, ⁴Monash University, Melbourne, Australia, ⁵Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ⁶BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁷BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ⁸BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁹BioPharmaceuticals R&D, AstraZeneca, Durham, NC
Background/Purpose: In the TULIP-2 and TULIP-1 trials of patients with SLE, the type I IFN receptor mAb anifrolumab resulted in higher BILAG–based Composite Lupus Assessment…
Abstract Number: 1804 • ACR Convergence 2021
Targeted Safety Analyses of Guselkumab (TREMFYA®): Long-term Results from Randomized Clinical Trials in Patients with Active Psoriatic Arthritis and Moderate to Severe Psoriasis
Philip Mease¹, Peter Foley², Kristian Reich³, Soumya Chakravarty⁴, May Shawi⁵, Ya-Wen Yang⁶, Megan Miller⁷, Alexa Kollmeier⁸, Xie Xu⁷, Jenny Yu⁷, Yanli Wang⁷, Shihong Sheng⁷, Yin You⁷ and Iain McInnes⁹, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²University of Melbourne, Carlton, Australia, ³University Medical Center Hamburg-Eppendorf, Hamburg, Germany, ⁴Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁵Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁶Janssen Global Services, LLC, Horsham, PA, ⁷Janssen Research & Development, LLC, Spring House, PA, ⁸Janssen Research & Development, LLC, La Jolla, CA, ⁹University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom
Background/Purpose: Guselkumab (GUS), a human monoclonal antibody that specifically binds to the p19 subunit of IL-23, demonstrated efficacy and a favorable safety profile in active…
Abstract Number: 0449 • ACR Convergence 2021
Identification of Serum Protein Biomarkers at Baseline to Distinguish Radiographic Progressors from Non-Progressors in Patients with Active Psoriatic Arthritis
Orla Coleman¹, Bruna Wundervald², Ruoyi Zhou³, James Waddington³, Robert LJ Graham⁴, Ciaren Graham⁴, Geoff McMullan⁴, Andrew C. Parnell⁵, Vinod Chandran⁶, Philip Mease⁷, Gaia Gallo⁸, Venkatesh Krishnan⁸, Stephen Pennington⁹ and Oliver FitzGerald¹⁰, ¹Atturos, Bray, Ireland, ²Atturos, Maynooth, Ireland, ³Atturos, Belfield, Ireland, ⁴Queen’s University Belfast, Belfast, Northern Ireland, United Kingdom, ⁵Maynooth University, Maynooth, Ireland, ⁶Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ⁷Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁸Eli Lilly and Company, Indianapolis, IN, ⁹University College Dublin, Dublin, Ireland, ¹⁰Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland
Background/Purpose: A delay in diagnosis and management of patients with PsA leads to poor radiographic and functional outcomes [1]. The need to identify which patients…
Abstract Number: 0967 • ACR Convergence 2021
Antigen-specific and Bystander Autoreactive T Cell Control in Peripheral Blood of ACPA+ Rheumatoid Arthritis Patients Administered Antigen-specific Tolerising Immunotherapy
Pascale Wehr¹, Ranjeny Thomas², Nishta Ramnoruth³, Swati Patel³, Jamie Rossjohn⁴ and Hugh Reid⁴, ¹University of Queensland Diamantina Institute, Brisbane, Australia, ²University of Queensland, Diamantina Institute, Brisbane, Australia, ³University Of Queensland, Brisbane, Australia, ⁴Monash University, Melbourne, Australia
Background/Purpose: The control of autoreactive T cells in an antigen-specific manner in autoimmune diseases is a major clinical research goal. Various regulatory immune signatures have…
Abstract Number: 1338 • ACR Convergence 2021
Bimekizumab in Patients with Psoriatic Arthritis: 3-Year Results for Overall and Tumor Necrosis Factor Inhibitor (TNFi)-Naïve Populations from a Phase 2b Open-Label Extension Study
Philip Mease¹, Atul Deodhar², Joseph Merola³, Iain McInnes⁴, Deepak Assudani⁵, Rajan Bajracharya⁵, Jason Coarse⁶, Barbara Ink⁷ and Georg Schett⁸, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Oregon Health & Science University, Portland, OR, ³Brigham and Women's Hospital, Harvard Medical School, Boston, MA, ⁴University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, ⁵UCB Pharma, Slough, United Kingdom, ⁶UCB Pharma, Raleigh, NC, ⁷UCB Celltech, Slough, UK, Slough, United Kingdom, ⁸Universitätsklinikum Erlangen, Department of Internal Medicine 3 – Rheumatology and Immunology, Erlangen, Germany, Erlangen, Germany
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, and has demonstrated clinical improvements in joint and skin outcomes…
Abstract Number: 1687 • ACR Convergence 2021
Integrated Laboratory Abnormality Profiles of Upadacitinib with up to 4.5 Years of Exposure in Patients with Rheumatoid Arthritis Treated in a Phase 3 Clinical Trial
Christina Charles-Schoeman¹, Jon Giles², Nancy Lane³, Ernest Choy⁴, Dan Furst⁵, Jiri Vencovsky⁶, Anthony Wilson⁷, Gerd Burmester⁸, Tim Shaw⁹, Yanna Song¹⁰, Heidi Camp¹⁰, Nasser Khan¹⁰, Jillian Yee¹⁰, Samuel Anyanwu¹⁰ and Iain McInnes¹¹, ¹Department of Medicine, University of California, Los Angeles, Los Angeles, CA, ²Columbia University Irving Medical Center, Division of Rheumatology, New York, NY, ³University of California Davis, Hillsborough, CA, ⁴CREATE Centre, Cardiff University, Cardiff, Wales, United Kingdom, ⁵University of California Los Angeles, Los Angeles, CA, ⁶Institute of Rheumatology, Prague, Czech Republic, ⁷Center for Arthritis Research, Conway Institute, University College Dublin, Dublin, Ireland, ⁸Charité University Medicine Berlin, Berlin, Germany, ⁹AbbVie Inc., North Chicago, ¹⁰AbbVie Inc., North Chicago, IL, ¹¹University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom
Background/Purpose: Upadacitinib (UPA) is an oral Janus kinase inhibitor approved for the treatment of rheumatoid arthritis (RA). The safety and efficacy of UPA has been…
Abstract Number: 1746 • ACR Convergence 2021
Baricitinib Decreases Anti-dsDNA and IgG Antibodies in Adults with Systemic Lupus Erythematosus from a Phase 2 Double-Blind, Randomized, Placebo-Controlled Trial
Thomas Dörner¹, Ronald Van Vollenhaven², Andrea Doria³, Bochao Jia⁴, Damiano Fantini⁴, Jorge Ross Terres⁴, Maria Silk⁵, Stephanie de Bono⁴, Peter Fischer⁶ and Daniel Wallace⁷, ¹Charite Universitätsmedizin Berlin and Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany, ²University Medical Center, Amsterdam, Netherlands, ³University of Padova, Padova, Italy, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Eli Lilly and Company, Carmel, IN, ⁶Eli Lilly and Company, North Easton, MA, ⁷Cedars-Sinai, Los Angeles, CA
Background/Purpose: Baricitinib (BARI), an oral, selective Janus kinase (JAK)1 and JAK2 inhibitor, improved disease activity in adults with systemic lupus erythematosus (SLE) receiving standard background…
Abstract Number: 1805 • ACR Convergence 2021
Low Rates of Radiographic Progression with 2 Years of Guselkumab (TREMFYA®), a Selective Inhibitor of the Interleukin-23p19 Subunit: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study of Biologic-naïve Patients with Active Psoriatic Arthritis
Philip Mease¹, Alice Gottlieb², Iain McInnes³, Proton Rahman⁴, Alexa Kollmeier⁵, Xie Xu⁶, Yusang Jiang⁶, Shihong Sheng⁶, May Shawi⁷, Soumya Chakravarty⁸, Frederic Lavie⁹ and Désirée van der Heijde¹⁰, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Icahn School of Medicine at Mount Sinai, New York, NY, ³University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, ⁴Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ⁵Janssen Research & Development, LLC, La Jolla, CA, ⁶Janssen Research & Development, LLC, Spring House, PA, ⁷Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁸Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁹Janssen Global Services, LLC, Horsham, PA, ¹⁰Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands
Background/Purpose: Guselkumab (GUS), an IL-23p19-subunit inhibitor, is efficacious in treating patients (pts) with psoriasis and psoriatic arthritis (PsA). In the Phase 3, double-blind, placebo (PBO)-controlled…
Abstract Number: 0453 • ACR Convergence 2021
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-Week Integrated Results from 2 Phase 3, Randomized, Double-blind Clinical Trials for CsDMARD-IR and Bio-IR Patients
Andrew Ostor¹, Kim Papp², Mireia Moreno³, Cathy Spargo⁴, Lisa Barcomb⁵, Ahmed M. Soliman⁵, Wenjing Lu⁶, Ann Eldred⁵ and Lars Erik Kristensen⁷, ¹Monash University, Cabrini Hospital, and Emertius Research, Melbourne, Australia, ²K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada, ³Rheumatology Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí, Universitat Autònoma de Barcelona, Barcelona, Spain, ⁴Vincent Pallotti Hospital, Johannesburg, South Africa, ⁵Abbvie Inc., North Chicago, IL, ⁶AbbVie Inc., North Chicago, ⁷The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Frederiksberg, Denmark
Background/Purpose: Risankizumab (RZB) is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit. RZB is being investigated…
Abstract Number: 1169 • ACR Convergence 2021
Patient Preferences for Outcome Measures for a Pragmatic Knee Osteoarthritis (OA) Clinical Trial: Results of a Cross-Sectional Patient Survey That Included Racial/Ethnic Minorities
Jasvinder Singh, University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Many effective treatments are available for knee osteoarthritis (OA), however comparative effectiveness research (CER) of various treatments to each other is limited. One of…
Abstract Number: 1341 • ACR Convergence 2021
Ixekizumab Shows a Pattern of Pain Improvement in Patients with and Without Measurable Inflammation in Psoriatic Arthritis
Kurt de Vlam¹, Gaia Gallo², Philip Mease³, Proton Rahman⁴, Venkatesh Krishnan², David Sandoval², Chen Yen Lin², Danting Zhu², Rebecca Bolce² and Philip Conaghan⁵, ¹University Hospitals Leuven, Leuven, Belgium, ²Eli Lilly and Company, Indianapolis, IN, ³Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁴Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ⁵Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom
Background/Purpose: The efficacy of ixekizumab (IXE) and adalimumab (ADA) in patients with psoriatic arthritis (PsA) has been previously reported using ACR 50 and Psoriasis Area…
Abstract Number: 1688 • ACR Convergence 2021
Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 9.3 Years: An Updated Integrated Safety Analysis
Peter C Taylor¹, Tsutomu Takeuchi², Gerd Burmester³, Patrick DUREZ⁴, Josef Smolen⁵, Walter Deberdt⁶, Jinglin Zhong⁷, Jorge Ross Terres⁶, Natalia Bello⁶ and Kevin Winthrop⁸, ¹University of Oxford, Oxford, United Kingdom, ²Div. Rheumatology, Keio University, Tokyo, Japan, ³Charité University Medicine Berlin, Berlin, Germany, ⁴Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Brussels, Belgium, ⁵Medical University of Vienna, Vienna, Austria, ⁶Eli Lilly and Company, Indianapolis, IN, ⁷IQVIA, Morrisville, NC, ⁸Oregon Health & Science University, Portland, OR
Background/Purpose: Baricitinib (bari) is an oral selective Janus kinase (JAK)1/JAK 2 inhibitor approved for the treatment of adult patients with moderately to severely active rheumatoid…
Abstract Number: 1747 • ACR Convergence 2021
BIIB059 Demonstrates Improvement in Joint Manifestations in Participants with Systemic Lupus Erythematosus in Part a of a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study
Ronald van Vollenhoven¹, Richard Furie², Kenneth Kalunian³, Maria Dall'Era⁴, Victoria Werth⁵, Xiaobi Huang⁶, Hua Carroll⁶, Cristina Musselli⁶, Catherine Barbey⁷ and Nathalie Franchimont⁶, ¹Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, ²Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ³UC San Diego, La Jolla, CA, ⁴University of California San Francisco, Corte Madera, CA, ⁵Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁶Biogen, Cambridge, MA, ⁷Biogen, Baar, Switzerland
Background/Purpose: Joint involvement, a frequent manifestation of SLE, can be assessed using global lupus disease activity indices (SLEDAI-2K, BILAG-2004) and/or by assessing joint tenderness and…
Abstract Number: 1806 • ACR Convergence 2021
Designing a Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Guselkumab (TREMFYA®/sup>) Dosing Interval in Psoriatic Arthritis Patients with Inadequate Response to Tumor Necrosis Factor Inhibition
Alexis Ogdie-Beatty¹, Joseph Merola², Philip Mease³, Christopher Ritchlin⁴, Jose Scher⁵, Daphne Chan⁶, Soumya Chakravarty⁷, Wayne Langholff⁸, Olivia Choi⁹, Yevgeniy Krol⁹, Katelyn Rowland⁹ and Alice Gottlieb¹⁰, ¹University of Pennsylvania, Philadelphia, PA, ²Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, ³Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁴Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ⁵New York University School of Medicine, New York, NY, ⁶Janssen Scientific Affairs, LLC, Spring House, PA, ⁷Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁸Janssen Research & Development, LLC, Spring House, PA, ⁹Janssen Scientific Affairs, LLC, Horsham, PA, ¹⁰Icahn School of Medicine at Mount Sinai, New York, NY
Background/Purpose: Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic therapy for patients (pts) with PsA, though a sizeable proportion of pts…
Abstract Number: 0455 • ACR Convergence 2021
Abatacept Reverses Subclinical Arthritis in Patients with High-risk to Develop Rheumatoid Arthritis -results from the Randomized, Placebo-controlled ARIAA Study in RA-at Risk Patients
Juergen Rech¹, Mikkel Ostergaard², Koray Tascilar³, Melanie Hagen⁴, Larissa Valor Mendez⁴, Arnd Kleyer⁴, Gerhard Kroenke⁴, David Simon⁵, Verena Schoenau⁴, Axel Hueber⁶, Stefan Kleinert⁷, Xenofon Baraliakos⁸, Martin Fleck⁹, Andrea Rubbert-Roth¹⁰, Frank Behrens¹¹, David Kofler¹², Martin Feuchtenberger¹³, Michael Zaenker¹⁴, Reinhard Voll¹⁵, Cornelia Glaser¹⁶, Eugen Feist¹⁷, Gerd Burmester¹⁸, Kirsten Karberg¹⁹, Johannes Strunk²⁰, Juan D Cañete²¹, Esperanza Naredo²², Maria Filkova²³, Ladislav Senolt²⁴ and Georg Schett²⁵, ¹Friedrich-Alexander University (FAU) Erlangen-Nuernberg and Universitaetsklinikum Erlangen, Department of Internal Medicine 3 - Rheumatology and Immunology, Germany, Erlangen, Germany, ²Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, and Department of Clinical Medicine, University of Copenhagen, Glostrup, Denmark, ³Friedrich Alexander University of Erlangen Nuremberg, Universitaetsklinikum Erlangen Department of Medicine-3 Rheumatology and Immunology, Erlangen, Germany, ⁴Friedrich-Alexander University (FAU) Erlangen-Nuernberg and Universitaetsklinikum Erlangen, Medical Department 3, Rheumatology & Immunology, Erlangen, Germany, ⁵Department of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nrnberg, Erlangen, Germany, ⁶sozialstiftung-bamberg.de, Bamberg, Germany, ⁷Praxisgemeinschaft Rheumatologie - Nephrologie (PGRN), Erlangen, Germany, ⁸Rheumazentrum Ruhrgebiet, Herne, Germany, ⁹Asklepios Klinikum Bad Abbach Klinik und Poliklinik für Rheumatologie/ Klin. Immunologie, Bad Abbach, Germany, ¹⁰Kantonspital St Gallen, St.Gallen, Switzerland, ¹¹Rheumatology & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Frankfurt/Main, Germany, ¹²Division of Rheumatology and Clinical Immunology, Department I of Internal Medicine; University Hospital Cologne, Cologne, Germany, ¹³MED | BAYERN OST GmbH Fachbereich Rheumatologie, Burghausen, Germany, ¹⁴Immanuel Klinikum Bernau Herzzentrum Brandenburg, Bernau, Germany, ¹⁵Department of Rheumatology and Clinical Immunology, University Medical Center, Faculty of Medicine, Albert-Ludwigs-University of Freiburg, Freiburg, Germany, ¹⁶Universitätsklinikum Freiburg Klinik für Rheumatologie und Klinische Immunologie, Freiburg, Germany, ¹⁷Helios Department of Rheumatology, Vogelsang-Gommern, Germany, ¹⁸Charité University Medicine Berlin, Berlin, Germany, ¹⁹Praxis für Rheumatologie und Innere Medizin, Berlin, Germany, ²⁰Krankenhaus Porz am Rhein GmbH Rheumaklinik, Köln (Porz), Germany, ²¹Rheumatology Department, Hospital Clinic, Barcelona, Spain, ²²Department of Rheumatology and Joint and Bone Research Unit, Hospital Fundación Jiménez Díaz and Autónoma University, Madrid, Spain, ²³Institute of Rheumatology and Connective Tissue Research Laboratory, Department of Rheumatology of First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic, ²⁴Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic, ²⁵Universitätsklinikum Erlangen, Department of Internal Medicine 3 – Rheumatology and Immunology, Erlangen, Germany, Erlangen, Germany
Background/Purpose: Rheumatoid arthritis (RA) has a preclinical phase that is characterized by the presence of antibodies against citrullinated proteins (ACPA), subclinical arthritis and pain. ACPA…

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Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. Academic institutions, private organizations and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part a scientific presentation or presentation of additional new information that will be available at the time of the meeting) is under embargo until Saturday, November 11, 2023.

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