Abstracts tagged "clinical trial"

Abstract Number: L14 • ACR Convergence 2022
Bimekizumab Maintains Improvements in Efficacy Endpoints and Has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies
Xenofon Baraliakos¹, Atul Deodhar², Désirée van der Heijde³, Marina Magrey⁴, Walter Maksymowych⁵, Tetsuya Tomita⁶, Huji Xu⁷, Marga Oortgiesen⁸, Ute Massow⁹, Carmen Fleurinck¹⁰, Alicia M Ellis⁸, Tom Vaux¹¹, Julie Shepherd-Smith¹¹, Alexander Marten⁹ and Lianne S Gensler¹², ¹Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, ²Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ³Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁴Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, US, Richfield, OH, ⁵Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka City, Osaka City, Osaka, Japan, ⁷Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China (People's Republic), ⁸UCB Pharma, Morrisvile, NC, ⁹UCB Pharma, Monheim am Rhein, Nordrhein-Westfalen, Germany, ¹⁰UCB Pharma, Brussels, Brussels Hoofdstedelijk Gewest, Belgium, ¹¹UCB Pharma, Slough, United Kingdom, ¹²Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL‑17A. In the phase 3 BE MOBILE 1 and 2…
Abstract Number: 0294 • ACR Convergence 2022
Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and Inadequate Response or Intolerance to Biologic DMARDs: Results Through 5 Years from the SELECT-BEYOND Study
Roy Fleischmann¹, Sebastian Meerwein², Christina Charles-Schoeman³, BERNARD COMBE⁴, Stephen Hall⁵, Nasser Khan⁶, Kyle Carter⁷, Heidi Camp⁸ and Andrea Rubbert-Roth⁹, ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²AbbVie Deutschland GmbH & Co KG, LUDWIGSHAFEN, Germany, ³Division of Rheumatology, University of California, Los Angeles, Santa Monica, CA, ⁴Montpellier University, Montpellier, France, ⁵Emeritus Research and Monash University, Melbourne, Australia, ⁶AbbVie, Inc., Abbott Park, IL, ⁷AbbVie, Inc., North Chicago, IL, ⁸Abbvie, Winnetka, IL, ⁹Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland
Background/Purpose: To evaluate the long-term efficacy and safety of upadacitinib (UPA) over 5 yrs among patients with rheumatoid arthritis (RA) in a long-term extension (LTE)…
Abstract Number: 0366 • ACR Convergence 2022
Phase II Trial of Enpatoran in Patients Hospitalized with COVID-19 Pneumonia
John McKinnon¹, Joel Santiaguel², Claudia Murta De Oliveira³, Dongzi Yu⁴, Mukhy Khursheed⁵, Flavie Moreau⁶, Lena Klopp-Schulze⁷, Jamie Shaw⁸, Sanjeev Roy⁹ and Amy Kao¹⁰, ¹Department of Medicine, Henry Ford Hospital, Detroit, MI, ²Internal Medicine, Quirino Memorial Medical Center, Quezon City, Philippines, ³Ambulatório de Pesquisa Clínica, Santa Casa de Misericórdia, Belo Horizonte, Brazil, ⁴Global Clinical Development, EMD Serono, Billerica, MA, ⁵Global Patient Safety, Merck Serono Ltd., an affiliate of Merck KGaA, Darmstadt, Germany, ⁶Global Biostatistics, EMD Serono, Billerica, MA, ⁷Translational Medicine, the healthcare business of Merck KGaA, Darmstadt, Germany, ⁸Translational Medicine, EMD Serono, Billerica, MA, ⁹Global Clinical Development, Ares Trading SA, an affiliate of Merck KGaA, Darmstadt, Germany, ¹⁰EMD Serono, Billerica, MA
Background/Purpose: Enpatoran is a selective and potent dual toll-like receptor (TLR) 7/8 inhibitor in development for the treatment of cutaneous and systemic lupus erythematosus (CLE/SLE).…
Abstract Number: 0544 • ACR Convergence 2022
Bimekizumab Improves Signs and Symptoms, Including Inflammation, in Patients with Active Non-Radiographic Axial Spondyloarthritis: 24-Week Efficacy & Safety from a Phase 3, Multicenter, Randomized, Placebo Controlled Study
Atul Deodhar¹, Désirée van der Heijde², Lianne Gensler³, Huji Xu⁴, Karl Gaffney⁵, Hiroaki Dobashi⁶, Walter P Maksymowych⁷, Martin Rudwaleit⁸, Marina Magrey⁹, Dirk Elewaut¹⁰, Marga Oortgiesen¹¹, Carmen Fleurinck¹², Natasha de Peyrecave¹³, Alicia Ellis¹⁴, Thomas Vaux¹⁵, Julie Shepherd-Smith¹⁵ and Xenofon Baraliakos¹⁶, ¹Oregon Health & Science University, Portland, OR, USA, Portland, OR, ²Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Leiden, Netherlands, ³Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, ⁴Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China, ⁵Norfolk and Norwich University Hospital NHS Trust, Norfolk, United Kingdom, ⁶Division of Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Faculty of Medicine, Kagawa, Kagawa, Japan, ⁷Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁸University of Bielefeld, Klinikum Bielefeld, Bielefeld; Germany Klinikum Bielefeld and Charité Berlin, Germany, and Gent University, Gent, Belgium, ⁹Case Western Reserve University, University Hospitals, Richfield, OH, ¹⁰Department of Rheumatology, Ghent University Hospital, Belgium, VIB-UGent Center for Inflammation Research, Ghent University, Heusden, Belgium, ¹¹UCB Pharma, Raleigh, NC, ¹²UCB Pharma, Brussels, Belgium, Oosterzele, Belgium, ¹³UCB Pharma, Brussels, Belgium, ¹⁴UCB Pharma, Raleigh, ¹⁵UCB Pharma, Slough, United Kingdom, ¹⁶Rheumazentrum Ruhrgebiet Herne, Herne, Germany
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. In patients (pts) with active ankylosing spondylitis (AS), BKZ…
Abstract Number: 1010 • ACR Convergence 2022
Comparison of Established and New, Preliminarily Proposed ASAS Cut-Offs for Inflammatory MRI Lesions in the Sacroiliac Joints of Axial Spondyloarthritis Patients and Implications for Recruitment in Clinical Studies
Xenofon Baraliakos¹, Pedro Machado², Lars Bauer³, Bengt Hoepken³, Mindy Kim⁴, Thomas Kumke³, Rachel Tham⁵ and Martin Rudwaleit⁶, ¹Rheumazentrum Ruhrgebiet Herne, Herne, Germany, ²University College London, London, United Kingdom, ³UCB Pharma, Monheim am Rhein, Germany, ⁴UCB Pharma, Smyrna, GA, ⁵UCB Pharma, Slough, UK, Overland Park, KS, ⁶University of Bielefeld, Klinikum Bielefeld, Bielefeld; Germany Klinikum Bielefeld and Charité Berlin, Germany, and Gent University, Gent, Belgium
Background/Purpose: The Assessment of SpondyloArthritis international Society (ASAS) recently proposed preliminary, more stringent, data-driven definitions for active and structural MRI lesions of the sacroiliac joint…
Abstract Number: 1528 • ACR Convergence 2022
Nintedanib in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) and Organ Damage: Data from the SENSCIS Trial
Janet Pope¹, Susanna Proudman², Wendy Stevens³, Joerg Henes⁴, Rozeta Simonovska⁵, Margarida Alves⁶ and Yannick Allanore⁷, ¹University of Western Ontario, London, ON, Canada, ²Rheumatology Unit, Royal Adelaide Hospital, and Discipline of Medicine, University of Adelaide, Adelaide, Australia, ³Department of Rheumatology, St Vincent’s Hospital, Melbourne, Australia, Melbourne, Australia, ⁴Center for Interdisciplinary Clinical Immunology, Rheumatology and Auto-inflammatory Diseases (INDIRA), University Hospital Tübingen, Tübingen, Germany, ⁵mainanalytics GmbH, Sulzbach (Taunus), Germany, Sulzbach (Taunus), Germany, ⁶Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, ⁷Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France, Paris, France
Background/Purpose: The Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI) was developed to quantify organ damage in patients with SSc. We assessed outcomes in the SENSCIS…
Abstract Number: 1807 • ACR Convergence 2022
Reduction in Monosodium Urate Crystal Deposit Volume During the MIRROR RCT Trial in Patients Treated with Pegloticase Plus Methotrexate Co-therapy: A Serial Dual-Energy Computed Tomography (DECT) Analysis
Nicola Dalbeth¹, John Botson², kenneth saag³, Ada Kumar⁴, Lissa Padnick-Silver⁵, Brian LaMoreaux⁵ and Fabio Becce⁶, ¹University of Auckland, Auckland, New Zealand, ²Orthopedic Physicians Alaska, Anchorage, AK, ³University of Alabama at Birmingham, Birmingham, AL, ⁴Horizon Therapeutics, Deerfield, IL, ⁵Horizon Therapeutics plc, Deerfield, IL, ⁶Lausanne University Hospital (CHUV), Lausanne, Switzerland
Background/Purpose: Dual-energy computed tomography (DECT) can reliably visualize and quantify monosodium urate (MSU) crystal deposits in gout patients.1 Two MIRROR open-label trial (pegloticase + oral…
Abstract Number: 1985 • ACR Convergence 2022
The BEGIN Study: A Double-blind, Multi-center, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks of Treatment with AP1189 in Early Rheumatoid Arthritis (RA) Patients with Active Joint Disease
Thomas Jonassen¹, Irene Sandholdt², Birgitte Telmer² and Ellen-Margrethe Hauge³, ¹SynAct Pharma, Holte, Denmark, ²CroxxMed, Hørsholm, Denmark, ³Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
Background/Purpose: Melanocortin (MC) type 1 and type 3 receptor stimulation is associated with anti-inflammatory activity and the promotion of inflammatory resolution. AP1189 is novel biased…
Abstract Number: 2115 • ACR Convergence 2022
Early Skin and Early Enthesitis Responses in Psoriatic Arthritis Patients Treated with Guselkumab Associate with Long-term Response: Post Hoc Analysis Through 2 Years of a Phase 3 Study
Laura Coates¹, Julio Ramírez², Dennis McGonagle³, Sibel Aydin⁴, Miriam Zimmermann⁵, Francois Nantel⁶, May Shawi⁷, Emmanouil Rampakakis⁸, Peter Nash⁹ and Philip J Mease¹⁰, ¹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom, ²Arthritis Unit, Rheumatology Department, Hospital Clinic, Barcelona, Spain, ³University of Leeds, Leeds, UK, Leeds, United Kingdom, ⁴University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada, ⁵Immunology, Janssen Scientific Affairs, LLC, Zug, Switzerland, ⁶Nantel MedSci Consult, Montréal, QC, Canada, ⁷Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁸McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, ⁹School of Medicine, Griffith University, Sunshine Coast, Australia, ¹⁰Swedish Medical Center/Providence St. Joseph Health, Seattle, WA
Background/Purpose: Guselkumab (GUS), an IL-23p19 inhibitor, has demonstrated efficacy in PsA across key Group for Research and Assessment of Psoriasis (PsO) and Psoriatic Arthritis (GRAPPA)-recommended…
Abstract Number: 0295 • ACR Convergence 2022
Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic DMARDs: Results Through 5 Years from the SELECT-NEXT Study
Gerd Burmester¹, Filip Van den bosch², John Tesser³, Anna K Shmagel⁴, Yuanyuan Duan⁴, Nasser Khan⁵, Heidi Camp⁶ and Alan Kivitz⁷, ¹Charité University Medicine Berlin, Berlin, Germany, ²Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium, ³Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie, Inc., Abbott Park, IL, ⁶Abbvie, Winnetka, IL, ⁷Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: In the phase 3 SELECT-NEXT study, upadacitinib (UPA) demonstrated efficacy at wk 12 and sustained efficacy up to wk 60 in patients with rheumatoid…
Abstract Number: 0371 • ACR Convergence 2022
A Phase 2, Double-blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101/Lenabasum in Systemic Lupus Erythematosus, an Autoimmunity Centers of Excellence Study (ALE09)
Meggan Mackay¹, Robert Zurier², Diane Kamen³, Fotios Koumpouras⁴, Anca Askanase⁵, Kenneth Kalunian⁶, Steffan Schulz⁷, Giovanni Franchin⁸, Nancy Olsen⁹, Andreea Coca¹⁰, Roberto Caricchio¹¹, Maureen McMahon¹², Maria Dall'Era¹³, Amit Saxena¹⁴, Megan Clowse¹⁵, Stanley Ballou¹⁶, Linna Ding¹⁷, Beverly Welch¹⁸, Jessica Springer¹⁹, Andrew Shaw¹, Lynette Keyes-Elstein²⁰, Kaitlyn Steinmiller²¹, Amanda Mickey²¹, Cynthia Aranow¹ and Betty Diamond¹, ¹Feinstein Institutes for Medical Research, Manhasset, NY, ²Feinstein Institutes, Wyckoff, NJ, ³Medical University of South Carolina, Charleston, SC, ⁴Yale School of Medicine, New Haven, CT, ⁵Columbia University Medical Center, New York, NY, ⁶University of California San Diego, La Jolla, CA, ⁷Univ Pennsylvania, Philadelphia, PA, ⁸BronxCare, Feinstein Institutes, Manhasset, NY, ⁹Penn State University/Milton S Hershey, Hershey, PA, ¹⁰UPMC, Pittsburgh, PA, ¹¹Lewis Katz School of Medicine at Temple University, Philadelphia, PA, ¹²University of California Los Angeles, Los Angeles, CA, ¹³University of California, Division of Rheumatology, San Francisco, CA, ¹⁴NYU School of Medicine, New York, NY, ¹⁵Duke University, Durham, NC, ¹⁶Case Western Reserve University - Metro Health, Cleveland, OH, ¹⁷NIH NIAID, Rhockvile, MD, ¹⁸NIAID/NIH, Bethesda, MD, ¹⁹NIH/NIAID, Rockville, MD, ²⁰Rho, Chapel Hill, NC, ²¹Rho Inc, Durham, NC
Background/Purpose: Musculoskeletal (MSK) symptoms are common in SLE, often associate with debilitating pain requiring immunosuppressive treatment. JBT-101 is a non-psychotropic, non-immunosuppressive, cannabinoid receptor 2 agonist…
Abstract Number: 0546 • ACR Convergence 2022
COmparison of the Effect of Treatment with NSAIDs Added to Anti-TNF Therapy versus Anti-TNF Therapy Alone on Progression of StrUctural Damage in the Spine over Two Years in Patients with Ankylosing Spondylitis (CONSUL): An Open-Label, Randomized Controlled, Multicenter Trial
Fabian Proft¹, Bukrhard Muche², valeria Rios-Rodriguez³, Murat Torgutalp⁴, Mikhail Protopopov⁵, Joachim Listing⁶, Maryna Verba⁷, Jan Brandt-Juergens⁸, Uta Kiltz⁹, Maren Sieburg¹⁰, Swen Jacki¹¹, Joachim Sieper⁴ and Denis Poddubnyy¹, ¹Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ²Charité University Hospital, CCM, Berlin, Germany, ³Charité-Universitätsmedizin Berlin, Berlin, Germany, ⁴Charité - Universitätsmedizin, Berlin, Berlin, Germany, ⁵Charité Universitätsmedizin Berlin, Berlin, Germany, ⁶German Rheumatism Research Centre, Epidemiology Unit, Berlin, Germany, ⁷Charité – Universitätsmedizin Berlin, Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Berlin, Germany, ⁸Rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁹Rheumazentrum Ruhrgebiet, Herne, Germany, ¹⁰Rheumatologische Facharztpraxis, Magdeburg, Germany, ¹¹Rheumatologische Schwerpunktpraxis, Tübingen, Germany
Background/Purpose: There is some evidence that NSAIDs, in particular celecoxib (CEL), might possess not only symptomatic efficacy but also disease-modifying properties in ankylosing spondylitis (AS),…
Abstract Number: 1015 • ACR Convergence 2022
Predictors of Nail Response with Guselkumab: A Post Hoc Analysis of the VOYAGE 2 Clinical Trial
Alexander Egeberg¹, William Tillett², Enikö Sonkoly³, Patricia Gorecki⁴, Anna Tjärnlund⁵, Jozefien Buyze⁶, Sven Wegner⁷ and Dennis McGonagle⁸, ¹Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark, ²Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ³Dermatology and Venereology Division, Karolinska Institutet; Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden, ⁴Janssen-Cilag Ltd, High Wycombe, United Kingdom, ⁵Janssen-Cilag AB, Solna, Sweden, ⁶Janssen Pharmaceutica NV, Beerse, Belgium, ⁷Janssen-Cilag GmbH, Neuss, Germany, ⁸Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; National Institute for Health Research, Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Background/Purpose: Understanding factors that impact response to therapy may help improve disease management, clinical outcomes and patient quality of life. Nails are often overlooked in…
Abstract Number: 1531 • ACR Convergence 2022
Continued Treatment with Nintedanib in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Three-Year Data from SENSCIS-ON
Yannick Allanore¹, Madelon Vonk², Oliver Distler³, Arata Azuma⁴, Maureen Mayes⁵, Alexandra James⁶, Veronika Kohlbrenner⁷, Margarida Alves⁸, Dinesh Khanna⁹ and Kristin Highland¹⁰, ¹Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France, Paris, France, ²Department of Rheumatology, Radboud University Medical Center, Nijmegen, Netherlands, ³Department of Rheumatology, University Hospital Zurich, University of Zurich, Zürich, Switzerland, ⁴Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan, ⁵Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, TX, ⁶Elderbrook solutions GmbH, Bietigheim-Bissingen, Germany, Bietigheim-Bissingen, Germany, ⁷Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA, Ridgefield, CT, ⁸Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, ⁹Division of Rheumatology, Department of Internal Medicine, Scleroderma Program, University of Michigan, Ann Arbor, MI, ¹⁰Cleveland Clinic, Cleveland, Ohio, USA, Cleveland, OH
Background/Purpose: In the randomized placebo-controlled SENSCIS trial in patients with SSc-ILD, nintedanib reduced the rate of decline in forced vital capacity (FVC) (mL/year) over 52…
Abstract Number: 1808 • ACR Convergence 2022
Assessing the Role of the NLRP3 Inflammasome in Driving Inflammation in Affected Joints of Patients with Inter-critical Gout
Swamy Venuturupalli¹, Ami Ben-artzi², Tasmia Amjad³, Amit Kumar⁴, Nikhil Davuluri³, Timothy Chu³, Umair Khan³, Diego Parra³, Natalie Fortune³ and Caroline Jefferies¹, ¹Cedars-Sinai Medical Center, Los Angeles, CA, ²Ami Ben-Artzi, MD Inc., Beverly Hills, CA, ³Attune Health, Beverly Hills, CA, ⁴Attune Health, Beverly Hils, CA
Background/Purpose: Percutaneous ultrasound-guided needle synovial biopsies can now be performed at the bedside. To date, no synovial biopsy studies have been conducted in gout patients.…

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