Abstracts tagged "clinical trial"

Abstract Number: 1904 • ACR Convergence 2022
Is Treating Painful Hand Osteoarthritis with Hormone Replacement Therapy Feasible? Primary Results from a Randomised Controlled Trial in Post-menopausal Women
Jennifer Williams¹, Mae Chester-Jones¹, Megan Goff², Anne Francis¹, Gretchen Brewer¹, Ioana Marian¹, Malvika Gulati¹, Charles Mackworth-Young³, Victoria Glover⁴, Sarah Lamb¹, Tonia Vincent⁵, Katy Vincent¹, Susan Dutton¹ and Fiona Watt⁶, ¹University of Oxford, Oxford, United Kingdom, ²University of Oxford, London, United Kingdom, ³Imperial College Healthcare NHS Trust, London, United Kingdom, ⁴White Horse Medical Practice, Faringdon, United Kingdom, ⁵Kennedy Institute of Rheumatology, University of Oxford, Oxford, United Kingdom, ⁶Imperial College London, London, United Kingdom
Background/Purpose: Hand osteoarthritis (OA) is more common in females and relative risk increases further around the age of menopause, potentially implicating sex hormone deficiency. There…
Abstract Number: 2112 • ACR Convergence 2022
Stringent Disease Activity Control at 2 Years Across Psoriatic Arthritis Domains Irrespective of Baseline Characteristics in Patients Treated with Guselkumab: Post Hoc Analysis of a Phase 3, Randomized, Double-blind, Placebo-controlled Study
Christopher Ritchlin¹, Philip J Mease², Wolf-Henning Boehncke³, John Tesser⁴, Soumya Chakravarty⁵, Emmanouil Rampakakis⁶, May Shawi⁷, Elena Schiopu⁸, Joseph Merola⁹, Iain B McInnes¹⁰ and Atul Deodhar¹¹, ¹Allergy, Immunology and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, ²Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ³Deptartment of Dermatology, Geneva University Hospitals, University of Geneva, Geneva, Switzerland, ⁴Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ⁵Janssen Scientific Affairs, LLC; Drexel University College of Medicine, Villanova, PA, ⁶McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, ⁷Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁸Michigan Medicine Rheumatology Clinic – Taubman Center, Ann Arbor, MI, ⁹Brigham and Women's Hospital, Harvard Medical School, Boston, MA, ¹⁰Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, United Kingdom, ¹¹Oregon Health & Science University, Portland, OR, USA, Portland, OR
Background/Purpose: Guselkumab (GUS) is associated with robust and sustained improvement in PsA signs and symptoms in subgroups of patients (pts) pooled from the phase 3…
Abstract Number: 0292 • ACR Convergence 2022
Malignancy in the Upadacitinib Clinical Trial Programs for Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
Andrea Rubbert-Roth¹, Adriana Kakehasi², Tsutomu Takeuchi³, Marc Schmalzing⁴, Hannah Palac⁵, Jianzhong Liu⁵, Samuel Anyanwu⁵, Ralph Lippe⁶ and Jeffrey Curtis⁷, ¹Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland, ²Federal University of Minas Gerais, Hospital das Clínicas, Belo Horizonte, Brazil, ³Keio University and Saitama Medical University, Tokyo, Japan, ⁴University Hospital Wuerzburg, Wuerzburg, Germany, ⁵AbbVie, Inc., North Chicago, IL, ⁶AbbVie, Inc, Wiesbaden, Germany, ⁷University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Increased risk of malignancies has been associated with chronic inflammation, as well as immunosuppressive and immunomodulatory therapies. The objective of this analysis is to…
Abstract Number: 0364 • ACR Convergence 2022
Efficacy of BIIB059 on Joint and Skin Manifestations in Participants with Systemic Lupus Erythematosus (SLE): Exploratory Analyses of the Phase 2, Randomized, Double-Blind, Placebo-Controlled LILAC Study (Part A)
Richard Furie¹, Ronald van Vollenhoven², Victoria Werth³, Kenneth Kalunian⁴, Sandra Navarra⁵, Juanita Romero-Diaz⁶, Ting Wang⁷, Cristina Musselli⁷, Catherine Barbey⁸ and Nathalie Franchimont⁷, ¹Northwell Health, Great Neck, NY, ²Amsterdam University Medical Centers, Amsterdam, Netherlands, ³University of Pennsylvania and Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, ⁴University of California San Diego, La Jolla, CA, ⁵University of Santo Tomas, Manila, Philippines, ⁶Instituto Nacional de Ciencias Medicas y Nutricion SZ, Ciudad de México, Mexico, ⁷Biogen, Cambridge, MA, ⁸Biogen, Baar, Switzerland
Background/Purpose: SLE is a heterogeneous illness that often manifests with skin and/or joint diseases.1 BIIB059 is a humanized monoclonal antibody that binds to BDCA2, a…
Abstract Number: 0530 • ACR Convergence 2022
Abatacept Significantly Reduces Subclinical Inflammation During Treatment (6 Months), This Persists After Discontinuation (12 Months), Resulting in a Delay in the Clinical Development of RA in Patients at Risk of RA (The ARIAA Study)
Juergen Rech¹, Arnd Kleyer², Mikkel Østergaard³, Melanie Hagen², Larissa Valor Mendez², Koray Tascilar², Gerhard Kroenke², Verena Schönau², David Simon², stefan Kleinert⁴, Xenofon Baraliakos⁵, Juergen Braun⁶, Axel Hueber⁷, Martin Fleck⁸, Andrea Rubbert-Roth⁹, Frank Behrens¹⁰, Martin Feuchtenberger¹¹, M. Zaenker¹², Reinhard Voll¹³, Cornelia Glaser¹⁴, Mária Filková¹⁵, Eugen Feist¹⁶, Gerd Burmester¹⁷, Kirsten Karberg¹⁸, Johannes Strunk¹⁹, Juan Canete²⁰, Ladislav Šenolt¹⁵, Esperanza Naredo²¹ and Georg Schett²², ¹University Clinic Erlangen, Erlangen, Germany, ²Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054 Erlangen, Germany; Deutsches Zentrum Immuntherapie, Friedrich-Alexander-UniversityErlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany, ³Rigshospitalet, University of Copenhagen, Glostrup, Denmark, ⁴Praxisgemeinschaft Rheumatologie - Nephrologie (PGRN), Erlangen, Germany, ⁵Ruhr University Bochum, Department of Rheumatology, Bochum, Germany; Rheumazentrum Ruhrgebiet, Rheumazentrum Ruhrgebiet, Herne, Germany, ⁶Rheumazentrum Ruhrgebiet, Herne, Germany, ⁷Klinikum Nuernberg Nord, Abteilung fuer Rheumatologie, Nuernberg, Germany, ⁸Asklepios Klinikum Bad Abbach, Klinik und Poliklinik für Rheumatologie/ Klin. Immunologie, Bad Abbach, Germany, ⁹Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland, ¹⁰Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany; Fraunhofer Institute for Translational Medicine & Pharmacology ITMP, Frankfurt, ¹¹MED | BAYERN OST GmbH, Fachbereich Rheumatologie, Burghausen, Germany, ¹²Immanuel Klinikum Bernau , Herzzentrum Brandenburg, Abteilung Innere Medizin, Bernau, Germany, ¹³Universitätsklinikum Freiburg, Klinik für Rheumatologie und Klinische Immunologie, Freiburg im Breisgau, Germany, ¹⁴Universitätsklinikum Freiburg, Klinik für Rheumatologie und Klinische Immunologie, Freiburg, Germany, ¹⁵Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ¹⁶Helios Clinic Vogelsang-Gommern, cooperation partner of the Otto von Guericke University Magdeburg, Magdeburg, Germany, ¹⁷Charité University Medicine Berlin, Berlin, Germany, ¹⁸Praxis für Rheumatologie und Innere Medizin, Rheumatologie, Berlin, Germany, ¹⁹Krankenhaus Porz am Rhein GmbH, Rheumaklinik, Köln (Porz), Germany, Koeln, Germany, ²⁰Unidad de Artritis Hospital Clinic, Barcelona, Spain, ²¹Hospital General Universitario Gregorio Marañón and Complutense University, Madrid, Spain, ²²Universitätsklinikum Erlangen, Erlangen, Germany
Background/Purpose: Development of the clinical phase of rheumatoid arthritis (RA) is preceded by an autoimmune phase, characterized by the presence of anti-citrullinated protein antibodies (ACPA),…
Abstract Number: 1001 • ACR Convergence 2022
Effect of Atacicept on Renal Function in Patients with Systemic Lupus Erythematosus (SLE)
David Isenberg¹, Celia Lin², Amy Kao³, Aida Aydemir⁴ and Caroline Gordon⁵, ¹University College London, London, United Kingdom, ²Vera Therapeutics, Inc, Burlingame, CA, ³EMD Serono, Billerica, MA, ⁴EMD Serono Research & Development Institute, Inc, Billerica, MA, ⁵Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom
Background/Purpose: Atacicept is a fusion protein that blocks B-lymphocyte stimulator and a proliferation-inducing ligand, which are increased in patients with SLE. APRIL-SLE was a double-blind,…
Abstract Number: 1509 • ACR Convergence 2022
Patient Clusters Identified by Machine Learning from a Pooled Analysis of the Clinical Development Program of Secukinumab in Psoriatic Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis with Axial Manifestations
Xenofon Baraliakos¹, Effie Pournara², Dafna Gladman³, Philip J Mease⁴, Samad S Jahandideh² and Laura Coates⁵, ¹Rheumazentrum Ruhrgebiet Herne, Herne, Germany, ²Novartis Pharma AG, Basel, Switzerland, ³Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada, ⁴Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ⁵Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom
Background/Purpose: Universally acceptable clinical and imaging criteria to define axial psoriatic arthritis (PsA) is lacking.1 Machine learning (ML) algorithms can detect patterns from large clinical…
Abstract Number: 1675 • ACR Convergence 2022
Effectiveness of Intensive Diet and Exercise on Knee Pain Among Communities with Knee Osteoarthritis, Overweight, and Obesity: The WE-CAN Pragmatic Randomized Clinical Trial
Stephen Messier¹, Daniel Beavers², Kate Queen³, Shannon Mihalko¹, Gary Miller¹, Elena Losina⁴, Jeffrey Katz⁴, Richard Loeser⁵, Paul DeVita⁶, David Hunter⁷, Jovita Newman¹, Sara Quandt⁸, Mary Lyles², Joanne Jordan⁹ and Leigh Callahan¹⁰, ¹Wake Forest University, Winston-Salem, NC, ²Wake Forest University School of Medicine, Winston-Salem, NC, ³Haywood Regional Medical Center, Waynesville, NC, ⁴Brigham and Women's Hospital, Boston, MA, ⁵University of North Carolina, Chapel Hill, NC, ⁶East Carolina University, Greenville, NC, ⁷University of Sydney, Sydney, Australia, ⁸Wake Forest School of Medicine, Winston-Salem, NC, ⁹University of North Carolina School of Medicine, Chapel Hill, NC, ¹⁰University of North Carolina Thurston Arthritis Research Center, Chapel Hill, NC
Background/Purpose: Many health systems that treat people with knee osteoarthritis (OA) have no infrastructure in place to implement weight loss and exercise treatments. The policy…
Abstract Number: 1909 • ACR Convergence 2022
Corticosteroids with or Without Hyaluronic Acid Injections in the Treatment of Trapeziometacarpal (TMC) Osteoarthritis : The Randomised Multicentre RHIZ’ART Trial Study Protocol
Grégoire Cormier¹, Amelie Denis², CHARLES LESKE³, Stephane Varin¹, Jerome Dimet⁴, Lucie Planche¹ and Benoit Le Goff⁵, ¹CHD Vendee, La Roche Sur Yon, France, ²CH Le Mans, Le Mans, France, ³Hospital, Cholet, France, ⁴CH Mont de Marsan, Mont de Marsan, France, ⁵CHU Nantes, Nantes, France
Background/Purpose: Trapeziometacarpal osteoarthritis is highly prevalent (affects 10 to 25% of people). Treatment modalities consist of non-pharmacological and pharmacological measures, including either corticosteroid or hyaluronic…
Abstract Number: 2113 • ACR Convergence 2022
Improvement in Key PsA Core Domains with Guselkumab Treatment in an Enriched Population of ACR20 Non-Responders at Week 24: Post Hoc Analysis of Two Phase 3 Studies
Dennis McGonagle¹, Derek Haaland², Philip Helliwell³, A. Marilise Marrache⁴, May Shawi⁵, Emmanouil Rampakakis⁶, Peter Nash⁷, Fedra Irazoque Palazuelos⁸ and Arthur Kavanaugh⁹, ¹Leeds 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, ²The Waterside Clinic, Oro Medonte, ON, Canada, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁴Janssen Inc., Dollard-des-Ormeaux, QC, Canada, ⁵Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁶McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, ⁷School of Medicine, Griffith University, Sunshine Coast, Australia, ⁸Angeles Mocel Hospital; Universidad Autónoma de México, Ciudad de México, Mexico, ⁹University of California San Diego, La Jolla, CA
Background/Purpose: Despite available PsA treatments, a portion of PsA patients (pts) does not achieve improvements in PsA signs and symptoms according to ACR response criteria.…
Abstract Number: 0293 • ACR Convergence 2022
Long-term Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs: Results Through 5 Years from SELECT-BEYOND
Ronald van Vollenhoven¹, Stephen Hall², Alvin Wells³, Sebastian Meerwein⁴, Yanna Song⁵, Jessica Suboticki⁶ and Roy Fleischmann⁷, ¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ²Emeritus Research and Monash University, Melbourne, Australia, ³Aurora Rheumatology and Immunotherapy Center, Franklin, WI, ⁴AbbVie Deutschland GmbH & Co KG, LUDWIGSHAFEN, Germany, ⁵AbbVie, Inc., North Chicago, IL, ⁶AbbVie, Inc., Mettawa, IL, ⁷Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: The primary treatment goal for patients with rheumatoid arthritis (RA) is sustained remission (REM), but low disease activity (LDA) is considered an appropriate target…
Abstract Number: 0365 • ACR Convergence 2022
Improvements in Skin Manifestations with BIIB059 Measured by CLASI in Participants with Cutaneous Lupus Erythematosus (CLE): Exploratory Analyses of the Phase 2, Randomized, Double-Blind, Placebo-Controlled LILAC Study (Part B)
Victoria Werth¹, Ronald van Vollenhoven², Richard Furie³, Filippa Nyberg⁴, Kenneth Kalunian⁵, Sandra Navarra⁶, Juanita Romero-Diaz⁷, Wenbin Zhu⁸, Catherine Barbey⁹, Cristina Musselli⁸ and Nathalie Franchimont⁸, ¹University of Pennsylvania and Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, ²Amsterdam University Medical Centers, Amsterdam, Netherlands, ³Northwell Health, Great Neck, NY, ⁴Karolinska University Hospital, Stockholm, Sweden, ⁵University of California San Diego, La Jolla, CA, ⁶University of Santo Tomas, Manila, Philippines, ⁷Instituto Nacional de Ciencias Medicas y Nutricion SZ, Ciudad de México, Mexico, ⁸Biogen, Cambridge, MA, ⁹Biogen, Baar, Switzerland
Background/Purpose: BIIB059 is a humanized monoclonal antibody against BDCA2, a receptor exclusively expressed on plasmacytoid dendritic cells, which are implicated in the pathogenesis of cutaneous…
Abstract Number: 0543 • ACR Convergence 2022
An Exploratory Analysis of the Potential Disconnect Between Objective Inflammatory Response and Clinical Response Following Certolizumab Pegol Treatment in Patients with Active Axial Spondyloarthritis
Martin Rudwaleit¹, Filip Van den bosch², Helena Marzo-Ortega³, Victoria Navarro-Compán⁴, Rachel Tham⁵, Thomas Kumke⁶, Lars Bauer⁶, Mindy Kim⁷ and Lianne Gensler⁸, ¹University of Bielefeld, Klinikum Bielefeld, Bielefeld; Germany Klinikum Bielefeld and Charité Berlin, Germany, and Gent University, Gent, Belgium, ²Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium, ³Leeds Teaching Hospitals Trust and University of Leeds, Leeds, United Kingdom, ⁴Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ⁵UCB Pharma, Slough, UK, Overland Park, KS, ⁶UCB Pharma, Monheim am Rhein, Germany, ⁷UCB Pharma, Smyrna, GA, ⁸Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA
Background/Purpose: In clinical trials of axial spondyloarthritis (axSpA), composite measures such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) response criteria, Assessment of Spondyloarthritis international…
Abstract Number: 1002 • ACR Convergence 2022
Investigation of Pharmacodynamic Biomarkers in a Phase 2b Study in Patients with Moderate to Severe SLE Treated with the S1P1 Receptor Modulator Cenerimod
Daniel Strasser¹, clélia Cahuzac², peter Cornelisse², Ouali Berkani², Peter Groenen² and Mark Murphy², ¹Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland, ²Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland
Background/Purpose: Sphingosine-1-phosphate (S1P) regulates lymphocyte egress from lymphoid organs into circulation. In a SLE proof-of-concept study, cenerimod—a potent, selective S1P1 receptor modulator—reduced circulating antibody-secreting cells…
Abstract Number: 1521 • ACR Convergence 2022
Long-term Follow-Up of Participants of the Phase II Study That Evaluated Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis (ASSET Trial)
Nadine Sarsam¹, Sindhu R. Johnson², Lorinda Chung³, Suzanne Kafaja⁴, Janet Pope⁵, Robyn Domsic⁶, Maureen Mayes⁷, Nora Sandorfi⁸, Virginia Steen⁹, Flavia Castelino¹⁰, Faye Hant¹¹, Suiyuan Huang¹ and Dinesh Khanna¹², ¹University of Michigan, Ann Arbor, MI, ²Division of Rheumatology, Department of Medicine, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western and Mount Sinai Hospitals; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada, ³Stanford University, Stanford, CA, ⁴UCLA Department of Medicine, Division of Rheumatology, Los Angeles, CA, ⁵University of Western Ontario, London, ON, Canada, ⁶University of Pittsburgh, Pittsburgh, PA, ⁷Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, TX, ⁸University of Pennsylvania, Philadelphia, PA, ⁹Georgetown University School of Medicine, Washington, DC, ¹⁰Massachusetts General Hospital, Boston, MA, ¹¹Medical University of South Carolina, Charleston, SC, ¹²Division of Rheumatology, Department of Internal Medicine, Scleroderma Program, University of Michigan, Ann Arbor, MI
Background/Purpose: Abatacept (ABA) is a cytotoxic T-lymphocyte-associated molecule-4 immunoglobulin fusion protein which has been shown to induce regression of dermal fibrosis in patients with systemic…

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