Abstracts tagged "clinical trial"

Abstract Number: 2233 • ACR Convergence 2023
Neutrophil Levels Associate with Early Improvement in Spinal Pain and Week 24 Multi-Domain Disease Control During Guselkumab Treatment in Active Psoriatic Arthritis: Post Hoc Pooled Analyses of Two Phase 3 Randomized Controlled Trials
Thomas Macleod¹, Xenofon Baraliakos², Emmanouil Rampakakis³, Warner Chen⁴, Antonius Pieter J Van Den Heuvel⁴, Loqmane Seridi⁴, May Shawi⁵, Frederic Lavie⁶, Joseph F. Merola⁷, Proton Rahman⁸ and Dennis McGonagle⁹, ¹University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, ²Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ³McGill University, Department of Pediatrics / JSS Medical Research, Scientific Affairs, Montreal, QC, Canada, ⁴Translational Sciences, Janssen Research & Development, LLC, Spring House, PA, ⁵Immunology, Janssen Research & Development, LLC, Titusville, NJ, ⁶The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France, ⁷Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ⁸Craig Dobbin Research Institute, Memorial University, St. John's, NL, Canada, ⁹Leeds Biomedical Research Centre, University of Leeds, Leeds, United Kingdom
Background/Purpose: Neutrophils have potential pathogenic roles in chronic inflammatory diseases (e.g., neutrophilic cutaneous microabscesses in psoriasis, and neutrophils in the synovial fluid/tissue in PsA and…
Abstract Number: 2345 • ACR Convergence 2023
Paired Kidney Biopsies from the AURORA 2 Study of Voclosporin in Active Lupus Nephritis
Samir Parikh¹, Salem Almaani², Arnon Arazi³, Huijuan Song¹, Pearlly Yan¹, Estela Puchulu-Campanella¹, Clint Abner⁴, Ernie Yap⁴, Krista Piper⁴, Robert B. Huizinga⁵ and Henry Leher⁴, ¹Ohio State University, Columbus, OH, ²Ohio State University Medical Center, Columbus, OH, ³Broad Institute of MIT and Harvard, Melrose, MA, ⁴Aurinia Pharmaceuticals Inc., Edmonton, AB, Canada, ⁵Reformation Consulting Services, North Saanich, BC, Canada
Background/Purpose: Voclosporin is approved for the treatment of adults with active lupus nephritis. Addition of voclosporin to mycophenolate mofetil (MMF) and low-dose glucocorticoids in the…
Abstract Number: 0372 • ACR Convergence 2023
Efficacy and Safety of Secukinumab in Juvenile Idiopathic Arthritis: Interim Results from the Extension of the JUNIPERA Trial
Hermine Brunner¹, Ivan Foeldvari², Ekaterina Alexeeva³, Nuray Aktay Ayaz⁴, Grant Schulert⁵, Seza Ozen⁶, Artem Popov⁷, Athimalaipet V Ramanan⁸, Christiaan Scott⁹, Betul Sozeri¹⁰, Elena Zholobova¹¹, Sudhanshu Chakraborty¹², Xuan Zhu¹³, Ruvie Martin¹³, Sarah Whelan¹⁴, Sharonjeet Kaur¹⁵, Luminita Pricop¹³, Daniel J Lovell¹⁶, Alberto Martini¹⁷ and Nicolino Ruperto¹⁸, ¹Cincinnati Children's Hospital Medical Center, Division of Rheumatology, Cincinnati, OH, ²Hamburger Zentrum fuer Kinder und Jugendrheumatologie, Rheumatology, Hamburg, Germany, ³National Scientific and Practical Center of Children's Health, Rheumatology, Moscow, Russia, ⁴Department of Pediatric Rheumatology, Faculty of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey, ⁵Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ⁶Hacettepe University Medical Faculty, Ankara, Turkey, ⁷Ural State Medical University Ekaterinburg, Sverdlovsk, Russia, ⁸Bristol Royal Hospital for Children & Translational Health Sciences, University of Bristol, Bristol, United Kingdom, ⁹Department of Paediatric Rheumatology, Red Cross War Memorial Children’s Hospital, University of Cape Town, Cape Town, South Africa, ¹⁰Division of Pediatric Rheumatology, University of Health Sciences, Ümraniye Training and Research Hospital, Istanbul, Turkey, ¹¹First Moscow State Medical University, n.a. I.M.Sechenov, Moscow, Russia, ¹²IQVIA, Durrham, NC, ¹³Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁴Novartis Ireland Ltd, Dublin, Ireland, ¹⁵Novartis Pharma AG, Basel, Switzerland, ¹⁶UC Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, OH, ¹⁷Università di Genova, Genova, Italy, ¹⁸IRCCS Istituto Giannina Gaslini, UOSID Centro Trial, Genova, Italy
Background/Purpose: Secukinumab has demonstrated efficacy and safety in patients with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) categories of juvenile idiopathic arthritis (JIA) for…
Abstract Number: 0600 • ACR Convergence 2023
Identification of Subsets of SLE Patients Responsive to Baricitinib by Transcriptomic Analysis at Baseline
Prathyusha Bachali¹, Amrie Grammer² and Peter Lipsky², ¹AMPEL BioSolutions, Redmond, WA, ²AMPEL BioSolutions, Charlottesville, VA
Background/Purpose: Baricitinib is an inhibitor of Jak1 approved for treatment of rheumatoid arthritis, atopic dermatitis, alopecia areata and Covid-19. A phase 2 trial showed success…
Abstract Number: 1104 • ACR Convergence 2023
Dotinurad, a Potent and Selective Uricosuric Agent, Exhibited Promising Pharmacokinetics and Pharmacodynamic Profiles to Significantly Reduce Serum Urate Levels Following Once Daily Dosing in Healthy U.S. Subjects in a Phase 1 Clinical Trial
Scott Baumgartner, Raymond Zheng, Mark Harnett and Jay Kranzler, Urica Therapeutics Inc., New York, NY
Background/Purpose: Dotinurad is a potent and selective URAT1 inhibitor that has been approved as a once-daily drug for the treatment of hyperuricemia with or without…
Abstract Number: 1379 • ACR Convergence 2023
Population Pharmacokinetic/Pharmacodynamic Modeling of Dazodalibep, a CD40L Antagonist, in Healthy Volunteers and Patients with Rheumatoid Arthritis and Sjogren’s Syndrome
Kenneth Der¹, Ryan Crass², Brendan Smith³, Wonkyung Byon⁴, Yan Xin⁵ and Jiayin Huang⁶, ¹Horizon Therapeutics, Danville, CA, ²Apellis Pharmaceuticals, Michigan, ³A2-Ai, Michigan, ⁴Amador Bioscience, Michigan, ⁵Horizon Therapeutics, South San Francisco, CA, ⁶Horizon Therapeutics, Chicago, IL
Background/Purpose: Sjögren's (SjS) is a chronic, systemic autoimmune disease caused by aberrant activation and infiltration of lymphocytes. Dazodalibep (DAZ), a novel non-antibody biologic antagonist of…
Abstract Number: 1505 • ACR Convergence 2023
Long-term Safety and Efficacy of Voclosporin in Black Patients with Lupus Nephritis: Results from the AURORA 1 and AURORA 2 Studies
Gabriel Contreras¹, Matt Baker², Lucy Hodge² and Ernie Yap², ¹University of Miami Health System, Miami, FL, ²Aurinia Pharmaceuticals Inc., Edmonton, AB, Canada
Background/Purpose: Black patients with lupus nephritis (LN) are reported to have more severe disease, are often refractory to treatment, and have worse long-term outcomes. Voclosporin…
Abstract Number: 1972 • ACR Convergence 2023
Evaluation of Myositis Autoantibodies as Predictors of Response to IVIG: Post-hoc Analysis of a Large Randomized, Double-Blind, Placebo-Controlled Phase III Trial
Christina Charles-Schoeman¹, Joachim Schessl², Rohit Aggarwal³ and and the ProDERM investigators⁴, ¹UCLA Medical Center, Santa Monica, CA, ²Friedrich-Baur-Institute, Ludwig-Maximilians University of Munich, Munich, Germany, ³University of Pittsburgh, Pittsburgh, PA, ⁴Institutions in Europe and North America, Vienna, Austria
Background/Purpose: Dermatomyositis (DM) is an immune-mediated inflammatory myopathy (IIM). Two subsets ofautoantibodies have been identified in patients with IIM: Myositis-specific antibodies (MSA) and myositis-associated antibodies…
Abstract Number: 2239 • ACR Convergence 2023
Achievement of Disease Control in PsA Patients Treated with Upadacitinib at Week 152: Post Hoc Analysis of the Long-term Extensions of Two Phase 3 Trials
Arthur Kavanaugh¹, Kristi Mizelle², Oliver FitzGerald³, Enrique Soriano⁴, Peter Nash⁵, Sandra Ciecinski⁶, Limei Zhou⁶, Arathi Setty⁶ and Laure Gossec⁷, ¹Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA, ²Tidewater Physicians Multispecialty Group, Newport News, VA, ³Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland, ⁴Rheumatology Section, Internal Medicine Services, Hospital Italiano de Buenos Aires, and University Institute Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁵School of Medicine, Griffith University, Brisbane, Australia, ⁶AbbVie, Inc., North Chicago, IL, ⁷Sorbonne Université and Pitié Salpêtrière Hospital, Paris, France
Background/Purpose: A main goal of therapy for patients (pts) with PsA is to achieve and maintain the lowest possible level of disease activity across domains.1…
Abstract Number: 2486 • ACR Convergence 2023
Should SLE Patients Entering Clinical Trials Be Required to Have at Least One BILAG a And/or Two BILAG B Scores?
Ewa Olech¹ and Joan Merrill², ¹IQVIA, Rheumatology Consultants, PLLC, Las Vegas, NV, ²Oklahoma Medical Research Foundation, Oklahoma City, OK
Background/Purpose: High placebo response rates have challenged interpretation of clinical trial results in SLE and may have contributed to failure of some effective treatments. One…
Abstract Number: 0429 • ACR Convergence 2023
Direct and Indirect Effects of Upadacitinib or Adalimumab on Pain in Rheumatoid Arthritis: Results from a Randomized Phase 3 Study
Peter C. Taylor¹, David Walsh², Tsutomu Takeuchi³, Bruno Fautrel⁴, Janet Pope⁵, Andrew Garrison⁶, Yanna Song⁶, Sara K. Penn⁶, Ralph Lippe⁷, Diane Caballero⁸ and Arthur Kavanaugh⁹, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²University of Nottingham, Nottingham, United Kingdom, ³Keio University School of Medicine and Saitama Medical University, Tokyo, Japan, ⁴Sorbonne Université APHP, Paris, France, ⁵University of Western Ontario, London, ON, Canada, ⁶AbbVie, Inc., North Chicago, IL, ⁷AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, ⁸AbbVie, Inc., Chicago, IL, ⁹University of California San Diego, School of Medicine, Riverside, CA
Background/Purpose: Rapid and sustained pain control is an important goal for patients (pts) with rheumatoid arthritis (RA). Control of inflammation in RA does not always…
Abstract Number: 0625 • ACR Convergence 2023
Use of Heated Gloves for Raynaud’s Phenomenon in Systemic Sclerosis
Kimti Kumar¹, Nor Hashimah Abu Mansor Matardiah², Kim Griggs³, Aline Kunnel⁴, Jennifer Walker⁵ and Susanna Proudman⁶, ¹SA Health and University of Adelaide, Millswood, Australia, ²Tuanku Fauziah Hospital, Kangar, Malaysia, ³Royal Adelaide Hospital, Adelaide, Australia, ⁴South Australian Health and Medical Research Institute, Adelaide, Australia, ⁵Flinders Medical Centre and Royal Adelaide Hospital, Bedford Park, Australia, ⁶Royal Adelaide Hospital and University of Adelaide, Adelaide, Australia
Background/Purpose: RP and its ischaemic complications are a major cause of morbidity in SSc. Non-pharmacological measures to minimise cold exposure can play a vital role…
Abstract Number: 1110 • ACR Convergence 2023
Pharmacokinetics and Pharmacodynamics of AR882 Following 12-Week Treatment in Patients with Gout
Roy Fleischmann¹, James Cheng-Chung Wei², Zancong Shen³, sarah Morris⁴, Elizabeth Polvent⁵, Andrea Clouser-Roche⁴, Vijay Hingorani⁶, Rongzi Yan⁷, Shunqi Yan⁸, Robert Keenan⁹ and Li-Tain Yeh¹⁰, ¹Division of Rheumatology, University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, ²Chung Shan Medical University Hospital, Department of Rheumatology, Taichung, Taiwan, ³Arthrosi Therapeutics, San Diego, CA, ⁴Arthrosi Therapeutics Inc, San Diego, CA, ⁵Arthrosi Therapeutics, Inc., Roseville, CA, ⁶Vanguard Healthsciences, Inc., San Diego, CA, ⁷Arthrosi Therapeutics, Inc, Irvine, CA, ⁸Arthrosi Therapeutics, Inc., Laguna Hills, CA, ⁹Arthrosi Therapeutics, Chapel Hill, NC, ¹⁰Arthrosi Therapeutics, Inc., Irvine, CA
Background/Purpose: In early phase studies AR882 exhibited good dose proportionality, long half-life and dose-dependent serum urate (sUA) lowering effect in a broad range of doses…
Abstract Number: 1397 • ACR Convergence 2023
Sustainability of Clinical Response at Week 52 to Upadacitinib Among Patients with Axial SpA: Data from the SELECT-AXIS 1 and SELECT-AXIS 2 Trials
Victoria Navarro-Compán¹, Lianne Gensler², Martin Rudwaleit³, Fabiana Ganz⁴, Shirley Chen⁴, Jayne Stigler⁴, Anna Schmagel⁴ and Xenofon Baraliakos⁵, ¹Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ²University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ³University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany, ⁴AbbVie, Inc., North Chicago, IL, ⁵Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Bochum, Germany
Background/Purpose: Upadacitinib 15 mg (UPA), an oral Janus kinase inhibitor, has shown efficacy and tolerability through 14 weeks in patients (pts) with active radiographic axial…
Abstract Number: 1511 • ACR Convergence 2023
B-Cell Recovery in a Randomized Controlled Trial of B-Cell Depletion with Obinutuzumab for the Treatment of Proliferative Lupus Nephritis
Ed Vital¹, Dario Roccatello², David Black³, Rhian Jacob-Moffatt⁴, Cary M. Looney⁵, Elsa Martins⁵, Huiyan (Ashley) Mao³, Thomas Schindler⁶, Himanshi Seghal⁵, Jay Garg⁷, Jorge Ross Terres⁷ and Richard Furie⁸, ¹University of Leeds, Leeds, United Kingdom, ²University of Torino, Torino, Italy, ³Hoffmann-La Roche Ltd, Mississauga, ON, Canada, ⁴F. Hoffmann-La Roche Ltd, Welwyn Garden City, United Kingdom, ⁵F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁶F. Hoffmann-La Roche Ltd, Basle, Switzerland, ⁷Genentech, Inc., South San Francisco, CA, ⁸Northwell Health, Manhasset, NY
Background/Purpose: Patients with LN who received obinutuzumab, a humanized type II anti-CD20 monoclonal antibody, with standard-of-care (MMF) immunosuppression (Phase II NOBILITY; NCT02550652; PMID 34615636) showed…

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