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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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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