Abstracts tagged "clinical trial"

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…
Abstract Number: 1988 • ACR Convergence 2023
Extended-Release versus Immediate-Release Triamcinolone Acetonide for Osteoarthritis of the Knee with Comorbid Diabetes Type 2 Diabetes Mellitus: A Post Hoc Analysis
Andrew Spitzer¹, Helena Rodbard², Sheikh Usman Iqbal³, Masato Nakazawa³, Mary DiGiorgi³ and Roy Winston³, ¹Cedars-Sinai Medical Center, Los Angeles, CA, ²Endocrine and Metabolic Consultants, Rockville, MD, ³Pacira BioSciences, Inc., Tampa, FL
Background/Purpose: Intraarticular (IA) corticosteroids are generally considered safe and effective to treat osteoarthritis of the knee (OAK) but may cause hyperglycemia that may last for…
Abstract Number: 2242 • ACR Convergence 2023
Irrespective of the Number of Erosions at Baseline, Patients with Psoriatic Arthritis Treated with Ixekizumab Show Improved Clinical Outcomes
M. Elaine Husni¹, Vinod Chandran², Jeffrey Lisse³, Rebecca Bolce³, Carlos Diaz³, Baojin Zhu³, Elaine Lui⁴ and Laura Coates⁵, ¹Cleveland Clinic / Department of Rheumatic and Immunologic Diseases, Cleveland, OH, ²Schroeder Arthritis Institute, Krembil Research Institute, University Health Network and Division of Rheumatology, Department of Medicine, University of Toronto, Toronto, ON, Canada, ³Eli Lilly and Company, Indianapolis, IN, ⁴Brightech International, An Everest Clinical Research Company, Somerset, NJ, ⁵University of Oxford, Oxford, United Kingdom
Background/Purpose: Psoriatic arthritis (PsA) is a chronic and progressive disease characterized by high rates of early joint erosions, which have been associated with impaired quality…
Abstract Number: 2487 • ACR Convergence 2023
Phase 2 Safety and Efficacy of Subcutaneous (s.c.) Dose Ianalumab (VAY736; Anti-BAFFR mAb) Administered Monthly over 28 Weeks in Patients with Systemic Lupus Erythematosus (SLE) of Moderate-to-Severe Activity
Nan Shen¹, Stanislav Ignatenko², Alexander Gordienko³, Josefina Cortés Hernández⁴, Nancy Agmon-Levin⁵, Pongthorn Narongroeknawin⁶, Katarzyna Romanowska -Prochnicka⁷, Hana Ciferska⁸, Masanari Kodera⁹, James Cheng-Chung Wei¹⁰, Piotr Leszczynski¹¹, Joung-Liang Lan¹², Eduardo Mysler¹³, Rafal Wojciechowski¹⁴, Tunde Tarr¹⁵, Elena Vishneva¹⁶, Yi-Hsing Chen¹⁷, Yuko Kaneko¹⁸, Stephanie Finzel¹⁹, Alberta Hoi²⁰, Ajchara Koolvisoot²¹, Shin-Seok Lee²², Lie Dai²³, Hiroshi Kaneko²⁴, Bernadette Rojkovich²⁵, Lingyun Sun²⁶, Eugeny Zotkin²⁷, Jean-Francois Viallard²⁸, Masao Katayama²⁹, Berta Paula Magallares-Lopez³⁰, Tirtha Sengupta³¹, Carol Sips³² and Stephen J Oliver³², ¹Shanghai Institute of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University (SJTUSM), Shanghai, China, ²Charité Research Organisation GmbH, Berlin, Germany, ³SM Kirov Military Medical Academy, St. Petersburg, Russia, ⁴Lupus Unit, Rheumatology Department, Vall d’Hebron Hospitals, Barcelona, Spain, ⁵Yabludowicz Center for Autoimmune Disease, Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel, ⁶Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand, ⁷Department of Systemic Connective Tissue Diseases, National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland, ⁸Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ⁹Department of Dermatology, Japan Community Healthcare Organization Chukyo Hospital, Nagoya, Japan, ¹⁰Chung Shan Medical University Hospital, Department of Rheumatology, Taichung, Taiwan, ¹¹Department of Internal Medicine, Poznan University of Medicine Sciences, Poznan, PL, Poznań, Poland, ¹²China Medical University Hospital, Taichung, Taiwan, ¹³Organizacion Medica de Investigacion, Buenos Aires, Argentina, ¹⁴Department of Rheumatology and Systemic Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, Poland, ¹⁵Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary, ¹⁶LLC Family Clinic, Yekaterinburg, RU, Yekaterinburg, Russia, ¹⁷Taichung Veterans General Hospital, Taichung, Taiwan, ¹⁸Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, ¹⁹Department of Rheumatology and Clinical Immunology, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany, ²⁰Monash University, Department of Medicine, Sub-faculty of Clinical and Molecular Medicine, Melbourne, Australia, ²¹Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, ²²Chonnam National University Medical School & Hospital, Gwangju, South Korea, ²³Department of Rheumatology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China, ²⁴Division of Rheumatic Disease, National Center for Global Health and Medicine, Tokyo, Japan, ²⁵Department of Rheumatology and Physiotherapy, Polyclinic of the Hospitaller Brothers of St. John of God, Semmelweis University, Budapest, Hungary, ²⁶Department of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China, ²⁷VA Nasonova Research Institute of Rheumatology, Moscow, Russia, ²⁸CHU de Bordeaux, Hôpital Haut-Lévêque, Pessac, France, ²⁹National Hospital Organization, Nagoya Medical Center, Nagoya, JP, Nagoya, Japan, ³⁰Department of Rheumatology, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain, ³¹Novartis Pharma India, Hyderabad, Hyderabad, India, ³²Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Ianalumab is a novel defucosylated human IgG1 mAb targeting the receptor for B cell Activating Factor belonging to the TNF Family (BAFF-R) providing potent…
Abstract Number: 0440 • ACR Convergence 2023
Baseline T Cell and B Cell-related Markers and HLA-DRB1 Shared Epitope Alleles Predict the Therapeutic Efficacy of Abatacept in Patients with Moderate to Severe Rheumatoid Arthritis
Ting Wang¹, Natalia V. Giltiay², Christian Lood² and Bobby Kwanghoon Han², ¹University of Washington, Seattle, WA, ²Division of Rheumatology, University of Washington, Seattle, WA
Background/Purpose: Abatacept, a CTLA-4-Ig fusion protein, is widely used as a treatment for rheumatoid arthritis (RA). However, data on predictive biomarkers associated with therapeutic response…
Abstract Number: 0749 • ACR Convergence 2023
Impact of Sprifermin on Denuded Areas of Subchondral Bone (dABs): A Post Hoc Analysis of the FORWARD Study
Felix Eckstein¹, Wolfgang Wirth², Philip Conaghan³, Marc Hochberg⁴, Ali Guermazi⁵, Jade Andrade⁶, Luping Zhao⁶ and Niti Goel⁷, ¹Paracelsus Medical University, Institute of Anatomy & Ludwig Boltzmann Institute, and Chondrometrics GmbH, Salzburg, Austria, ²Paracelsus Medical University, Institute of Anatomy & Ludwig Boltzmann Institute, and Chondrometrics GmbH, Freilassing, Germany, ³University of Leeds, Leeds, United Kingdom, ⁴University of Maryland School of Medicine, Baltimore, MD, ⁵Boston University, Boston, MA, ⁶TrialSpark, New York, NY, ⁷TrialSpark, Duke University, Durham, NC
Background/Purpose: Sprifermin, recombinant human fibroblast growth factor 18 (rhFGF-18), is being investigated as a potential disease-modifying osteoarthritis drug. The Phase 2 FORWARD study demonstrated that…

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