Abstracts tagged "clinical trial"

Abstract Number: 1833 • ACR Convergence 2023
Development of a Polygenic Risk Model for Therapeutic Response to Bedtime Sublingual Cyclobenzaprine (TNX-102 SL*) in Fibromyalgia Based on Polygenic Single Nucleotide Polymorphism (SNP)-Count Scores
Jeffrey Rosenfeld¹, Greta Linse², Sally Slipher², Candace Flint³, Annie Iserson³, Herbert Harris⁴, Jean Engels³, Gregory Sullivan⁵ and Seth Lederman⁶, ¹Tonix Pharmaceuticals, Chatham, NJ, ²Montana State University, Bozeman, MT, ³Tonix Pharmaceuticals, New York, NY, ⁴Tonix Pharmaceuticals, Chapel Hill, NC, ⁵Tonix Pharmaceuticals Inc, Chatham, NJ, ⁶Tonix Pharmaceuticals, South Dartmouth, MA
Background/Purpose: Fibromyalgia (FM) is characterized by widespread pain, non-restorative sleep, fatigue, and cognitive dysfunction. TNX-102 SL is a sublingual cyclobenzaprine tablet designed for daily use…
Abstract Number: 2162 • ACR Convergence 2023
Safety and Efficacy of Filgotinib: An Update from the DARWIN 3 Phase 2 Long-term Extension with a Maximum of 8.2 Years of Exposure
René Westhovens¹, Rieke Alten², Lorenzo Dagna³, Arthur Kavanaugh⁴, Kevin Withrop⁵, Jane Barry⁶, Robin Besuyen⁷, Claudio Corallo⁸, Dick de Vries⁹, Nicolas Martin¹⁰, Chris Watson⁶, Mark C. Genovese¹¹, Alberto Spindler¹², Mykola Stanislavchuk¹³, Maria Greenwald¹⁴ and Paul Emery¹⁵, ¹Department of Rheumatology, KU Leuven, Skeletal Biology and Engineering Research Center, Leuven, Belgium, ²Department of Internal Medicine and Rheumatology, Schlosspark Klinik, University Medicine Berlin, Berlin, Germany, ³Department of Internal Medicine, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy, ⁴Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA, ⁵Oregon Health & Science University, Schools of Medicine and Public Health,, Portland, OR, ⁶Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ⁷Clinical Development, Galapagos BV, Leiden, Netherlands, ⁸Medical Affairs, Galapagos Biopharma Italy S.R.L., Milan, Italy, ⁹Research and Development, Clinical Research, Galapagos BV, Leiden, Netherlands, ¹⁰Biostatistics, Galapagos NV, Mechelen, Belgium, ¹¹Clinical Development, Gilead Sciences Inc., Foster City, CA, ¹²Rheumatology Section, Centro Medico Privado de Reumatologia, San Miguel de Tucuman, Argentina, ¹³Rheumatology, National Pirogov Memorial Medical University, Vinnytsia, Ukraine, ¹⁴Rheumatology, Desert Medical Advances, Palm Desert, CA, ¹⁵Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Background/Purpose: DARWIN 3 (NCT02065700) is a long-term extension (LTE) study assessing the safety and efficacy of filgotinib (FIL) in patients with rheumatoid arthritis (RA) and…
Abstract Number: 2339 • ACR Convergence 2023
Fragility of Randomized Clinical Trials of Systemic Lupus Erythematosus and Lupus Nephritis Therapies
Gabriel Figueroa-Parra¹, Mike Putman² and Ali Duarte-Garcia³, ¹Division of Rheumatology, Mayo Clinic, Rochester, MN, ²Division of Rheumatology, Medical College of Wisconsin, Milwaukee, WI, ³Mayo Clinic, Rochester, MN
Background/Purpose: Randomized controlled trials (RCTs) in systemic lupus erythematosus (SLE) for novel therapeutics have frequently failed to meet criteria for regulatory approval. Even among drugs…
Abstract Number: 0314 • ACR Convergence 2023
Lack of Systemic Effects from Intra-articular XT-150 for the Treatment of Moderate to Severe Pain Due to OA of the Knee: Safety Results from a Phase 2 Trial
Leonard Kapural¹, Stephen D. Collins², Eric Grigsby³, Mark McBride⁴, Jayson Rieger⁵, Morgan Stokes⁶, Howard Rutman⁶ and Flavia Cicuttini⁷, ¹Center for Clinical Research, Winston-Salem, NC, ²Xalud Therapeutics, Inc., Chicago, IL, ³Neurovations Clinical Research, Napa, CA, ⁴Instat Clinical Research, Chatham, NJ, ⁵PBM Capital, Charlottesville, VA, ⁶Xalud Therapeutics, Inc., Berkeley, CA, ⁷Monash University, Melbourne, Australia
Background/Purpose: This study (NCT04124042) was designed to assess the safety, tolerability, and efficacy of XT-150, a non-viral gene therapy, in adult participants with moderate to…
Abstract Number: 0530 • ACR Convergence 2023
Impact of Upadacitinib on Wearable Device-Measured Physical Activity in Patients with Ankylosing Spondylitis from the SELECT-AXIS 2 Trial
Jeffrey Curtis¹, Rebecca Grainger², Dan Webster³, Jie Shen⁴, Ana Biljan⁵, Anna Shmagel⁴, Peter Wung⁴ and Philip J. Mease⁶, ¹University of Alabama at Birmingham, Birmingham, AL, ²University of Otago, Wellington, New Zealand, ³AbbVie, Inc., Libertyville, IL, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie, Inc., Buffalo Grove, IL, ⁶Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA
Background/Purpose: Physical activity is associated with reduced pain, improved mobility and physical function in people with ankylosing spondylitis (AS) and plays a crucial role in…
Abstract Number: 0838 • ACR Convergence 2023
Infusion of Etanercept into the Peripheral Lymphatics Significantly Reduces Disease Activity in Rheumatoid Arthritis Patients with Inadequate Response to Subcutaneous Injections
Russell Ross¹, Vibeke Strand², Roel Querubin³, John Goldman⁴, Richard Leff⁵, Alexis Melson¹, Pei-Ling Roerig⁶ and Alan Smith⁷, ¹Sorrento Therapeutics, Atlanta, GA, ²Stanford University, Portola Valley, CA, ³Marietta Rheumatology Associates, Marietta, GA, ⁴Northside Hospital, Atlanta, GA, ⁵Kezar Life Sciences, Chadds Ford, PA, ⁶4P Therapeutics, Orlando, FL, ⁷4P Therapeutics, Atlanta, GA
Background/Purpose: The lymphatic system serves as a conduit for transporting immune cells and inflammatory molecules present in arthritic joints to lymph nodes (LN), playing a…
Abstract Number: 1327 • ACR Convergence 2023
Effects of Long-Term Low Dose Glucocorticoid Treatment for Rheumatoid Arthritis on Body Weight and Blood Pressure: A Pooled Analysis of Individual Patient Data from Five Randomised Trials
Andriko Palmowski¹, Sabrina Mai Nielsen², Zhivana Boyadzhieva³, Linda Hartman⁴, Judith Oldenkott⁵, Björn Svensson⁶, Ingiäld Hafström⁷, Siegfried Wassenberg⁸, Ernest Choy⁹, John Kirwan¹⁰, Robin Christensen¹¹, Maarten Boers¹² and Frank Buttgereit¹³, ¹Charité - Universitätsmedizin Berlin, Berlin, Germany, ²The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, ³Charité Universitatsmedizine - Berlin, Berlin, Germany, ⁴Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁵Charite - University Medicine Berlin, Berlin, Germany, ⁶Lund University, Lund, Sweden, ⁷Karolinska Institutet, Stockholm, Sweden, ⁸Rheumazentrum Ratingen, Ratingen, Germany, ⁹Section of Rheumatology, Cardiff University, Cardiff, United Kingdom, ¹⁰University of Bristol, Bristol, United Kingdom, ¹¹Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Denmark, ¹²Amsterdam UMC, Vrije Universiteit, Amersfoort, Netherlands, ¹³Charité Universitätsmedizin, Dept. Rheumatology, Berlin, Germany
Background/Purpose: High-dose glucocorticoids (GCs) can cause weight gain and hypertension. It is unclear whether GCs at ≤7.5mg/day prednisone equivalent ("low dose"), administered for rheumatoid arthritis…
Abstract Number: 1496 • ACR Convergence 2023
Clinical Safety and Efficacy Results from EQUALISE Type B: A Phase 1b Open-label Clinical Study of Itolizumab, a Novel anti-CD6 Therapy, in Subjects with Active Proliferative Lupus Nephritis
Kenneth Kalunian¹, Robert Levin², Sreejith Parameswaran³, nelson kopyt⁴, Stephen Connelly⁵, Eugene Sun⁵, Katie Kim⁵, maple fung⁵ and Manish Rathi⁶, ¹University of California San Diego, La Jolla, CA, ²South Florida University, Tampa, FL, ³JIPMER, New Delhi, India, ⁴LeHigh University, LeHigh, PA, ⁵Equillium, La Jolla, CA, ⁶Postgraduate Institute of Medical education and Research, Chandigarh, India
Background/Purpose: Itolizumab is a first-in-class, non-depleting, monoclonal antibody against the co-stimulatory receptor CD6 that blocks its interaction with ALCAM, to inhibit Teff cell activity and…
Abstract Number: 1883 • ACR Convergence 2023
Thalamocortical Mechanisms of a Remote Mind-body Intervention for Knee Osteoarthritis Pain
Jian Kong¹, Valeria Sacca¹ and Chenchen Wang², ¹Massachusetts General Hospital, Boston, MA, ²Center of Integrative Medicine and Division of Rheumatology, Tufts Medical Center, Boston, MA
Background/Purpose: Studies found that individuals with pain exhibit altered thalamocortical rhythm, abnormal function, and structural connectivity within the network. Effective treatment may relieve pain by…
Abstract Number: 2176 • ACR Convergence 2023
Cellular and Proteomic Changes Following Administration of Peresolimab, in a Phase 2a Trial in Rheumatoid Arthritis
Robert J. Benschop¹, Jay Tuttle¹, Paul Emery², Christoph Preuss¹, Mark Daniels¹, Veavi Ching-Yun Chan¹, Pia Yachi¹ and Ajay Nirula¹, ¹Eli Lilly and Company, Indianapolis, IN, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Background/Purpose: Peresolimab is a humanized immunoglobulin G1 monoclonal antibody that stimulates human programmed cell death protein 1 (PD-1). Peresolimab demonstrated superiority to placebo in Disease…
Abstract Number: 2340 • ACR Convergence 2023
Multi-targeted Therapy Better in Achieving Complete Response in Lupus Nephritis: A Systematic Review and Meta-analysis
Omer Pamuk¹, Bisma Shaikh², Saif Khan³, Ali Abbas⁴, Sarah Abi Doumeth⁵ and sarfaraz Hasni⁶, ¹University Hospitals Cleveland Medical Center, Cleveland, OH, ²Jinnah Sindh Medical University, Karachi, Pakistan, ³College of Medical and Dental Sciences, Birmingham, United Kingdom, ⁴Alabama College of Osteopathic Medicine, Dothan, AL, ⁵Case Western Reserve University/University Hospitals Cleveland Medical Center, Cleveland, OH, ⁶Lupus Clinical Trials Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health (NIH), Bethesda, MD
Background/Purpose: The overall management of SLE and Lupus Nephritis (LN) has significantly improved over the last four decades.Recently great therapeutic strides have been made in…
Abstract Number: 0354 • ACR Convergence 2023
Open-label Phase 3 Study of Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis: Pharmacokinetics, Effectiveness, Safety, and Immunogenicity over 252 Weeks
Nicolino Ruperto¹, Daniel J Lovell², Sarah Ringold³, Xie L. Xu⁴, Jocelyn H. Leu³, Edwin Lam³, Yuhua Wang³, Alberto Martini⁵ and Hermine Brunner⁶, ¹IRCCS Istituto Giannina Gaslini, UOSID Centro Trial, Genova, Italy, ²UC Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, OH, ³Janssen Research & Development, LLC, Spring House, PA, ⁴Janssen Research & Development, LLC, San Diego, CA, ⁵Universita degli Studi di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Genova, Italy, ⁶Cincinnati Children's Hospital Medical Center, Division of Rheumatology, Cincinnati, OH
Background/Purpose: The phase 3, Intravenous Golimumab in Pediatric Participants with Active Polyarticular-Course JIA Despite MTX (GO-VIVA) study demonstrated that golimumab (GLM) 80 mg/m2 at Week…
Abstract Number: 0596 • ACR Convergence 2023
Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in a Phase 2 Trial in Systemic Lupus Erythematosus (SLE): Achievement of Sustained SRI(4), BICLA and Dual Responses over 48 Weeks
Richard Furie¹, Cristina Arriens², Kenneth Kalunian³, Marilyn Pike⁴, Ronald van Vollenhoven⁵, Coburn Hobar⁶, Ayanbola Elegbe⁶, Samantha Pomponi⁶, Subhashis Banerjee⁶, Shalabh Singhal⁶, Thomas Wegman⁷ and Eric Morand⁸, ¹Northwell Health, Manhasset, NY, ²Oklahoma Medical Research Foundation and University of Oklahoma Health Sciences Center, Department of Arthritis & Clinical Immunology, Oklahoma City, OK, ³University of California San Diego, La Jolla, CA, ⁴MedPharm consulting, Inc., Raleigh, NC, ⁵Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁶Bristol Myers Squibb, Princeton, NJ, ⁷Bristol Myers Squibb, Beaver Falls, PA, ⁸Monash University, Centre for Inflammatory Diseases, Melbourne, Australia
Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor approved in multiple countries for the treatment of adults with plaque psoriasis. In…
Abstract Number: 0839 • ACR Convergence 2023
Efficacy and Safety of Nipocalimab in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA): The Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2a IRIS-RA Study
Peter C. Taylor¹, Georg Schett², Fowzia Ibrahim³, Bei Zhou⁴, Jocelyn H. Leu⁵, Sophia G. Liva⁵, Qingmin Wang⁵, Ricardo Rojo Cella⁵, Chetan S. Karyekar⁵ and Kaiyin Fei⁵, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, ³Janssen Research & Development, LLC, High Wycombe, United Kingdom, ⁴Janssen Research & Development, LLC, Chesterbrook, PA, ⁵Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: RA is a chronic inflammatory disease associated with autoantibodies. Despite the use of targeted therapies, up to half of patients fail to achieve remission…
Abstract Number: 1339 • ACR Convergence 2023
Neutrophil Activation and Formation of Neutrophil Extracellular Traps Are Associated with Response to 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: Neutrophil activation and formation of neutrophil extracellular traps (NETs) have been implicated in the pathogenesis of rheumatoid arthritis (RA). Calprotectin, a neutrophil activation marker,…

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