Abstracts tagged "clinical trial"

Abstract Number: 2548 • ACR Convergence 2023
Low Uveitis Rates in Patients with Axial Spondyloarthritis Treated with Bimekizumab: Pooled Results from Phase 2b/3 Trials
Martin Rudwaleit¹, Matthew A. Brown², Floris Van Gaalen³, Nigil Haroon⁴, Lianne Gensler⁵, Carmen Fleurinck⁶, Alexander Marten⁷, Ute Massow⁸, Natasha De Peyrecave⁹, Thomas Vaux¹⁰, Katy White¹⁰, Atul Deodhar¹¹ and Irene van der Horst-Bruinsma¹², ¹University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany, ²Genomics England, London, United Kingdom, ³Leiden University Medical Center, Department of Rheumatology, Leiden, Netherlands, ⁴University of Toronto, University Health Network, Schroeder Arthritis Institute, Department of Medicine/Rheumatology, Toronto, ON, Canada, ⁵University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ⁶UCB Pharma, Oosterzele, Belgium, ⁷UCB Pharma, Monheim, Germany, ⁸UCB Pharma, Monheim am Rhein, Germany, ⁹UCB Pharma, Brussels, Belgium, ¹⁰UCB Pharma, Slough, United Kingdom, ¹¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ¹²Radboud University Medical Centre, Department of Rheumatology, Nijmegen, Netherlands
Background/Purpose: Acute anterior uveitis ('uveitis'), or 'iritis', is a common extra-musculoskeletal manifestation among patients (pts) with axial spondyloarthritis (axSpA).1 IL-17 has been implicated in the…
Abstract Number: 0480 • ACR Convergence 2023
Non-random Sampling in Rheumatology Randomized Controlled Trials: Evidence of Concerning Trial Conduct?
Victoria Le¹, Mats Junek², Mike Putman³, Maximilian Casey¹, Kenrick Manswell¹, Jay Goldsher¹, Elizabeth Nettleton¹, Desh Nepal¹ and Sanket Shah¹, ¹Medical College of Wisconsin, Milwaukee, WI, ²McMaster University, Hamilton, ON, Canada, ³Division of Rheumatology, Medical College of Wisconsin, Milwaukee, WI
Background/Purpose: Non-random sampling of baseline variables in randomized controlled trials (RCTs) may be due unintentional errors, stratified randomization strategies, or data fabrication. Prior studies have…
Abstract Number: 0818 • ACR Convergence 2023
Efficacy of XT-150, a Novel Non-Viral Gene Therapy Delivering IL-10v, on Moderate to Severe Pain Due to Osteoarthritis of the Knee: Results of a Phase 2 Trial
Eric Grigsby¹, Stephen D. Collins², Leonard Kapural³, Mark McBride⁴, Jayson Rieger⁵, Morgan Stokes⁶, Howard Rutman⁶ and Flavia Cicuttini⁷, ¹Neurovations Clinical Research, Napa, CA, ²Xalud Therapeutics, Inc., Chicago, IL, ³Center for Clinical Research, Winston-Salem, NC, ⁴Instat Clinical Research, Chatham, NJ, ⁵PBM Capital, Charlottesville, VA, ⁶Xalud Therapeutics, Inc., Berkeley, CA, ⁷Monash University, Melbourne, Australia
Background/Purpose: Interleukin (IL)-10 is a regulator of cytokine activity and has the potential to restore homeostasis in osteoarthritis (OA) of the knee. Unfortunately, relatively short…
Abstract Number: 1314 • ACR Convergence 2023
Safety Results from a Phase 1 Double-blind Randomized Clinical Trial of Allogeneic Mesenchymal Stem Cells in Early RA
Nora Singer¹, Maya Breitman², Maricela Haghiac², Larraine Gordesky³, Jane Reese⁴, Steven Lewis², Emma Barnboym², Noor Hussein⁵, Susan Lasalvia⁶, Elizabeth Mellins⁷, Tracey Bonfield⁸, Donald Anthony⁹, Arnold Caplan¹⁰ and Hillard Lazarus⁸, ¹The MetroHealth System at Case Western Reserve University School of Medicine, Cleveland, OH, ²The MetroHealth System at CWRU, Cleveland, OH, ³The MetroHealth System at CWRU and Louis Stokes Cleveland VA, Cleveland, OH, ⁴CWRU, University Hospitals of Cleveland, Cleveland, OH, ⁵Stanford University, Palo Alta, CA, ⁶The MetroHealth System, Cleveland, OH, ⁷Stanford University, Stanford, CA, ⁸CWRU and University Hospitals of Cleveland, Cleveland, OH, ⁹Case Western Reserve University, Cleveland VA Medical Center, The MetroHealth System, Cleveland, OH, ¹⁰CWRU, Center for Skeletal Biology, Cleveland, OH
Background/Purpose: The purpose of this study was to evaluate the safety of bone-marrow derived allogeneic mesenchymal stem cells (MSCs) as therapeutic agents in early rheumatoid…
Abstract Number: 1436 • ACR Convergence 2023
Secukinumab Demonstrates a Consistent Safety Profile in Patients with Psoriasis, Psoriatic Arthritis and Axial Spondyloarthritis: Updated Pooled Safety Analysis from Clinical Trials
Atul Deodhar¹, Iain McInnes², Xenofon Baraliakos³, Alice B. Gottlieb⁴, Uta Kiltz⁵, Stefan Schreiber⁶, Braja Gopal Sahoo⁷, Weibin Bao⁸, Hanno Richards⁹, Luminita Pricop¹⁰, Corine Gaillez¹¹, Victor Dong¹⁰ and Philip J. Mease¹², ¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ²University of Glasgow, Glasgow, United Kingdom, ³Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁴Icahn School of Medicine at Mount Sinai, New York, NY, ⁵Rheumazentrum Ruhrgebiet, Herne, Germany, ⁶University Hospital Schleswig-Holstein, Kiel, Germany, ⁷Novartis Healthcare Pvt, Hyderabad, India, ⁸Novartis Pharmaceuticals Corporation, Hanover, NJ, ⁹Novartis Pharma AG, Basel, Switzerland, ¹⁰Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹¹Novartis Pharma AG, Croissy Sur Seine, France, ¹²Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA
Background/Purpose: Pooled safety data have been reported for secukinumab administration in patients with psoriasis (PsO), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA).1,2 The aim of…
Abstract Number: 1652 • ACR Convergence 2023
Lupus Research Action Network: Increasing Minority Clinical Trial Participation Through Peer Leaders
Melicent Miller¹, Stephanie Slan¹, Rosalind Ramsey-Goldman², Rodlescia Sneed³, Candace Feldman⁴, Patrick Wildman¹, Tori Justin⁵, Lydia Oberholtzer⁵ and Joy Buie⁶, ¹Lupus Foundation of America, Washington, DC, ²Northwestern University, Chicago, IL, ³Wayne State University, Detroit, MI, ⁴Brigham and Women's Hospital, Boston, MA, ⁵Sharp Insight, LLC, Montgomery County, MD, ⁶Lupus Foundation of America, York, SC
Background/Purpose: Black/African American people with lupus (PWL) experience greater disease prevalence and severity than White PWL. The need for more racial and ethnic diversity amongst…
Abstract Number: 2067 • ACR Convergence 2023
A New Tool Assessing Trainees’ Interventional Musculoskeletal Ultrasound Skills
Stine Maya Dreier Carstensen¹, Lene Terslev², Søren Just³, Mikkel Østergaard⁴, Mogens Pfeiffer-Jensen¹ and Lars Konge⁵, ¹Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Copenhagen University Hospital – Rigshospitalet Glostrup, Copenhagen, Denmark, ²Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, ³Section of Rheumatology, Department of Medicine, Odense University Hospital – Svendborg Hospital, Odense, Denmark, ⁴Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet; University of Copenhagen, Copenhagen, Denmark, ⁵Copenhagen Academy for Medical Education and Simulation The Capital Region of Denmark, Copenhagen, Denmark
Background/Purpose: Interventional musculoskeletal ultrasound (MSUS) procedures, such as ultrasound-guided arthrocentesis and joint injections, are routinely used in rheumatology practice. However, the efficacy and safety of…
Abstract Number: 2332 • ACR Convergence 2023
Dapirolizumab Pegol Efficacy by Subgroups in Patients with SLE: A Post Hoc Analysis of Phase 2b Clinical Trial Data
Anca Askanase¹, Christian Stach², Claire Brittain³, George Stojan⁴ and Richard Furie⁵, ¹Columbia University Medical Center, New York, NY, ²UCB Pharma, Monheim am Rheim, Germany, ³UCB Pharma, Slough, United Kingdom, ⁴UCB, Baltimore, MD, ⁵Northwell Health, Manhasset, NY
Background/Purpose: Systemic lupus erythematosus (SLE) clinical trials are challenged by high standard of care plus placebo (SOC+PBO) response rates.1 Previous post hoc analyses of the…
Abstract Number: 2549 • ACR Convergence 2023
Effect of Ixekizumab Treatment on MRI Structural Lesions in the Sacroiliac Joints of Patients with Radiographic Axial Spondyloarthritis; A Post-hoc Analysis of a Placebo and Active Controlled RCT
Walter P. Maksymowych¹, Robert Lambert², Eswar Krishnan³, Baojin Zhu³, Rebecca Bolce³ and Mikkel Østergaard⁴, ¹University of Alberta, Edmonton, AB, Canada, ²Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, AB, Canada, ³Eli Lilly and Company, Indianapolis, IN, ⁴Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet; University of Copenhagen, Copenhagen, Denmark
Background/Purpose: The effect of Ixekizumab (IXE) on structural lesions in the sacroiliac joints (SIJ) of patients (pts) with radiographic Axial Spondylarthritis (r-axSpA) assessed by magnetic…
Abstract Number: 0099 • ACR Convergence 2023
Cell-bound Complement Activation Products in Antiphospholipid Antibody-positive Patients Without Other Systemic Autoimmune Diseases
Doruk Erkan¹, JoAnn Vega¹, Tyler O'Malley² and Andrew Concoff³, ¹Hospital for Special Surgery, New York, NY, ²Exagen, Vista, CA, ³Exagen, Los Angeles, CA
Background/Purpose: Based on animal models, complement activation is part of Antiphospholipid Syndrome (APS) pathogenesis. However, studies investigating complement activation in antiphospholipid antibody (aPL)-positive patients are…
Abstract Number: 0482 • ACR Convergence 2023
Preference and Relative Sensitivity of Indicators Reporting Response Rate in Pharmaceutical Trials of Psoriasis and Psoriatic Arthritis
Jingru Tian¹, Shuntong Kang², Dingyao Zhang³ and Qianjin Lu⁴, ¹Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China, ²Department of Dermatology, Hunan Key Laboratory of Medical Epigenomics, The Second Xiangya Hospital, Central South University, Nanjing, China, ³Graduate Program in Biological and Biomedical Sciences, Yale University, New Haven, CT, ⁴Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Changsha, China
Background/Purpose: Numerous indicators have been proposed to evaluate the efficacy for randomized clinical trials (RCTs) of psoriasis (Pso) and psoriatic arthritis (PsA), but the comparability…
Abstract Number: 0819 • ACR Convergence 2023
Regression to the Mean for Physical Function and Quality of Life in Trials for Symptomatic Knee Osteoarthritis
Martin Englund and Aleksandra Turkiewicz, Lund University, Lund, Sweden
Background/Purpose: Improvement in pain reported in clinical trials for osteoarthritis (OA) is typically strongly depending on the regression-to-the-mean phenomenon. Regression to the mean has been…
Abstract Number: 1318 • ACR Convergence 2023
Abatacept Modulates Both Global and Citrulline Specific T Cell Signatures: Results from Inhibition of Co-Simulation in Rheumatoid Arthritis Phase IV Trial
Ravi Kumar Sharma¹, Aysin Tulunay Virlan², Louise Bennett³, John Cole³, Sam McAllister², Sara Turcinov⁴, Samantha Miller³, Fraser Morton³, Ashley Gilmour³, Sean Kerrigan³, Anatoly Dubnovitsky¹, Leonid Padyukov⁵, Caron Paterson³, William Kwok⁶, René Toes⁷, Lars Klareskog⁸, Arthur Pratt⁹, John Isaacs¹⁰, Sean Connolly¹¹, Duncan Porter³, Stefan Siebert¹², Iain McInnes³, Vivianne Malmström⁸ and Carl Goodyear³, ¹Division of Rheumatology, Department of Medicine Solna, Center for Molecular Medicine, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden, ²University of Glasgow - School of Infection & Immunity, Glasgow, United Kingdom, ³University of Glasgow, Glasgow, United Kingdom, ⁴Division of Rheumatology, Department of Medicine Solna, Center for Molecular Medicine, Karolinska Institutet. Theme of Inflammation and Ageing, Medical Unit Gastro, Derma, Rheuma, Karolinska University Hospital, Stockholm, Sweden, ⁵Karolinska Institutet, Solna, Sweden, ⁶Benaroya Research Institute at Virginia Mason, Seattle, WA, ⁷Leiden University Medical Center, Leiden, Netherlands, ⁸Karolinska Institutet, Stockholm, Sweden, ⁹Immunity and Inflammation Theme, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom, ¹⁰Translational and Clinical Research Institute, Newcastle University and Musculoskeletal Unit, Newcastle Hospitals, Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom, ¹¹Bristol Myers Squibb, Princeton, NJ, ¹²School of Infection and Immunity, University of Glasgow, Glasgow, United Kingdom
Background/Purpose: Clinical outcomes in Rheumatoid arthritis (RA) have improved with the introduction of biological and targeted synthetic disease modifying anti-rheumatic drugs (b & tsDMARDs). Abatacept…
Abstract Number: 1438 • ACR Convergence 2023
Efficacy of Guselkumab in Early-Onset and Late-Onset Psoriatic Arthritis: Post Hoc Pooled Analyses of Two Phase 3 Randomized Controlled Trials in Patients with Active PsA
Enrique Soriano¹, Mitsumasa Kishimoto², Emmanouil Rampakakis³, Francois Nantel⁴, May Shawi⁵, Frederic Lavie⁶, Philip J. Mease⁷ and Dafna Gladman⁸, ¹Rheumatology Section, Internal Medicine Services, Hospital Italiano de Buenos Aires, and University Institute Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ²Kyorin University School of Medicine, Yokohoma, Japan, ³McGill University, Department of Pediatrics / JSS Medical Research, Scientific Affairs, Montreal, QC, Canada, ⁴Nantel Medsci Consult, Consultant, Montreal, QC, Canada, ⁵Immunology, Janssen Research & Development, LLC, Titusville, NJ, ⁶The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France, ⁷Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁸Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Department of Medicine, University of Toronto, Toronto, ON, Canada
Background/Purpose: Late-onset PsA may be associated with elevated acute phase reactants, higher joint count, and erosive disease at diagnosis1,2. Given potential phenotype differences and increasing…
Abstract Number: 1677 • ACR Convergence 2023
Two-week Break in Methotrexate Treatment and COVID-19 Vaccine Response. Results of the Vaccine Response on off Methotrexate (VROOM) Study, an Open Label, Prospective, Two-arm Parallel-group, Multi-center, Superiority, Randomized Controlled Trial
Abhishek Abhishek¹, Nicholas Peckham², Corinna Pade³, Joseph Gibbons³, Lucy Cureton², Anne Francis², Vicki Barber², Jennifer Williams², duncan Appelbe², lucy Eldridge², patrick Julier², daniel Altmann⁴, James Bluett⁵, Tim Brooks⁶, Laura Coates², ines Rombach⁷, Amanda Semper⁶, Ashley Otter⁶, Ana Valdes¹, Jonathan Nguyen-Van-Tam¹, Hywel Williams¹, Aine McKnight³, Rosemary Boyton⁴ and jonathan Cook², ¹University of Nottingham, Nottingham, United Kingdom, ²University of Oxford, Oxford, United Kingdom, ³Queen Mary University of London, London, United Kingdom, ⁴Imperial College London, London, United Kingdom, ⁵University of Manchester, Manchester, United Kingdom, ⁶UK Health Security Agency, Porton Down, United Kingdom, ⁷University of Sheffield, Sheffield, United Kingdom
Background/Purpose: Immunosuppressive treatments inhibit vaccine-induced immunity. We evaluated if a two-week interruption of methotrexate treatment immediately after COVID-19 booster improved antibody response against spike protein…

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