Abstracts tagged "clinical trial"

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…
Abstract Number: 2111 • ACR Convergence 2023
Self-reported Methotrexate Adherence Underestimates Biochemical Adherence: Results from the Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback Trial
James Bluett¹, Kimme Hyrich², Brian Keevil³, Patty Doran⁴ and Anne Barton⁵, ¹University of Manchester, Manchester, United Kingdom, ²Versus Arthritis Centre for Epidemiology, Centre for Musculoskeletal Research, The University of Manchester, Manchester, United Kingdom, ³Department of Clinical Biochemistry, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ⁴School of Social Sciences, The University of Manchester, Manchester, United Kingdom, ⁵Versus Arthritis Centre for Genetics and Genomics, Centre for Musculoskeletal Research, The University of Manchester, Manchester, United Kingdom
Background/Purpose: Methotrexate (MTX) adherence is suboptimal and is associated with disease flare, DAS-28 response, radiographic damage and healthcare costs. Adherence can be measured using self-reported…
Abstract Number: 2333 • ACR Convergence 2023
Dapirolizumab Pegol Impacts Important Immunologic Pathways in SLE: Pharmacodynamic Analysis of B Cell and Type I Interferon Pathways from a Phase 2b Trial
Ioana Cutcutache¹, Alex Powlesland¹, Andrew Skelton¹, Yunyun Sun¹, Matthew Page¹, George Stojan², Peter Lipsky³, Ania Skowera¹ and Christian Stach⁴, ¹UCB Pharma, Slough, United Kingdom, ²UCB, Baltimore, MD, ³AMPEL BioSolutions, Charlottesville, VA, ⁴UCB Pharma, Monheim am Rheim, Germany
Background/Purpose: The pivotal role of CD40-CD40L interactions in systemic lupus erythematosus (SLE) pathogenesis stems from the orchestration of a range of immune and inflammatory responses…
Abstract Number: 2576 • ACR Convergence 2023
Rapid Onset of Response in Adult Dermatomyositis Patients Receiving Anti-interferon β (PF-06823859): Results of a Phase 2, Double-blind, Randomized, Placebo-Controlled Study
Rohit Aggarwal¹, Elena Peeva², Aaron Mangold³, Abigail Sloan² and Myron Chu², ¹University of Pittsburgh, Pittsburgh, PA, ²Pfizer, Cambridge, MA, ³Mayo Clinic, Scottsdale, AZ
Background/Purpose: Interferon (IFN) dysregulation is a key feature in the pathogenesis of Dermatomyositis (DM). PF-06823859 is a potent, selective, humanized IgG1 neutralizing antibody directed against…
Abstract Number: 0183 • ACR Convergence 2023
Barriers and Facilitators to Recruiting Underrepresented Participants for Clinical Trials: Insights from the Lupus Clinical Investigators Network (LuCIN)
Tessa Englund¹, Christine Lee², Julie Hsieh², Richardae Araojo², Julia Mariano¹, Emily McCormick³, Stacie Bell⁴, Albert Roy⁵ and Saira Sheikh¹, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²U.S. Food and Drug Administration, Silver Spring, MD, ³Thurston Arthritis Research Center, Chapel Hill, NC, ⁴Lupus Therapeutics, Lakewood, CO, ⁵Lupus Research Alliance, New York, NY
Background/Purpose: Despite greater prevalence of lupus among diverse, racial and ethnic minority populations, marked gaps exist between populations affected by lupus and those enrolled in…
Abstract Number: 0519 • ACR Convergence 2023
Long-Term Safety and Efficacy of Bimekizumab in Patients with Active Ankylosing Spondylitis: 5-Year Results from a Phase 2b Study and Its Open-Label Extension
Atul Deodhar¹, Victoria Navarro-Compán², Denis Poddubnyy³, Lianne Gensler⁴, Sofia Ramiro⁵, Tetsuya Tomita⁶, Helena Marzo-Ortega⁷, Carmen Fleurinck⁸, Thomas Vaux⁹, Ute Massow¹⁰, Désirée van der Heijde⁵ and Xenofon Baraliakos¹¹, ¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ²Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ³Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁴University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ⁵Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka, Japan, ⁷NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁸UCB Pharma, Oosterzele, Belgium, ⁹UCB Pharma, Slough, United Kingdom, ¹⁰UCB Pharma, Monheim am Rhein, Germany, ¹¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Bimekizumab (BKZ), a monoclonal IgG1 antibody, selectively inhibits IL-17F in addition to IL17A. BKZ has demonstrated clinical efficacy and safety up to 3 years…
Abstract Number: 0820 • ACR Convergence 2023
Radiographic and Pain Outcomes from a Phase 3 Extension Study Evaluating the Safety and Efficacy of Lorecivivint in Subjects with Severe Osteoarthritis of the Knee (OA-07): 36 Month Single Blind and Placebo Crossover Phase Results
Yusuf Yazici¹, Christopher Swearingen², Victor Lopez³, Jon Britt⁴, Sarah Kennedy⁵, Jeyanesh Tambiah² and Timothy McAlindon⁶, ¹NYU Grossman School of Medicine, La Jolla, CA, ²Biosplice Therapeutics, Inc., San Diego, CA, ³Biosplice Therapeutics, Inc., Santa Clarita, CA, ⁴Biosplice Therapeutics, Inc., Los Angeles, CA, ⁵Biosplice Therapeutics, Inc., Superior, CO, ⁶Tufts Medical Center, Arlington, MA
Background/Purpose: Knee osteoarthritis (OA) has unmet need for safe, efficacious symptom and disease-modifying treatments. Lorecivivint (LOR), an intra-articular (IA) CLK/DYRK inhibitor thought to modulate Wnt…

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