Abstracts tagged "clinical trial"

Abstract Number: 0776 • ACR Convergence 2023
Efficacy and Safety of Intravenous Secukinumab for the Treatment of Active Psoriatic Arthritis: 16- and 52-Week Results from a Randomized, Double-Blind, Phase 3 Study
Alan Kivitz¹, Liliana Sedova², Melvin Churchill³, Roshan Kotha⁴, Atul Singhal⁵, Alexander Torres⁶, Guillermo Valenzuela⁷, Sarah Whelan⁸, Thomas Dumortier⁹, Xuan Zhu¹⁰, Ruvie Martin¹⁰ and Luminita Pricop¹⁰, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Institute of Rheumatology, Prague, Czech Republic, ³Arthritis Center of Nebraska, Lincoln, NE, ⁴Sharp Community Medical Group, La Mesa, CA, ⁵Southwest Arthritis Research Group, Mesquite, TX, ⁶Highlands Advanced Rheumatology and Arthritis Center, Avon Park, FL, ⁷Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁸Novartis Ireland Ltd, Dublin, Ireland, ⁹Novartis Pharma AG, Basel, Switzerland, ¹⁰Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: To investigate the long-term efficacy, safety, and tolerability of intravenous (IV) secukinumab (SEC) in patients with active psoriatic arthritis (PsA) through 52 weeks.Methods: INVIGORATE-2…
Abstract Number: 1183 • ACR Convergence 2023
CoLchicine for Treatment of OsteoArthritis of the Knee—Updated Data from a Double-blind, Placebo-controlled Trial
Katherine Tse¹, Roni Meidan², Michael Toprover³, David Wei², Nicole Leung⁴, Maryfe Coronel², Julia Cai², Aryan Jain², maria lessa², Renata La Rocca Vieira², Svetlana Krasnokutsky Samuels², Michael Pillinger⁵ and Jonathan Samuels⁶, ¹NYU Langone, New York, NY, ²NYU Langone Helath, New York, NY, ³New York University Langone Health, New York, NY, ⁴New York University Langone Hospital, New York, NY, ⁵New York University Grossman School of Medicine, New York, NY, ⁶NYU Langone, Rye Brook, NY
Background/Purpose: Knee osteoarthritis (OA) has a probable inflammatory role for IL-1b. The presence of calcium and urate crystals may contribute to OA by activating the…
Abstract Number: 1429 • ACR Convergence 2023
Longitudinal Evaluation of the Novel Psoriatic Arthritis 5-Thermometer Scale (PsA-5Ts) Domains During Treatment with Guselkumab: Pooled Analysis of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies
Carlo Selmi¹, Fausto Salaffi², Sibel Aydin³, Enrique Soriano⁴, Emmanouil Rampakakis⁵, Mohamed Sharaf⁶, Miriam Zimmermann⁷, Frederic Lavie⁸, Peter Nash⁹ and Philip J. Mease¹⁰, ¹Rheumatology and Clinical Immunology, Humanitas Research Hospital / Internal Medicine, Humanitas University, Rozzano, Italy, ²Polytechnic University of Marche, Department of Clinical and Molecular Sciences, Carlo Urbani Hospital, Ancona, Italy, ³Department of Medicine, Ottawa Hospital Riverside Campus, Ottawa, ON, Canada, ⁴Rheumatology Section, Internal Medicine Services, Hospital Italiano de Buenos Aires, and University Institute Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁵McGill University, Department of Pediatrics / JSS Medical Research, Scientific Affairs, Montreal, QC, Canada, ⁶Immunology, Janssen MEA, Dubai, United Arab Emirates, ⁷Immunology, Janssen Medical Affairs, LLC, Zug, Switzerland, ⁸The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France, ⁹School of Medicine, Griffith University, Brisbane, Australia, ¹⁰Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA
Background/Purpose: PsA-5Ts is a simple multidimensional composite measure, assessing pain, fatigue, physical function, skin problems, and depression, recently developed to measure overall health in PsA…
Abstract Number: 1525 • ACR Convergence 2023
Chelation Therapy in the Management of Calcinosis Associated with Systemic Sclerosis
Alison Fernandes, Ashraf El-Meanawy and ME Csuka, Medical College of Wisconsin, Milwaukee, WI
Background/Purpose: Calcinosis is a common complication of systemic sclerosis (SSc), though effective treatment options are limited. Of the several medical therapies that have been employed…
Abstract Number: 2003 • ACR Convergence 2023
Effects of Abaloparatide on Cortical and Trabecular Compartments by 3D-DXA in Men with Osteoporosis
Ruban Dhaliwal¹, John Boxberger², Yamei Wang², Bruce Mitlak², Ludovic Humbert³ and Neil Binkley⁴, ¹Massachusetts General Hospital, Boston, MA, ²Radius Health, Inc., Boston, MA, ³3D-Shaper Medical, Barcelona, Spain, ⁴University of Wisconsin Osteoporosis Clinical Research Program, Madison, WI
Background/Purpose: Abaloparatide (ABL) increases BMD in men with osteoporosis. In the Abaloparatide for the Treatment of Men with Osteoporosis (ATOM) trial, DXA-measured BMD change with…
Abstract Number: 2255 • ACR Convergence 2023
Bimekizumab versus Secukinumab for the Treatment of Nail Psoriasis in Patients with Moderate to Severe Plaque Psoriasis: Results from the BE RADIANT Phase 3b Trial
Kilian Eyerich¹, Alice B. Gottlieb², Stefano Piaserico³, Stefan Beissert⁴, Melinda Gooderham⁵, Brian Kirby⁶, Nicola Tilt⁷, Cynthia Madden⁸, Susanne Wiegratz⁹, Dirk de Cuyper¹⁰, Joseph F. Merola¹¹ and Boni Elewski¹², ¹Department of Dermatology, Medical Center, University of Freiburg, Freiburg, Germany, ²Icahn School of Medicine at Mount Sinai, New York, NY, ³Dermatology Unit, Department of Medicine, Università di Padova, Padova, Italy, ⁴Department of Dermatology, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany, ⁵SKiN Centre for Dermatology, Probity Medical Research, Peterborough, ON, Canada, and Queen’s University, Kingston, ON, Canada, ⁶Elm Park and the Charles Institute, St Vincent's University Hospital, University College Dublin, Dublin, Ireland, ⁷UCB Pharma, Slough, United Kingdom, ⁸UCB Pharma, Morrisville, NC, ⁹UCB Pharma, Monheim am Rhein, Germany, ¹⁰UCB Pharma, Brussels, Belgium, ¹¹Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ¹²Department of Dermatology, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, OH
Background/Purpose: Psoriatic lesions in highly visible areas, including the nails, disproportionately affect patients' health‑related quality of life.[1] Here, we compare the efficacy of bimekizumab (BKZ)…
Abstract Number: 2501 • ACR Convergence 2023
Selection of Indicators Reporting Response Rate in Pharmaceutical Trials for Systemic Lupus Erythematosus: Preference and Relative Sensitivity
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: Systemic lupus erythematosus (SLE) is a common multisystem autoimmune disease with chronic inflammation. Many efficacy evaluation indicators of randomized clinical trials (RCTs) for SLE…
Abstract Number: 0450 • ACR Convergence 2023
Baricitinib versus TNF-inhibitors in Patients with Active Rheumatoid Arthritis After Failure of CsDMARDs: A Pragmatic, Multicenter, Real-Life Study in a Treat-to-Target Setting
Martinus Van de Laar¹, Martijn Oude Voshaar¹, Peter ten Klooster¹, Danyta Tedjo² and celine van de laar³, ¹University of Twente, Hengelo (OV), Netherlands, ²TiH @ University of Twente, Hengelo (OV), Netherlands, ³Erasmus School of Health Policy and Management, Erasmus University, Rotterdam, Netherlands
Background/Purpose: The EULAR guidelines for Rheumatoid Arthritis (RA) patients advise to use a strategy aiming at a predefined target of disease activity (T2T). If this…
Abstract Number: 0780 • ACR Convergence 2023
Assessing Differential Effects of DMARDs on Psoriasis Area and Severity Index and Patient Global Assessment in Subgroups of Patients with Active PsA Treated over 52-weeks with Secukinumab in a Non-Interventional Trial (AQUILA) Using a Multistage Clustering Approach
Michaela Koehm¹, Maximilian Klippstein², Sabine Kugler³, Sina Mackay³, Daniel Schulz³, Asmir Vodencarevic⁴, Guillaume Wendt⁴, Daniel Peterlik⁴, Uta Kiltz⁵, Jan Brandt-Juergens⁶ and Frank Behrens⁷, ¹University Hospital Frankfurt, Frankfurt, Germany, ²Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Fraunhofer Cluster of Excellence Immune Mediated Diseases CIMD, Frankfurt, Germany, ³Fraunhofer Institute for Intelligent Analysis and Information Systems IAIS, Fraunhofer Cluster of Excellence Immune Mediated Diseases CIMD, Sankt Augustin, Germany, ⁴Novartis Pharma GmbH, Nürnberg, Germany, ⁵Rheumazentrum Ruhrgebiet, Herne, Germany, ⁶rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁷Goethe-University & Fraunhofer ITMP, Frankfurt, Germany
Background/Purpose: Individualized treatment strategies are of high importance in the treatment of patients with active psoriatic arthritis (PsA), a heterogeneous immune-mediated disease. IL-17 inhibition has…
Abstract Number: 1191 • ACR Convergence 2023
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dosing, Ascending-Dose Study Evaluating the Safety, Tolerability and Pharmacokinetics of XG004 Applied Topically in Participants with Osteoarthritis of the Knee
Guang-Liang Jiang¹ and Feng Xu², ¹Xgene Pharmaceutical Inc., Lexington, MA, ²Xgene Pharmaceutical Inc., Altos Hills, CA
Background/Purpose: Globally osteoarthritis affects about 302 million patients, knee osteoarthritis accounts for 263 million and ranks the highest in disability and pain compared to OA…
Abstract Number: 1433 • ACR Convergence 2023
Bimekizumab Impact on Core Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Domains for Patients with Psoriatic Arthritis: 52-Week Results from Four Phase 3 Studies
Joseph Merola¹, Philip J. Mease², Atul Deodhar³, Barbara Ink⁴, Carmen Fleurinck⁵, Rajan Bajracharya⁴, Jason Coarse⁶ and Laura Coates⁷, ¹Harvard Medical School, Brigham and Women's Hospital, Newton, MA, ²Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ³Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ⁴UCB Pharma, Slough, United Kingdom, ⁵UCB Pharma, Oosterzele, Belgium, ⁶UCB Pharma, Morrisville, NC, ⁷University of Oxford, Oxford, United Kingdom
Background/Purpose: The Group for Research and Assessment of Psoriasis and PsA (GRAPPA) domain‑based treatment recommendations for PsA focus on six key domains: peripheral arthritis, axial…
Abstract Number: 1612 • ACR Convergence 2023
Design and Validation of a Comparator for Randomized Controlled Trials of a Digital Cognitive Behavioral Therapy
Michael Gendreau¹, Yifei Dai², Michael Rosenbluth³, David Williams⁴ and Daniel Clauw⁵, ¹Gendreau Consulting, LLC, Poway, CA, ²Swing Therapeutics, Gainesville, FL, ³Swing Therapeutics, San Francisco, CA, ⁴Chronic Pain and Fatigue Research Center, Department of Anesthesiology, University of Michigan, Ann Arbor, MI, ⁵Department of Anesthesiology, University of Michigan, Ann Arbor, MI
Background/Purpose: The use of a control arm (comparator) in randomized controlled trials (RCTs) is considered the gold standard for trial conduct and interpretation. Choosing an…
Abstract Number: 2024 • ACR Convergence 2023
Patient-Reported Outcomes in Patients with Lupus Nephritis: A Post Hoc Analysis of Control Arm Data from Two Completed Phase III Randomized Clinical Trials
Christophe T. Tchakoute¹, Huiyan (Ashley) Mao², Gene Wallenstein¹, Jorge Ross Terres¹, Seitaro Yoshida¹ and Lisa Lindsay¹, ¹Genentech, Inc., South San Francisco, CA, ²Hoffmann-La Roche Ltd, Mississauga, ON, Canada
Background/Purpose: Lupus nephritis (LN) is a severe and common (50%) organ-threatening manifestation of systemic lupus erythematosus and is associated with a high risk of progression…
Abstract Number: 2256 • ACR Convergence 2023
The Impact of Clinical Trial Metrics in Psoriatic Arthritis
Maxine Yarnall and Kara Murray, Spherix Global Insights, Exton, PA
Background/Purpose: Rheumatologists have access to a plethora of advanced biologic and small molecule agents for the treatment of psoriatic arthritis (PsA). Prior to FDA approval,…
Abstract Number: 2539 • ACR Convergence 2023
Baseline IL-10 Levels as a Predictive Biomarker for Achieving Clinical Response with Abatacept in ACPA+ Patients with Early RA
Jinqi Liu¹, Yicong Li², Kai Fu¹, Chun Wu¹, Peter Schafer³, Sean Connolly¹, Ian M. Catlett⁴, Michael Maldonado¹, Robert Wong⁵, Paul Emery⁶, Yoshiya Tanaka⁷, Vivian Bykerk⁸, Clifton Bingham⁹, Thomas Huizinga¹⁰ and Roy Fleischmann¹¹, ¹Bristol Myers Squibb, Princeton, NJ, ²Parexel International, Durham, NC, ³Bristol Myers Squibb, Belle Mead, NJ, ⁴Bristol Myers Squibb, Pennington, NJ, ⁵Bristol Myers Squibb (at the time of analysis), Princeton, NJ, ⁶Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁷University of Occupational and Environmental Health, Kitakyushu, Japan, ⁸Department of Rheumatology, Hospital for Special Surgery, New York, NY, ⁹Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, MD, ¹⁰Leiden University Medical Center, Leiden, Netherlands, ¹¹Division of Rheumatology, University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: A key target of RA treatment is to achieve early and sustained remission in order to ensure lower levels of long-term structural joint damage…

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