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…

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

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Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. Academic institutions, private organizations and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part a scientific presentation or presentation of additional new information that will be available at the time of the meeting) is under embargo until Saturday, November 11, 2023.

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