Abstracts tagged "clinical trial"

Abstract Number: 2577 • ACR Convergence 2024
Efficacy and Safety of ABBV-599 (Elsubrutinib and Upadacitinib Combination) and Upadacitinib Monotherapy for the Treatment of Systemic Lupus Erythematosus: Results Through 104 Weeks in a Long-Term Extension Study
Joan Merrill¹, Amit Saxena², Martin Aringer³, Yoshiya Tanaka⁴, Xiaofeng Zeng⁵, Peter Wung⁶, Ling Cheng⁶, Thao Doan⁶, Shelly Kafka⁶, David DCruz⁷ and Kristin D'Silva⁶, ¹Oklahoma Medical Research Foundation, Oklahoma City 73104, OK, ²NYU Grossman School of Medicine, New York, NY, ³University Medical Center and Faculty of Medicine, TU Dresden, Dresden, Germany, ⁴Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ⁵Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China, ⁶AbbVie Inc., North Chicago, IL, ⁷The Louise Coote Lupus Unit, Guy's and St Thomas' Hospitals NHS Foundation Trust, London, United Kingdom
Background/Purpose: ABBV-599 (a combination of a selective Bruton’s tyrosine kinase inhibitor, elsubrutinib [ELS], and a selective Janus kinase inhibitor, upadacitinib [UPA]) targets a spectrum of…
Abstract Number: 0468 • ACR Convergence 2024
Plasma Calprotectin Assessed in Multiple Biological Treatment Strategies for Early Rheumatoid Arthritis over 48 Weeks
David Stevens¹, Lene Sundbakk², Amirhossein Kazemi², Marte Heiberg³, Tuulikki Sokka-Isler⁴, Bjorn Gudbjornsson⁵, Kristina Lend⁶, Anna Rudin⁷, Michael Nurmohamed⁸, Jon Lampa⁹, Merete Hetland¹⁰, Mikkel Ostergaard¹¹, Ronald Van Vollenhoven¹², Tillmann Uhlig², Espen Haavardsholm² and Hilde Hammer³, ¹St. Olavs hospital, Trondheim, Norway, ²Diakonhjemmet Hospital, Oslo, Norway, ³Diakonhjemmet Hospital, Oslo, Oslo, Norway, ⁴University of Eastern Finland, Faculty of Health Sciences, Jyvaskyla, Finland, ⁵Landspitali University Hospital and University of Iceland, Reykjavik, Iceland, ⁶Amsterdam UMC, Karolinska Institute, Stockholm, Sweden, ⁷Institute of Medicine, University of Gothenburg, Gothenburg, Sweden, ⁸Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁹Karolinska University Hospital, Hässelby, Sweden, ¹⁰Rigshospitalet Glostrup and University of Copenhagen, Glostrup, Denmark, ¹¹Department of Clinical Medicine, University of Copenhagen and Center for Rheumatology, Copenhagen Center for Arthritis Research, Glostrup, Denmark, ¹²Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands
Background/Purpose: Plasma calprotectin is a sensitive biomarker of inflammation in patients with rheumatoid arthritis (RA) and reflects activation of granulocytes and macrophages. Calprotectin has not…
Abstract Number: 0620 • ACR Convergence 2024
Clinical Efficacy and Patient-Reported Outcomes in Anti-Ro/Sjögren’s Syndrome–Related Antigen a Antibody–Positive Patients with Active SLE Treated WithDeucravacitinib in the Phase 2 PAISLEY Trial
Benjamin A. Fisher¹, Hendrika Bootsma², Vibeke Strand³, Wan-Fai Ng⁴, Thomas Wegman⁵, Brandon Becker⁶, Jiyoon Choi⁶, Antoine Sreih⁶, Leo Chen⁷, Antonia Christodoulou⁶ and Eric Morand⁸, ¹University of Birmingham, Birmingham, United Kingdom, ²Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, Groningen, Netherlands, ³Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, ⁴Institute of Cellular Medicine, Newcastle University, Gateshead, United Kingdom, ⁵Bristol Myers Squibb, Beaver Falls, PA, ⁶Bristol Myers Squibb, Princeton, NJ, ⁷Bristol Myers Squibb, Richmond, BC, Canada, ⁸School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia
Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved in multiple countries for the treatment of adults with moderate to…
Abstract Number: 0790 • ACR Convergence 2024
CoLchicine for Treatment of OsteoArthritis of the Knee: Clinical Outcomes from a 90-day Double-Blind, Placebo-Controlled Study
Jonathan Samuels¹, Katherine Tse², Wei David², maryfe Coronel², Fernando Bomfim², Renata La Rocca Vieira³, Nicole Leung⁴, Svetlana Krasnokutsky Samuels⁵, Michael Toprover⁶ and Michael Pillinger⁷, ¹NYU Langone, Rye Brook, NY, ²NYU Langone Health, new york, NY, ³NYU., New York, NY, ⁴New York University Langone Medical Center, New York, NY, ⁵Summit Health, Rye Brook, NY, ⁶New York University Langone Health, New York, NY, ⁷New York University Grossman School of Medicine, New York,, NY
Background/Purpose: Knee osteoarthritis (OA) leads to progressive disability, but approved pharmacologic treatments target analgesia without affecting disease course. Colchicine is well-tolerated and inhibits inflammation thought…
Abstract Number: 1221 • ACR Convergence 2024
Efficacy of Immersive Virtual Reality-based Biofeedback on Chronic Pain and Daily Life Impact in Fibromyalgia: A Pilot Randomized Controlled Trial
Luca Chittaro¹, Simone Longhino², Marta Serafini¹, Sofia Cacioppo² and Luca Quartuccio³, ¹Human-Computer Interaction Lab, Department of Mathematics, Computer Science and Physics, University of Udine, Udine, Italy, ²Division of Rheumatology, Department of Medicine, University of Udine, UDine, Italy, ³Division of Rheumatology, Department of Medicine (DMED), University of Udine, Udine, Italy, Udine, Italy
Background/Purpose: Fibromyalgia (FM) affects 2% of the global population, causing chronic musculoskeletal pain, fatigue, sleep and mood disorders, significantly impacting quality of life. Although many…
Abstract Number: 1471 • ACR Convergence 2024
Sex-related Differences in Efficacy and Safety Outcomes in Axial Spondyloarthritis Randomized Clinical Trials: A Systematic Literature Review and Meta-analysis
Angel Gao¹, Jordi Pardo Pardo², Steven Dang³, Lianne S Gensler⁴, Philip Mease⁵ and Lihi Eder⁶, ¹Queens University, Kingston, Canada, ²University of Ottawa, Ottawa, Canada, ³Women's College Hospital, Institute of Medical Science, University of Toronto, Toronto, ON, Canada, ⁴Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁵Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ⁶University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada
Background/Purpose: Limited information exists on sex-related differences in axial spondyloarthritis (axSpA) randomized controlled trials (RCTs). Through a systematic literature review and meta-analysis we aimed to assess…
Abstract Number: 1733 • ACR Convergence 2024
Safety and Efficacy of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-MyositisTM and RESET-SLETM Clinical Trials
Saira Sheikh¹, Tahseen Mozaffar², Vimal Derebail¹, Natalie Grover¹, Jonathan Hogan³, Courtney Little³, Yvonne White³, Claire Miller³, Rebecca Estremera³, Jenell Volkov³, Daniel Nunez³, Jason Stadanlick³, Mallorie Werner³, Zachary Vorndran³, Alexandra Ellis³, Jazmean Williams³, Justin Cicarelli³, Quynh Lam³, thomas Furmanak³, Chris Schmitt³, Fatemeh Nezhad³, Dan Thompson³, Samik Basu³ and David Chang³, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²University of California, Irvine, Irvine, CA, ³Cabaletta Bio, Philadelphia, PA
Background/Purpose: CD19 targeting chimeric antigen receptor (CAR) T cells have demonstrated durable drug-free responses and remission in patients with idiopathic inflammatory myopathies (IIM) and systemic…
Abstract Number: 2023 • ACR Convergence 2024
A PEGylated Mammalian Uricase Suitable for Intramuscular Administration to Patients with Refractory Chronic Gout
Frank Fan¹, Riyong Liu¹ and Yu Wang², ¹Chongqing PegBio Biopharm Co.,Ltd., Chongqing, China (People's Republic), ²Hangzhou Grand Biologic Pharmaceutical, Inc., Hangzhou, China (People's Republic)
Background/Purpose: For patients with refractory chronic gout, i.e., those who have frequent gout flares and/or persistent tophi despite treatment with the highest tolerable doses of…
Abstract Number: 2342 • ACR Convergence 2024
Guselkumab Shows Similar Domain-Specific Efficacy in Females and Males with Active Psoriatic Arthritis: Post Hoc Analyses of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies
Lihi Eder¹, Carlo Selmi², Philip Mease³, Alexis Ogdie⁴, Francois Nantel⁵, Frederic Lavie⁶, Mohamed Sharaf⁷, Oyediran Adelakun⁸, Emmanouil Rampakakis⁹, Laura PINA VEGAS¹⁰ and Laura Coates¹¹, ¹University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada, ²IRCCS Istituto Clinico Humanitas, Rozzano, Italy, ³Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ⁴Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁵Nantel MedSci Consult, Montreal, QC, Canada, ⁶Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁷Johnson & Johnson, Middle East FZ LLC, Dubai, UAE, Dubai, United Arab Emirates, ⁸Janssen Research & Development, LLC, Titusville, NJ, ⁹McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, ¹⁰Leiden University Medical Center, Leiden, Netherlands, ¹¹University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom
Background/Purpose: PsA occurs in males and females at similar rates. Females participating in randomized controlled trials (RCTs) have shown lower treatment efficacy based on composite…
Abstract Number: 2578 • ACR Convergence 2024
Safety, Biomarker Response, and Efficacy of E6742, a Dual Antagonist of Toll-Like Receptor 7 and 8, in a First-in-Patient, Randomized, Double-Blind, Phase1/2 Study in Systemic Lupus Erythematosus
Yoshiya Tanaka¹, Atsushi Kumanogoh², Tatsuya Atsumi³, Tomonori Ishii⁴, Fumitoshi Tago⁵, Mari Aoki⁵, Shintaro Yamamuro⁵, Keisuke Sakayori⁵, Kentaro Takahashi⁵ and Shizuo Akira⁶, ¹Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ²Osaka University, Osaka, Japan, ³Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan, Sapporo, Japan, ⁴Tohoku Medical and Pharmaceutical University / Department of Hematology and Rheumatology, sendai, Japan, ⁵Eisai Company, Ltd., Tokyo, Japan, ⁶Osaka University Immunology Frontier Research Center, Osaka, Japan
Background/Purpose: There is strong evidence for the relationship between Toll-like receptor (TLR)7/8 and systemic lupus erythematosus (SLE) pathophysiology. Dual inhibition of TLR7/8 will modulate innate…
Abstract Number: 0003 • ACR Convergence 2024
CLN-978, a CD19-directed T Cell Engager (TCE), Leads to Rapid and Deep B Cell Depletion and Has Broad Potential for Development in Autoimmune Diseases
Máire F. Quigley¹, Jennifer S. Michaelson¹, Jeffrey Jones¹, Farrukh T. Awan², Geoffrey P. Shouse³, Yue Zhang¹, Todd Shearer¹, Judy Inumerable¹, Irina M. Shapiro¹, Patrick A. Baeuerle¹ and Stephen Wax¹, ¹Cullinan Therapeutics, Inc., Cambridge, ²UT Southwestern Medical Center, Dallas, ³City of Hope Comprehensive Cancer Center, Duarte
Background/Purpose: CD19-directed CAR T cell therapy has been reported to induce profound B cell depletion and deep clinical responses, including drug-free remission, in patients with…
Abstract Number: 0500 • ACR Convergence 2024
An Update on the Integrated Safety Analysis of Filgotinib in Patients with Moderate to Severe Active Rheumatoid Arthritis over a Median of 4.3 Years
Kevin Winthrop¹, Daniel Aletaha², Roberto Caporali³, Yoshiya Tanaka⁴, Tsutomu Takeuchi⁵, Vikas Modgill⁶, Edmund V. Ekoka Omoruyi⁷, Dick de Vries⁸, Katrien Van Beneden⁹, Jacques-Eric Gottenberg¹⁰ and Gerd Burmester¹¹, ¹School of Medicine, Oregon Health and Science University, Portland, OR, ²Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Wien, Austria, ³Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milan, Italy, ⁴Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ⁵Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, ⁶Medical Safety, Galapagos NV, Mechelen, Belgium, ⁷Biostatistics, Galapagos NV, Mechelen, Belgium, ⁸Clinical Development, Galapagos BV, Leiden, Netherlands, ⁹Medical Affairs, Galapagos NV, Mechelen, Belgium, ¹⁰Rheumatology Department, Strasbourg University Hospital,, Strasbourg, France, ¹¹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany
Background/Purpose: The oral Janus kinase 1-preferential inhibitor filgotinib (FIL) is approved at doses of 100 mg (FIL100) and 200 mg (FIL200) for the treatment of…
Abstract Number: 0658 • ACR Convergence 2024
Zetomipzomib (KZR-616), a First-in-Class Selective Immunoproteasome Inhibitor, Demonstrated Improvements in SLE/LN Disease Measures and Biomarkers in Patients with Highly Active SLE or Nephrotic Range Proteinuria in the Open-label Phase 1b/2 MISSION Study
Richard Furie¹, Amit Saxena², Samir Parikh³, Richard Leff⁴, Lucas Bohnett⁵, Kathryn Ray⁶, Brian Tuch⁴, Janet Anderl⁴, Jennifer Whang⁴ and Kiruthi Palaniswamy⁷, ¹Northwell Health, Manhasset, NY, ²NYU School of Medicine, New York, NY, ³Ohio State University, Columbus, OH, ⁴Kezar Life Sciences, South San Francisco, CA, ⁵Kezar Life Sciences, El Cajon, ⁶Kezar Life Sciences, Mill Valley, CA, ⁷Kezar Life Sciences, Inc, South San Francisco, CA
Background/Purpose: Zetomipzomib is a selective inhibitor of the immunoproteasome with anti-inflammatory and immunomodulatory potential without evidence of immunosuppression to date. The MISSION study (NCT03393013), a…
Abstract Number: 0792 • ACR Convergence 2024
Radiographic and Pain Outcomes from a Phase 3 Trial (OA-07) Evaluating the Efficacy and Safety of Repeat Lorecivivint Injections over 3 Years in Subjects with Knee OA
Yusuf Yazici¹, Jeyanesh Tambiah², Christopher Swearingen³ and Timothy McAlindon⁴, ¹NYU Grossman School of Medicine, La Jolla, CA, ²Biosplice Therapeutics Inc., San Diego, CA, ³Biosplice Therapeutics, Inc, San Diego, CA, ⁴University of Massachusets, Worchester, MA
Background/Purpose: Knee OA has unmet need for safe and efficacious symptom and disease-modifying treatments. Lorecivivint (LOR), an intra-articular (IA) CLK/DYRK inhibitor thought to modulate inflammatory…
Abstract Number: 1367 • ACR Convergence 2024
Maintained Improvement of Disease Activity and Patient-reported Outcomes (PROs) with Filgotinib in Patients with Rheumatoid Arthritis (RA) in the Real World: Up to 2-year Interim Data from FILOSOPHY
James Galloway¹, Jérôme Avouac², Gerd Burmester³, Roberto Caporali⁴, Thomas P.A. Debray⁵, Katrien Van Beneden⁶, Neil Betteridge⁷, Susana Romero Yuste⁸, Monia Zignani⁵, Patrick Verschueren⁹ and Karen Bevers¹⁰, ¹Centre for Rheumatic Diseases, King's College London, London, United Kingdom, ²Rheumatology A Department, Hôpital Cochin, AP-HP Centre - Université Paris Cité, Paris, France, ³Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁴Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milan, Italy, ⁵Alfasigma S.p.A., Bologna, Italy, ⁶Medical Affairs, Galapagos NV, Mechelen, Belgium, ⁷Neil Betteridge Associates, Lonodn, United Kingdom, ⁸Department of Rheumatology, University Hospital Complex of Pontevedra, Pontevedra, Spain, ⁹Department of Rheumatology, University Hospital Leuven and KU Leuven, Leuven, Belgium, ¹⁰Department of Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands
Background/Purpose: FILOSOPHY (NCT04871919) and PARROTFISH (NCT05323591) are ongoing, prospective, observational Phase 4 studies of filgotinib in patients with RA. This interim analysis evaluated effectiveness and…

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