Abstracts tagged "clinical trial"

Abstract Number: 2584 • ACR Convergence 2024
Zasocitinib (TAK-279), an Oral, Selective Tyrosine Kinase 2 Inhibitor: Achievement of Remission and Additional Improvements in Disease Activity in Patients with Psoriatic Arthritis Enrolled in a Phase 2b Trial
Philip Mease¹, Alan Kivitz², Elena Muensterman³, Apinya Lertratanakul⁴, Ting Hong⁴, Jingjing Chen⁴, Ejim Mark⁵ and Xenofon Baraliakos⁶, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²Altoona Center for Clinical Research, Duncansville, PA, ³Takeda Development Center Americas, Cambridge, MA, ⁴Takeda Development Center Americas, Inc., Cambridge, MA, ⁵Takeda Development Center Americas Inc., Cambridge, ⁶Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany
Background/Purpose: Zasocitinib (TAK-279) is an oral, selective TYK2 inhibitor under investigation for the treatment of immune-mediated inflammatory diseases including psoriatic arthritis (PsA). In a phase…
Abstract Number: 0179 • ACR Convergence 2024
Bridging the Gap: Enhancing Diversity in Lupus Clinical Trials Through Investigator and Research Staff Engagement
Tessa Englund¹, Katherine Holben¹, Simone Frank², Khadeejatul-Kubraa Lawal¹, Julie Hsieh³, Christine Lee³ and Saira Sheikh¹, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²North Carolina Translational and Clinical Sciences Institute, University of North Carolina at Chapel Hill, Chapel Hill, NC, ³U.S. Food and Drug Administration, Silver Spring, MD
Background/Purpose: Lupus disproportionately affects diverse racial and ethnic minority populations, yet there is a significant disparity between those affected and those enrolled in clinical trials.…
Abstract Number: 0518 • ACR Convergence 2024
Sustained Patient Meaningful Outcomes of Pain and Fatigue Relief and Improved Physical Functioning with Filgotinib in Rheumatoid Arthritis: A Post Hoc Analysis
Rieke Alten¹, Bruno Fautrel², Philip G Conaghan³, Dick de Vries⁴, Margaux Faes⁵, Mercedes Piovesan⁶, Katrien Van Beneden⁷, Chris Watson⁸, Angelique E.A.M. Weel-Koenders⁹, Eugen Feist¹⁰ and Kurt de Vlam¹¹, ¹Department of Internal Medicine and Rheumatology, Schlosspark Klinik, University Medicine Berlin, Berlin, Germany, ²INSERM, UMRS 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Sorbonne University – Assistance Publique-Hôpitaux de Paris, Département de Rhumatologie, Hôpital Pitié-Salpêtrière, Paris, Ile-de-France, France, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁴Clinical Development, Galapagos BV, Leiden, Netherlands, ⁵Biostatistics, Galapagos NV, Mechelen, Belgium, ⁶Medical Affairs, Galapagos Biopharma Spain SLU, Madrid, Spain, ⁷Medical Affairs, Galapagos NV, Mechelen, Belgium, ⁸Medical Affairs, Galapagos Biotech Ltd, Cambridge, United Kingdom, ⁹Erasmus School of Health Policy and Management, Erasmus University Rotterdam, and Department of Rheumatology and Clinical Immunology, Maasstad Hospital, Rotterdam, Netherlands, ¹⁰Department of Rheumatology, Helios Clinic Vogelsang-Gommern, cooperation partner of the Otto von Guericke University Magdeburg, Gommern, Germany, ¹¹Department of Rheumatology, UZ Leuven, and Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, KU Leuven, Leuven, Belgium
Background/Purpose: Quality of life for patients with RA can be severely impacted by pain, fatigue and impaired physical functioning.1 Filgotinib (FIL) has demonstrated early onset…
Abstract Number: 0662 • ACR Convergence 2024
Deucravacitinib, a First-in-Class, Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in SLE: Efficacy by Baseline Demographics and Disease Characteristics in the Phase 2 PAISLEY Trial
Eric Morand¹, Cristina Arriens², Laura Geraldino³, Ann E. Clarke⁴, Samantha Pomponi⁵, Coburn Hobar⁵, Thomas Wegman⁶, Ravi Koti⁵, Subhashis Banerjee⁵ and Ronald Van Vollenhoven⁷, ¹School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia, ²Department of Arthritis and Clinical Immunology, Rheumatology, Oklahoma Medical Research Foundation and Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, ³Division of Rheumatology, Department of Medicine, Columbia University, New York, NY, ⁴Division of Rheumatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada, ⁵Bristol Myers Squibb, Princeton, NJ, ⁶Bristol Myers Squibb, Beaver Falls, PA, ⁷Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands
Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase (TYK2) inhibitor approved in multiple countries for the treatment of adults with moderate to severe…
Abstract Number: 0828 • ACR Convergence 2024
Efficacy of Eosinophil-Targeting Therapies on Specific Disease Manifestations of Eosinophilic Granulomatosis with Polyangiitis in the Phase 3 MANDARA Trial
Peter Merkel¹, David Jayne², Ulrich Specks³, Christian Pagnoux⁴, Benjamin Terrier⁵, Bernhard Hellmich⁶, Sofia Necander⁷, Anat Shavit⁸, Claire Walton⁹ and Michael Wechsler¹⁰, ¹University of Pennsylvania, Philadelphia, PA, ²University of Cambridge, Cambridge, United Kingdom, ³Mayo Clinic, Rochester, MN, ⁴Mount Sinai Hospital, Toronto, ON, Canada, ⁵Service de Médecine interne, Hôpital Cochin, AP-HP, Paris, Ile-de-France, France, ⁶Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, ⁷Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁸BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ⁹Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ¹⁰National Jewish Health, Denver, CO
Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare inflammatory disorder characterized by small- to medium-vessel vasculitis, asthma and eosinophilia. In the head-to-head MANDARA trial…
Abstract Number: 1385 • ACR Convergence 2024
A Novel Oral 3D-Printed Delayed- and Extended-Release Tofacitinib (T19) for the Treatment of Rheumatoid Arthritis and Related Inflammatory Diseases
Yue Zhou, Meng Ji, luo wang, Feihuang Deng, Senping Cheng, Xiaoling Li and Yulian Zhang, Triastek, Inc., Nanjing, China (People's Republic)
Background/Purpose: Patients with inflammatory diseases, such as rheumatoid arthritis (RA), frequently continue to suffer from morning symptoms despite treatment with conventional therapies 1,2. Routine morning…
Abstract Number: 1481 • ACR Convergence 2024
Safety of Secukinumab in Patients with Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis and Hidradenitis Suppurativa: Updated Pooled Data from 69 Clinical Trials
Atul Deodhar¹, Iain McInnes², Xenofon Baraliakos³, Alice Gottlieb⁴, Uta Kiltz⁵, Stefan Schreiber⁶, Braja Gopal Sahoo⁷, Weibin Bao⁸, Corine Gaillez⁹, Mercedes Bustamante⁹ and Philip Mease¹⁰, ¹Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ²University of Glasgow, College of Medical Veterinary and Life Sciences, Glasgow, United Kingdom, ³Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany, ⁴Icahn School of Medicine at Mount Sinai, Department of Dermatology, Seattle, WA, ⁵Rheumazentrum Ruhrgebiet Herne, Ruhr-University, D-44649 Herne, Germany, ⁶University Hospital Schleswig-Holstein, Kiel, Germany, Kiel, Germany, ⁷Novartis Healthcare Private Limited, Hyderabad, India, ⁸Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁹Novartis Pharma AG, Basel, Switzerland, ¹⁰Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA
Background/Purpose: Secukinumab, a fully human anti-interleukin (IL)-17A monoclonal antibody, is approved for multiple immunological disorders, including moderate-to-severe plaque psoriasis (PsO), psoriatic arthritis (PsA), axial spondyloarthritis…
Abstract Number: 1758 • ACR Convergence 2024
Minimal Spinal Radiographic Progression in Patients with Radiographic Axial Spondyloarthritis over 2 Years of Bimekizumab Treatment: Results from a Phase 3 Open-Label Extension Study
Xenofon Baraliakos¹, Sofia Ramiro², Walter Maksymowych³, Mikkel Ostergaard⁴, Ute Massow⁵, Thomas Vaux⁶, Chetan Prajapati⁶, Alexander Marten⁵, Natasha de Peyrecave⁷ and Denis Poddubnyy⁸, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ²Leiden University Medical Center, Bunde, Netherlands, ³University of Alberta, Edmonton, AB, Canada, ⁴Department of Clinical Medicine, University of Copenhagen and Center for Rheumatology, Copenhagen Center for Arthritis Research, Glostrup, Denmark, ⁵UCB Pharma, Monheim am Rhein, Germany, ⁶UCB Pharma, Slough, United Kingdom, ⁷UCB Pharma, Brussels, Belgium, ⁸Charite-Universitatsmedizin Berlin, Berlin, Germany
Background/Purpose: The effect of bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)‑17F in addition to IL-17A, on structural radiographic progression in the…
Abstract Number: 2093 • ACR Convergence 2024
Treatment of Advanced Knee OA with Lorecivivint Leads to Improved Long-Term Patient Acceptable Symptom State (PASS) Compared to Placebo: Data from Phase 3 Extension Trial
Christopher Swearingen¹, Yusuf Yazici², Jeyanesh Tambiah³ and Philip G Conaghan⁴, ¹Biosplice Therapeutics, Inc, San Diego, CA, ²NYU Grossman School of Medicine, La Jolla, CA, ³Biosplice Therapeutics Inc., San Diego, CA, ⁴Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Background/Purpose: Lorecivivint (LOR), an intra-articular CLK/DYRK inhibitor thought to modulate inflammatory and Wnt pathways, demonstrated beneficial effects on clinical and radiographic outcomes in previous knee…
Abstract Number: 2366 • ACR Convergence 2024
Improvement in Pain-Associated Biomarkers with Deucravacitinib, a First-in-Class, Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Patients with PsA in a Double-Blind Phase 2 Study (IM011-084)
Philip Mease¹, Christopher Ritchlin², Lu Gao³, Peter Schafer⁴, Miroslawa Nowak³, Ian M. Catlett³ and Jinqi Liu³, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²Department of Medicine, Allergy, Immunology, and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, ³Bristol Myers Squibb, Princeton, NJ, ⁴Bristol Myers Squibb, BELLE MEAD, NJ
Background/Purpose: Pain is a core domain of PsA, and reduction of pain is a primary treatment concern for patients with PsA. Pain has been reported…
Abstract Number: 2611 • ACR Convergence 2024
Continuation versus Temporary Interruption of Immunomodulatory Agents in Case of an Infection in IRD Patients: Results of a Randomized Controlled Trial
Merel Opdam¹, Nathan den Broeder², Reinout van Crevel³, Lisa Schapink⁴, Léon Raijmakers⁴, Jasper Broen⁵, Lise Verhoef⁴ and Alfons den Broeder¹, ¹Sint Maartenskliniek, Ubbergen, Netherlands, ²Sint Maartenskliniek, Ubbergen, Gelderland, Netherlands, ³Radboudumc, Nijmegen, Netherlands, ⁴Sint Maartenskliniek, Nijmegen, Netherlands, ⁵Máxima Medical Centre, Eindhoven, Netherlands
Background/Purpose: Immunomodulatory agents (IA) are widely used for the treatment of inflammatory rheumatic diseases (IRDs). Although IA are safe and effective, management of infections and infection…
Abstract Number: 0180 • ACR Convergence 2024
Collaborative Solutions to Lupus Trial Challenges for Underrepresented Participant Recruitment & Engagement: Perspectives from the Lupus Clinical Investigators Network (LuCIN)
Brandon Jackson¹, Maria Dall'Era², Saira Sheikh³, Xueting Zhang⁴, Taylor Irons⁵, Claire Finney⁶, Taylor Adjei⁷, Jennifer Meriwether⁷, Caroline Donovan⁸, Carla Menezes⁹ and Stacie Bell¹⁰, ¹Lupus Research Alliance / Lupus Therapeutics, Miami, FL, ²UCSF, Corte Madera, CA, ³University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁴Weill Cornell, New York, NY, ⁵Lupus Research Alliance / Lupus Therapeutics, Houston, ⁶Lupus Research Alliance / Lupus Therapeutics, Birmingham, AL, ⁷Lupus Research Alliance / Lupus Therapeutics, New York, NY, ⁸Lupus Research Alliance / Lupus Therapeutics, Arlington, VA, ⁹Lupus Research Alliance / Lupus Therapeutics, Brooklyn, NY, ¹⁰Lupus Therapeutics, Lakewood, CO
Background/Purpose: Racial and ethnic minority groups face higher lupus prevalence and severity and remain inadequately represented in lupus clinical trials. Lupus Therapeutics, the clinical affiliate…
Abstract Number: 0526 • ACR Convergence 2024
Comparing Immunogenicity and Safety Following Transition from Reference Rituximab to Biosimilar Rituximab (DRL_RI) in Patients with Rheumatoid Arthritis: A Randomized, Double-blind, Phase 3 Study
Narendra Maharaj¹, Dharma rao Uppada², Naveen Reddy MAREDDY¹, Pramod Reddy Pundra¹, Anastas Batalov³, Delina Ivanova⁴, nedyalka staykova⁵, Asta Baranauskaite⁶ and Laila Hassan⁷, ¹Clinical Development - Biologics, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad 500090, India, Hyderabad, India, ²Clinical Development - Biologics, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad 500090, India, Hyderabad, ³Medical University of Plovdiv, Medical Faculty, University Hospital "Kaspela", Clinic of Rheumatology, Plovdiv 4000, Bulgaria, Plovdiv, Bulgaria, ⁴Diagnostic and Consulting Center Aleksandrovska EOOD Sofia 1431, Bulgaria, Sofia, Bulgaria, ⁵Outpatient Clinic for Specialized Medical Help – Medical Center Kuchuk Paris OOD; Plovdiv 4004, Bulgaria, plovdiv, Bulgaria, ⁶Hospital of Lithuanian University of Health Sciences Kauno Klinikos, LT-50161, Lithuania, Kaunas, Lithuania, ⁷11914 Astoria Blvd. Ste. 330, Houston TX 77089 United States, Houston, TX
Background/Purpose: To assess immunogenicity and safety in patients with active rheumatoid arthritis (RA) transitioning from US-Rituximab (RP) or EU-Rituximab (RMP) to DRL_RI (proposed rituximab biosimilar),…
Abstract Number: 0670 • ACR Convergence 2024
A Randomized, Open-Label, Phase III Trial Comparing Efficacy and Safety of Intravenous Cyclophosphamide, Mycophenolate Mofetil, or Tacrolimus as Induction Therapy in Lupus Nephritis
Alekhya Amudalapalli, Ashlesha Shukla, Abhichandra Maddineni, Sandeep Nagar, Sudhish Gadde, Harish BV, Rashmi Ranjan Sahoo and Pradeepta Sekhar Patro, IMS and SUM Hospital, Bhubaneswar, India
Background/Purpose: The optimal treatment for lupus nephritis is challenging due to its heterogeneity and the lack of prognostic factors favoring one immunosuppressive drug over another.…
Abstract Number: 1030 • ACR Convergence 2024
Diversity in Axial Spondyloarthritis Drug Trials: Examining Enrollment by Sex, Race, Ethnicity and Geographic Region
Mathieu Choufani¹, Wissam Ghusn² and Joerg Ermann³, ¹Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, ²Department of Internal Medicine, Boston Medical Center, Boston, MA, ³Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
Background/Purpose: While axial spondyloarthritis (AxSpA) was historically perceived as a "white man's disease", it is now appreciated as a condition that can affect individuals of…

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