Abstracts tagged "clinical trial"

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…
Abstract Number: 1392 • ACR Convergence 2024
Safety and Efficacy of Upadacitinib (UPA) in Japanese Patients with Rheumatoid Arthritis (RA) and Inadequate Response to Conventional Synthetic DMARDs: Results Through 5 Years from the SELECT-SUNRISE Study
Hideto Kameda¹, Tsutomu Takeuchi², Kunihiro Yamaoka³, Motohiro Oribe⁴, Mitsuhiro Kawano⁵, Masayuki Yokoyama⁶, Yuko Konishi⁶, Sumi Chonan⁶, Sara Penn⁷, Heidi S Camp⁷ and Yoshiya Tanaka⁸, ¹Toho University, Tokyo, Japan, ²Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, ³Kitasato University School of Medicine, Kanagawa, Japan, ⁴Oribe Clinic of Rheumatism and Medicine, Oita, Japan, ⁵Kanazawa Medical University, Ishikawa, Japan, ⁶AbbVie GK, Tokyo, Japan, ⁷AbbVie, North Chicago, IL, ⁸Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan
Background/Purpose: To evaluate the efficacy and safety of UPA in Japanese RA patients (pts) up to 5 yrs in a long term extension (LTE) of…
Abstract Number: 1494 • ACR Convergence 2024
Trajectories of Disease Evolution upon Treatment Initiation in Systemic Lupus Erythematosus: Pooled Results from Three Randomized Clinical Trials of Belimumab
Ioannis Parodis¹, Julius Lindblom², Alexandre Tsoi³, Dionysis Nikolopoulos⁴ and Lorenzo Beretta⁵, ¹Karolinska Institutet, Karolinska University Hospital; Örebro University, Solna, Sweden, ²Karolinska Institutet, Stockholm, Sweden, ³Karolinska Institute, Stockholm, Sweden, ⁴Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, ⁵Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di MIlano, Milan, Milan, Italy
Background/Purpose: The efficacy of belimumab in treating SLE has been demonstrated in several phase 3 randomized clinical trials (RCTs). These trials showed belimumab efficacy on…
Abstract Number: 1759 • ACR Convergence 2024
Predictors of Radiographic Spinal Progression in Patients with Axial Spondyloarthritis Receiving IL-17A Inhibitor or TNF Inhibitor Therapy over 2 Years: A Post Hoc Analysis of a Phase IIIb Study
Denis Poddubnyy¹, Juergen Braun², Pedro M Machado³, Victoria Navarro Compán⁴, Lianne S Gensler⁵, Kay Geert Hermann⁶, Erhard Quebe-Fehling⁷, Christelle C Pieterse⁸, Aimee Readie⁹, Corine Gaillez⁷ and Xenofon Baraliakos¹⁰, ¹Charite-Universitatsmedizin Berlin, Berlin, Germany, ²Rheuma Praxis, Ruhr-University Bochum, Berlin, Germany, ³Department of Neuromuscular Diseases and Centre for Rheumatology, University College London, London, United Kingdom, ⁴La Paz University Hospital, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain, ⁵Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁶Charite Medical School, Berlin, Germany, ⁷Novartis Pharma AG, Basel, Switzerland, ⁸Syneos Health, Amsterdam, Netherlands, ⁹Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁰Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany
Background/Purpose: Previous studies have identified predictors of radiographic spinal progression in patients with axial spondyloarthritis (axSpA). In this post hoc analysis of the SURPASS study…
Abstract Number: 2102 • ACR Convergence 2024
Unraveling Knee Osteoarthritis Subtypes: Differential Effect of Oral Salmon Calcitonin Treatment
Monica Hannani¹, Peder Frederiksen², Morten Karsdal², Asger Reinstrup Bihlet³, Jaume Bacardit⁴, Anne-Christine Bay-Jensen² and Christian Thudium², ¹Nordic Bioscience & University of Copenhagen, Herlev, Denmark, ²Nordic Bioscience, Herlev, Denmark, ³NBCD A/S, Soeborg, Denmark, ⁴School of Computing, Newcastle University, Newcastle upon Tyne, United Kingdom
Background/Purpose: Osteoarthritis (OA) patients are to this day left without effective treatment options. Despite different etiologies, trials designs do not account for the substantial heterogeneity…
Abstract Number: 2370 • ACR Convergence 2024
Redefining Clinical Trial Inclusion Criteria Using Quality of Life in Cutaneous Lupus Erythematosus
Daniella Faden¹, lillian Xie², Caroline Stone¹, Lais Lopes Almeida Gomes¹, Ahmed Eldaboush¹, Cristina Ricco², Rui Feng² and Victoria Werth³, ¹University of Pennsylvania, Philadelphia, PA, ²University of Pennsylvania, Philadelphia, ³University of Pennsylvania, Wynnewood, PA
Background/Purpose: Regulatory guidance on endpoint measures for disease activity in cutaneous lupus erythematosus (CLE) patients is essential to improve therapies. CLE profoundly impacts quality of…
Abstract Number: 0200 • ACR Convergence 2024
Evaluating the Effectiveness of Educational Initiatives on Recruiting Underrepresented Participants into SLE Clinical Trials
Maria Bacalao¹, Marie Maitre² and Shivani Kottur³, ¹UT Southwestern, Dallas, TX, ²Parkland Hospital, Dallas, TX, ³UT Southwestern Medical Center, Dallas, TX
Background/Purpose: Healthcare disparities in SLE clinical trials are well known, with minoritized individuals facing more significant SLE morbidity and mortality, while being underrepresented in randomized…

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