Abstracts tagged "clinical trial"

Abstract Number: L05 • ACR Convergence 2024
Prolonged Plasma Urate-Lowering After a Single Intravenous Administration of PRX-115, a Novel PEGylated Uricase, in Participants with Elevated Urate Levels
Christian Schwabe¹, Orit Cohen Barak², Alexandra Cole³, Hadar Reuveni², Liron Shelev², Liora Blinder-Haddad² and Nicola Dalbeth⁴, ¹NZCR, Auckland, New Zealand, ²Protalix Ltd, Karmiel, Israel, ³NZCR, Christchurch, New Zealand, ⁴University of Auckland, Auckland, New Zealand
Background/Purpose: PEGylated uricases have already demonstrated therapeutic modality in the treatment of refractory gout patients. PRX-115 is a recombinant homotetrameric uricase enzyme, produced from Candida…
Abstract Number: L09 • ACR Convergence 2024
Efficacy and Safety of Tofacitinib in Patients with Active Systemic Juvenile Idiopathic Arthritis
Hermine Brunner¹, Caifeng Li², Kogie Chinniah³, Yosef Uziel⁴, Olga Synoverska⁵, Sujata Sawhney⁶, Inmaculada Calvo Penades⁷, Ingrid Clara Louw⁸, Meiping Lu⁹, Pooja Nikunj Patel¹⁰, Pamela F. Weiss¹¹, Cheng Chang¹², Ivana Vranic¹³, Shixue Liu¹⁴, Annette Diehl¹⁵, Jose L. Rivas¹⁶, Carol A. Connell¹⁷, Gary G. Koch¹⁸, Alberto Martini¹⁹, Daniel J. Lovell¹, Nicolino Ruperto²⁰ and the PRINTO and PRCSG investigators, ¹Cincinnati Children’s Hospital Medical Center, and University of Cincinnati, Cincinnati, OH, ²Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, Bejing, China, ³Department of Paediatrics and Child Health, University of Kwa-Zulu, and Enhancing Care Foundation, Durban, South Africa, ⁴Pedriatric Rheumatology Unit, Department of Pediatrics, Meir Medical Center and Israel Tel Aviv University School of Medicine, Kfar Saba, Israel, ⁵Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine, ⁶Sir Ganga Ram Hospital, New Delhi, India, ⁷Hospital Universitario y Politécnico La Fe, Valencia, Spain, ⁸Panorama Medical Centre, Cape Town, South Africa, ⁹Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China, ¹⁰Ann & Robert H. Lurie Children’s Hospital of Chicago; Northwestern University School of Medicine, Chicago, IL, ¹¹Division of Rheumatology, Children's Hospital of Philadelphia, and University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, ¹²Pfizer Inc, New York, NY, ¹³Pfizer Ltd, Tadworth, United Kingdom, ¹⁴Pfizer Inc, Shanghai, China, ¹⁵Pfizer Inc, Collegeville, PA, ¹⁶Pfizer SLU, Madrid, Spain, ¹⁷Pfizer Inc, Groton, CT, ¹⁸University of North Carolina at Chapel Hill, Chapel Hill, NC, ¹⁹University of Genoa, Genoa, Italy, ²⁰Università Milano Bicocca, Milano, and IRCCS Fondazione San Gerardo dei Tintori, Monza, Italy
Background/Purpose: Tofacitinib (TOF) has been shown to be efficacious in the treatment of polyarticular course JIA, including systemic JIA (sJIA) without active systemic features. Here…
Abstract Number: L10 • ACR Convergence 2024
Neuroimmune Modulation in Adults with Rheumatoid Arthritis and Inadequate Response or Intolerance to Biological or Targeted Synthetic DMARDs: Results at 12 and 24 Weeks from a Randomized, Sham-Controlled, Double-Blind Pivotal Study
John Tesser¹, Joshua June², Pendleton Wickersham³, Jane Box⁴, Guillermo Valenzuela⁵, Angela Crowley⁶, Nikila Kumar⁷, Norman Gaylis⁸, Gordan Lam⁹, David Ridley¹⁰, Gineth Paola Pinto-Patarroyo¹¹ and David Chernoff¹², ¹Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ²Great Lakes Center of Rheumatology, Lansing, MI, ³Arthritis Associates PA, San Antonio, TX, ⁴DJL Clinical Research, PLLC, Charlotte, NC, ⁵Guillermo Valenzuela MD PA/ IRIS Rheumatology, Plantation, FL, ⁶Illinois Bone and Joint Institute - Hinsdale Orthopaedics, Hinsdale, IL, ⁷Arizona Arthritis & Rheumatology Associates, Scottsdale, AZ, ⁸Arthritis & Rheumatic Disease Specialties, Aventura, FL, ⁹Arthritis & Osteoporosis Consults of the Carolinas, Charlotte, NC, ¹⁰St. Paul Rheumatology, Eagan, MN, ¹¹Annapolis Rheumatology, Fairfax, VA, ¹²SetPoint Medical, Sausalito, CA
Background/Purpose: In this study, we evaluated the safety and efficacy of an implantable, cervical vagus nerve stimulation device for treatment of RA. Methods: This randomized,…
Abstract Number: L16 • ACR Convergence 2024
Dapirolizumab Pegol Demonstrated Significant Improvement in Systemic Lupus Erythematosus Disease Activity: Efficacy and Safety Results of a Phase 3 Trial
Megan Clowse¹, David Isenberg², Joan Merrill³, Thomas Dörner⁴, Michelle Petri⁵, Edward Vital⁶, Eric Morand⁷, Teri Jimenez⁸, Stephen Brookes⁹, Janine Gaiha-Rohrbach¹⁰, Christophe Martin¹¹, Annette Nelde¹² and Christian Stach¹³, ¹Division of Rheumatology and Immunology, Duke University, Durham, NC, ²Department of Ageing, Rheumatology and Regenerative Medicine, Division of Medicine, University College London, London, United Kingdom, ³Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁴Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany, ⁵Johns Hopkins University School of Medicine, Baltimore, MD, ⁶Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁷Centre for Inflammatory Diseases, Monash University, Melbourne, Australia, ⁸UCB, Raleigh, NC, ⁹Biogen, Maidenhead, United Kingdom, ¹⁰Biogen, Cambridge, MA, ¹¹UCB, Slough, United Kingdom, ¹²Biogen, Baar, Switzerland, ¹³UCB, Monheim am Rhein, Germany
Background/Purpose: Dapirolizumab pegol (DZP) is a novel, polyethylene glycol (PEG)-conjugated antigen-binding (Fab') fragment, lacking an Fc domain, that inhibits CD40L signaling. By binding to CD40L,…
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…
Abstract Number: 0533 • ACR Convergence 2024
Using Adalimumab Serum Concentration to Choose a Subsequent DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment (ADDORA-switch): Results of a Blinded Randomized Test Treatment Trial
Maike Wientjes¹, Sadaf Atiqi², Gertjan Wolbink³, Michael Nurmohamed⁴, Maarten Boers⁵, Femke Hooijberg², Theo Rispens⁶, Annick De Vries⁶, Floris Loeff⁶, Ronald Van Vollenhoven⁷, Sofia Ramiro⁸, Noortje van Herwaarden⁹, Bart van den Bemt¹⁰ and Alfons den Broeder¹, ¹Sint Maartenskliniek, Ubbergen, Netherlands, ²Reade, Amsterdam, Netherlands, ³Reade and Sanquin Diagnostic Services, Amsterdam, Netherlands, ⁴Reade and Amsterdam UMC, Kortenhoef, Netherlands, ⁵Amsterdam UMC, Vrije Universiteit, Amersfoort, Netherlands, ⁶Sanquin Diagnostic Services, Amsterdam, Netherlands, ⁷Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁸Leiden University Medical Center, Bunde, Netherlands, ⁹Sint Maartenskliniek, Nijmegen, Netherlands, ¹⁰Sint Maartenskliniek / Radboudumc, Ubbergen, Netherlands
Background/Purpose: Adalimumab is an effective and safe treatment for RA, however a substantial proportion of RA patients discontinue its use due to inefficacy. Upon failure,…

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