Abstracts tagged "clinical trial"

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: 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: 0671 • ACR Convergence 2024
Effect of Litifilimab on Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI-A) Subcomponents and Physician Global Assessment–Skin (PGA–Skin) in Patients with Cutaneous Lupus Erythematosus (CLE) in a Phase 2 Study
Victoria Werth¹, Joseph F. Merola², Qianyun Li³, Weihong Yang³ and Catherine Barbey⁴, ¹Hospital of the University of Pennsylvania, Philadelphia, PA, ²UT Southwestern Medical Center, Dallas, TX, ³Biogen, Cambridge, MA, ⁴Biogen, Baar, Switzerland
Background/Purpose: In the randomized, placebo-controlled Phase 2 LILAC study of litifilimab (NCT02847598), Part B (participants with active CLE with/without SLE) met its primary endpoint of…
Abstract Number: 1039 • ACR Convergence 2024
Through the LuCIN Lens: Defining Barriers and Forging Solutions for Lupus Clinical Trials in North America
Brandon Jackson¹, Maria Dall'Era², Saira Sheikh³, Xueting Zhang⁴, Taylor Irons⁵, Jennifer Meriwether⁶, Maya Merrell¹ and Stacie Bell⁷, 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, New York, NY, ⁷Lupus Therapeutics, Lakewood, CO
Background/Purpose: Lupus Therapeutics (LT), the clinical affiliate of the Lupus Research Alliance, oversees the Lupus Clinical Investigators Network (LuCIN), a network of premier research sites…
Abstract Number: 1393 • ACR Convergence 2024
Relationship Between Disease Activity and Adverse Events in Rheumatoid Arthritis: An Integrated Post Hoc Analysis of Upadacitinib Phase 3 Trials
Roy Fleischmann¹, Zoltán Szekanecz², Eduardo Mysler³, Kevin Winthrop⁴, Kunihiro Yamaoka⁵, Kirsten Famulla⁶, Yanna Song⁷, Birgit Kovacs⁷, Sander Strengholt⁸ and Gerd Burmester⁹, ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²University of Debrecen, Debrecen, Hungary, ³Organizacion Medica de Investigacion, Buenos Aires, AR, Buenos Aires, Argentina, ⁴School of Medicine, Oregon Health and Science University, Portland, OR, ⁵Kitasato University School of Medicine, Sagamihara, Japan, ⁶AbbVie Deutschland GmbH & Co. KG, Immunology, North Chicago, ⁷AbbVie, North Chicago, IL, ⁸AbbVie Inc., North Chicago, IL, ⁹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany
Background/Purpose: Patients with RA are at a heightened risk of developing significant adverse events (AEs) such as MACE, VTE, and serious infectious events (SIE). Limited…
Abstract Number: 1531 • ACR Convergence 2024
Prospective mRNA SARS-CoV-2 Additional Vaccination in Systemic Autoimmune Disease Patients on Immunosuppressive Medications in a Randomized Controlled Trial
Meggan Mackay¹, Catriona Wagner², Ashley Pinckney³, Jeffrey Cohen⁴, Zachary Wallace⁵, Arezou Khosroshahi⁶, Jeffrey Sparks⁷, Sandra Lord⁸, Amit Saxena⁹, Roberto Caricchio¹⁰, Alfred Kim¹¹, Diane Kamen¹², Fotios Koumpouras¹³, Anca Askanase¹⁴, Kenneth Smith¹⁵, Joel Guthridge¹⁵, Susan Macwana¹⁶, Sean McCarthy¹⁷, Matthew Sherman¹⁸, Sanaz Daneshfar Hamrah¹⁹, Maria Veri¹⁹, Kate York²⁰, Sarah Walker²¹, Sandeep Narpala²², Robin Carroll²², Bob Lin²², Leonid Serebryanny²², Adrian McDermott²³, William Barry²¹, Ellen Goldmuntz²⁴, James McNamara²⁵, Sara Tedeschi²⁶, Amit Bar-Or²⁷, Dinesh Khanna²⁸, ACV01 Clinical Study Team¹⁵ and Judith James¹⁵, ¹Feinstein Institutes for Medical Research, Manhasset, NY, ²Oklahoma Medical Research Foundation, Santa Cruz, CA, ³Rho, St Louis Park, NC, ⁴Neurologic Institute, Cleveland Clinic, Cleveland, OH, USA, Cleveland, OH, ⁵Massachusetts General Hospital, Newton, MA, ⁶Emory University, Atlanta, GA, ⁷Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA, Boston, MA, ⁸Center for Interventional Immunology, Benaroya Research Institute, Seattle, WA., Seattle, WA, ⁹NYU School of Medicine, New York, NY, ¹⁰University of Massachusetts Chan Medical School, Worcester, MA, ¹¹Washington University School of Medicine, Division of Rheumatology, Department of Medicine, St Louis, MO, ¹²Medical University of South Carolina, Charleston, SC, ¹³Yale School of Medicine, New Haven, CT, ¹⁴Columbia University Medical Center, New York, NY, ¹⁵Oklahoma Medical Research Foundation, Oklahoma City, OK, ¹⁶Oklahoma Medical Research Foundation, Oklahoma City, ¹⁷DAIT/NIAID/NIH, Rockville, MD, ¹⁸DAIT/NIAID/NIH, Washington, DC, ¹⁹Division of Allergy, Immunology, and Transplantation, NIH/NIAID, Bethesda, MD, USA., Bethesda, MD, ²⁰Rho Federal Systems Division, Durham, NC, USA., Durham, NC, ²¹Rho, Durham, NC, ²²Vaccine Research Center, NIH/NIAID, Bethesda, MD, USA, Bethesda, MD, ²³Vaccine Research Center, NIH/NIAID, Bethesda, MD, ²⁴NIAID/ NIH, Washington, DC, ²⁵NIH, Bethesda, MD, ²⁶Brigham and Women's Hospital, Boston, MA, ²⁷Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA, Philadelphia, PA, ²⁸Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA, Ann Arbor, MI
Background/Purpose: Autoimmune disease patients treated with mycophenolate mofetil/mycophenolic acid (MMF/MPA), methotrexate (MTX), or B cell-depleting therapies (BCDT) exhibit reduced humoral responses following primary two-dose COVID-19…
Abstract Number: 1760 • ACR Convergence 2024
A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of a Mitogen-activated Protein Kinase-Activated Protein Kinase 2 (MK2) Inhibitor in Active Ankylosing Spondylitis
Walter Maksymowych¹, Robert Lambert¹, Paula Śliwinska-Stańczyk², Piotr Adrian Klimiuk³, Anusha Yeshokumar⁴, Elizabeth Cerullo⁴, Rebecca Kepich⁴, Chahin Pachai⁴ and Steven Greenberg⁴, ¹University of Alberta, Edmonton, AB, Canada, ²Centrum Medyczne ReumaPark, Warsaw, Poland, ³Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Department of Rheumatology and Internal Diseases, Białystok, Poland, ⁴Bristol Myers Squibb, Princeton, NJ
Background/Purpose: CC-99677 (also known as BMS-986371) is a novel, orally bioavailable, small-molecule covalent inhibitor of mitogen-activated protein (MAP) kinase-activated protein kinase 2 (MK2). The MK2…
Abstract Number: 2106 • ACR Convergence 2024
EP-104IAR (Long-Acting Intra-Articular Injection of Fluticasone Propionate) Shows Sustained Improvement in Pain for Subjects with Moderate Baseline Pain and BMI Less Than 30 in SPRINGBOARD, a Phase 2, Randomized, 24-Week Study of Osteoarthritis of the Knee
Amanda Malone¹, James Helliwell¹, Mark Kowalski¹, Helene Rovsing², Sidsel Lynggaard Boll³, Asger Reinstrup Bihlet⁴, Claire Prener Miller⁵, Alejandro Castillo Mondragón⁶, Yanqi Li⁶, Christine Dobek¹, Vik Peck¹, Andrew Dye¹, Mike Wilmink⁷, Lee Simon⁸ and Philip G Conaghan⁹, ¹Eupraxia Pharmaceuticals, Victoria, BC, Canada, ²NBCD A/S, Nordjylland, Denmark, ³NBCD A/S, Syddanmark, Denmark, ⁴NBCD A/S, Soeborg, Denmark, ⁵Novo Nordisk A/S, Bagsværd, Denmark, ⁶NBCD A/S, Soborg, Denmark, ⁷OrthoArizona, Phoenix, AZ, ⁸SDG LLC, West Newton, MA, ⁹Leeds 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: Knee osteoarthritis (KOA) is a leading cause of disability associated with risk of cardiovascular disease and reduced self-management of diabetes and hypertension. Recommended treatment…
Abstract Number: 2410 • ACR Convergence 2024
A Novel Treatment Response Measure for SLE Clinical Trials (TRM-SLE): Selection of Domains and Candidate Measures
Kathryn Connelly¹, Rachel Koelmeyer¹, Darshini Ayton¹, Lavanya Rajagopala², Ambika Wahklu², John May³, Raychel Barallon⁴, Rangi Kandane-Rathnayake⁵, Laura Eades¹, kate Gregory¹ and Eric Morand⁶, and the TRM-SLE Taskforce, ¹Monash University, Melbourne, Victoria, Australia, ²Monash Health, Melbourne, Victoria, Australia, ³Monash Medical Centre, Richmond, Victoria, Australia, ⁴Monash Health, Clayton, Victoria, Australia, ⁵Monash University, Clayton, Victoria, Australia, ⁶School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia
Background/Purpose: The success of randomised controlled trials (RCTs) in SLE has been hampered by limitations of current outcome measures, contributing to negative or discordant trial…

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