Abstracts tagged "clinical trial"

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…
Abstract Number: 0217 • ACR Convergence 2024
Understanding Treatment Goals and Factors Influencing Decisions About Clinical Trial Participation in Lupus Patients from Diverse Backgrounds
Joy Buie¹, Safoah Agyemang¹ and Joan Merrill², ¹Lupus Foundation of America, Washington, DC, ²Oklahoma Medical Research Foundation, Oklahoma City 73104, OK
Background/Purpose: With many emerging treatments in development for lupus, clinical trial recruitment has become increasingly difficult. Growing appreciation of patient input into trial design may be of …
Abstract Number: 0583 • ACR Convergence 2024
Impact of Prior Tumor Necrosis Factor Inhibitor Treatment and Baseline Psoriatic Arthritis Disease Activity on Minimal Clinically Important Improvement Thresholds for Efficacy Outcomes: Post Hoc Analysis of Three Phase 3 Studies of Guselkumab in Patients with Active Psoriatic Arthritis
Alexis Ogdie¹, Philip Mease², Francois Nantel³, Frederic Lavie⁴, Mohamed Sharaf⁵, Emmanouil Rampakakis⁶, Helena Marzo-Ortega⁷ and Laure Gossec⁸, ¹Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ²Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ³Nantel MedSci Consult, Montreal, QC, Canada, ⁴Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁵Johnson & Johnson, Middle East FZ LLC, Dubai, UAE, Dubai, United Arab Emirates, ⁶McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, ⁷NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁸Sorbonne Université, Paris, France
Background/Purpose: PsA disease activity (DA) and impact on patients (pts) are measured with clinical and pt-reported outcomes1. Minimal clinically important improvement (MCII), the smallest improvement…
Abstract Number: 0673 • ACR Convergence 2024
BCMA-CD19 Compound CAR-T (cCAR) Safely Provides a Complete Humoral Reset Eliminating All Autoantibodies Resulting in Long-term Medication-Free Complete Remission Among Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN) Patients
Yong Yuan¹, Shanzhi He², Wenli Zhang³, Hongyu Zhang⁴, Vincent M DeStefano⁵, Masayuki Wada⁵, Kevin Pinz⁵, Greg Deener⁵, Yu Ma⁶, Min Wang², Fugui Li⁷, Ming Hong¹, Chanjuan Zou², Mingxia Wang², Ling Ding², Yingwen Liang⁸, Yupo Ma⁵ and Weija Wang⁹, ¹Department of Translational Medicine, Zhongshan people's Hospital, Zhongshan, China (People's Republic), ²Department of Rheumatoid Immunology, Zhongshan people's Hospital, Zhongshan, China (People's Republic), ³Department of Hematology, Peking University Shenzhen Hosptial, Shenzhen, China (People's Republic), ⁴Department of Hematology, Peking University Shenzhen Hospital, Shenzhen, China (People's Republic), ⁵iCell Gene Therapeutics, Inc., Stony Brook, NY, ⁶iCAR Bio Therapeutics Ltd, Zhongshan, China (People's Republic), ⁷Department of Translational Medicine. Zhongshan people's Hospital, Zhongshan, China (People's Republic), ⁸Department of Translational Medicine, Zhongshan's people Hospital, Zhongshan, China (People's Republic), ⁹Department of Translational Research, Zhongshan people's Hospital, Zhongshan, China (People's Republic)
Background/Purpose: Medication free complete remission (CR) has been elusive in SLE. An open label investigator-initiated trial (IIT) infused SLE/LN patients with a novel cCAR targeting…
Abstract Number: 1121 • ACR Convergence 2024
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of AMG 329, a Monoclonal Antibody, in Conventional and Plasmacytoid Dendritic Cell-Mediated Rheumatic Diseases
Alan Kivitz¹, Stanley Cohen², Annie Lau-Kilby³, Yajing Sun³, Jiayin Huang³, Atasi Jana³, Susie Kim³, Yanping Wu³, Quinnie Yang³ and Lin Zhao³, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Metroplex Clinical Research Center, dallas, TX, ³Amgen Inc., Thousand Oaks, CA
Background/Purpose: AMG 329 (formerly HZN-1116), a human monoclonal antibody (mAb), binds to soluble and membrane-bound human feline McDonough sarcoma (FMS)-like tyrosine kinase 3 receptor ligand…
Abstract Number: 1395 • ACR Convergence 2024
Effects of Butyrate Supplementation in Modulation of Gut Microbiome and Its Metabolites in New Onset Rheumatoid Arthritis
Rebecca Blank¹, Alba Boix-Amoros², Erin Reilly³, Kevin Bu⁴, Ian Cunningham⁵, Renuka Nayak⁶, Andrew Patterson⁷, Jose Clemente⁴ and Jose Scher⁸, ¹NYU, New York, NY, ²Icahn School of Medicine, New York, NY, ³Penn State, State Park, PA, ⁴Icahn School of Medicine at Mount Sinai, New York, NY, ⁵NYU Langone Health, New York, NY, ⁶University of California, San Francisco (UCSF), San Francisco, CA, ⁷Penn State University, State College, PA, ⁸New York University School of Medicine, New York, NY
Background/Purpose: The gut microbiome and its metabolites are dysregulated in RA and other immune-mediated inflammatory diseases. However, the significance of this observation and its implications…
Abstract Number: 1538 • ACR Convergence 2024
Patient Reported Outcomes Analyses from AURORA 1 Clinical Trial: Lupus Impact Tracker and LupusPRO
Meenakshi Jolly¹, Matt Truman², Ronald Flauto³ and Kathryn Dao⁴, ¹Rush University, Chicago, IL, ²Aurinia Pharmaceuticals, Victoria, BC, Canada, ³Aurinia Pharmaceuticals, Rockville, MD, ⁴Rheum101, Rockville, MD
Background/Purpose: Voclosporin used in addition to Mycophenolate Mofetil and low dose oral steroids in patients with active Lupus Nephritis (LN) was found to be superior…
Abstract Number: 1927 • ACR Convergence 2024
Ethnic and Racial Minorities in Clinical Trials for Autoimmune Connective Tissue Disease Therapeutic Agents
Connor Buechler, Lindsey Wanberg, Cody Rasner, Nicole Theis-Mahon, Dawn Hackman and David Pearson, University of Minnesota, Minneapolis, MN
Background/Purpose: Black, Indigenous, and people of color (BIPOC) experience greater morbidity and mortality from autoimmune connective tissue diseases (AICTDs); thus, equitable access to randomized controlled…
Abstract Number: 2112 • ACR Convergence 2024
Discontinuation and Non-Publication of Osteoporosis Studies: An Observational Analysis of 7,670,624 Patients
Mohamed Abdelsalam¹, Asmaa al-Najjar², omnia Samy³, Rawan morse⁴, roaa Rafat⁵ and Mona Sajed⁶, ¹Rheumatology, Rehabilitation and Physical medicine department - faculty of medicine -Misr University for science and technology, 6th of October, Al Jizah, Egypt, ²Faculty of medicine - Al-Azhar university in Gaza, Gaza, Palestinian Territories, ³Faculty of medicine - Zagazig university, Al Zagazig, Egypt, ⁴Medical Research Group of Egypt, Bur sa'id, Egypt, ⁵Faculty of medicine, Ahfad University for Women, Khartoum, Sudan, Cairo, Egypt, ⁶Faculty of Pharmacy - Al-Azhar university for girls, Mansoura, Ad Daqahliyah, Egypt
Background/Purpose: Osteoporosis (OP) is one of the most common diseases, especially in old age, and as the population ages, the burden of osteoporosis is expected…
Abstract Number: 2425 • ACR Convergence 2024
Ianalumab Induced Durable Depletion of Circulating B Cell Subsets and Associated Changes in B Cell and Neutrophil Transcriptomic and Proteomic Profiles in Patients with Systemic Lupus Erythematosus: 52-Week Treatment Results from a Phase 2 Trial
Marianna Rowlands¹, Thomas Dörner², Diego Saldana Miranda³, Justin McMullen³, Aida Santos da Costa³, Ulrike Sommer³, Rainer Hillenbrand³, Andre Nogueira da Costa³, Claire Bonal³, Isabelle Isnardi³, Edward Khokhlovich¹ and Stephen J Oliver³, ¹Biomedical Research, Novartis, Cambridge, MA, ²Department of Medicine, Rheumatology and Clinical Immunology,Charite Universitätsmedizin Berlin, Germany and DRFZ, Berlin, Berlin, Germany, ³Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Ianalumab (VAY736), a B cell activating factor receptor (BAFFR) targeting mAb, depletes B cells via both antibody dependent cellular cytotoxicity and blockade of BAFF:BAFFR…
Abstract Number: 0278 • ACR Convergence 2024
Efficacy and Safety of Genakumab versus Compound Betamethasone in Gout: The GUARD-1 Study
Yu Xue¹, Tianshu Chu², Jiankang Hu³, Wei Gou⁴, Ning Zhang⁵, Juan Li⁶, Jing Yu⁷, Songping Li⁸, Songbin Li⁹, Long Qian¹⁰, Xinwang Duan¹¹, Lihua Duan¹² and Hejian Zou¹, ¹Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China, Shanghai, China (People's Republic), ²Department of Rheumatology, Henan Provincial People's Hospital, Zhengzhou, China, Zhengzhou, China (People's Republic), ³Department of Rheumatology, Pingxiang People's Hospital, Pingxiang, China, Pingxiang, China (People's Republic), ⁴Department of Rheumatology, Hebei Petro China Central Hospital, Langfang, China, Langfang, China (People's Republic), ⁵Department of Rheumatology, Shengjing Hospital of China Medical University, Shenyang, China, Shenyang, China (People's Republic), ⁶Department of Rheumatology, The First Affiliated Hospital of Hainan Medical University, Haikou, China, Haikou, China (People's Republic), ⁷Department of Rheumatology, The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China, Shenyang, China (People's Republic), ⁸Department of Rheumatology, The First Affiliated Hospital of Ganna Medical University, Ganzhou, China, Ganzhou, China (People's Republic), ⁹Department of Rheumatology, The First Hospital of Qiqihar, Qiqihar, China, Qiqihar, China (People's Republic), ¹⁰Department of Rheumatology, The Second Hopital of Anhui Medical University, Hefei, China, Hefei, China (People's Republic), ¹¹Department of Rheumatology, The Second Affiliated Hospital of Nanchang University, Nanchang, China, Nanchang, China (People's Republic), ¹²Department of Rheumatology, Jiangxi Provincial People's Hospital, Nanchang, China, Nanchang, China (People's Republic)
Background/Purpose: The GUARD (Genakumab in high Uric Acid-induced Arthritis/goutfor Resolution and Delay study) program was designed to investigate the efficacy and safety of Genakumab, a…
Abstract Number: 0587 • ACR Convergence 2024
Achieving Stringent Disease Control Criteria Was Associated with Greater Work Productivity Improvements in Patients with Active Psoriatic Arthritis: Results from Two Phase 3 Studies of Bimekizumab
William Tillett¹, Dafna Gladman², Laure Gossec³, Jason Eells⁴, Patrick Healy⁵, Barbara Ink⁴, Nikos Lyris⁴ and Jessica A Walsh⁶, ¹Royal National Hospital of Rheumatic Diseases; Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, ²University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ³Sorbonne Université, Paris, France, ⁴UCB Pharma, Slough, United Kingdom, ⁵UCB Pharma, Morrisville, NC, ⁶Division of Rheumatology, Salt Lake City Veterans Affairs Health and University of Utah Health, Salt Lake City, UT
Background/Purpose: Psoriatic arthritis (PsA) negatively impacts patients’ physical health and functional ability, which can contribute to reduced work productivity.1,2 We examined the association between achieving…
Abstract Number: 0682 • ACR Convergence 2024
Results from Outcomes Selection and Development of a Patient-reported Outcome Measure for a Combined Response Index for Limited Cutaneous SSc: The CRISTAL Project
Alain Lescoat¹, Yen Chen², Susan Murphy³, Nadia Vann², Neda Kortam², Rosemary Gedert², Sue Farrington⁴, Yannick Allanore⁵, David Cella⁶, Lorinda Chung⁷, Philip Clements⁸, Christopher Denton⁹, Francesco Del Galdo¹⁰, Oliver Distler¹¹, Monique Hinchcliff¹², Michael Hughes¹³, Laura Hummers¹⁴, John Pauling¹⁵, Janet Pope¹⁶, Virginia Steen¹⁷, John Varga², Peter Merkel¹⁸, Maya H. Buch¹⁹ and Dinesh Khanna², and all CRISTAL collaborators, ¹CHU Rennes - University Rennes 1, Rennes, France, ²University of Michigan, Ann Arbor, MI, ³University of Michigan, Plymouth, MI, ⁴Scleroderma & Raynaud UK, London, United Kingdom, ⁵Université Paris Cité, Paris, France, ⁶Northwestern University, Chicago, IL, ⁷Stanford University, Woodside, CA, ⁸United States, Los Angeles, CA, ⁹University College London, Northwood, United Kingdom, ¹⁰University of Leeds, Leeds, United Kingdom, ¹¹Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland, Zurich, Switzerland, ¹²Yale School of Medicine, Westport, CT, ¹³Tameside and Glossop Integrated NHS Foundation Trust & The University of Manchester, Manchester, United Kingdom, ¹⁴Johns Hopkins University, Division of Rheumatology, Baltimore, MD, Ellicott City, MD, ¹⁵North Bristol NHS Trust, Bristol, United Kingdom, ¹⁶University of Western Ontario, London, ON, Canada, ¹⁷Georgetown University School of Medicine, Washington, DC, ¹⁸University of Pennsylvania, Philadelphia, PA, ¹⁹Division of Musculoskeletal & Dermatological Sciences, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom
Background/Purpose: Limited cutaneous systemic sclerosis (lcSSc) is the most frequent subset of scleroderma, yet there is a paucity of outcome measures available to assess symptoms…
Abstract Number: 1134 • ACR Convergence 2024
First-in-Human Evaluation of the Safety, Tolerability and Pharmacokinetics of the T Cell Receptor Signal Modulator AX-158
Christopher VanDeusen¹, Andres Gagete¹, Annelize Koch² and D Scott Batty Jr¹, ¹Artax Biopharma, Inc, Cambridge, MA, ²Simbec-Orion, Merthyr Tydfil, Wales, United Kingdom
Background/Purpose: Nck is a cytosolic protein that binds a domain of the T cell receptor (TCR) following TCR interaction to amplify responses from low affinity…

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