Abstracts tagged "clinical trial"

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…
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…

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