№ files_lp_3_process_7_073791
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Nonprofit healthcare organization announcement detailing the initiation of a Phase 3 sponsored clinical trial site in rural South Carolina to evaluate deucravacitinib for systemic lupus erythematosus and outlining participating investigators, institutional collaboration, and regional research context.
Date:
August 29, 2025
Location:
Florence, South Carolina
Organization:
HopeHealth
Sponsor:
Bristol Myers Squibb
Type of document:
Press release
Subject:
Launch of Phase 3 clinical trial site for systemic lupus erythematosus (SLE)
Clinical trial phase:
Phase 3
Investigational medication:
Deucravacitinib
Principal investigator:
Supen Patel
Chief medical officer:
Edward Behling
Corporate representative:
Andrew Whitehead
Disease focus:
Systemic lupus erythematosus (SLE)
Geographic focus:
Rural South Carolina, Pee Dee region
Participating population:
Patients with systemic lupus erythematosus
Issuing contact:
Monica Hanna, [email protected]
Note:
, (843) 432-2959
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Note:
Year
Subject:
Thrombophilia testing, Lupus Anticoagulant screening
Document Type:
Medical form
Target Audience:
Medical team, requesting clinicians
Context:
Medical form for requesting thrombophilia and lupus anticoagulant testing, including details for genetic testing and sample collection.
Document Type:
Supplementary table
Database:
Ovid MEDLINE
Subject:
Cutaneous Lupus Erythematosus and plant-derived or antimalarial interventions
Content Type:
Search strategy
Medical Subject Headings (MeSH):
Lupus Erythematosus, Cutaneous; Plants; Plant Structures; Fungi; Bacteria; Herbal Medicine; Antimalarials; Artemisinins; Chloroquine; Quinidine; Quinine
Keywords Included:
botanical terms, herbal medicine, traditional Chinese medicine, Janus kinase inhibitors, antimalarial agents, specific plant genera and compounds
Search Fields:
Title and abstract (ti,ab)
Boolean Logic:
Combination of controlled vocabulary and keyword terms using AND/OR operators
Purpose:
Identification of relevant biomedical literature
Year:
2010
Location:
Bethesda, Maryland, USA
Subject:
Systemic Lupus Erythematosus, Autoimmune Disease, Translational Research
Document type:
Conference Report
Organizers:
National Cancer Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Allergy and Infectious Diseases, Office of Research on Women’s Health, NIH
Collaborators:
Lupus Foundation of America, Inc.
Authors/Speakers:
Dr. Betty Diamond, Dr. Timothy Behrens, Dr. Howard Young, Dr. Silvia Bolland, Dr. Juan Rivera, Dr. Joe Craft, Dr. Mary Crow, Dr. David Close, Dr. Virginia Pascual, Dr. Mariana Kaplan
Conference dates:
September 2–3, 2010
Topics covered:
Interferon and innate responses, autoantibodies, lymphocyte activation, clinical challenges, genetic analysis of lupus, translational research from mouse models to human disease
Target audience:
Basic and clinical scientists, researchers in academia, industry, and government
Type of sessions:
Lectures, panel discussions, and research presentations
Research focus:
Mechanisms of lupus pathogenesis, type I interferon signature, B cell and T cell involvement, translational insights from mouse models, therapeutic development, clinical trials
Summary:
Conference proceedings detailing presentations and discussions on systemic lupus erythematosus, including translational studies from mouse models to human disease, mechanisms of immune dysregulation, and emerging therapies.
Year:
2013–2016
Region / City:
Belo Horizonte, Brazil
Topic:
Systemic Lupus Erythematosus, Endothelial Microparticles
Document Type:
Research Article
Institution:
Federal University of Minas Gerais, Santa Casa Hospital
Authors:
Walter B. Cicarini, Karine S. Ferreira, Cristina M.G. Loures, Renato V. Consoli, Cláudia L.S. Neiva, Paulo M. Pádua, Fernanda F.C. Nunes, Luan C.V. Alves, Edna A. Reis, Vicente P.C.P Toledo, Bashir A. Lwaleed, Maria G. Carvalho
Funding:
CNPq, CAPES, FAPEMIG
Study Design:
Cross-sectional
Participants:
90 women, including healthy volunteers and SLE patients with low and moderate/high disease activity
Methods:
Blood collection, ultracentrifugation, flow cytometry
Outcome Measures:
Endothelial microparticles levels, correlation with SLEDAI-2K Score and age
Ethical Approval:
Research Ethics Committee of the Federal University of Minas Gerais, Reference 01928412.8.0000.5149
Inclusion Criteria:
Women aged-matched, SLE diagnosis per ACR criteria 1997
Exclusion Criteria:
Other autoimmune diseases, anticoagulant use, pregnancy, immunosuppressive diseases
Treatment:
Azathioprine, Prednisone, Hydroxychloroquine
Corresponding Author:
Bashir A. Lwaleed, University of Southampton, UK
Year:
2023
Region / City:
Australia
Topic:
Oncology, Urothelial carcinoma, Immunotherapy
Document type:
Medical submission
Organization / Institution:
Bristol-Myers Squibb Australia Pty Ltd
Author:
Unknown
Target audience:
Medical practitioners, healthcare professionals
Period of validity:
Ongoing
Approval date:
2023
Date of amendments:
N/A
Source:
TGA/PBAC Parallel Process
Indication:
First-line treatment for unresectable or metastatic urothelial carcinoma
Treatment phase:
Initial and Continuing treatment
Condition:
Unresectable or metastatic urothelial carcinoma
Treatment criteria:
Patient must meet specific clinical and therapeutic criteria
Year:
2022
Region / City:
Australia
Theme:
Oncology, Medical Treatment
Document Type:
Pharmaceutical Submission
Organization / Institution:
Bristol-Myers Squibb Australia Pty Ltd
Author:
Not specified
Target Audience:
Medical professionals, Oncologists
Period of validity:
Ongoing
Approval Date:
4 July 2018
Date of Changes:
Not specified
Note:
Contextual Description
Year:
2021
Region / city:
Australia
Theme:
Cancer treatment
Document type:
Submission for Authority Required listing
Organization / institution:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Bristol-Myers Squibb Australia Pty Ltd
Target audience:
Medical practitioners
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
Australia
Subject:
Cancer Treatment / Immunotherapy
Document Type:
Submission
Organ / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Bristol-Myers Squibb
Target Audience:
Medical professionals, healthcare policy makers, pharmaceutical industry stakeholders
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Organization:
Child Development Center for Bristol-Myers Squibb
Date:
Monday, October 3, 2016
Type of document:
Weekly newsletter
Region:
United States
Programs mentioned:
Preschool/Kindergarten (PS/K)
Events:
Picture Day; Parent Partnership Call; Music for PS/K; Field Trip to Windsor Farm; Read for the Record; Harvest Festival; Homefront Food Drive
Workshops:
Weekly pregnancy workshop by March of Dimes
Location details:
Lawrenceville and Hopewell Child Development Centers
Contacts:
Kelli Mueller; Cyndi Guler; Jessica Goldfarb; Kim Murillo
Related platform:
Yammer (U.S. Work/Life Programs)
Curriculum reference:
Bright Horizons – The World at Their Fingertips®
Audience:
Families of enrolled children
Year:
2023
Region / City:
Not specified
Topic:
Program Scope Change
Document Type:
Instruction Form
Organization:
Bristol Myers Squibb
Author:
Not specified
Target Audience:
Requestors submitting program change requests
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Contextual Description:
Instruction form for submitting program scope change requests to Bristol Myers Squibb.
Year:
2025
Region / City:
Australia
Subject:
Myelofibrosis treatment
Document Type:
Pharmaceutical Submission
Organization / Institution:
Services Australia
Author:
Unknown
Target Audience:
Medical Practitioners
Period of Validity:
N/A
Approval Date:
February 13, 2025
Modification Date:
N/A