Ignite Creation Date:
2024-05-06 @ 3:28 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02298491
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2014-11-14
Brief Title:
CNS Sarcoidosis and Acthar Gel
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Clinical Biomarkers of Disease Activity and Treatment Responses in Patients With CNS Sarcoidosis Treated With HP Acthar Gel
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if treatment with HP Acthar Gel will result in the improvement and long-term stabilization of clinical and radiographic abnormalities that occur in patients with CNS sarcoidosis In addition it will also look at whether treatment will be also associated with improvement in measures of quality of life The treatment of CNS sarcoidosis involves the use of either corticosteroids such as prednisone or potent immunosuppressive agents such as methotrexate both which can induce severe long term side effects The adverse effects of steroids may be avoided by treatment with adrenocorticotropic hormone ACTH which is available for patient use as HP Acthar Gel The efficacies of HP Acthar Gel in the treatment of CNS sarcoidosis and the impact on quality of life have not been previously studied In addition little is known regarding the expression of immune markers in CNS sarcoidosis and the association of such markers with disease activity and response to treatment
Detailed Description:
Sarcoidosis is a chronic and frequently progressive systemic disease that affects the central nervous system CNS in approximately 5 of patients The hallmark of the disease is the development of chronic inflammation with formation of non-caseating granulomas that can involve the brain parenchyma and meninges and appear as contrast-enhancing mass lesions on magnetic resonance imaging The granulomas are primarily comprised of proinflammatory T cells Th1 cells and Th17 cells and macrophages which accumulate during the early stages of granuloma formation The inflammation that is generated by these cells is modulated by anti-inflammatory responses mediated by Th2 cells and regulatory T Treg cells that later appear and populate the outer regions of the granuloma The presence of Treg cells are of particular interest since these cell are also detected in high numbers in peripheral blood and the immune suppression that results may underlie the occurrence of anergy in patients with the disease The treatment of CNS sarcoidosis involves the use of either corticosteroids or potent immunosuppressive agents both which can induce severe long-term side effects The adverse effects of steroids may be avoided by treatment with adrenocorticotropic hormone ACTH which is available for patient use as HP Acthar Gel The efficacy of HP Acthar Gel in the treatment of CNS sarcoidosis and the impact on quality of life have not been previously examined In addition little is known regarding the expression of immune markers in CNS sarcoidosis and the association of such markers with disease activity and response to treatment These issues therefore will be explored in the context of this proposal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None