Ignite Creation Date:
2024-05-06 @ 8:35 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02779153
Status:
WITHDRAWN
Last Update Posted:
2019-09-13
First Post:
2016-05-18
Brief Title:
Acthar SLE Systemic Lupus Erythematosus
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Efficacy Safety and Steroid Sparing Effect of Acthar in Patients With Hematologic Manifestations of Systemic Lupus Erythematosus
Status:
WITHDRAWN
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
closed in agreement of the sponsor and institution due to lack of patient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Acthar SLE
Brief Summary:
This is a randomized study exploring the efficacy safety and steroid sparing ability of two doses 40 U and 80 U of Acthar in SLE patients with immune mediated hematologic manifestations requiring steroid use for a minimum of 2 weeks prior to screening
Detailed Description:
Acthar is currently labeled for use during an exacerbation or for maintenance therapy in selected SLE cases however data from prospective trials on hematologic manifestations of SLE are not available Due to the potential effect of lowering or eliminating autoantibodies the absence of bone marrow suppression and a steroid sparing effect Acthar may represent a novel therapeutic option in recalcitrant cases of hematologic SLE
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