Ignite Creation Date:
2024-05-06 @ 1:14 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01769937
Status:
COMPLETED
Last Update Posted:
2013-07-23
First Post:
2013-01-15
Brief Title:
Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus
Sponsor:
Fiechtner Justus J MD PC
Organization:
Fiechtner Justus J MD PC
Study Overview
Official Title:
A Single-site Investigator Initiated Open-Label Trial of HP Acthar Gel Repository Corticotropin Injectionan Adrenocorticotropic Hormone ACTH Analogue in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus SLE
Status:
COMPLETED
Status Verified Date:
2013-07
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:
ACTH
Brief Summary:
Systemic lupus erythematosus is a serious and potentially life-threatening condition with significant unmet medical need The aim of this Investigator Initiated single center open-label study is to evaluate the efficacy and safety of a daily subcutaneously SQ injection of HP Acthar Gel for 10 days with an optional 5 day rescue period for non-responders after day 10 dose The primary objective of this study is to evaluate whether the addition of HP Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score Patient and Physician global assessments
Detailed Description:
This is a Phase 4 Open-label Study to Evaluate the Treatment of Lupus Flares with HP Acthar Gel
The primary objective is to evaluate whether the addition of HP Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score Patient and Physician global assessments
The secondary objective is to evaluate any changes to the subjects BILAG scores and markers of inflammation eg ESR andor CRP
The Exploratory objective will determine the feasibility of a long-term double-blind study using HP Acthar Gel versus other usual treatments for lupus
The primary objective is to evaluate whether the addition of HP Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score Patient and Physician global assessments
The secondary objective is to evaluate any changes to the subjects BILAG scores and markers of inflammation eg ESR andor CRP
The Exploratory objective will determine the feasibility of a long-term double-blind study using HP Acthar Gel versus other usual treatments for lupus
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