Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430677
Status:
TERMINATED
Last Update Posted:
2015-03-20
First Post:
2007-02-01
Brief Title:
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase IIIII Multi-Center Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus SLE
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to failure to meet the primary efficacy endpoint in the Short-term Period
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 clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil MMF and corticosteroids
Detailed Description:
Double Blind Period Treatment Parallel Assignment Double Blind Subject Investigator Randomized Active Control SafetyEfficacy Study
Open Label Period Prevention Single Group Assignment Open Label Uncontrolled SafetyEfficacy Study
Open Label Period Prevention Single Group Assignment Open Label Uncontrolled SafetyEfficacy Study
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