Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119678
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2005-06-30
Brief Title:
Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus SLE Flares in Combination With Prednisone
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase IIB Multi-Center Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares
Status:
COMPLETED
Status Verified Date:
2014-09
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 clinical research study is to learn whether Abatacept can treat and prevent lupus flares specifically in patients with active lupus flares in at least one of three organ systems skin discoid lesions inflammation of the lining of the heart pericarditis or inflammation of the lining of the lung pleuritispleurisy or inflammation of more than 4 joints arthritis All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication The safety of this treatment will also be studied
Detailed Description:
None
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