Ignite Creation Date:
2024-05-05 @ 11:30 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01345253
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2011-04-28
Brief Title:
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus SLE Located in Northeast Asia
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus SLE Located in Northeast Asia
Status:
COMPLETED
Status Verified Date:
2019-09
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 study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus SLE over a 52 week period
Detailed Description:
The purpose of this study is to demonstrate the efficacy and safety of belimumab 10mgkg administered intravenously IV every 4 weeks compared to placebo in patients with SLE when added to standard of care therapy as measured by the SLE Responder Index SRI at 52 weeks defined by a composite endpoint using SELENA SLEDAI score Physicians Global Assessment PGA and BILAG A and B organ domain scores
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None