Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410384
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2006-12-08
Brief Title:
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
Sponsor:
Human Genome Sciences Inc
Organization:
Human Genome Sciences Inc
Study Overview
Official Title:
A Phase 3 Multi-Center Randomized Double-Blind Placebo-Controlled 76-Week Study to Evaluate the Efficacy and Safety of Belimumab HGS1006 LymphoStat-B a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus SLE
Status:
COMPLETED
Status Verified Date:
2016-12
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:
BLISS-76
Brief Summary:
The purpose of this study is to evaluate the efficacy safety tolerability and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active autoantibody-positive systemic lupus erythematosus SLE disease
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 110751 | OTHER | GSK | None |
| BLISS-76 | None | None | None |