Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071487
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2003-10-24
Brief Title:
Safety and Efficacy Study of LymphoStat-B Belimumab in Subjects With Systemic Lupus Erythematosus SLE
Sponsor:
Human Genome Sciences Inc
Organization:
Human Genome Sciences Inc
Study Overview
Official Title:
A Phase 2 Multi-Center Double-Blind Placebo-Controlled Dose-Ranging Study to Evaluate the Safety Tolerability and Efficacy of LymphoStat-B Antibody Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus SLE
Status:
COMPLETED
Status Verified Date:
2013-08
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 safety and efficacy of 3 different doses of belimumab administered in addition to standard therapy in patients with active SLE disease
Detailed Description:
The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab 1 mgkg 4 mgkg and 10 mgkg administered in addition to standard therapy compared to placebo plus standard therapy in patients with active SLE disease Patients were randomly assigned following stratification by the screening SELENA SLEDAI score 4 to 7 versus 8 to 1 of the 4 study arms 3 active arms and 1 placebo arm plus standard therapy for SLE All patients were to be dosed on Days 0 14 and 28 then every 28 days for the remainder of 52 weeks Patients completing the 52-week period could enter a 24-week open-label extension belimumab patients received the same dose or were switched to 10 mgkg at the investigators discretion and former placebo patients received belimumab 10 mgkg
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