Ignite Creation Date:
2024-05-06 @ 12:43 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01649765
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-11-16
First Post:
2012-07-23
Brief Title:
Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multi-center Randomized Placebo-Controlled Trial to Evaluate the Safety Efficacy and Pharmacokinetics of Belimumab a Human Monoclonal Anti-BLyS Antibody Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03125486
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
PLUTO
Brief Summary:
This is a multi-center study to evaluate the safety pharmacokinetics and efficacy of belimumab intravenous IV in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus
Detailed Description:
This is a multi-center study to evaluate the safety pharmacokinetics and efficacy of belimumab intravenous IV in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus SELENA SLEDAI score 6 The study will consist of three phases a 52-week randomized placebo-controlled double-blind phase a long term open label continuation phase and a long term safety follow up phase The long term open label continuation and safety follow up periods will continue for at least 5 years and possibly up to 10 years from a subjects initial treatment with belimumab Enrolment will be staggered by age cohorts to allow safety and PK interim analyses Subjects will be randomized to belimumab 10mgkg or placebo IV monthly dosing while continuing to receive background standard therapy throughout the study An independent data monitoring committee IDMC will monitor the study as it progresses
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 |
|---|---|---|---|
| 2011-000368-88 | EUDRACT_NUMBER | None | None |