Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426218
Status:
COMPLETED
Last Update Posted:
2011-08-09
First Post:
2007-01-23
Brief Title:
Safety Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis SJIA
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
Safety Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis SJIA
Status:
COMPLETED
Status Verified Date:
2011-08
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:
This study is a multi-center open label repeated dose range finding study to evaluate the safety tolerability immunogenicity pharmacokinetics and efficacy of ACZ885 a fully human anti-interleukin-1B anti-IL-1B monoclonal antibody given subcutaneously in pediatric subjects with active SJIA
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