Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465985
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2007-04-25
Brief Title:
Efficacy Safety and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Three-partMulticenter StudyWith a RandomizedDouble-blindPlacebo ControlledWithdrawal Design in Part II to Assess EfficacySafetyand Tolerability of ACZ885Anti-interleukin-1beta Monoclonal Antibodyin Patients With Muckle-Wells Syndrome
Status:
COMPLETED
Status Verified Date:
2017-07
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:
REMITTER
Brief Summary:
This study is designed to provide efficacy and safety data for ACZ885 a fully human anti-interleukin-1beta anti-IL-1beta monoclonal antibody administered as an injection subcutaneously sc in patients with Muckle-Wells Syndrome
Part I is an 8-week open-label active treatment period to identify ACZ885 responders
Part II is a double-blind placebo-controlled period to assess primarily the efficacy of ACZ885 compared to placebo
Part III is an open-label active treatment period where patients will receive ACZ885 every 8 weeks after withdrawal or completion of Part II
Part I is an 8-week open-label active treatment period to identify ACZ885 responders
Part II is a double-blind placebo-controlled period to assess primarily the efficacy of ACZ885 compared to placebo
Part III is an open-label active treatment period where patients will receive ACZ885 every 8 weeks after withdrawal or completion of Part II
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