Ignite Creation Date:
2024-05-05 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00685373
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2008-05-27
Brief Title:
Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes Familial Cold Autoinflammatory Syndrome Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
An Open-label Long-term Safety and Efficacy Study of ACZ885 Anti-interleukin-1β Monoclonal Antibody Administered for at Least 6 Months in Patients With the Following Cryopyrin-associated Periodic Syndromes Familial Cold Autoinflammatory Syndrome Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease
Status:
COMPLETED
Status Verified Date:
2016-09
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 will provided long-term safety and efficacy data for ACZ885 a fully human anti-interleukin-1β anti-IL-1β monoclonal antibody given as an injection subcutaneously in patients who participated in the CACZ885A2102 NCT00487708 CACZ885D2201 NCT00685373 or CACZ885D2304NCT00465985 studies or newly identified patients with the following cryopyrin-associated periodic syndromes Familial Cold Autoinflammatory Syndrome Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease
The duration of this study was 6 months with a maximum duration of 2 years
The duration of this study was 6 months with a maximum duration of 2 years
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