Ignite Creation Date:
2024-05-05 @ 9:57 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00991146
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2009-10-06
Brief Title:
Efficacy and Safety Study of Canakinumab Administered for 6 Months 24 Weeks in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open-label Efficacy and Safety Study of Canakinumab Anti-interleukin-1β Monoclonal Antibody Administered for 6 Months 24 Weeks in Japanese Patients With the Following Cryopyrin-associated Periodic Syndromes Familial Cold Autoinflammatory Syndrome Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease Followed by an Extension Phase to Provide Canakinumab to Study Patients Until it is Approved and Marketed in Japan
Status:
COMPLETED
Status Verified Date:
2020-09
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:
To date there are no approved effective therapies for the treatment of cryopyrin-associated periodic syndromes CAPS including Familial Cold Autoinflammatory Syndrome FCAS Muckle-Wells Syndrome MWS or Neonatal Onset Multisystem Inflammatory Disease NOMID in Japan
The study will assess the efficacy and safety of canakinumab in Japanese patients with cryopyrin-associated periodic syndromes CAPS In previous and currently ongoing CAPS studies CACZ885A2102 CACZ885D2201 CACZ885D2304 CACZ885D2306 it has been observed that treatment with canakinumab in patients with CAPS contributed to ensure absence of relapse to improve signs and symptoms and to prevent secondary disease complications However no Japanese patients have been included in those studies This study will allow access for Japanese patients to a new potentially efficacious treatment for CAPS patients with a convenient dosing regimen
The study will assess the efficacy and safety of canakinumab in Japanese patients with cryopyrin-associated periodic syndromes CAPS In previous and currently ongoing CAPS studies CACZ885A2102 CACZ885D2201 CACZ885D2304 CACZ885D2306 it has been observed that treatment with canakinumab in patients with CAPS contributed to ensure absence of relapse to improve signs and symptoms and to prevent secondary disease complications However no Japanese patients have been included in those studies This study will allow access for Japanese patients to a new potentially efficacious treatment for CAPS patients with a convenient dosing regimen
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None